Legislature(2017 - 2018)SENATE FINANCE 532

03/29/2017 09:00 AM Senate FINANCE

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09:04:12 AM Start
09:04:38 AM SB32
09:43:15 AM Adjourn
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
<Bill Hearing Canceled>
Heard & Held
Scheduled but Not Heard
+ Bills Previously Heard/Scheduled TELECONFERENCED
                 SENATE FINANCE COMMITTEE                                                                                       
                      March 29, 2017                                                                                            
                         9:04 a.m.                                                                                              
9:04:12 AM                                                                                                                    
CALL TO ORDER                                                                                                                 
Co-Chair  MacKinnon  called  the  Senate  Finance  Committee                                                                    
meeting to order at 9:04 a.m.                                                                                                   
MEMBERS PRESENT                                                                                                               
Senator Lyman Hoffman, Co-Chair                                                                                                 
Senator Anna MacKinnon, Co-Chair                                                                                                
Senator Click Bishop, Vice-Chair                                                                                                
Senator Mike Dunleavy                                                                                                           
Senator Peter Micciche                                                                                                          
Senator Donny Olson                                                                                                             
Senator Natasha von Imhof                                                                                                       
MEMBERS ABSENT                                                                                                                
ALSO PRESENT                                                                                                                  
Senator  Shelley  Hughes,  Sponsor; Aimee  Bushnell,  Staff,                                                                    
Senator   Shelley  Hughes;   Jeannie   Monk,  Alaska   State                                                                    
Hospitals and Nursing Homes, Juneau.                                                                                            
PRESENT VIA TELECONFERENCE                                                                                                    
Rylan  Hanks,   Amgen,  Los   Angeles;  Mark   Guimond,  The                                                                    
Arthritis  Foundation,  Washington D.C.;  Ashlyn  Antonelli,                                                                    
Self, Anchorage;  Robert Thoms, Self, MatSu;  Cindy Caserta,                                                                    
US Pain  Foundation, MatSu;  Kerry McClelland,  Colon Cancer                                                                    
Alliance, Anchorage.                                                                                                            
HB 57     APPROP: OPERATING BUDGET/LOANS/FUNDS                                                                                  
          HB 57 was SCHEDULED but not HEARD.                                                                                    
SB 32     PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS                                                                                 
          SB 32 was HEARD and HELD in committee for further                                                                     
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."                                                                            
9:04:38 AM                                                                                                                    
Co-Chair MacKinnon invited the  sponsor and staff to present                                                                    
the bill.                                                                                                                       
SENATOR  SHELLEY HUGHES,  SPONSOR, discussed  the bill.  She                                                                    
relayed  that  the  bill  provided safe  access  to  a  new,                                                                    
affordable,  Federal  Drug   Administration  (FDA)  approved                                                                    
treatment    option    called   "interchangeable    biologic                                                                    
products." She  asserted that the State  Medical Association                                                                    
and  Alaska  State  Hospital and  Nursing  Home  Association                                                                    
(ASHNHA) supported the bill.                                                                                                    
Senator Hughes  discussed generic  medical products  and how                                                                    
they differ from biologic products.  She stated that generic                                                                    
prescription  drugs  were  100   percent  identical  to  the                                                                    
corresponding  medical  product.   She  conveyed  that  bio-                                                                    
similar products were  made from living cells  and could not                                                                    
be   replicated  identically.   Biologic  products   include                                                                    
insulin and  Humira. She  detailed that the  FDA was  on the                                                                    
verge   of  creating   a  new   category  of   drugs  called                                                                    
"interchangeable biologic products."                                                                                            
9:07:49 AM                                                                                                                    
Senator  Hughes  continued   discussing  bio-similar  drugs,                                                                    
indicating that there  would be a very  specific category of                                                                    
biologics that were  not a 100 percent copy,  and that there                                                                    
could be a very slight  variance from the original. The bill                                                                    
would require  a pharmacist to  notify the physician  of the                                                                    
substitution  with  the  interchangeable  biologic  product.                                                                    
The new  category of "interchangeables" would  be so similar                                                                    
to  the original  drug that  there would  be no  discernable                                                                    
clinical  difference.  She   emphasized  the  importance  of                                                                    
