Legislature(2017 - 2018)HOUSE FINANCE 519

05/03/2017 01:30 PM FINANCE

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Audio Topic
01:36:21 PM Start
01:37:49 PM Presentations: the Economy and Fiscal Policy Overview
04:01:01 PM SB32
04:46:30 PM Adjourn
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ Overview: The Economy & Fiscal Policy by TELECONFERENCED
- Joey Crum, President, AK Truckers Assoc.,
President & CEO, Northern Industrial Training
- Joe Schierhorn, President & Chief Operation
Officer, Northrim Bank
- Vince Beltrami, President, AK American
Federation of Labor & Congress of Industrial
Organizations (AFL-CIO)
- Mike Navarre, Kenai Peninsula Borough Mayor
- Angie Newby, Homer Realty
+ SB 32 PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS TELECONFERENCED
Heard & Held
+ Bills Previously Heard/Scheduled TELECONFERENCED
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."                                                                            
                                                                                                                                
4:01:01 PM                                                                                                                    
                                                                                                                                
SENATOR SHELLEY HUGHES, SPONSOR,  asked for direction on the                                                                    
bill presentation.                                                                                                              
                                                                                                                                
Co-Chair  Foster  answered  that   a  brief  overview  would                                                                    
suffice.                                                                                                                        
                                                                                                                                
Senator Hughes  complied. She explained that  the bill would                                                                    
update  statutes to  allow pharmacists  to substitute  a new                                                                    
category  of   medicines  called   interchangeable  biologic                                                                    
products. The  medicines were life-changing for  people with                                                                    
debilitating diseases and could  make the difference between                                                                    
being bed-ridden  or up and  functional. The drugs  were not                                                                    
the same as  generics. She detailed that a  biologic is made                                                                    
from  a   living  cell  and   is  a   complicated  molecular                                                                    
structure.  Whereas, a  generic  drug copies  a recipe.  She                                                                    
furthered that a biosimilar  or interchangeable biologic was                                                                    
trying to replicate  a complex cell and the  items would not                                                                    
be identical. The bill maintained  the physician's control -                                                                    
if the doctor  did not want a substitution  they could write                                                                    
"dispense as  written (DAW)." If  the doctor wanted  to know                                                                    
whether  an interchangeable  was available,  they could  ask                                                                    
the pharmacist  to call  if it  was available.  A pharmacist                                                                    
could  do the  substitution if  it  was not  written on  the                                                                    
script pad,  but they would  be required to  communicate the                                                                    
substitution to  the physician. The  bill also  required the                                                                    
pharmacist to receive the patient's  consent prior to making                                                                    
a substitution.                                                                                                                 
                                                                                                                                
Representative  Wilson  asked  if   the  bill  pertained  to                                                                    
compound prescriptions.                                                                                                         
                                                                                                                                
Senator  Hughes replied  in the  negative. She  stated there                                                                    
were    entrepreneurs,    small   companies,    and    large                                                                    
pharmaceutical companies who were  currently working to make                                                                    
more  affordable biologic  products  as  biosimilars and  to                                                                    
raise  them  to  the  standard   where  there  would  be  no                                                                    
different  clinical reaction  for the  patient. She  relayed                                                                    
that 33 states  had passed similar legislation  and 7 others                                                                    
had pending  legislation. The states  had done  analysis and                                                                    
had  determined there  should be  some  savings to  Medicaid                                                                    
budgets  because biologics  were expensive.  Interchangeable                                                                    
biosimilars  should help  the budget.  She did  not want  to                                                                    
make a claim about what the  savings may be, but some states                                                                    
had done  so. She  continued that  the Centers  for Medicare                                                                    
and   Medicaid  Services   (CMS)  believed   interchangeable                                                                    
biosimilars should bring down the cost for Medicaid.                                                                            
                                                                                                                                
Representative  Wilson  referred  to the  fiscal  note  that                                                                    
included  the following  language:  "in  addition this  bill                                                                    
requires the Board  of Pharmacy to post and  maintain a link                                                                    
to  the   U.S.  Food  and  Drug   Administration's  list  of                                                                    
currently  approved interchangeable  biological products  on                                                                    
the board's website." She asked  if the board already had to                                                                    
post  medications   and  how  much   the  bill   would  cost                                                                    
pharmacies.                                                                                                                     
                                                                                                                                
