Legislature(2017 - 2018)BUTROVICH 205

02/10/2017 01:30 PM HEALTH & SOCIAL SERVICES

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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
*+ SB 32 PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS TELECONFERENCED
Heard & Held
-- Public Testimony --
+ Bills Previously Heard/Scheduled: TELECONFERENCED
+= SB 20 LIST U-47700 AS A CONTROLLED SUBSTANCE TELECONFERENCED
Moved CSSB 20(HSS) Out of Committee
          SB 32-PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS                                                                       
                                                                                                                                
1:37:36 PM                                                                                                                    
CHAIR WILSON announced the consideration of SB 32.                                                                              
                                                                                                                                
1:38:05 PM                                                                                                                    
SENATOR  SHELLEY   HUGHES,  Alaska   State  Legislature,   Juneau,                                                              
Alaska, sponsor  of SB 32,  set forth that  the bill  will provide                                                              
Alaskans   with  safe   access   to  new   U.S.   Food  and   Drug                                                              
Administration   (FDA)   approved    treatment   options   called,                                                              
"interchangeable biological products." She detailed as follows:                                                                 
                                                                                                                                
     Under  current  state  law   pharmacists  can  prescribe                                                                   
     lower-cost  generic drugs for  the prescribed drug,  but                                                                   
     currently  there's  absolutely no  provision  pertaining                                                                   
     to biologic medicines.                                                                                                     
                                                                                                                                
     The urgency of this bill is twofold:                                                                                       
                                                                                                                                
        1. Right  now   a   pharmacist    could   technically                                                                   
          substitute a biosimilar for a biologic product                                                                        
          and not be in violation of state law because we                                                                       
          don't have anything preventing that.                                                                                  
        2. Within a year the FDA will begin to be approving                                                                     
          interchangeable biologic products.                                                                                    
                                                                                                                                
     We've  had biologic  products around  for years,  Humira                                                                   
     is one  that is used for  arthritis as an  example; but,                                                                   
     now being developed  are the biosimilars and  there also                                                                   
     are a number  of those on the market which  a doctor can                                                                   
     now prescribe  and a pharmacist can dispense  in Alaska.                                                                   
     What  we  are  talking  about   is  a  new  category  of                                                                   
     interchangeable biosimilars.                                                                                               
                                                                                                                                
     A  generic drug  is chemically  based and  so it can  be                                                                   
     reproduced  identically,  the  chemistry,  the  cellular                                                                   
     structure.  A biological  product  is  different, it  is                                                                   
     made from a  living organism and so biosimilar  does not                                                                   
     have an  absolutely identical structure to  the original                                                                   
     biological  products. So,  a biosimilar  is going to  be                                                                   
     as  the word  indicates,  "similar, but  not  absolutely                                                                   
     identical;"  however,  the  new  category  that  FDA  is                                                                   
     working on,  the interchangeable, the goal will  be that                                                                   
     it will  be extremely  similar so  that if a  substitute                                                                   
     were dispensed,  it would be  expected that  there would                                                                   
     not  be  the  adverse reactions  of  something  that  is                                                                   
     quite different.                                                                                                           
                                                                                                                                
SENATOR  HUGHES  set forth  that  SB 32  would  be  very good  for                                                              
Alaska in reference  to the state's Medicaid budget.  She revealed                                                              
that all  of the states  that have  passed legislation  similar to                                                              
SB 32  have indicated  savings expectations  for Medicaid  as well                                                              
as family  budgets. She noted that  Missouri has "gone  out on the                                                              
limb"   regarding   interchangeable    biological   products   and                                                              
projected an  overall savings between  federal and  state Medicaid                                                              
budgets of  over $100 million. She  conceded that Alaska  will not                                                              
see similar  savings due  to the  state's smaller population,  but                                                              
asserted that every dollar counts at this point in Alaska.                                                                      
                                                                                                                                
1:42:23 PM                                                                                                                    
AIMEE  BUSHNELL,  Staff,  Senator  Shelley  Hughes,  Alaska  State                                                              
Legislature,  Juneau, Alaska, provided  an introductory  statement                                                              
on SB 32 as follows:                                                                                                            
                                                                                                                                
     SB  32 follows  model-consensus language  that has  been                                                                   
     worked on  extensively and  agreed by numerous  patient-                                                                   
     advocacy  groups,   along  with   prescriber-association                                                                   
     groups and  pharmacists throughout the country;  most of                                                                   
     these     specialty    organizations     and     patient                                                                   
     organizations   use  biologics  primarily   in  treating                                                                   
     specialty   and   serious    conditions   like   cancer,                                                                   
     rheumatoid  arthritis,  multiple   sclerosis  (MS),  and                                                                   
     other  neurological  disorders.   There  also  has  been                                                                   
     significant   outreach   and  discussion   with   Alaska                                                                   
     stakeholders   for  months,   some  of   which  may   be                                                                   
     testifying today.                                                                                                          
                                                                                                                                
She explained that to allow access to interchangeable biologics                                                                 
with the necessary agreed upon safety provisions, SB 32 provides                                                                
the following:                                                                                                                  
                                                                                                                                
   1. Defines the relevant terms of "biological product,"                                                                       
     "interchangeable   biological   product,"   consistent   with                                                              
     federal law.                                                                                                               
   2. Limits substitution of biologics to only those biosimilars                                                                
     approved as interchangeable by the FDA.                                                                                    
   3. Preserves  the    ability   for   prescriber    to   prevent                                                              
     substitution  and allows prescribers  to write,  "Dispense as                                                              
     written" to keep  the patient taking what they  believe is in                                                              
     their best interest.                                                                                                       
   4. Requires the pharmacists to maintain communication with the                                                               
     prescriber  of  the  specific drug  dispensed  by  electronic                                                              
     means if accessible  and if not, by phone,  fax or prevailing                                                              
     means and  to maintain a record;  so it won't be  to just the                                                              
     pharmacist's   discretion,   there  is   also   communication                                                              
     involved  between  the  prescriber,  the pharmacist  and  the                                                              
     patient.                                                                                                                   
                                                                                                                                
