Legislature(2009 - 2010)BELTZ 211

03/12/2009 01:30 PM LABOR & COMMERCE


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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ SB 10 MEDICAID/INS FOR CANCER CLINICAL TRIALS TELECONFERENCED
Moved CSSB 10(HSS) Out of Committee
*+ SB 114 EXT BD OF ARCHITECTS, ENGRS, & SURVEYORS TELECONFERENCED
Moved CSSB 114(L&C) Out of Committee
*+ SB 125 AK AEROSPACE CORPORATION TELECONFERENCED
Moved SB 125 Out of Committee
+ Bills Previously Heard/Scheduled TELECONFERENCED
= SB 39 EXTEND BOARD OF PUBLIC ACCOUNTANCY
Moved SB 39 Out of Committee
         SB  10-MEDICAID/INS FOR CANCER CLINICAL TRIALS                                                                     
                                                                                                                                
1:59:42 PM                                                                                                                    
CHAIR PASKVAN  announced SB 10  to be up for  consideration; CSSB
10(HSS), labeled 26-LS0073\S, was before the committee.                                                                         
                                                                                                                                
2:00:10 PM                                                                                                                    
TOM  OBERMEYER,  staff  to  Senator  Davis,  sponsor  of  SB  10,                                                               
explained  the CS  for  SB  10. He  said  the  CS regards  cancer                                                               
clinical  trials and  requires  health care  insurers to  provide                                                               
insurance for medical  care received by a  patient during certain                                                               
approved   clinical  trials   designed   to   test  and   improve                                                               
prevention,  diagnosis, treatment  or  palliation  of cancer.  It                                                               
directs the  Department of Health  and Social Services  (DHSS) to                                                               
provide  Medicaid services  to persons  who participate  in those                                                               
clinical trials  relating to the experimental  procedures under a                                                               
state   plan  offered   by  a   comprehensive  health   insurance                                                               
association and provides for an effective date.                                                                                 
                                                                                                                                
He explained that clinical trials  are research studies that test                                                               
how  well new  medical approaches  work in  patients. Each  study                                                               
answers specific  scientific questions  and tries to  find better                                                               
ways to prevent, screen for,  diagnose or treat disease. Patients                                                               
who take  part in  cancer clinical trial  have an  opportunity to                                                               
contribute to the knowledge of  and progress against cancer. They                                                               
also  receive  state-of-the-art  treatment from  experts  in  the                                                               
field.  The  National  Cancer  Institute  is  part  of  the  U.S.                                                               
National Institutes of Health reports  6,000 cancer trials in the                                                               
U.S. at any one time.                                                                                                           
                                                                                                                                
MR. OBERMEYER explained that SB  10 removes important barriers to                                                               
the  participation  of  patients  in cancer  clinical  trials  in                                                               
Alaska. It requires that applicable  health care plans, including                                                               
Medicaid, cover routine patient  care costs for patients enrolled                                                               
in all phases of clinical  trials. Currently, Alaska health plans                                                               
may  exclude coverage  for  routine patient  care  costs while  a                                                               
patient with cancer  is enrolled in a clinical  trial thinking it                                                               
saves them money.  However, these patients who  have not enrolled                                                               
in clinical  trials, continue to receive  conventional therapy at                                                               
roughly the same or slightly increased cost in the short-run.                                                                   
                                                                                                                                
Over 2,600  Alaskans are diagnosed  with cancer each year.  In FY                                                               
2007,  an estimated  4,600  patients  received cancer  treatments                                                               
through Alaska's  Medicare program  at a  cost of  $21.5 million.                                                               
The  average  payment  for beneficiaries  is  about  $4,675.  The                                                               
federal government  reimburses the state  at about 50  percent of                                                               
total costs.  Without in-state facilities in  support of clinical                                                               
trials,  participants from  Alaska must  now travel  out-of-state                                                               
increasing  the cost  of non-emergency  transportation, which  is                                                               
about 3 percent of total Medicaid costs.                                                                                        
                                                                                                                                