allowing pharmacists  to substitute them, as  they carried a                                                                    
far lesser cost. She highlighted  that this category had not                                                                    
passed the  FDA, but  was in  the pipeline,  and legislation                                                                    
needed to be  put in place. She thought the  issue needed to                                                                    
be  addressed to  ensure Alaskans  who  were suffering  from                                                                    
serious conditions  could access the  drugs as soon  as they                                                                    
passed the FDA.                                                                                                                 
9:10:52 AM                                                                                                                    
Senator Olson  asked if  a patient would  have to  request a                                                                    
biologic in lieu of the prescribed product.                                                                                     
Senator  Hughes  stated  that   a  doctor  may  prescribe  a                                                                    
biologic, and the pharmacist would  be able to substitute an                                                                    
"interchangeable"  and   then  notify  the   physician.  She                                                                    
relayed that  the terms "dispense  as written" and  "call if                                                                    
substitution" would mean the pharmacist  could not make that                                                                    
determination.   The bill would  not change  the prescribing                                                                    
doctor's   authority  over   the   prescription.  No   prior                                                                    
authorization  would be  needed, but  notification would  be                                                                    
Senator  Olson   asked  if  a  pharmacist   could  make  the                                                                    
substitution   if   the   patient   did   not   request   it                                                                    
Senator Hughes answered that a  patient retained control and                                                                    
could   request  the   original   product   that  had   been                                                                    
9:13:16 AM                                                                                                                    
Senator von  Imhof relayed  that she had  heard the  bill in                                                                    
the  Senate  Health  and Social  Services  Committee,  where                                                                    
there had been a rich  and robust discussion. She underlined                                                                    
that  the product  would be  FDA-approved.  She thought  the                                                                    
bill provided the  flexibility for the doctor  or patient to                                                                    
stipulate that  the prescribed  product not  be substituted.                                                                    
She thought it was important to  note that under the bill, a                                                                    
pharmacist would have a three-day  window in which to notify                                                                    
the  prescribing  doctor.  The  patient  would  have  to  be                                                                    
informed at the time of  filling the prescription, and would                                                                    
have  a   variety  of  options,  including   requesting  the                                                                    
original product. She asked the sponsor for confirmation.                                                                       
Senator Hughes  answered affirmatively, and stated  that the                                                                    
patient   would   be   informed   and   could   refuse   the                                                                    
interchangeable product.                                                                                                        
Senator  Hughes  pointed  out that  some  history  would  be                                                                    
helpful in understanding the bill.  She recounted that there                                                                    
had  been  a  robust discussion  between  physicians,  nurse                                                                    
practitioners and  other prescribers.  Originally physicians                                                                    
had wanted to require  prior authorizations. Pharmacists had                                                                    
countered  that they  were qualified  to fill  prescriptions                                                                    
without  waiting  for  authorization. The  notification  was                                                                    
consensus  language   that  had  been  worked   out  between                                                                    
physician and pharmacist groups.  She continued that younger                                                                    
doctors  were  happy  to proceed  without  the  notification                                                                    
period, however it  had been left in as the  product was not                                                                    
identical to the originally prescribed product.                                                                                 
9:16:40 AM                                                                                                                    
Senator  von Imhof  added that  legislation  similar to  the                                                                    
bill  had already  passed  in 26  states,  and the  proposed                                                                    
process had  been occurring successfully in  Europe for many                                                                    
Senator Hughes concurred.                                                                                                       
9:17:04 AM                                                                                                                    
Senator  Olson  asked  about a  letter  of  opposition  from                                                                    
representatives  of the  pharmacist  community and  wondered                                                                    
what had been the objection.                                                                                                    
Senator  Hughes thought  there had  been  concern about  the                                                                    
notification   requirement.   She    reiterated   that   the                                                                    
notification  provision   had  been   worked  out   and  was                                                                    
Senator  Olson identified  that there  were three  boards in                                                                    