1:44:25 PM                                                                                                                    
MS. BUSHNELL proceeded with a sectional analysis of SB 32 as                                                                    
follows:                                                                                                                        
                                                                                                                                
     Sec. 1 - AS 08.80.030:                                                                                                 
     Adds a  new subsection requiring  the Board  of Pharmacy                                                                   
     to  have a  link on  the board's  website  to the  FDA's                                                                   
     list of approved interchangeable biological products.                                                                      
                                                                                                                                
     Sec. 2 - AS 08.80.294:                                                                                                 
     Amends  this  section  by   requiring  a  pharmacist  to                                                                   
     include on the  label of a biological  product container                                                                   
     the  proprietary  or  proper   name  of  the  biological                                                                   
     product;   this  section  also   includes  language   to                                                                   
     differentiate  between  drugs   that  are  and  are  not                                                                   
     biological  products to ensure  that statutes  regarding                                                                   
     equivalent   generic   drugs   are   not   substantively                                                                   
     changed.                                                                                                                   
                                                                                                                                
     Sec. 3 - AS 08.80.294:                                                                                                 
     Adds a new  subsection to define the term  "proper name"                                                                   
     being    the     name    that    reflects     scientific                                                                   
     characteristics  of  a  biological   product;  this  new                                                                   
     subsection  also  defines "proprietary  name"  which  is                                                                   
     the trademarked and registered name of the product.                                                                        
                                                                                                                                
     Sec. 4 - AS 08.80.295:                                                                                                 
     Adds language  to differentiate between  equivalent drug                                                                   
     products  and  interchangeable biological  products,  it                                                                   
     prevents  substitution   if  the  prescriber   indicates                                                                   
     "Dispense  only as  written;"  this is  similar to  what                                                                   
     has  already been  in law  for  generic chemical  drugs.                                                                   
     Also  provides  that  a  pharmacist  who  substitutes  a                                                                   
     biologic in  compliance with this section in  law incurs                                                                   
     no greater  liability than  what is incurred  in filling                                                                   
     the  original  prescription,  also similar  to  what  is                                                                   
     already in law for generic chemical drugs.                                                                                 
                                                                                                                                
     Sec. 5 - AS 08.80.295:                                                                                                 
     Adds  new subsections  to provide guidelines  as to  how                                                                   
     pharmacists or  their designee will need  to communicate                                                                   
     with a prescribing  doctor when dispensing  a biological                                                                   
     or    interchangeable   biological    product   if    an                                                                   
     interchangeable product is available.                                                                                      
                                                                                                                                
     Under subsection  (c), a pharmacist must  communicate to                                                                   
     the  prescribing doctor  the  name and  manufacturer  of                                                                   
     the  biological product  provided to  the patient;  this                                                                   
     communication  must  happen   within  three  days  after                                                                   
     dispensing   the  product   by  an   entry  through   an                                                                   
     interoperable  electronic  medical  records  system,  an                                                                   
     electronic  prescribing technology,  a pharmacy  benefit                                                                   
     management  system, or  a pharmacy  record. If an  entry                                                                   
     under this  subsection is  not possible, the  pharmacist                                                                   
     may  communicate by  e-mail, telephone,  fax, or by  any                                                                   
     other prevailing means.                                                                                                    
                                                                                                                                
     Under  subsection  (d)  provides  an  exception  to  the                                                                   
     communication  requirement  under (c)  if the  dispensed                                                                   
     biological product  is a refill of the  prescription and                                                                   
     is   the  same   biological   product.  Subsection   (e)                                                                   
     provides  that communication  provided  under (c)(1)  of                                                                   
     this  section is  providing  notice  to the  prescribing                                                                   
     doctor. Under  subsection (f), a pharmacist  is required                                                                   
     to maintain  a record for  two years after  a biological                                                                   
     product  is dispensed.  Finally  subsection (g)  defines                                                                   
     "designee" as  an agent or employee of a  pharmacist who                                                                   
     has  been authorized  to communicate  information  under                                                                   
     subsection (c).                                                                                                            
                                                                                                                                
     Sec. 6 - AS 08.80.480(34):                                                                                             
     Changes  language and  gives option  to change the  term                                                                   
     "drug"  and "equivalent  drug"  to "biological  product"                                                                   
     and "interchangeable biological product".                                                                                  
                                                                                                                                
     Sec. 7 AS 08.80.480:                                                                                                   
     Adds  new subsection  (37)  to define  term  "biological                                                                   
     product".                                                                                                                  
                                                                                                                                
     Adds    new    subsection    (36)   to    define    term                                                                   
     "interchangeable  biological  product" as  a  biological                                                                   
     product  as determined  by  the United  States Food  and                                                                   
     Drug Administration.                                                                                                       
                                                                                                                                
     Under  subsection   (A)  provides  that  it   meets  the                                                                   
     standard   for   interchangeability  under   U.S.   code                                                                   
     (Regulation  of  biological products,  Safety  standards                                                                   
     for determining interchangeability).                                                                                       
                                                                                                                                
     Under    subsection   (B)    provides    that   it    is                                                                   
     therapeutically  equivalent in  the most recent  edition                                                                   
     of  the  United  States  Food  and  Drug  Administration                                                                   
     evaluations.                                                                                                               
                                                                                                                                
     Sec. 8 AS 08.80.480:                                                                                                   
     Amends  this section  by adding  transition  regulations                                                                   
     if  necessary to  implement  changes made  by this  Act.                                                                   
     Having changes  take place  in accordance with  AS 44.62                                                                   
     (Administrative  Procedure   Act)  but  not  before  the                                                                   
     effective date of this Act.                                                                                                
                                                                                                                                