Studies have  shown that only  about 2-3 percent of  adult cancer                                                               
patients and  less than 0.5  percent Medicare patients  enroll in                                                               
clinical trials of the approximately  20 percent who are eligible                                                               
- largely  due to  fear of  denial of  insurance. A  recent study                                                               
found  only a  slight increase  in the  costs for  adult clinical                                                               
trials  with  patients  compared  to  non-participants  -  35,000                                                               
versus 33,000 or about a 6-percent increase in costs.                                                                           
                                                                                                                                
MR.  OBERMEYER noted  even if  enrollment were  increased to  the                                                               
full  eligible 20  percent, it  is unlikely  these numbers  would                                                               
significantly impact  the overall  cost of  health plans  per the                                                               
National  Conference  of  State Legislatures,  "Clinical  Trials:                                                               
What are the States Doing," February 2009 update.                                                                               
                                                                                                                                
He  said that  at  least  23 states  have  passed legislation  or                                                               
instituted special agreements requiring  health care plans to pay                                                               
for  the cost  of  routine medical  care  patients receive  while                                                               
participating in  clinical trials. Passage  of SB 10  will result                                                               
in  more  successful outcomes  in  cancer  treatments in  Alaska,                                                               
increase retention  of patients in  Alaska for their  cancer care                                                               
and also  after full  implementation, result  in cost  savings in                                                               
the short and long run.                                                                                                         
                                                                                                                                
MR. OBERMEYER  said they should  be encouraging  participation in                                                               
clinical  trials, not  discouraging it  by removing  coverage for                                                               
routine care. Were it not for  patients who have enrolled in past                                                               
trials,  the  medical  advancements we  have  experienced  toward                                                               
finding a cure for cancer would not be possible.                                                                                
                                                                                                                                
2:06:21 PM                                                                                                                    
SENATOR BUNDE said  anyone with common sense in  this arena wants                                                               
progress  made in  the treatment  of cancer.  He asked  if anyone                                                               
covered by  the Employee  Retirement and  Income Security  Act of                                                               
1974 (ERISA) would be covered by this legislation.                                                                              
                                                                                                                                
MR. OBERMEYER replied that was his understanding.                                                                               
                                                                                                                                
SENATOR BUNDE  asked, in  reference to the  zero fiscal  note. if                                                               
there would be an impact on Medicaid.                                                                                           
                                                                                                                                
MR.  OBERMEYER responded  there  was a  zero  fiscal note,  dated                                                               
February 4, regarding Medicaid insurance.                                                                                       
                                                                                                                                
2:08:48 PM                                                                                                                    
JON  SHERWOOD, Medicaid  Special Projects,  Department of  Health                                                               
and Social  Services, said  they did submit  a zero  fiscal note.                                                               
They don't  cover experimental treatment,  but they do  cover the                                                               
routine costs  of care. Making  it a statutory  requirement would                                                               
not impact their budget.                                                                                                        
                                                                                                                                
SENATOR BUNDE asked  if someone under Medicaid  would be impacted                                                               
by this legislation.                                                                                                            
                                                                                                                                
MR. SHERWOOD  responded that this legislation  would require them                                                               
to pay for what they are already paying for through regulations.                                                                
                                                                                                                                
SENATOR  THOMAS asked  if anyone  considered the  idea that  some                                                               
change  in  a Medicaid  cancer  patient's  situation would  cause                                                               
someone to  say this  experimental treatment  is causing  it and,                                                               
therefore, deny payment for it.                                                                                                 
                                                                                                                                
2:11:05 PM                                                                                                                    
MR. SHERWOOD  answered they  didn't factor  that in  because they                                                               
already  pay  for  ancillary  costs,   and  their  program  would                                                               
continue to operate the way it is today.                                                                                        
                                                                                                                                
2:12:35 PM                                                                                                                    
SENATOR MEYER  asked if SB  10 imposes  the same mandate  on self                                                               
insured groups.                                                                                                                 
                                                                                                                                
MR.  SHERWOOD  replied that  he  understands  that ERISA  largely                                                               
applies  to self-insured  entities. But  he is  not an  expert on                                                               
insurance.                                                                                                                      
                                                                                                                                