the  state that  oversaw  prescriptive  authority. He  asked                                                                    
whether the sponsor had heard from nurse practitioners.                                                                         
Senator  Hughes was  not  sure whether  they  had and  would                                                                    
check with her staff.                                                                                                           
AIMEE BUSHNELL,  STAFF, SENATOR SHELLEY HUGHES,  stated that                                                                    
she  had  been  approached  by  nurse  practitioners  asking                                                                    
whether other groups had supported the legislation.                                                                             
Senator Olson asked whether the state medical board had                                                                         
supported it.                                                                                                                   
Ms. Bushnell relayed that the Alaska State Medical Board                                                                        
had submitted a letter of neutrality.                                                                                           
9:19:22 AM                                                                                                                    
Ms. Bushnell reviewed the document "SB 32 Interchangeable                                                                       
Biological Products - Sectional Analysis":                                                                                      
     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                                                                    
     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                                                                    
     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                                                                          
     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.                                                                               
9:21:13 AM                                                                                                                    
Senator  Hughes added  that  she had  received  a letter  of                                                                    
neutrality  from   the  Alaska  State   Medical  Association                                                                    
initially, and  later the  board had  submitted a  letter of                                                                    
Ms. Bushnell  informed that currently  there were  29 states                                                                    
and Puerto Rico that had  passed similar legislation and two                                                                    
states in the process of doing the same.                                                                                        
9:22:03 AM                                                                                                                    
Co-Chair MacKinnon OPENED public testimony.                                                                                     
9:22:10 AM                                                                                                                    
AT EASE                                                                                                                         
9:22:46 AM                                                                                                                    
Co-Chair  MacKinnon  informed  the committee  that  she  had                                                                    
received a list of testifiers from the sponsor.                                                                                 
9:23:05 AM                                                                                                                    
RYLAN  HANKS,  AMGEN,   LOS  ANGELES  (via  teleconference),                                                                    
testified in  support of  the bill. He  relayed that  he was                                                                    
Director  of  Regulatory  Policy for  biotechnology  company                                                                    
Amgen,  which made  biosimilars.  He was  also a  practicing                                                                    
pharmacist. He  was formerly with  the FDA in the  Office of                                                                    
Generic  Drugs.  He  noted  that  biosimilars  were  in  the                                                                    
process of coming  to market. The FDA was in  the process of                                                                    
outlining  guidelines  for  these  products.  He  wanted  to                                                                    
ensure  that good  communication happened  between patients,                                                                    
pharmacists and physicians.                                                                                                     
9:24:37 AM                                                                                                                    
JEANNIE  MONK, ALASKA  STATE  HOSPITALS  AND NURSING  HOMES,                                                                    
JUNEAU,  spoke in  support of  the bill.  She was  the Vice-                                                                    
President  of Policy  and  Programs for  ASHNHA.   When  the                                                                    
legislation   first  came   forward  the   organization  had                                                                    
consulted with hospital-based  pharmacists and physicians to                                                                    
ensure the bill  would provide guidance needed  to give safe                                                                    
and  effective   treatments  to  patients   while  providing                                                                    
potential  to  lower  pharmaceutical  costs.  Based  on  the                                                                    
positive views held, ASHNA had  made the decision to support                                                                    
the bill. She specified  that the communication and timeline                                                                    
required  were critical  elements  to  ASHNA's support.  The                                                                    
legislation  included a  three-day  notification period  for                                                                    
pharmacists to  contact the  prescribing physician.  It also                                                                    
provided   accessibility  and   affordability  as   well  as                                                                    
competition for  biological drugs  in the way  that generics                                                                    
did  for  brand name  drugs.  She  believed the  legislation                                                                    
protected patients and benefitted the state of Alaska.                                                                          
9:26:27 AM                                                                                                                    
Senator  Olson  asked if  Ms.  Monk  was familiar  with  the                                                                    