     Sec. 9 AS 08.80.480:                                                                                                   
     Adds language  that section 8  of this Act  takes effect                                                                   
     July 1, 2017.                                                                                                              
                                                                                                                                
     Sec. 10 AS 08.80.480:                                                                                                  
     Adds  language that  this Act will  take effect  January                                                                   
     1, 2018, except for a provided in section 9.                                                                               
                                                                                                                                
1:46:08 PM                                                                                                                    
SENATOR VON  IMHOF asked  if physicians  will be  able to  check a                                                              
box  on  their   prescription  pads  that  says,   "No  biosimilar                                                              
substitutions."   She   stated   that  she   believed   physicians                                                              
currently   have    a   check-box    that   says,    "No   generic                                                              
substitutions."                                                                                                                 
                                                                                                                                
SENATOR HUGHES explained that prescription pads are different.                                                                  
She suggested that [Senator Giessel] could possibly provide                                                                     
input on  prescription pads.  She said  her understanding  is that                                                              
some prescribers  can check-off  or write, "Dispense  as written."                                                              
She  added  that  a  prescriber   considering  an  interchangeable                                                              
biologic may  also write,  "Call if  the substitute is  available"                                                              
and that  way the prescriber  will know  exactly what  the patient                                                              
would or would not be taking.                                                                                                   
                                                                                                                                
SENATOR VON  IMHOF noted that something  similar has passed  in 26                                                              
states  already.  She  said sometimes  there  are  questions  from                                                              
doctors on being  notified within a certain time  frame. She asked                                                              
how many days the notification period is.                                                                                       
                                                                                                                                
SENATOR  HUGHES  disclosed  that   the  topic  Senator  von  Imhof                                                              
addressed  involved  a  lot  of groups  and  has  been  thoroughly                                                              
debated and vetted.  She revealed that the notification  topic was                                                              
initially a  tug-of-war because  pharmacists preferred to  be able                                                              
to just substitute  like they do with the generics  and they don't                                                              
want to  have to make a  request or to  even notify; on  the other                                                              
hand, the  prescribers often  wanted to make  sure that  a request                                                              
came in  first. She  added that the  patient wants their  medicine                                                              
as soon as  possible, but a  timely response from a  prescriber is                                                              
very unlikely. She  reiterated that bearing in  mind the patient's                                                              
needs, prescribers  can indicate,  "Dispense as written"  and also                                                              
add,  "Call   if  a  substitute   is  available."  She   said  the                                                              
prescription-pad  notations seemed  to be  the consensus  language                                                              
across the  nation that seems to  work and addresses the  needs of                                                              
busy pharmacists,  patients  who need their  medicine right  away,                                                              
and  prescribers  who want  to  make  sure  they know  what  their                                                              
patients are taking.                                                                                                            
                                                                                                                                
1:49:19 PM                                                                                                                    
CHAIR WILSON  inquired if Senator  Hughes knew what  percentage of                                                              
doctors actually  write, "As prescribed" for  their prescriptions.                                                              
He  noted  that   he  is  concerned  about  adverse   effects  for                                                              
substituting  medications  for  biologicals.  He added  that  many                                                              
doctors  may  not know  about  the  side effects  of  substituting                                                              
medications for biological drugs.                                                                                               
                                                                                                                                
SENATOR HUGHES replied  that once the FDA begins  to put medicines                                                              
in the  new category of "interchangeable,"  the medicines  will be                                                              
extremely  similar.  She  noted  that as  testing  continues,  the                                                              
intent is to make  sure biologicals are similar to  a generic with                                                              
no  problems. She  asserted  that the  drug  manufacturers do  not                                                              
want problems and will be monitoring for adverse reactions.                                                                     
                                                                                                                                
She pointed  out that the  number of prescribers  will tend  to be                                                              
specialists involved  with chronic diseases such  as arthritis and                                                              
lupus.  She  asserted that  the  specialists  will be  aware  that                                                              
biologicals are available and more affordable for patients.                                                                     
                                                                                                                                
SENATOR  HUGHES   communicated   that  biological  products   were                                                              
currently not  inexpensive and asserted  that SB 32 is  needed for                                                              
pharmacists  to  stock  biologicals  in  order  to  be  ready  for                                                              
prescriptions,  otherwise pharmacists  will  not make  biologicals                                                              
available and Alaskans  will miss out on the  opportunity. She set                                                              
forth  that  biological  products  are  going  to be  a  safe  and                                                              
affordable   option  upon   FDA   approval.   She  conceded   that                                                              
biological products are  a new concept that will require  a bit of                                                              
education.                                                                                                                      
                                                                                                                                
She noted that  generics are accepted because they  are chemically                                                              
identical; however,  there is confusion that a  biological product                                                              
like Humira  will be  substituted with  a biosimilar.  She pointed                                                              
out   that   a   biosimilar   has  not   been   approved   to   be                                                              
interchangeable and  that was another  reason why SB 32  is needed                                                              
because  currently a  pharmacist  could interchange  a  biosimilar                                                              
and that  would not be  a violation of  state law and  the patient                                                              
could have an adverse effect.                                                                                                   
                                                                                                                                
She  summarized  that  SB  32  is  important  to  make  sure  that                                                              
substituting  occurs  with  the  interchangeable  biosimilars  and                                                              
that the practice  is in law. She  set forth that SB  32 is needed                                                              
now  rather than  later because  biosimilars  are expected  within                                                              
six months to a year.                                                                                                           
                                                                                                                                
1:52:41 PM                                                                                                                    
SENATOR  BEGICH  revealed  that  all of  the  information  he  has                                                              
received regarding  interchangeable  biological products  has been                                                              
very  positive.   He  asked  if  there  has   been  any  organized                                                              
opposition  from  Alaska or  any  of  the  states that  have  been                                                              
reviewed.                                                                                                                       
                                                                                                                                