4:06:49 PM                                                                                                                    
                                                                                                                                
Senator  Hughes  answered   that  pharmacists  could  choose                                                                    
whether to  carry interchangeable biological  products. Most                                                                    
pharmacists  had automated  systems  to contact  physicians.                                                                    
She did  not know whether there  was a current link  to post                                                                    
medications.  She  thought  it   was  a  simple  thing.  She                                                                    
believed the fiscal note was  related to the requirement for                                                                    
the  board to  send  something out  by  mail to  pharmacists                                                                    
around the  state. She thought  the legislature may  want to                                                                    
consider   why   the   information  was   not   being   sent                                                                    
electronically.                                                                                                                 
                                                                                                                                
Representative Wilson  explained that  her question  was not                                                                    
related  to  the  fiscal  note because  the  state  did  not                                                                    
normally care  about the  cost for the  private sector  - it                                                                    
only  cared about  the  cost  to the  state.  She asked  for                                                                    
follow up on whether there would  be a cost to pharmacies or                                                                    
whether  it was  something the  pharmacies already  did. She                                                                    
asked about  the fiscal  note and the  legal costs  to amend                                                                    
the regulation and  printing and postage in  the first year.                                                                    
She  noted  the funding  source  was  receipt services.  She                                                                    
asked if all  business licenses would pay.  She wondered why                                                                    
it  was a  receipt  service "for  this  area." She  reasoned                                                                    
bill's  goal was  to make  things easier  for Alaskans.  She                                                                    
wondered  if   the  Board  of   Pharmacy  would   be  solely                                                                    
responsible for  paying or  whether all  corporate licensing                                                                    
would pay a portion for the writing of regulations.                                                                             
                                                                                                                                
Senator  Hughes  replied  that  she  would  follow  up.  She                                                                    
reiterated that  pharmacists could  choose whether  to carry                                                                    
interchangeable biological products.  She specified that not                                                                    
all pharmacists  would carry the  products that  were highly                                                                    
specialized.  She deferred  to  the  department for  further                                                                    
detail.                                                                                                                         
                                                                                                                                
JANEY   HOVENDEN,   DIRECTOR,  DIVISION   OF   CORPORATIONS,                                                                    
BUSINESS   AND   PROFESSIONAL   LICENSING,   DEPARTMENT   OF                                                                    
COMMERCE, COMMUNITY AND  ECONOMIC DEVELOPMENT, answered that                                                                    
they  were  receipt  supported  services  and  the  pharmacy                                                                    
program  would pay  through licensing  fees.  She could  not                                                                    
imagine the cost impacting every  licensee. It was a nominal                                                                    
one-time cost to do the regulation project.                                                                                     
                                                                                                                                
4:09:44 PM                                                                                                                    
                                                                                                                                
Representative  Wilson asked  if pharmacists  had asked  for                                                                    
the  bill. She  surmised it  appeared to  be an  improvement                                                                    
over  what could  be given  to Alaskans.  She was  trying to                                                                    
determine why the fiscal note  would not come out of general                                                                    
funds  versus  being charged  back  to  the pharmacist.  She                                                                    
stated the situation was unique  - typically items were more                                                                    
closely related to the board when  they were paid for by the                                                                    
board. She observed  that the bill was  different because it                                                                    
was trying to  do something positive for  Alaskans by making                                                                    
medication  more affordable  and  did  not necessarily  fall                                                                    
under the board's responsibility.                                                                                               
                                                                                                                                
Ms.  Hovenden  replied that  the  changes  would impact  the                                                                    
statutes  of the  pharmacy program;  the  Board of  Pharmacy                                                                    
members would  help design the regulations  to implement the                                                                    
legislation.                                                                                                                    
                                                                                                                                
Representative  Kawasaki  asked   for  verification  that  a                                                                    
biosimilar was  not identical to  another product.  He asked                                                                    
for   the   difference   between   a   biosimilar   and   an                                                                    
interchangeable.                                                                                                                
                                                                                                                                