SENATOR MEYER asked how many people this bill would impact.                                                                     
                                                                                                                                
MR. SHERWOOD didn't have that information.                                                                                      
                                                                                                                                
SENATOR BUNDE said he thought  this would affect only people with                                                               
private  insurance,   and  most  people  in   Alaska  have  state                                                               
insurance.                                                                                                                      
                                                                                                                                
SENATOR THOMAS said  ERISA plans could be either  self funded bid                                                               
on by various insurance companies.                                                                                              
                                                                                                                                
2:14:37 PM                                                                                                                    
JACK MCCRAY,  Sr. Vice President,  Primera Blue Cross,  said they                                                               
cover phase  2 and 3 of  cancer clinical trials. The  main reason                                                               
phase 1  clinical trials  aren't covered is  because those  get a                                                               
tremendous amount  of funding  from pharmaceutical  companies and                                                               
others  just because  it  is so  experimental.  They don't  cover                                                               
phase 4  clinical trials, because  there may be  other treatments                                                               
or  procedures  that are  be  better  for  the patient  than  the                                                               
clinical trial. That  needs to be evaluated by the  doctor at the                                                               
time.                                                                                                                           
                                                                                                                                
He said Premera Blue Cross is not  required to cover phase 1 or 4                                                               
in  Oregon  or  Washington.  Since  they  don't  pay  for  it  in                                                               
Washington or  Oregon, he doesn't  have any  idea of how  much it                                                               
would be. If they start paying  for phase 1, there would possibly                                                               
be more phase 1 treatments done  not using some of the grants and                                                               
Institute  of   Health  funding.  Their  costs   would  increase,                                                               
therefore, in Alaska.                                                                                                           
                                                                                                                                
2:17:53 PM                                                                                                                    
CHAIR PASKVAN asked him to clarify  when he uses the term "better                                                               
for the  patient" with  respect to  either phase 1  or 2  that he                                                               
wasn't offering that as a medical opinion.                                                                                      
                                                                                                                                
MR. MCCRAY  answered it  is not  a medical  opinion, but  they do                                                               
discuss different options with the patient's doctor.                                                                            
                                                                                                                                
SENATOR BUNDE  asked from  Blue Cross' point  of view  would this                                                               
bill  impact the  policies  they write  for  private industry  in                                                               
Alaska, but not the state policies that they administer.                                                                        
                                                                                                                                
MR.  MCCRAY replied  yes; it  would  not affect  any ERISA  self-                                                               
funded plans, but  it would impact the individual  market and the                                                               
small group marketplace.                                                                                                        
                                                                                                                                
SENATOR BUNDE said  he thought it was  ordinary business practice                                                               
to pass increased costs on to the consumer.                                                                                     
                                                                                                                                
MR. MCCRAY answered yes.                                                                                                        
                                                                                                                                
2:19:37 PM                                                                                                                    
KRISTA  RAYGITSCH,  cancer   research  nurse,  Providence  Alaska                                                               
Medical Center,  said she  is testifying on  her own  behalf. She                                                               
supported  SB  10  saying  everyone  should  be  have  the  equal                                                               
opportunity  to  participate  in  a clinical  trial  if  they  so                                                               
choose.                                                                                                                         
                                                                                                                                
She explained  when a clinical  trial is recommended  to patients                                                               
by  their  physician  as  the best  treatment  option,  they  are                                                               
referred to her  office. Part of her discussion  with the patient                                                               
includes informing them that the  insurance company may not cover                                                               
some or all of the  routines costs associated with treating their                                                               
cancer  while on  the  study. This  is the  stage  at which  they                                                               
encounter  the  majority of  barriers  to  patient enrollment  to                                                               
clinical  trials.  Patients  go  through a  lot  emotionally  and                                                               
financially when being diagnosed with  cancer, and the last thing                                                               
they  should have  to worry  about is  finding out  whether their                                                               
insurance will cover a clinical  trial that their doctor feels is                                                               
in their best interest.                                                                                                         
                                                                                                                                