SENATOR  HUGHES  replied  that  she  is  not  aware  of  organized                                                              
opposition.  He disclosed  that there have  been some  prescribers                                                              
that have  been concerned.  She reiterated that  there has  been a                                                              
tug-of-war   between   prescribers   and   pharmacists   regarding                                                              
notification.  She   added  that  the  bill  applies   to  an  FDA                                                              
interchangeable   that  should  not   cause  the  reactions   that                                                              
patients might be concerned about.                                                                                              
                                                                                                                                
CHAIR WILSON pointed  out that most of the  biological medications                                                              
are not  stocked on  pharmacy shelves  and the  majority are  mail                                                              
ordered.  He  noted that  most  people  he  knows that  get  their                                                              
biologics  directly through  their doctor's  office do so  without                                                              
having to  go to a  pharmacy. He asked  how dealing  directly with                                                              
doctors impacts mail-order purchases.                                                                                           
                                                                                                                                
SENATOR HUGHES  revealed that the Alaska Pharmacists  Association,                                                              
a medical  doctor and  a pharmacist from  the College  of Pharmacy                                                              
in Arizona are available to answer Chair Wilson's question.                                                                     
                                                                                                                                
1:55:43 PM                                                                                                                    
CHAIR WILSON opened public testimony on SB 32.                                                                                  
                                                                                                                                
1:56:28 PM                                                                                                                    
RYLAN HANKS,  Director, Global  R&D and  Regulatory Policy,  Amgen                                                              
Incorporated,  Los Angeles,  California, testified  in support  of                                                              
SB  32.  He  explained  that  Amgen  is  a  manufacturer  of  both                                                              
innovative  biologic medicines  and has leveraged  their  35 years                                                              
of  experience to  start making  biosimilar  medications. He  said                                                              
Amgen sees  the value in the  importance of biosimilar  medication                                                              
to its patients.                                                                                                                
                                                                                                                                
He  noted  that  generic  drugs  provide a  bit  of  a  conceptual                                                              
overview    or   framework   about    today's   biosimilars    and                                                              
interchangeable biologics,  but noted that there  is a difference.                                                              
He  detailed that  biologics are  much  more complex  in size  and                                                              
structure  than traditional  chemical  drugs;  i.e. small  tablet-                                                              
based  pills.  He  revealed  that the  size  difference  is  quite                                                              
immense,  on  the order  of  800  to  1,000  times larger  than  a                                                              
chemical drug. He  added that biologics are  largely protein-based                                                              
products that  are much more  complex than traditional  medicines.                                                              
He  pointed out  that  biologics and  biosimilars  will be  things                                                              
that are highly  similar, but not exactly the same  as referred to                                                              
earlier.  He   emphasized  that  biologics  and   biosimilars  are                                                              
products that have been rigorously tested by the FDA.                                                                           
                                                                                                                                
He  disclosed  that  biologics,  biosimilars  and  interchangeable                                                              
biologics  are  granted  authority  to  the  FDA  to  approve.  He                                                              
explained that  there are  two standards  to meet: biosimilar  and                                                              
interchangeable  biologic. He  specified that  biosimilar meets  a                                                              
certain standard which  means it can be used in  practice and does                                                              
not cause  any clinical effect or  adverse problems to  a patient,                                                              
and it should be in a "good standard."                                                                                          
                                                                                                                                
He  specified  that  an  interchangeable   biologic  must  meet  a                                                              
biosimilar  standard  with  no   clinical  differences,  including                                                              
looking at switching  back and forth between the  original product                                                              
and  the  proposed  interchangeable  product. He  added  that  the                                                              
interchangeable   biologic   must   also   show   no   significant                                                              
differences in safety or efficacy.                                                                                              
                                                                                                                                
He set  forth that when an  interchangeable biologic  is approved,                                                              
the  product   will  have  been   vetted  significantly   with  an                                                              
understanding  that the  FDA's  process also  addressed  switching                                                              
back-and-forth and safety when the products come to market.                                                                     
                                                                                                                                
1:59:52 PM                                                                                                                    
MR.  HANKS   summarized  that   biosimilars  and   interchangeable                                                              
biologics  are   going  to  be  highly  important   medicines  for                                                              
patients by  providing additional  access for affordable  and cost                                                              
saving medicines  for Alaskan  patients. He opined  that SB  32 is                                                              
truly a patient-first  bill that will improve patients'  lives for                                                              
very serious and chronic medical conditions.                                                                                    
                                                                                                                                
SENATOR   MICCICHE  asked   if   Amgen  produces   biologics   and                                                              
biosimilars.                                                                                                                    
                                                                                                                                
MR. HANKS answered yes.                                                                                                         
                                                                                                                                
SENATOR  MICCICHE  said  he  referenced  data  that  says  no  two                                                              
biologics are exactly  the same, just as no two  finger prints are                                                              
exactly  the  same.  He asked  if  different  batches  of  Amgen's                                                              
biologics are also not the same.                                                                                                
                                                                                                                                
2:01:06 PM                                                                                                                    
MR. HANKS  answered that  the biologics'  batches can  have slight                                                              
variability,  but manufacturers'  batch-to-batch  production of  a                                                              
biologic medicine  have specific controls in place  to manufacture                                                              
within  a  tight  spectrum.  He   added  that  the  biologics  are                                                              
rigorously  tested,  have  additional   scientific  criteria,  and                                                              
noted their long  history with manufacturing the  same product. He                                                              
admitted that  a slight  variation can  happen, but the  variation                                                              
is within  a very tight  and narrow window,  so it does  not cause                                                              
an  effect. He  reiterated  that the  FDA  reviews biologics'  for                                                              
causing changes.  He detailed that  biosimilars are  a significant                                                              
kind  of development  based  on  a novel  product  that takes  the                                                              
original  product  and  a  biosimilar   process  is  created  from                                                              
scratch to  make new biosimilars,  so each  batch is a  little bit                                                              
distinct.                                                                                                                       
                                                                                                                                