Senator Hughes answered  that a generic is a  duplicate of a                                                                    
medicine made  of various chemicals and  ingredients - there                                                                    
was  no requirement  to communicate  between the  pharmacist                                                                    
and the  doctor. A complicated biologic  called a biosimilar                                                                    
was  made  from  living  cells (e.g.  Insulin  and  Humira).                                                                    
Companies were trying  to develop a product  that would have                                                                    
the same clinical impact. The  companies were using the same                                                                    
basic thing,  but because they  were using living  cells the                                                                    
product   would  never   be  100   percent  identical.   The                                                                    
interchangeable   biosimilar  or   interchangeable  biologic                                                                    
product  was  the  gold  standard  of  the  biosimilar.  She                                                                    
detailed that the FDA would  test and approve the product as                                                                    
interchangeable because  if administered  to a  patient, the                                                                    
patient  would  have  to  have  the  same  clinical  results                                                                    
whether  they  were  taking   the  original  biologic,  were                                                                    
alternating   between   the   original  biologic   and   the                                                                    
interchangeable,  or were  only taking  the interchangeable.                                                                    
There would  be no difference  in the clinical  results. She                                                                    
continued  that biosimilars  would  not all  fit within  the                                                                    
interchangeable  category.  She  clarified that  the  doctor                                                                    
would have to specify on a  script when a biosimilar was not                                                                    
categorized as  interchangeable. It was a  new category that                                                                    
would  be somewhat  like a  generic, but  not identical  (it                                                                    
would be  clinically similar, but  the genetic  makeup would                                                                    
be different).                                                                                                                  
                                                                                                                                
Representative  Kawasaki shared  that he  took fish  oil for                                                                    
cholesterol    for   triglycerides.    He   detailed    that                                                                    
prescription  fish oils  were ten  times the  price of  non-                                                                    
prescription  fish  oils.  He  asked   if  a  fish  oil  was                                                                    
considered biosimilar.                                                                                                          
                                                                                                                                
DR.  THOMAS FELIX,  DIRECTOR, MEDICAL  RESEARCH, AMGEN  INC.                                                                    
(via teleconference),  communicated that he had  worked with                                                                    
the   coalition  of   organizations  to   present  coalition                                                                    
language included  in the bill.  He replied that a  fish oil                                                                    
was not  considered a biosimilar  product. A  biosimilar was                                                                    
something that  took a very specific  regulatory pathway for                                                                    
approval  by the  FDA  to  try to  create  and reference  an                                                                    
existing biologic. A  fish oil was not  as closely regulated                                                                    
as  a  biologic  and  another  fish  oil  from  a  different                                                                    
manufacturer would  not be considered  a biosimilar.  It was                                                                    
necessary  to take  the 351(k)  pathway to  be considered  a                                                                    
biosimilar.                                                                                                                     
                                                                                                                                
Representative  Kawasaki   asked  if   fish  oil   would  be                                                                    
considered  a  biosimilar product  if  it  was regulated  as                                                                    
other specific drugs.                                                                                                           
                                                                                                                                
Mr. Felix believed  the question was whether  fish oil would                                                                    
be considered a biologic because  it was derived from living                                                                    
tissues. He relayed  that it could be  considered a biologic                                                                    
in a very technical  definition, but for regulatory purposes                                                                    
it was not considered like  or governed like biologics would                                                                    
be. However,  in a  technical term,  because it  was derived                                                                    
from living tissues or living  cells, it was possible to say                                                                    
that it was a derivative of a biologic entity.                                                                                  
                                                                                                                                
Representative  Kawasaki  asked  for verification  that  the                                                                    
point was  for a  biosimilar to mimic  the exact  same thing                                                                    
that an interchangeable would do.                                                                                               
                                                                                                                                
Mr. Felix replied  it was important to understand  why a new                                                                    
industry   had  been   built  around   the  development   of                                                                    
biosimilars. He  explained that biologic  drugs had  been on                                                                    
the  market   for  over   40-plus  years   and  intellectual                                                                    
properties  around long-existing  biologics were  coming off                                                                    
patent.  He furthered  that biosimilars  or versions  of the                                                                    
older  products coming  off patent  were intended  to create                                                                    
competition  to lower  healthcare costs  and the  analog was                                                                    
generics. Biosimilars were  coming to the market  to do what                                                                    
generics  have   done,  but  with  a   different  scientific                                                                    
framework and expectation financially.                                                                                          
                                                                                                                                