MS.  RAYGITSCH said  she has  noticed the  ever-increasing reason                                                               
for patients not enrolling in  clinical trials is because of lack                                                               
of or  fear of lack  of insurance coverage. Sometimes  because of                                                               
the severity of  the cancer and the necessity  to start treatment                                                               
immediately,  there  isn't  enough  time   to  find  out  if  the                                                               
insurance company will  cover the clinical trial  expenses or the                                                               
company  takes  too long  to  determine  coverage. "If  insurance                                                               
companies were  mandated to cover  routine care  costs associated                                                               
with clinical trials,  I'm confident that many  more people would                                                               
be able  to participate  in clinical trials  which in  turn would                                                               
hopefully increase  the likelihood of improved  cancer treatments                                                               
and maybe someday lead to a cure."                                                                                              
                                                                                                                                
2:22:00 PM                                                                                                                    
CHAIR PASKVAN  asked if she  saw any distinction between  phase 1                                                               
and phase 4 as compared to phases 2 or 3 for coverage.                                                                          
                                                                                                                                
MS.  RAYGITSCH replied  that  phase 1  clinical  trials are  many                                                               
times  covered  by  cooperative   groups  or  the  pharmaceutical                                                               
companies, so  she didn't see  that there would be  any increased                                                               
cost.  She couldn't  speak to  phase 4,  because she  doesn't get                                                               
many of those and doesn't have any of those open at the time.                                                                   
                                                                                                                                
2:23:04 PM                                                                                                                    
EMILY  NENON,  Director,   Alaska  Government  Relations,  Cancer                                                               
Action  Network,   American  Cancer  Society  (ACS),   said  this                                                               
legislation is  a key piece  in a  much broader effort  to remove                                                               
barriers  and  increase  participation in  clinical  trials.  The                                                               
State   and   Alaska    Native   Comprehensive   Cancer   Control                                                               
Partnerships   are    working   together   on    developing   and                                                               
disseminating  provider  and  patient  education  and  increasing                                                               
understanding  of clinical  trials.  They are  also working  with                                                               
non-state  regulated  plans and  specifically  with  some of  the                                                               
larger  self insured  plans  to educate  them  on providing  this                                                               
coverage. Providence  has just decided  to add this  coverage for                                                               
its employees. It  is important to include all the  phases of the                                                               
trials. She recommended  that they look at the  collection of ACS                                                               
studies that look specifically at the costs.                                                                                    
                                                                                                                                
2:26:05 PM                                                                                                                    
CLAIRE  WADDOUP, representing  herself,  Anchorage, supported  SB
10. She said she has  benefited personally from her breast cancer                                                               
treatment  gained through  clinical trials,  and she  wouldn't be                                                               
able to participate in them if financial hardship was added.                                                                    
                                                                                                                                
DR.  LATH SUBRAMANIAN,  medical oncologist  representing herself,                                                               
Anchorage  supported SB  10. She  said she  takes care  of cancer                                                               
patients  and  is a  strong  proponent  of clinical  trials.  The                                                               
reason  is because  she has  run into  many situations  where she                                                               
helps  patients decide  that the  best  treatment for  them is  a                                                               
clinical trial.  She remembered two patients,  in particular. One                                                               
had esophageal  cancer, which is  often a death sentence,  and he                                                               
had  the  opportunity to  receive  a  new  drug, which  was  only                                                               
available for that cancer under a  clinical trial. He opted to be                                                               
treated  under that  clinical trial,  but he  found out  that his                                                               
insurance  wouldn't pay  for it.  They even  appealed it  "to the                                                               
limit." When he  had surgery, his esophageal cancer  was found to                                                               
be in remission because of it.                                                                                                  
                                                                                                                                
She  said another  patient  has sarcoma  and  couldn't enter  the                                                               
clinical trials  because of  lack of  insurance. This  happens to                                                               
real people,  and cancer  is one of  the commonest  diseases. She                                                               
stated  the only  way to  make  advances in  cancer treatment  is                                                               
through clinical  trials, and  it is one  of those  diseases that                                                               
doesn't  have a  lot  of  time or  a  lot  of effective  standard                                                               
treatments. All  the benefits  they have  seen have  come through                                                               
patients who have been brave  enough to enter clinical trials and                                                               
through the insurers who have paid for these patients.                                                                          
                                                                                                                                