2:02:04 PM                                                                                                                    
SENATOR  MICCICHE referenced  a Rand  Corporation prediction  that                                                              
biosimilar savings  between 2014 and  2024 will be  $44.2 billion.                                                              
He  cited an  Express Scripts  estimation  that potential  savings                                                              
between  2014  and  2014  will be  $250  billion,  a  500  percent                                                              
difference  from  the Rand  prediction.  He  asked why  there  are                                                              
savings  when the  process sounds  the  same. He  inquired if  the                                                              
biosimilar process is as rigorous.                                                                                              
                                                                                                                                
MR.  HANKS  explained that  the  FDA  looks  at biosimilars  as  a                                                              
product   that  already   has  an   established  and   efficacious                                                              
reference product.  He specified that  biosimilars have to  meet a                                                              
standard  of comparable  safety and  efficacy where  new safe  and                                                              
efficacious  standards   do  not   have  to  be   established.  He                                                              
summarized that  cost savings are  realized from  the biosimilars'                                                              
development process.                                                                                                            
                                                                                                                                
SENATOR  VON IMHOF  asked  what the  benefits  are from  switching                                                              
back and forth, other than cost.                                                                                                
                                                                                                                                
MR.  HANKS replied  that  switching back  and  forth will  provide                                                              
some  flexibility  for  physicians  when  medication  options  are                                                              
considered. He reiterated  that biosimilars' profiles  will not be                                                              
exactly the  same and  prescribers will be  able to  establish the                                                              
best product from multiple options.                                                                                             
                                                                                                                                
2:04:23 PM                                                                                                                    
SENATOR  VON  IMHOF  remarked that  genetic  research  will  allow                                                              
medications to  be fine-tuned for  the person. She asked  what can                                                              
happen  in  three  days  between  the  time  that  the  pharmacist                                                              
dispenses  an  interchangeable  biologic  and the  time  that  the                                                              
doctor is notified.                                                                                                             
                                                                                                                                
MR. HANKS  admitted that  he is not  an expert on  immunogenicity;                                                              
however,  he  disclosed that  Amgen  does  not predict  an  immune                                                              
response from a  patient in a short period of time.  He said Amgen                                                              
does not  expect to  see concerns, issues  or adverse  events that                                                              
happen quickly  after a  patient moves  from one biologic  product                                                              
to interchangeable  biologic products.  He explained  that Amgen's                                                              
expectations are  based on the  extensive research done  on moving                                                              
back   and  forth   between   products.   He  pointed   out   that                                                              
communication and updating patients' medical records are key.                                                                   
                                                                                                                                
SENATOR  BEGICH  asked  if  any  projections  were  done  for  the                                                              
potential savings in Alaska that might occur from the change.                                                                   
                                                                                                                                
MR. HANKS replied not to his knowledge.                                                                                         
                                                                                                                                
2:06:32 PM                                                                                                                    
SENATOR  GIESSEL asked  when Mr.  Hanks anticipates  the FDA  will                                                              
approve the interchangeable biologics.                                                                                          
                                                                                                                                
MR. HANKS  answered  that he could  not provide  a specific  time,                                                              
but noted that he expects interchangeables in the near future.                                                                  
                                                                                                                                
SENATOR  GIESSEL asked  why  rush SB  32 if  FDA  approval is  not                                                              
known.  She inquired  why  speeding up  the  FDA approval  process                                                              
would  be  considered  when  the   diseases  and  medications  are                                                              
complex.                                                                                                                        
                                                                                                                                
2:08:06 PM                                                                                                                    
MR.  HANKS  explained   that  the  rationale   behind  introducing                                                              
legislation  at the  current time  is  to clarify  interchangeable                                                              
biologic use and  to make clear what a similar should  not be used                                                              
as.  He  opined  that  the  urgency is  based  on  the  fact  that                                                              
biosimilars are coming  to the market and being  used by patients.                                                              
He said  there needs  to be clearly  defined rules on  appropriate                                                              
use of interchangeable biologic products.                                                                                       
                                                                                                                                
He asked  that Senator  Giessel clarify  her questions  pertaining                                                              
to speeding up the approval process.                                                                                            
                                                                                                                                
SENATOR GIESSEL  replied that when  the FDA will  provide approval                                                              
is  not known.  She  asked  why not  wait  for FDA  approval.  She                                                              
pointed out that approval could take two years.                                                                                 
                                                                                                                                
MR. HANKS  reiterated that  interchangeables  are coming  with the                                                              
need to clarify  and provide rules around how  to use biosimilars.                                                              
He  pointed out  that  Alaska  has nothing  in  state  law in  the                                                              
Pharmacy   Practice   Act   about    either   biosimilar   or   an                                                              
interchangeable.  He  noted  that  Senator  Hughes  discussed  the                                                              
possible impact  if a pharmacist  does not have clear  ideas about                                                              
how to  use either  of the  two products.  He added that  multiple                                                              
biosimilars are currently  under FDA review and  a robust increase                                                              
could occur during the current year.                                                                                            
                                                                                                                                
SENATOR GIESSEL asked  Chair Wilson if the Board  of Pharmacy will                                                              
be available to address questions from the committee.                                                                           
                                                                                                                                
CHAIR WILSON  replied that  he did not  see a representative  from                                                              
the  Board  of Pharmacy.  He  suggested  that questions  could  be                                                              
asked for follow up if the board could present.                                                                                 
                                                                                                                                
