04/11/2017 03:00 PM House HEALTH & SOCIAL SERVICES

          SB 32-PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS                                                                       
                                                                                                                                
4:14:22 PM                                                                                                                    
                                                                                                                                
CHAIR SPOHNHOLZ announced that the  final order of business would                                                               
be SENATE BILL  NO. 32, "An Act relating  to biological products;                                                               
relating to  the practice of  pharmacy; relating to the  Board of                                                               
Pharmacy; and providing for an effective date."                                                                                 
                                                                                                                                
4:15:12 PM                                                                                                                    
                                                                                                                                
SENATOR SHELLEY HUGHES, Alaska State Legislature, paraphrased                                                                   
from the Sponsor Statement [Included in members' packets], which                                                                
read:                                                                                                                           
                                                                                                                                
     Senate Bill  32 allows for  Alaskans to have  access to                                                                    
     safe,  new,  and  effective  treatment  options  called                                                                    
     interchangeable  biological   products.  Under  current                                                                    
     state  law, pharmacists  are  allowed  to substitute  a                                                                    
     generic product  for drugs that are  identical to their                                                                    
     proprietary  product  but  cannot   do  the  same  with                                                                    
     interchangeable  biological  products.   Under  SB  32,                                                                    
     pharmacists will  be able to  dispense an  FDA approved                                                                    
     interchangeable  product   as  a  substitute   for  the                                                                    
     proprietary biological product.                                                                                            
                                                                                                                                
     Due  to   the  complexity  and  nature   of  biological                                                                    
     products,  an  exact  replication  of  these  drugs  is                                                                    
     impossible,  so  a   new  category  of  interchangeable                                                                    
     products was created by the  FDA. This category of drug                                                                    
     allows for pharmaceutical companies  to create safe and                                                                    
     affordable  substitutes  for   drugs  that  help  treat                                                                    
     conditions   including   cancer,  multiple   sclerosis,                                                                    
     severe rheumatoid  arthritis, heart disease,  and other                                                                    
     immune system, neurological and hematologic disorders.                                                                     
                                                                                                                                
     In  addition to  the  clear benefits  to patients,  the                                                                    
     lower   costs  and   competition   should  also   bring                                                                    
     measurable costs  savings to Alaska's  Medicaid program                                                                    
     and  budget.  The  Center  for  Medicare  and  Medicaid                                                                    
     Services recommends that  state Medicaid programs "view                                                                    
     the  launch  of  biosimilar biological  products  as  a                                                                    
     unique opportunity  to achieve measurable  cost savings                                                                    
     and   greater    beneficiary   access    to   expensive                                                                    
     therapeutic treatments for chronic conditions."                                                                            
                                                                                                                                
     SB  32 allows  pharmacists to  dispense interchangeable                                                                    
     biological products  if they communicate this  with the                                                                    
     prescribing doctor. This bill  only allows a pharmacist                                                                    
     to  substitute  an  interchangeable product  if  it  is                                                                    
     approved  by the  FDA,  and it  allows  for doctors  to                                                                    
     require   the   pharmacist   to   only   dispense   the                                                                    
     proprietary  product   if  they  feel  it   is  a  more                                                                    
     effective   option.  Patient   consent  will   also  be                                                                    
     required  before  any  substitution   is  made  for  an                                                                    
     interchangeable over the proprietary product.                                                                              
                                                                                                                                
     It is  important for Alaska  to address this  issue now                                                                    
     as  more interchangeable  products become  available to                                                                    
     patients.  Senate  Bill  32  will  allow  for  new  and                                                                    
     effective   options   at    a   lower   cost,   without                                                                    
     jeopardizing  patient   safety,  and  will   allow  for                                                                    
     measurable Medicaid  and budget savings for  the State.                                                                    
     Please  join  in  supporting access  to  an  affordable                                                                    
     medication option for Alaskans.                                                                                            
                                                                                                                                