DR.  SUBRAMANIAN said  they are  not talking  about covering  the                                                               
cost of  the whole clinical  trial, but  just one little  piece -                                                               
the routine  patient care costs.  There are several  other costs,                                                               
but a  majority of those are  borne by the sponsor  and the study                                                               
groups. The routine care would  be covered under insurance anyhow                                                               
if the patient was not participating  in a clinical trial and not                                                               
covering  it for  clinical studies  - "It  just doesn't  make any                                                               
sense."                                                                                                                         
                                                                                                                                
DR. SUBRAMANIAN  said one  thing that has  not been  mentioned is                                                               
that phase  1 studies involve a  very small number of  patients -                                                               
sometimes as  few as 20  or maybe  as many as  80. Phase 2  and 3                                                               
trials involve  3-4,000 people; phase  2 trials involve  a couple                                                               
hundred. The  cost of a  phase 1  trial for routine  patient care                                                               
cannot be that enormous, and there  is no reason that would drive                                                               
up the cost  of insurance for everybody. The picture  for phase 4                                                               
trials, especially  for cancer, has  changed; there are  more new                                                               
drugs and  more knowledge available. Since  companies are "antsy"                                                               
to get the  new drugs out into the market,  they are conducted to                                                               
fully study the  safety and other possible benefits  of the drug.                                                               
It may have been approved for  a certain condition, but a phase 4                                                               
trial could find  it works for something else. A  good example of                                                               
this  is Temoxifin,  which is  an  old drug  for treating  breast                                                               
cancer; a  phase 4 study was  conducted and it was  shown to work                                                               
for prevention of breast cancer, as well.                                                                                       
                                                                                                                                
2:32:29 PM                                                                                                                    
She  also  pointed out  that  when  a  patient has  a  successful                                                               
clinical trial,  he gets  better and saves  money by  not needing                                                               
further expensive  treatment. Also,  she said,  Medicare patients                                                               
are covered, so why not cover younger patients, too?                                                                            
                                                                                                                                
She questioned where the data was  that would back up claims that                                                               
paying for  routine care  during clinical  trials would  drive up                                                               
premium  costs,   because  it   is  already  being   covered  for                                                               
traditional treatments.                                                                                                         
                                                                                                                                
2:34:57 PM                                                                                                                    
SENATOR  BUNDE said  the actual  drugs are  incredibly expensive,                                                               
thousands of dollars  per treatment, and asked what  she means in                                                               
talking about routine care - is  it the I.V. that administers the                                                               
drug, the infusion room and things like that?                                                                                   
                                                                                                                                
DR. SUBRAMANIAN replied yes.                                                                                                    
                                                                                                                                
SENATOR  BUNDE asked  if someone  was  in for  a cancer  fighting                                                               
infusion drug that  might cost $3-$4,000 per  treatment, what the                                                               
routine care for that infusion would cost.                                                                                      
                                                                                                                                
DR.  SUBRAMANIAN  replied the  infusion  charge  is the  same  no                                                               
matter whether it  is for a clinical trial drug  or not. Clinical                                                               
trials collect data, as well,  that might benefit future patients                                                               
or sometimes  a patient gets a  drug that might otherwise  not be                                                               
available  commercially to  them. If  that  turns out  to be  the                                                               
better treatment, then those patients have benefited from it.                                                                   
                                                                                                                                
SENATOR BUNDE asked what routine care costs per visit.                                                                          
                                                                                                                                
DR. SUBRAMANIAN replied  it depends on how long  the infusion is.                                                               
Some are just  30 minutes; some are three hours.  She didn't know                                                               
the costs.                                                                                                                      
                                                                                                                                
2:37:57 PM                                                                                                                    
DR. JEANNIE  ANDERSON, Oncologist, representing herself,  aid she                                                               
is a  member of the Katmai  Oncology Group in Anchorage,  and she                                                               
supported  SB 10.  From  Linda Hall's  testimony  last year,  she                                                               
knows that about  40 percent of Alaskans would  benefit from this                                                               
bill.  The other  60 percent  are self-insured.  The benefits  of                                                               
participating  in  clinical  trials  are clear  to  patients  and                                                               
physicians.                                                                                                                     
                                                                                                                                