Representative  Kawasaki   relayed  that  the   bill  packet                                                                    
included a letter of opposition  from the Board of Pharmacy.                                                                    
He thought the  board may support a bill like  the one under                                                                    
consideration. He asked for comment.                                                                                            
                                                                                                                                
Senator Hughes answered that there  were some pharmacists in                                                                    
support of  the bill.  She explained that  pharmacists would                                                                    
prefer  having the  ability  to  substitute [drugs]  without                                                                    
making the  communication. Physicians would  probably prefer                                                                    
total control and that substitutions  could not be made. She                                                                    
detailed  that  because of  the  ability  for physicians  to                                                                    
specify  "dispense  as  written" they  ultimately  had  full                                                                    
control.  She  furthered  that the  change  the  bill  would                                                                    
implement  would  be  best  for  the  patient  in  terms  of                                                                    
affordability. The extra step  was communication - something                                                                    
pharmacists  did   not  have  to   do  with   generics.  Her                                                                    
understanding was that the pharmacies  - the number would be                                                                    
relatively  low  because  there were  a  limited  number  of                                                                    
individuals with applicable diseases  -  would probably have                                                                    
the  automated  system  set  up, meaning  it  would  not  be                                                                    
burdensome. She relayed that  the State Medical Association,                                                                    
Alaska   State  Hospital   and   Nursing  Home   Association                                                                    
(ASHNHA),  the Alaska  Commission on  Aging, and  the Alaska                                                                    
Cancer   Action  Network   were  all   in  support   of  the                                                                    
legislation.                                                                                                                    
                                                                                                                                
Senator Hughes  corrected her earlier example  of biosimilar                                                                    
drugs  and clarified  she  had been  referring  to the  drug                                                                    
Humira for rheumatoid arthritis. She  shared an example of a                                                                    
Vietnam veteran  from Wasilla named Cajun  Bob. She detailed                                                                    
he had been featured in Life  or Time Magazine in the 1960s.                                                                    
He had been  bed-ridden, and the use of a  biologic drug had                                                                    
given him a  new lease on life. She  stressed the importance                                                                    
of the  drugs for  Alaskans with debilitating  diseases. She                                                                    
discussed that  sometimes the effectiveness of  a medication                                                                    
wore off  for an individual,  making it necessary  to switch                                                                    
to a new medicine. The  goal was to ensure individuals would                                                                    
have immediate access to all options.                                                                                           
                                                                                                                                
4:20:15 PM                                                                                                                    
                                                                                                                                
Representative Kawasaki  referred to a letter  of opposition                                                                    
from  the Alaska  Rheumatology Alliance  in  the packet.  He                                                                    
added  that members'  packets were  very comprehensive  with                                                                    
letters of support.                                                                                                             
                                                                                                                                
Senator Hughes replied  that her office had  worked with the                                                                    
group and  it had been helpful  for them to learn  that they                                                                    
could specify to dispense as written and maintain control.                                                                      
                                                                                                                                
Representative Kawasaki  provided a scenario of  the receipt                                                                    
of a prescription. He thought in  the past he had been asked                                                                    
by  the pharmacist  whether he  wanted  the cheaper  generic                                                                    
prescription. He asked how it would work with a biosimilar.                                                                     
                                                                                                                                
Senator Hughes  answered that the physician  would prescribe                                                                    
the biologic. When the patient  went to the pharmacy to pick                                                                    
up the  prescription the pharmacist  would notice  there was                                                                    
an interchangeable and would ask  the patient if they wanted                                                                    
the interchangeable. She noted  that the interchangeable was                                                                    
the FDA approved gold standard.  If the patient selected the                                                                    
interchangeable, the pharmacist would  be required to inform                                                                    
the   physician  within   three  business   days  that   the                                                                    
substitution  had  been  made.  She stated  that  with  most                                                                    
pharmacies   the   information  would   be   instantaneously                                                                    
communicated as  the medicine was processed  and provided to                                                                    
the patient.                                                                                                                    
                                                                                                                                