SENATOR  HUGHES  reported that  31  states  had already  adjusted                                                               
statutes  to  allow  for  these  bio-similars  when  they  became                                                               
available,  and  that competition  should  make  these much  more                                                               
affordable  than  the  original.   She  read:    "state  Medicaid                                                               
programs should view the launch  of bio-similar biologic products                                                               
as a  unique opportunity to  achieve measurable cost  savings and                                                               
greater  beneficiary access  to expansive  therapeutic treatments                                                               
for  chronic conditions."   She  reiterated that  there were  the                                                               
original  biologic products,  the bio-similar  products, and  now                                                               
the  interchangeable product.   The  proposed bill  would clarify                                                               
this in  statute to  allow for a  pharmacist to  substitute, with                                                               
patient consent and notification to  the prescriber.  She pointed                                                               
out  that  this  proposed  bill offered  equal  control  to  both                                                               
pharmacists and physicians.                                                                                                     
                                                                                                                                
4:22:07 PM                                                                                                                    
                                                                                                                                
REPRESENTATIVE KITO  asked about the character  of the biologics.                                                               
He said that  the generic drug replacement for a  name brand drug                                                               
had  the   exact  same   chemical  make-up.     He   offered  his                                                               
understanding that  patents did  not allow  biologics to  use the                                                               
same process or  procedure, even though they were  aiming for the                                                               
same result.   He asked if there were recognitions  for how these                                                               
act or  react to different  people.  He  asked if these  were the                                                               
same  drug  or different,  or  similar  enough to  be  considered                                                               
similar to a generic.                                                                                                           
                                                                                                                                
SENATOR HUGHES  said that  the cells, as  they were  derived from                                                               
living organisms, would  never be identical.  Even  with the same                                                               
process, these  would be "incredibly similar  but not identical."                                                               
She noted  that this  was part  of the  thorough FDA  testing for                                                               
this new  category.  She  declared that  the drugs would  have to                                                               
reach  a  level of  no  clinical  difference  in results  to  the                                                               
original or the interchangeable drugs.                                                                                          
                                                                                                                                
4:24:19 PM                                                                                                                    
                                                                                                                                
REPRESENTATIVE  SULLIVAN-LEONARD asked  about the  aspect of  the                                                               
bio-chemical use  for pharmaceuticals, and whether  this included                                                               
blood born pathogens or blood products.                                                                                         
                                                                                                                                
4:25:03 PM                                                                                                                    
                                                                                                                                
THOMAS  FELIX, M.D.,  AMGEN, explained  that  the definition  for                                                               
biologics  in  federal  statute  was  very  broad,  and  included                                                               
vaccines  and blood  products and  components.   He  said it  was                                                               
important  to realize  that blood  components were  not currently                                                               
being considered for bio-similar development.   He noted that the                                                               
focus  was for  products created  in  a living  cell that  either                                                               
mimicked something already existing in  our body such as insulin,                                                               
or  something  that targeted  a  pathway  of disease  that  would                                                               
interfere with  a cell cycle for  growth related to a  tumor cell                                                               
or a growth around a tumor.                                                                                                     
                                                                                                                                
REPRESENTATIVE  SULLIVAN-LEONARD asked  if  stem  cells would  be                                                               
interspersed in this biological system.                                                                                         
                                                                                                                                
DR. FELIX,  in response, said  that stem cells were  biologics in                                                               
terms  of  concepts, but  bio-similars  would  not be  stem  cell                                                               
therapies.    He   explained  that  stem  cells   were  what  was                                                               
administered to a patient as  therapy, whereas biologics and bio-                                                               
similars were  derived from  cells, which  were not  embryonic or                                                               
human  cells,  to  make  it  produce a  protein  which  was  then                                                               
isolated, purified from  the cell, and injected  into the patient                                                               
as a therapy.                                                                                                                   
                                                                                                                                
4:27:25 PM                                                                                                                    
                                                                                                                                
CHAIR SPOHNHOLZ asked  if all insulin were derived  from the same                                                               
original  set  of  cells,  and therefore  not  a  bio-similar  or                                                               
biologic interchangeable.                                                                                                       
                                                                                                                                