She said  some health care  insurers have refused to  cover these                                                               
routine care costs  because the perception has been  that it will                                                               
make costs  increase. However, one  popular study  indicated that                                                               
including patients on  clinical trials would make  costs only 6.5                                                               
percent  higher; and  as several  people  have already  testified                                                               
(including  her  Oncology Group)  costs  may  become even  lower.                                                               
Since the year 2000, Medicare  beneficiaries have been allowed to                                                               
participate in  these trials, and  there have been no  reports of                                                               
increased cost for those patients.                                                                                              
                                                                                                                                
She  emphasized   that  participation  in  clinical   trials  can                                                               
actually reduce  costs. In the  80s and 90s patients  with breast                                                               
cancers thought  they would  live longer  if they  received high-                                                               
dose chemotherapy  followed by bone marrow  transplants, which is                                                               
a very  costly treatment.  Many patients  sued their  health care                                                               
insurers  and  that resulted  in  thousands  of these  procedures                                                               
being done outside the guidelines  of clinical trials and without                                                               
the information  that could be  obtained from them on  safety and                                                               
efficacy. Eventually  patients did enroll in  clinical trials and                                                               
this  aggressive treatment  was compared  to standard  treatment,                                                               
and transplantation  was found to  be neither effective  nor safe                                                               
as treatment for  breast cancer. In her opinion,  if patients and                                                               
health care insurers  had been more motivated  to participate and                                                               
more able  to participate in these  carefully controlled clinical                                                               
trials,  they  would  have  obtained the  results  of  the  study                                                               
sooner,  thus maximizing  their safety  and reducing  health care                                                               
costs.                                                                                                                          
                                                                                                                                
The second example  she mentioned was an  on-going national study                                                               
at Providence Alaska  Medical Center, in which  she enrolled four                                                               
patients. The study takes a  simple blood test to predict whether                                                               
or not patients  respond to chemotherapy after they  have been on                                                               
treatment for  only three  weeks. Typically, a  patient not  on a                                                               
clinical trial like this will get  treated for six or eight weeks                                                               
before making that prediction. If  that prediction can be made in                                                               
three  weeks, treatments  could be  stopped earlier  reducing the                                                               
risks of  chemotherapy and preventing additional  treatments that                                                               
patients may not benefit from in a much sooner fashion.                                                                         
                                                                                                                                
2:42:01 PM                                                                                                                    
Finally,  on the  issue of  safety in  participating in  studies,                                                               
multiple layers  of safety are  built into a clinical  trial. She                                                               
emphasized  that  all phases  of  a  trial have  sound  rationale                                                               
behind them.  She recommended  all phases to  be opened  to allow                                                               
unrestricted consideration of them  that would result in positive                                                               
outcomes for all cancer patients.                                                                                               
                                                                                                                                
2:43:32 PM                                                                                                                    
SENATOR  BUNDE  said  he  was still  trying  to  understand  what                                                               
routine costs would be for non-experimental people.                                                                             
                                                                                                                                
DR. ANDERSON said she didn't  know, because she doesn't deal with                                                               
the  billing. Furthermore,  she very  intentionally stays  out of                                                               
that because  she wants her decision  making to be based  on what                                                               
is best for  the patient, not what the treatment  would cost. The                                                               
cost of  many drugs that  are FDA  approved and still  on patent,                                                               
but not  generic, are in the  order of thousands of  dollars, she                                                               
explained, but the  office visit and infusion is in  the order of                                                               
hundreds of  dollars. She tries  to remember what doses  of drugs                                                               
to give rather than how much it costs.                                                                                          
                                                                                                                                
She  explained  that  for  most   clinical  trials  the  drug  is                                                               
supplied,  especially when  it  is relatively  new  and they  are                                                               
sorting  out the  indications.  Generic drugs  are  used in  just                                                               
comparing one  schedule drug against  another one, and  those are                                                               
not extremely  expensive or  they would be  given anyway  even if                                                               
the patient were not on a clinical trial.                                                                                       
                                                                                                                                