BUDDY WHITT,  STAFF, SENATOR SHELLEY HUGHES,  referred to an                                                                    
earlier  question by  Representative  Wilson  and wanted  to                                                                    
ensure he  understood the  question. He  noted she  had been                                                                    
speaking about  links to the  FDA's list. He thought  he had                                                                    
heard  her ask  if  the  pharmacist had  to  post links.  He                                                                    
clarified that  the Board of  Pharmacy had to post  the link                                                                    
to the  FDA website with  a list of all  the interchangeable                                                                    
biological products  approved by the  FDA. The bill  did not                                                                    
require individual pharmacists to provide the information.                                                                      
                                                                                                                                
4:22:42 PM                                                                                                                    
                                                                                                                                
Representative Ortiz asked how  long the term biosimilar had                                                                    
existed.                                                                                                                        
                                                                                                                                
Senator Hughes deferred the question to Dr. Felix.                                                                              
                                                                                                                                
Mr.  Felix responded  that the  term biosimilar  had existed                                                                    
since   the  early   2000s  when   Europe  had   been  first                                                                    
considering development  and existence of a  pathway forward                                                                    
for  biosimilars.   The  issue  had  arisen   because  their                                                                    
intellectual     properties     were     expiring     [audio                                                                    
indecipherable].                                                                                                                
                                                                                                                                
Representative  Ortiz  surmised  that the  movement  towards                                                                    
biosimilars  was based  on similar  motivations of  movement                                                                    
towards  generics, which  had probably  taken  place in  the                                                                    
1970s or 1980s. He believed  the motivation was about trying                                                                    
to provide medications  that were equally as  effective at a                                                                    
lower price.                                                                                                                    
                                                                                                                                
Senator Hughes  replied in the  affirmative. The  intent was                                                                    
to increase access and affordability.                                                                                           
                                                                                                                                
Representative  Ortiz referred  to  a  letter of  opposition                                                                    
from the  Board of  Pharmacy dated March  6, 2017.  He asked                                                                    
for verification that  the group was still  in opposition to                                                                    
the bill.                                                                                                                       
                                                                                                                                
Senator Hughes  replied that the  board had not  submitted a                                                                    
letter  of   support,  but  individual  pharmacists   and  a                                                                    
national pharmacy association had  vocalized support for the                                                                    
bill. The  individuals understood  the importance  of access                                                                    
to  the medicines.  She stated  that the  Board of  Pharmacy                                                                    
retained its position.                                                                                                          
                                                                                                                                
4:25:12 PM                                                                                                                    
                                                                                                                                
Representative  Guttenberg believed  the biosimilars  were a                                                                    
good  thing.  He  referred  to  letter  from  the  Board  of                                                                    
Pharmacy. He  believed one  of the  problems was  related to                                                                    
who  was  paying  the  bill   and  who  had  the  burden  of                                                                    
fulfilling  the legislative  requirements  for reporting  by                                                                    
doctors and pharmacies. He thought  the issue of payment may                                                                    
mean large-scale pharmacies would  be supportive, but smal1-                                                                    
scale  pharmacists may  feel burdened.  He  referred to  the                                                                    
last few lines  of the letter - the board  believed the bill                                                                    
would  create an  unintended barrier  to access.  The letter                                                                    
also    stated   there    were   currently    no   available                                                                    
interchangeable  biosimilar medications  on the  market. The                                                                    
board  did  not  see  the  need  for  legislation  regarding                                                                    
biosimilars, but  wanted the legislation to  follow the BPCI                                                                    
Act  of 2009  [Biologics  Price  Competition and  Innovation                                                                    
Act] and its  intent of increasing access  to medication. He                                                                    
asked  if any  changes had  happened in  the bill  regarding                                                                    
some of  the board's position on  the bill. He did  not know                                                                    
what the  BPCI Act was.  He asked  for detail about  the act                                                                    
and about the bill's conflict with the act.                                                                                     
                                                                                                                                
Senator Hughes deferred the question to Dr. Felix.                                                                              
                                                                                                                                