2:10:53 PM                                                                                                                    
DR.   DAVID  CHARLES,   Chair,   Alliance   for  Patient   Access,                                                              
Nashville, Tennessee,  testified in support of SB  32. He detailed                                                              
that  AFPA  is  a  national  organization  consisting  of  several                                                              
hundred  physician members  across  various specialties  including                                                              
urology,  rheumatology, dermatology,  oncology, and  so forth.  He                                                              
noted  that  many of  the  member  specialists use  biologics.  He                                                              
added  that  he  is  a  neurologist  and  uses  biologics  in  his                                                              
practice.                                                                                                                       
                                                                                                                                
DR. CHARLES  stated that  biologics are  revolutionizing  the care                                                              
of people with  a host of conditions including  cancer, arthritis,                                                              
inflammatory  bowel  disease,  and  multiple  sclerosis.  He  said                                                              
biologics  are phenomenal  and provide  treatments  that were  not                                                              
available before.                                                                                                               
                                                                                                                                
He  declared  that  he  endorsed  SB  32  and  remarked  that  the                                                              
provisions  in the  bill are excellent.  He agreed  that there  is                                                              
some back-and-forth  between physicians and pharmacists  about the                                                              
medication and how substitutions will be handled.                                                                               
                                                                                                                                
He   explained  that   the  FDA   is  addressing   two  types   of                                                              
biosimilars:     regular    biosimilars    and     interchangeable                                                              
biosimilars. He  specified that for  the pharmacist to be  able to                                                              
substitute there  are really only those that  are interchangeable.                                                              
He  opined  that  many physicians  may  be  comfortable  with  the                                                              
pharmacy  doing the  change with  interchangeable biosimilars.  He                                                              
remarked  that SB  32  got it  right because  the  bill keeps  the                                                              
ability of the physician to write, "Dispense as written."                                                                       
                                                                                                                                
He stated  that SB  32 struck the  right balance in  notification.                                                              
He added  that communication  is key  between the pharmacists  and                                                              
prescribers.  He  opined that  AFPA  members  would agree  with  a                                                              
timely  notification within  72  hours to  update patient  records                                                              
and noted that SB  32 says 3 days. He noted that  bills across the                                                              
U.S. are  striking the  balance of  compromise between  physicians                                                              
and  pharmacists. He  added  that he  agreed  with including  the,                                                              
"Dispense as written"  part if there was a concern  by a physician                                                              
when medically necessary.                                                                                                       
                                                                                                                                
2:16:43 PM                                                                                                                    
DR. PHILIP  SCHNEIDER, Chair,  Advisory Board,  Alliance  for Safe                                                              
Biologic  Medicines   (ASBM),  Phoenix,   Arizona,  testified   in                                                              
support  of SB  32.  He detailed  that  that ASBM  is  a group  of                                                              
patients,  physicians,   pharmacists  and  manufacturers   working                                                              
towards  the  safe   introduction  and  use  of   biosimilars.  He                                                              
asserted that  biologic medicines  have helped patients  with some                                                              
of the  serious chronic conditions  like cancer,  immune disorder,                                                              
arthritis,  diabetes,  Crohn's  disease,  and  multiple  sclerosis                                                              
(MS); copies  of these medicines  called biosimilars  are becoming                                                              
available  in  the  U.S.  and they  have  the  potential  for  new                                                              
therapeutic options for patients at lower costs.                                                                                
                                                                                                                                
He  specified that  unlike  generic  versions of  simple  chemical                                                              
drugs,  biosimilars  are not  exact  duplicates of  the  reference                                                              
product.  He  pointed  out  that  due to  the  complexity  of  the                                                              
biologics  in  the proprietary  manufacturing  process,  they  are                                                              
viewed as copies  and can only be  similar and never the  same. He                                                              
disclosed  that the  smallest  structural  difference between  the                                                              
biologic  and its  biosimilar  can have  a  significant impact  on                                                              
patients.  He disclosed  that regulators,  including  the FDA  and                                                              
the World Health  Organization, have made "naming"  to distinguish                                                              
products  a priority  in order  to  make inadvertent  substitution                                                              
less likely.  He set  forth that with  biosimilars it  is critical                                                              
that the physician,  pharmacist, patient and regulators  know what                                                              
medicine the patient is actually receiving.                                                                                     
                                                                                                                                
DR. SCHNEIDER explained  that current Alaska law  does not provide                                                              
a clear pathway  to the substitution of biosimilar  drug products;                                                              
therefore,  pharmacist  will  need to  require  advanced  approval                                                              
from  the   prescriber  before  substituting   an  interchangeable                                                              
biologic for  a brand-name biologic,  a provision that SB  32 will                                                              
remove.  He detailed  that  SB 32  will  allow Alaska  pharmacists                                                              
with  the ability  to dispense  safe and  less expensive  biologic                                                              
medicines   to   patients   by  allowing   the   substitution   of                                                              
interchangeable   biologic  that   are  prescribed  for   anything                                                              
biologic. He  asserted that  SB 32  protects patients  and ensures                                                              
only  FDA  approved  interchangeable   biologic  products  may  be                                                              
substituted without  prior prescriber consent, this  is similar to                                                              
substitution requirements  of generic substitution.  He added that                                                              
physicians  will  retain  the authority  to  write,  "Dispense  as                                                              
written"  which   is  identical  to  the  authority   for  generic                                                              
substitution.                                                                                                                   
                                                                                                                                
He  pointed  out  that  because   biologic  products  differ  from                                                              
generics  in   their  complexity   and  are  not   identical,  the                                                              
legislation  assures  that  there  will  be  a  clear  and  timely                                                              
communication  between  pharmacists   and  prescribers  to  ensure                                                              
patient   records  reflect   which  specific   product  is   being                                                              
dispensed  to the patient.  He said  pharmacists  will have  up to                                                              
three-business  days  to  relay  medication  information  that  is                                                              
being  dispensed  so  all  providers   have  an  accurate  patient                                                              
medical  record.  He  stated  that   having  an  accurate  patient                                                              
medical record allows  providers to assess the  patient's response                                                              
to a particular treatment.                                                                                                      
                                                                                                                                