DR. FELIX  pointed out that  insulins were covered by  a separate                                                               
legal  and  regulatory  pathway,  the  Federal  Food,  Drug,  and                                                               
Cosmetic Act.   By 2020, these insulins would be  rolled into the                                                               
legal  and  regulatory pathway  for  approval  of biologics,  the                                                               
Public  Health Service  Act.    He shared  that  the history  for                                                               
making  insulins  had  evolved  over  time,  as  it  used  to  be                                                               
collected  from animals,  whereas now  a cell  was programmed  to                                                               
produce the insulin  more closely to a human insulin.   He shared                                                               
that  there  was a  spectrum  of  complexity  of other  types  of                                                               
biologics which were  more complex than insulin.   He pointed out                                                               
that a standard biologic technology  called a monoclonal antibody                                                               
was used,  which could target a  pathway of disease or  a healthy                                                               
pathway.                                                                                                                        
                                                                                                                                
4:29:56 PM                                                                                                                    
                                                                                                                                
CHAIR  SPOHNHOLZ asked  if insulin  had  been traditionally  held                                                               
under  an older  regulatory model  and,  in 2020,  this would  be                                                               
rolled into the more modern laws which related to biologics.                                                                    
                                                                                                                                
DR.  FELIX expressed  his agreement  and said  that insulins  and                                                               
other older  biologics which  had been approved  a long  time ago                                                               
and were much  simpler would be transitioned, with  a very strict                                                               
scientific standard  for inclusion based  on the number  of amino                                                               
acids each contained.                                                                                                           
                                                                                                                                
CHAIR  SPOHNHOLZ   reflected  on   the  definition   of  biologic                                                               
interchangeables,   which  were   designed  to   have  the   same                                                               
therapeutic  outcome,  even  though  they were  not  exactly  100                                                               
percent  replicable.     She  asked   if  this  was   related  to                                                               
proprietary law or if it was a biological limitation.                                                                           
                                                                                                                                
DR. FELIX explained that when  a bio similar was developed, there                                                               
was  not  a  recipe  book  for the  process  to  manufacture  the                                                               
original, hence  the need  to reverse  engineer from  an original                                                               
reference  products vial  or injection  device.   He shared  that                                                               
keeping an  understanding of the intellectual  property landscape                                                               
in  mind would  include, in  the development,  an approach  for a                                                               
slight  structural  variation  whether  or not  it  had  clinical                                                               
significance  that was  important.   He  pointed  out that,  once                                                               
approved, these would  be highly similar to  an existing product.                                                               
He emphasized that this was  very different than the way generics                                                               
were  approved,  as  they  typically  did  not  require  clinical                                                               
trials.  He said that it  would require clinical trials for a bio                                                               
similar or for an interchangeable biologic product.                                                                             
                                                                                                                                
CHAIR SPOHNHOLZ mused  that there was both a  cellular reason for                                                               
difference as well as for  avoidance of conflict for intellectual                                                               
property.                                                                                                                       
                                                                                                                                
4:34:20 PM                                                                                                                    
                                                                                                                                
AIMEE  BUSHNELL,  Staff,  Senator Shelley  Hughes,  Alaska  State                                                               
Legislature,  paraphrased from  the Sectional  Analysis [Included                                                               
in members' packets], which read:                                                                                               
                                                                                                                                
      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   United  States   Food   and   Drug                                                                    
     Administration's     (FDA)     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.                                                                                                       
                                                                                                                                
     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  US   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.                                                                                                                 
                                                                                                                                
                                                                                                                                
MS.  BUSHNELL stated  that  there were  also  several letters  of                                                               
support,  including from  the Alaska  State Hospital  and Nursing                                                               
Home  Association  (ASHNHA) and  from  the  Alaska State  Medical                                                               
Association (ASMA).  She pointed  out that ASMA had first written                                                               
a letter  of neutrality and,  subsequently, had written  a letter                                                               
of support for the proposed bill.                                                                                               
                                                                                                                                
4:36:21 PM                                                                                                                    
                                                                                                                                
CHAIR SPOHNHOLZ announced that SB 32 would be held over.