Mr.  Felix replied  that the  BPCI  Act allowed  the FDA  to                                                                    
create regulatory pathways for  approval for biosimilars and                                                                    
interchangeable biologic  products. The act had  been passed                                                                    
in March 2010  as part of the Affordable Care  Act (ACA); it                                                                    
was  one of  the few  portions  of the  ACA with  bipartisan                                                                    
support. He  believed the most important  recent development                                                                    
was   that,   at   the   beginning    of   the   year,   the                                                                    
interchangeability designation finally  had a draft guidance                                                                    
released by  the FDA. The guidance  provided transparency to                                                                    
the  community  in terms  of  what  was required  to  obtain                                                                    
interchangeability.   He   spoke   to  the   importance   of                                                                    
understanding that  for companies  that were  not developing                                                                    
biosimilars  or interchangeables,  the  area had  previously                                                                    
not been  clear. However, for  developers of  biosimilars or                                                                    
interchangeables, the  FDA had been transparent  in terms of                                                                    
providing direction  for the development of  clinical trials                                                                    
and  data requirements.  There had  been companies  that had                                                                    
completed clinical trials that  may satisfy the requirements                                                                    
for   an   interchangeability   designation.   Additionally,                                                                    
companies had  announced starting clinical trials  to pursue                                                                    
an interchangeability designation.  He stated that sometimes                                                                    
there   was  a   description  that   the  only   reason  the                                                                    
legislation  was needed  was to  ensure the  facilitation of                                                                    
interchangeability and  that substitutions could be  made by                                                                    
pharmacists.  In general,  the  community was  not aware  of                                                                    
what  biosimilars were  as compared  to generics.  He shared                                                                    
that  five  biosimilars had  been  approved  to date  [audio                                                                    
indecipherable]. He noted they were  awaiting an approval of                                                                    
an interchangeable  in the future. People  typically thought                                                                    
of   biosimilars   as   generics  -   most   generics   were                                                                    
substitutable  -  but  biosimilars were  not  substitutable.                                                                    
Another   reason  to   pass  legislation   was  to   clearly                                                                    
communicate how to use the  products when they were approved                                                                    
under different designations.                                                                                                   
                                                                                                                                
Co-Chair Foster passed the gavel to Vice-Chair Gara.                                                                            
                                                                                                                                
Vice-Chair Gara remarked that some  of Dr. Felix's testimony                                                                    
had been difficult to hear.                                                                                                     
                                                                                                                                
Mr. Felix  apologized and  reiterated his  previous remarks.                                                                    
He restated  his previous testimony related  to the creation                                                                    
of the  BPCI Act and draft  guidance released by the  FDA in                                                                    
January  on the  path  to  obtaining the  interchangeability                                                                    
designation.  He  explained  that were  companies  that  had                                                                    
completed  trials to  try to  achieve an  interchangeability                                                                    
designation.  When  they  would be  approved  was  currently                                                                    
unknown.  Companies   had  also  announced  they   would  be                                                                    
interchangeability  trials  to  pursue the  designation.  He                                                                    
underscored  the importance  of the  legislation because  it                                                                    
would  facilitate substitution  of an  interchangeable by  a                                                                    
pharmacist.                                                                                                                     
                                                                                                                                
4:32:18 PM                                                                                                                    
                                                                                                                                
Mr.   Felix   reiterated   that  the   legislation   clearly                                                                    
communicated  how to  use  biosimilars and  interchangeables                                                                    
when they  were approved  under different  designations. The                                                                    
five biosimilars approved to date  were only biosimilars and                                                                    
did  not   have  the  FDA   designation  that   would  allow                                                                    
substitution  by   a  pharmacist.  He  explained   that  the                                                                    
products were very different than  how generics were viewed.                                                                    
If  the  community was  uneducated  and  began to  think  of                                                                    
biosimilars as  approved and immediately used  their closest                                                                    
analog, which was generic approval,  the community may think                                                                    
the  biosimilars were  substitutable unless  clear terms  of                                                                    
use  were  in   place.  He  stated  that   every  aspect  of                                                                    
healthcare  was  trying  to increase  communication  between                                                                    
members  of  the  healthcare  team.  The  bill  would  allow                                                                    
transparency for  a prescriber  to know what  was ultimately                                                                    
dispensed to the patient for the  prescriber to be on top of                                                                    
their care. If there was  any change in a patient's response                                                                    
to  a  medication the  prescriber  would  know exactly  what                                                                    
medication the patient was on.                                                                                                  
                                                                                                                                