situation in the health corporations in rural Alaska.                                                                           
Ms.  Monk  replied  that  she  had  some  knowledge  of  the                                                                    
Senator Olson asked whether she had visited those areas.                                                                        
Ms.  Monk relayed  that she  had  been in  Bethel two  weeks                                                                    
Senator Olson  asked Ms. Monk  whether the  organization had                                                                    
discussed   the  current   legislation  with   rural  health                                                                    
corporations and what their response had been.                                                                                  
Ms. Monk  specified that ASHNHA  had shared  the information                                                                    
with their partners and there had been no response.                                                                             
Senator Olson asked about adverse reactions.                                                                                    
Ms. Monk  stated that there  was no concern  expressed about                                                                    
the  language in  the bill  including  the notification  and                                                                    
process of  using biologic  drugs. She noted  she was  not a                                                                    
medical provider  and could not  speak to any risks,  but no                                                                    
one had expressed concern to the organization about risks.                                                                      
9:27:37 AM                                                                                                                    
MARK  GUIMOND,  THE  ARTHRITIS FOUNDATION,  WASHINGTON  D.C.                                                                    
(via  teleconference),  spoke in  support  of  the bill.  He                                                                    
thought biologic  products changed lives in  a positive way.                                                                    
He stated it made the difference  between a child being in a                                                                    
wheelchair, or  someone being on disability  aid, and living                                                                    
an active  life. He furthered that  biosimilar products were                                                                    
composed  of   living  cells  and   would  be   injected  or                                                                    
intravenous. They  were not products  that would  be readily                                                                    
available outside  a pharmacy. In Alaska,  retail pharmacies                                                                    
dispensed  about 1,100  medical products  a week,  and these                                                                    
products would represent only 13  of that 1,100. Biosimilars                                                                    
offered a  more affordable option. The  foundation supported                                                                    
the   communication   stipulation   within  the   bill.   He                                                                    
underlined that  it had been  a part of every  other similar                                                                    
piece of  legislation that had  passed, and Alaska  would be                                                                    
aligned  with other  states in  maintaining  it. He  relayed                                                                    
that the  majority of arthritis patients  also suffered from                                                                    
additional chronic  conditions and knowing the  specifics of                                                                    
the  drug product  was vital  to ensuring  that those  other                                                                    
medications were not affected.                                                                                                  
9:29:56 AM                                                                                                                    
ASHLYN  ANTONELLI,  SELF,  ANCHORAGE  (via  teleconference),                                                                    
testified in  support of the  bill. She had suffered  from a                                                                    
brain tumor and other chronic  pain illnesses. Her course of                                                                    
therapy had  included biologic products.  If her  doctor had                                                                    
not prevented the substitution and  it was FDA approved, she                                                                    
wanted  that option.  She wanted  the substitution  recorded                                                                    
for her  doctor. She agreed with  the three-day notification                                                                    
rule. She  did not  want to wait  for future  legislation to                                                                    
enable her to  benefit from the new  products. She discussed                                                                    
her  personal  experience  with  high  costs  of  the  other                                                                    
biologics.  She answered  a query  about anaphylactic  shock                                                                    
previously posed  to the sponsor  by Senator  Olson, stating                                                                    
that it had  taken six weeks to appear and  that she did not                                                                    
think it would happen within three days.                                                                                        
Senator  Olson  asked  about  her  experience  with  adverse                                                                    
reactions and asked for verification  that it had manifested                                                                    
in a rash.                                                                                                                      
Ms.  Antonelli recounted  having an  allergic reaction  to a                                                                    
drug  and  seeing  a  specialist to  find  another  drug  to                                                                    
counteract  the reaction.  She detailed  that  it had  taken                                                                    
about six  weeks for the  rash to  appear. She felt  that in                                                                    
the  three-day  notification  period, her  doctor  would  be                                                                    
fully informed of which medication she was taking.                                                                              
Senator Olson asked if Ms.  Antonelli knew about HLA-B27. He                                                                    
wondered how  she knew  that the biologic  was the  cause of                                                                    