He set  forth that ASBM and  various pharmaceutical,  pharmacy and                                                              
insurance  companies   support  SB  32  because   the  legislation                                                              
provides  a clear substitution  process by  which pharmacists  can                                                              
dispense  a FDA  approved interchangeable  biologic without  first                                                              
seeking approval.  He added  that the  bill also increases  access                                                              
to  lower-cost medicines  for patients.  He  added that  SB 32  is                                                              
similar  to legislation  that has  been  passed in  26 states  and                                                              
Puerto Rico.                                                                                                                    
                                                                                                                                
DR.  SCHNEIDER summarized  that ASBM  supports SB  32 because  the                                                              
bill  removes   barriers  to  low-cost  medicines   and  increases                                                              
treatment  options while  recognizing  the  need for  transparency                                                              
and communication  among health-care  providers to ensure  patient                                                              
safety when using the promising new biologic medicines.                                                                         
                                                                                                                                
2:22:25 PM                                                                                                                    
MARK  GUIMOND, Director  of State  Legislative Affairs,  Arthritis                                                              
Foundation, Washington,  D.C., testified  in support of SB  32. He                                                              
set  forth  that   biologics  for  the  arthritis   community  are                                                              
critical.  He said  biologics have  changed in  a generation,  the                                                              
difference  for children  in  particular  with juvenile  arthritis                                                              
that were  living their  lives in  a wheelchair  to going  out and                                                              
playing. He  stated that  the Arthritis  Foundation wants  to make                                                              
sure biologics are available to everybody.                                                                                      
                                                                                                                                
He  pointed  out   that  biosimilars  as  a  science   offers  the                                                              
opportunity to have  new biologics come to market  that are proven                                                              
and safe.  He revealed  that the  new drugs  coming to  market are                                                              
innovative, less  expensive and more available to  people. He said                                                              
the Arthritis  Foundation wants to  change lives in  the arthritis                                                              
community and biologics does that.                                                                                              
                                                                                                                                
He set forth that the Arthritis Foundation supports a post-                                                                     
substitution  notification  as  specified  in the  bill  from  the                                                              
pharmacist  to  the  prescriber   because  the  mechanism  in  the                                                              
legislation will be consistent with federal law.                                                                                
                                                                                                                                
2:25:53 PM                                                                                                                    
GARY MCCLELLAND,  Patient Advocate,  Anchorage, Alaska,  testified                                                              
in support of SB  32. He revealed that he is a  cancer patient. He                                                              
set  forth that  the  additional  options provided  by  biological                                                              
medicine  allows  him to  receive  treatment in  Anchorage  rather                                                              
than  having to  travel  to the  Lower 48.  He  added that  making                                                              
biosimilars available  in a short period  of time will  be a cost-                                                              
cutting measure for himself, other patients and the state.                                                                      
                                                                                                                                
2:28:19 PM                                                                                                                    
ROBERT  THOMS, representing  himself,  Wasilla, Alaska,  testified                                                              
in  support  of  SB  32.  He  revealed   that  he  has  rheumatoid                                                              
arthritis  and uses  Humira.  He revealed  that  using Humira  has                                                              
allowed him to enjoy a functional life.                                                                                         
                                                                                                                                
2:32:27 PM                                                                                                                    
CINDY CASERTA,  representing herself,  Wasilla, Alaska,  testified                                                              
in support  of SB 32.  She disclosed that  she is the wife  of Mr.                                                              
Thoms  and confirmed  that  Humira has  helped  him. She  asserted                                                              
that  Mr.  Thoms  and other  Alaska  residents  can  benefit  from                                                              
additional  options  if the  FDA  approves more  biosimilars.  She                                                              
said the  passage of SB  32 will allow  patients to  make informed                                                              
choices about  other, perhaps  cheaper biologics.  She added  that                                                              
patients'  doctors and  others will  be notified  within days  and                                                              
together they can modify the biologic's effect.                                                                                 
                                                                                                                                
2:35:19 PM                                                                                                                    
ASHLYN   ANTONELLI,  representing   herself,  Anchorage,   Alaska,                                                              
testified  in  support of  SB  32.  She asserted  that  biological                                                              
drugs  are necessary  and  noted  that she  would  not  be at  the                                                              
committee meeting  without the  use 0f  biologics. She  added that                                                              
she  supported  SB 32  due  to  the potential  cost  savings  from                                                              
biological drugs as well.                                                                                                       
                                                                                                                                
2:42:02 PM                                                                                                                    
EMILY  NENON,  Alaska  Government   Relations  Director,  American                                                              
Cancer   Society  Cancer   Action   Network,  Anchorage,   Alaska,                                                              
testified in  support of  SB 32. She  set forth that  SB 32  is an                                                              
opportunity  to  update  state   statutes  to  keep  up  with  the                                                              
advances  in medical  science. She  asserted  that biologic  drugs                                                              
are providing tremendous  promise in the treatment  of cancer. She                                                              
revealed    that    there   are    currently    no    FDA-approved                                                              
interchangeable biosimilars  for cancer treatment;  however, there                                                              
are a number  in the research  pipeline and statutes will  need to                                                              
be updated.                                                                                                                     
                                                                                                                                
She revealed  that biologic drugs  are some of the  most expensive                                                              
cancer  drugs  on  the  market  today.  She  noted  that  just  as                                                              
generics  have  done for  small  molecule  drugs,  interchangeable                                                              
biosimilars  have  the  potential to  increase  price  competition                                                              
with some  of the older  biologic drugs  and result in  lower cost                                                              
burdens for cancer patients.                                                                                                    
                                                                                                                                