Representative Guttenberg spoke to  who was paying the bill.                                                                    
He observed  that Dr.  Felix had not  stated whether  any of                                                                    
the products  were approved by  the FDA. He referred  to Dr.                                                                    
Felix's  testimony   about  clarity  and   transparency.  He                                                                    
wondered  why  the decision  would  not  be handled  in  the                                                                    
doctor's  office instead  of at  the pharmacy.  He continued                                                                    
that  patients were  often in  a hurry  at the  pharmacy and                                                                    
were amenable to whatever was  given to them. Alternatively,                                                                    
he  thought  it  made  sense  to  have  the  physician  tell                                                                    
patients  what  they  would  receive.  He  referred  to  Dr.                                                                    
Felix's  earlier  testimony   that  many  practitioners  and                                                                    
people were  not up  on the issue.  He thought  the doctor's                                                                    
office was  the best place  to do prescribing.  He continued                                                                    
that  the doctor  could  specify for  a  pharmacist to  only                                                                    
prescribe a prescription as written.                                                                                            
                                                                                                                                
Mr. Felix  answered that biologics were  distributed through                                                                    
either  a  medical  benefit (administered  by  a  healthcare                                                                    
professional) or were  self-administered (pharmacy benefit).                                                                    
The  legislation  pertained  to biologics  that  were  self-                                                                    
administered. The  medications would  not be dispensed  in a                                                                    
physician's office. Often the  pharmacist would be the first                                                                    
to  become aware,  especially  when  an interchangeable  was                                                                    
approved  in  the  marketplace. He  explained  that  medical                                                                    
benefit   biologics  were   typically   administered  by   a                                                                    
healthcare  professional in  a clinic,  hospital, or  office                                                                    
setting.   Whereas  self-administered   biologics  meant   a                                                                    
patient  self-injected  the  medication.  The  physician  or                                                                    
their  delegate  would  not be  directly  administering  the                                                                    
product  to  the  patient. The  method  of  facilitation  of                                                                    
substitution by  a pharmacist had  worked well  for generics                                                                    
and had worked to lower cost and facilitate access.                                                                             
                                                                                                                                
4:38:02 PM                                                                                                                    
                                                                                                                                
Senator   Hughes   referenced  Representative   Guttenberg's                                                                    
comments about  the letter from  the Board of  Pharmacy. She                                                                    
agreed there were not any  [interchangeables] on the market;                                                                    
the products  were in the  testing phases. There had  been a                                                                    
projection that the products could  be out within a month to                                                                    
a year.  The primary  issue was  that they  did not  want to                                                                    
wait an extra  year to provide the products  (if they became                                                                    
available)  to  Alaskans  suffering from  diseases  such  as                                                                    
lupus,  multiple sclerosis,  and  rheumatoid arthritis.  She                                                                    
reiterated her  earlier testimony  that pharmacists  did not                                                                    
have  to  carry  the  products.  She  relayed  that  if  the                                                                    
communication requirement was not  included, it would be bad                                                                    
for patients  - patients  wanted the substitution  listed in                                                                    
their  medical  records;   doctors  needed  the  information                                                                    
because they were not 100 percent identical like a generic.                                                                     
                                                                                                                                
Representative Wilson asked who had requested the bill.                                                                         
                                                                                                                                
Senator Hughes replied it had  been a combination of patient                                                                    
groups and companies developing  the products. The companies                                                                    
were spending  millions on product development;  if statutes                                                                    
were  not set  up, patients  would  not have  access to  the                                                                    
products.  The  individuals  suffering,   who  had  tried  a                                                                    
biologic, wanted continued access.                                                                                              
                                                                                                                                
Representative Wilson  stated it had been  her understanding                                                                    
that a pharmacist would have  to call the physician prior to                                                                    
giving the product  to a patient; however, that  was not the                                                                    
case. She  summarized that there was  discussion between the                                                                    
pharmacist   and  the   patient,   the   patient  made   the                                                                    
determination,  and the  doctor may  not know  what happened                                                                    
for  three days.  She was  uncomfortable with  that process.                                                                    
She  referred  to  a  letter  in  members'  packets  from  a                                                                    
physician specifying  their practice would be  in harm's way                                                                    
because they were not notified  right away. She requested to                                                                    
hear from  the Board  of Pharmacy at  a future  hearing. She                                                                    
remarked  that the  bill would  charge pharmacists  and they                                                                    
had not asked  for it. She asked  for additional information                                                                    
at a future hearing.                                                                                                            
                                                                                                                                