the allergic reaction.                                                                                                          
Ms.  Antonelli   replied  that  her  doctor   had  staggered                                                                    
administration  of the  drug. She  discussed  the timing  of                                                                    
prescription aimed  at determining which product  had caused                                                                    
any reactions.                                                                                                                  
9:34:29 AM                                                                                                                    
ROBERT THOMS,  SELF, MAT-SU  (via teleconference),  spoke in                                                                  
support  of the  bill. He  discussed his  decorated military                                                                    
experience. He  informed that he suffered  from chronic pain                                                                    
for  the  last 45  years.  He  had  been on  a  non-biologic                                                                    
medication  and   had  suffered  adverse  effects.   He  had                                                                    
switched  to  a biologic  product  that  had benefitted  him                                                                    
tremendously.  He  was  concerned that  his  medication  may                                                                    
cease working.  He had  taken an  allergy medicine  that had                                                                    
stopped working,  and he had subsequently  used a substitute                                                                    
which  had   begun  working  immediately.  He   discussed  a                                                                    
previous bill hearing at which  an individual had questioned                                                                    
the need  for haste in  passing the bill. He  responded that                                                                    
the  bill was  needed in  advance of  those products  coming                                                                    
onto the  market so that  patients could make  immediate use                                                                    
of them.                                                                                                                        
9:37:18 AM                                                                                                                    
CINDY   CASERTA,    US   PAIN   FOUNDATION,    MAT-SU   (via                                                                    
teleconference),  testified  in  support of  the  bill.  She                                                                    
stated  that the  bill would  help all  patients who  needed                                                                    
immediate access to the products  in question. She discussed                                                                    
her personal experience caring for her husband.                                                                                 
Senator Olson thanked Mr. Thoms for his service.                                                                                
Co-Chair  MacKinnon  thanked  Mr.  Thoms on  behalf  of  the                                                                    
entire committee.                                                                                                               
9:38:55 AM                                                                                                                    
KERRY  MCCLELLAND,  COLON  CANCER ALLIANCE,  ANCHORAGE  (via                                                                    
teleconference), testified in support of  the bill. He was a                                                                    
cancer  survivor and  hoped the  legislation could  make the                                                                    
products available  as soon as  possible. He stated  that if                                                                    
his cancer were to return, he  wanted to access the drugs in                                                                    
question in-state rather than having  to travel to the Lower                                                                    
9:40:20 AM                                                                                                                    
Co-Chair MacKinnon CLOSED public testimony.                                                                                     
Vice-Chair Bishop read FN1 from  the Department of Commerce,                                                                    
Community and Economic Development.                                                                                             
     If  the bill  passes the  division will  require $4,500                                                                    
     for  legal costs  to amend  regulations, printing,  and                                                                    
     postage in the first year.                                                                                                 
     Professional licensing programs  within the Division of                                                                    
     Corporations, Business  and Professional  Licensing are                                                                    
     funded by Receipt Supported  Services, fund source 1156                                                                    
     Rcpt  Svcs (DGF).  Licensing fees  for each  occupation                                                                    
     are  set  per  AS  08.01.065 so  the  total  amount  of                                                                    
     revenue    collected     approximately    equals    the                                                                    
     occupation's actual regulatory costs.                                                                                      
9:41:51 AM                                                                                                                    
Senator Dunleavy suggested that the  money be taken from the                                                                    
Board  of  Pharmacy  budget which  showed  a  carry-over  of                                                                    
$544,000, as opposed to General Fund money.                                                                                     
Co-Chair MacKinnon  relayed that  there was no  General Fund                                                                    
money in the  item, that it was coming  from designated fund                                                                    
receipts, but that it could be more closely examined.                                                                           
Co-Chair MacKinnon informed committee members that proposed                                                                     
amendments were due the following Friday at 5:00 p.m.                                                                           
Co-Chair MacKinnon discussed the schedule for the following                                                                     
9:43:15 AM                                                                                                                    
The meeting was adjourned at 9:43 a.m.                                                                                          

Document Name Date/Time Subjects