She  summarized that  there are  three-basic  principles that  are                                                              
important  to the American  Cancer Society  Cancer Action  Network                                                              
regarding legislation:  consent, notification and  record keeping,                                                              
and safety and interchangeability.                                                                                              
                                                                                                                                
2:45:18 PM                                                                                                                    
DR. BARRY  CHRISTENSEN, Co-Chair,  Alaska Pharmacist  Association,                                                              
Ketchikan,   Alaska,   testified   that  the   Alaska   Pharmacist                                                              
Association is neutral  on SB 32. He addressed  previous testimony                                                              
and  noted   that  most   pharmacies  in   Alaska  are   currently                                                              
dispensing  biological products,  mostly  in the  form of  insulin                                                              
and drugs for rheumatoid arthritis.                                                                                             
                                                                                                                                
DR. CHRISTENSEN  announced that the Alaska  Pharmacist Association                                                              
is neutral  on SB 32, mostly  because the association has  not had                                                              
enough  time  to  review  the  legislation.   He  noted  that  the                                                              
association  has asked  for clarification  on part  of the  naming                                                              
portion  of the  bill  on page  2. He  detailed  that naming  will                                                              
impact pharmacy software systems for correct labeling.                                                                          
                                                                                                                                
SENATOR  GIESSEL   asked  if   pharmacists  in  Alaska   currently                                                              
dispense biosimilars.                                                                                                           
                                                                                                                                
DR. CHRISTENSEN  replied that biosimilars  are new  territory, but                                                              
will definitely  be part of the  future. He said he  believed that                                                              
some biosimilars  are being  dispensed. He noted  that one  of the                                                              
bigger biosimilars  that have  come on  the market  is one  of the                                                              
long-acting insulins  that insurance  companies are  promoting for                                                              
its lower costs.                                                                                                                
                                                                                                                                
2:48:04 PM                                                                                                                    
SENATOR  GIESSEL  asked if  an  Alaskan  pharmacist at  this  time                                                              
would make  a substitution for either  a biosimilar or  a biologic                                                              
without  consulting the  prescriber and  getting affirmation  from                                                              
the prescriber.                                                                                                                 
                                                                                                                                
DR.  CHRISTENSEN  answered no.  He  specified that  currently  all                                                              
pharmacists  should   be  getting  a  new  prescription   for  the                                                              
biosimilar product.                                                                                                             
                                                                                                                                
SENATOR BEGICH  asked how  consent communication  would work  with                                                              
mail-order  companies.  He  inquired if  the  consent  requirement                                                              
would   essentially   prohibit  the   use   of  mail   order   for                                                              
biosimilars.                                                                                                                    
                                                                                                                                
DR.  CHRISTENSEN  replied  that he  did  not  see a  problem  with                                                              
compliance  because information  can  be sent  electronically  via                                                              
the insurance-side of things.                                                                                                   
                                                                                                                                
2:50:02 PM                                                                                                                    
LIS  HOUCHEN,  Chair, National  Association  of  Chain  Drugstores                                                              
(NACDS), Anchorage,  Alaska, testified  that the NACDS  is neutral                                                              
on SB  32 if notification is  changed from three-business  days to                                                              
five-business  days. She  set forth  that a change  to Section  5,                                                              
line  28  from  a three  day  to  a  five-day  notification  would                                                              
provide a larger reporting window in the event that something                                                                   
outside of a pharmacist's control occurs.                                                                                       
                                                                                                                                
2:51:52 PM                                                                                                                    
CHAIR WILSON closed public testimony on SB 32.                                                                                  
                                                                                                                                
2:52:18 PM                                                                                                                    
CHAIR WILSON held SB 32 in committee for future consideration.                                                                  

Document Name Date/Time Subjects
SB 32 Legislation - Version J.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SHSS 2/15/2017 1:30:00 PM
SB 32
SB 32 - Sectional Analysis.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
Fiscal Note DCCED CBPL.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
AK SB 32 Biosimilar Support Letter.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
ALF_AK SB 32__2 1 17 support.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
Alliance of Specialty Medicine AK SB 32 020317.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
GHLF AK SB 32 Comment Letter_Support 2-3-17.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
LADAAK support.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
NORD AK_SB 32_ltr.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
2-6-17 biosimilar AK support.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
NFK BioSimilars State Letter - Alaska 2.1.17.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
Alliance for Patient Access AfAP - SB32.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
Alliance for Safe Biologic Medicines AK-SB 32 -FNL.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
American Liver Foundation ALF_AK SB 32__2 1 17.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
SB 32 AARDA support.docx HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
Digestive Disease National Coalition Support for SB 32.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
Global Healthy Living Foundation GHLF AK SB 32 Comment Letter_Support 2-3-17.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
International Cancer Advocacy Network (ICAN) letter of support SB32.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
National Hispanic Medical Association (NHMA) _AK SB 32.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
Pharmaceutical Research and Manufacturers of America (PhRMA) Support SB32.PDF HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
Bios for Dr. Charles and Dr. Schneider.docx HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
SB 32 - BIO Support Letter 2-2-17 Biotechnology Innovation Organization.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
State Advocacy & Alliance Development, U.S. Pain Foundation - Alaska Senate Bill 32 Support.pdf SHSS 2/10/2017 1:30:00 PM
SB 32
RetireSafe support SB32 2-6-17 biosimilar AK.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
US Pain.doc SHSS 2/10/2017 1:30:00 PM
SB 32
1-12-17 Group letter.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
Potential Cost Savings of Biosimilar Drugs.pdf SHSS 2/10/2017 1:30:00 PM
SB 32
SB 32 - 1 page handout explaining biosimilar legislation.docx HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
Alaska ACS CAN Biosimilars Fact Sheet 2017.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
Senate Bill 32 opposition AK Rheumatoloty Alliance.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
Alaska SB 32 - Merriman Comments 20170209.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32
SupportLetter_Bio_SB32_psoriasis.docx HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SB 32