Senator   Hughes   reiterated   that   the   State   Medical                                                                    
Association  supported  the  bill.   She  explained  that  a                                                                    
physician could retain control  by specifying a prescription                                                                    
was to be dispensed as  written. She added that the products                                                                    
were  FDA   approved  and  clinical  results   would  be  no                                                                    
different than the original reference product.                                                                                  
                                                                                                                                
Representative Wilson understood, but  she surmised it could                                                                    
constitute a  significant medical  change. She wanted  to be                                                                    
very  careful. She  surmised there  could be  a change  from                                                                    
what the physician wanted. She  wanted to ensure all parties                                                                    
were involved, not only groups or outside entities.                                                                             
                                                                                                                                
4:42:45 PM                                                                                                                    
                                                                                                                                
Mr. Whitt pointed to Section 4  of the bill that specified a                                                                    
pharmacist  who substituted  a biologic  in compliance  with                                                                    
the section did  not incur any greater  liability than would                                                                    
be  incurred  in  filling  the  original  prescription.  The                                                                    
section also specified the dispense as written provision.                                                                       
                                                                                                                                
Representative  Wilson  noted  that  her  concern  was  with                                                                    
Section 5  related to the  three-day timeframe  a pharmacist                                                                    
had to  communicate a prescription  to a physician.  She was                                                                    
concerned  about the  liability  to the  physician. She  was                                                                    
certain that  if a person had  side effects it would  be the                                                                    
physician who  was accountable. She stated  that prescribing                                                                    
was a physician's duty. She  was concerned that the Board of                                                                    
Pharmacy  would have  to pay  for  something it  was not  in                                                                    
favor of. She  had not understood earlier  that the pharmacy                                                                    
would  be   telling  a   physician  what   prescription  was                                                                    
dispensed without obtaining approval from the physician.                                                                        
                                                                                                                                
Senator Hughes noted  that the process for  medication to be                                                                    
approved by  the FDA was incredibly  rigorous. She furthered                                                                    
that  if a  medication was  categorized as  interchangeable,                                                                    
there was a  high assurance level, which was  the reason for                                                                    
the State Medical Association's support of the bill.                                                                            
                                                                                                                                
Representative  Wilson   clarified  her  concern   was  that                                                                    
pharmacists  were not  doctors.  She stated  that a  patient                                                                    
could  receive  a doctor  prescription,  but  then go  to  a                                                                    
pharmacy and get something that  was slightly different. She                                                                    
was  concerned that  the doctor  would  not know  for up  to                                                                    
three days  what prescription had been  dispensed. She spoke                                                                    
to the  liability to  the physician.  She believed  the bill                                                                    
would allow a medical decision  to be made by the pharmacist                                                                    
and  patient. She  had initially  believed the  doctor would                                                                    
know about the prescription before it had been dispensed.                                                                       
                                                                                                                                
Senator Hughes  answered that the  types of  pharmacies that                                                                    
would be  handling the expensive medication  would more than                                                                    
likely  have instantaneous  notification  to the  physician.                                                                    
She  reasoned  that  the FDA's  rigorous  process  had  been                                                                    
trusted with great success and savings.                                                                                         
                                                                                                                                
SB  32  was   HEARD  and  HELD  in   committee  for  further                                                                    
consideration.                                                                                                                  
                                                                                                                                
Co-Chair  Foster addressed  the schedule  for the  following                                                                    
day.                                                                                                                            
                                                                                                                                

Document Name Date/Time Subjects
SB032 Opposing Document-Opposition Letters 04.17.17.pdf HFIN 5/3/2017 1:30:00 PM
SB 32
SB032 Sectional Analysis ver J 04.17.17.pdf HFIN 5/3/2017 1:30:00 PM
SB 32
SB032 Sponsor Statement 04.17.17.pdf HFIN 5/3/2017 1:30:00 PM
SB 32
SB032 Supporting Documents-Support Letters 04.17.17.pdf HFIN 5/3/2017 1:30:00 PM
SB 32
SB32_Support_050317.pdf HFIN 5/3/2017 1:30:00 PM
SB 32
HFIN Crum ATA.pdf HFIN 5/3/2017 1:30:00 PM