2:46:26 PM                                                                                                                    
DOUGLAS  BLANEY, President-elect,  American  Society of  Clinical                                                               
Oncology (ASCO),  a 26,000-member professional  association, said                                                               
ASCO  has helped  many states'  legislatures understand  and move                                                               
forward with clinical trial legislation such as this.                                                                           
                                                                                                                                
He  wanted  to  submit  three   points  in  regards  to  previous                                                               
testimony.  First, the  issue  of phase  1  clinical trials:  new                                                               
drugs  are given  to patients  with a  known diagnosis  of cancer                                                               
with  the  intent  of  determining the  toxicity,  the  dose  and                                                               
effectiveness in  that type  of tumor. Clearly  phase 1  drugs in                                                               
cancer  are   different  than  phase   1  when  used   in  normal                                                               
volunteers.  Often,  high   blood  pressure  medicines,  headache                                                               
remedies,  et  cetera  will  be used  in  normal  volunteers.  He                                                               
suggested  it would  be useful  for them  to distinguish  phase 1                                                               
drugs for  cancer, which  are used  with some  therapeutic intent                                                               
and are covered by Medicare.                                                                                                    
                                                                                                                                
2:48:21 PM                                                                                                                    
Second, with regard to phase 4  studies, these are drugs that are                                                               
approved  for  marketing  so  they  are  paid  for  by  insurance                                                               
companies already  or third-party  payers. The clinical  study is                                                               
done to  determine side effects  and gain larger  experience with                                                               
these drugs. So,  the costs of collecting the data  or making the                                                               
observations are paid  for by the sponsors of the  study. But the                                                               
drugs are typically  given with therapeutic intent  as they would                                                               
be  routinely even  if the  patient  was not  participating in  a                                                               
clinical study. He advocated that all phases be covered.                                                                        
                                                                                                                                
In response  to routine  care costs, he  said, costs  of infusion                                                               
are typically  about $100/hr. The  more important aspect  is what                                                               
happens if  a patient  suffers a  complication from  the therapy.                                                               
For instance, people with lung  cancer often get plural effusions                                                               
or collections of fluid around their  lung that has to be drained                                                               
so  that breathing  can be  restored  and other  symptoms of  the                                                               
cancer can  be managed. Often  they have seen these  routine care                                                               
costs  denied  coverage  after  a  complication  occurs,  another                                                               
discouragement to enrollment.                                                                                                   
                                                                                                                                
Finally,  he   said,  allowing  your  oncologist   in  Alaska  to                                                               
participate in  clinical trials will  keep patients  Alaska close                                                               
to  home, and  not  have them  go to  cancer  centers outside  of                                                               
Alaska - and this is better for all concerned.                                                                                  
                                                                                                                                
2:51:48 PM                                                                                                                    
MARIE  DARLIN, AARP  Capital City  Task Force,  supported SB  10.                                                               
Most  of  the significant  advances  in  cancer have  come  about                                                               
because of clinical trials, she added.                                                                                          
                                                                                                                                
2:53:34 PM                                                                                                                    
MR. OBERMEYER reminded  them of the letter in  their packets from                                                               
the  American Association  of Cancer  Research dated  December 1,                                                               
2008 indicating the tremendous need for phase 1 trials.                                                                         
                                                                                                                                
2:55:31 PM                                                                                                                    
DENNIS BAILEY,  Legislative Counsel, Legislative  Affairs Agency,                                                               
said he was available to answer questions on SB 10.                                                                             
                                                                                                                                
CHAIR  PASKVAN  observed  there were  no  questions,  and  closed                                                               
public testimony.                                                                                                               
                                                                                                                                
SENATOR  DAVIS said  this bill  had gone  through the  Health and                                                               
Social Services Committee already, and  the issue was before them                                                               
last year  when it passed  the Labor and Commerce  Committee, but                                                               
couldn't get out  of the Finance Committee. Many  people who have                                                               
gone  through clinical  trials have  said  their expensive  drugs                                                               
were paid for through grants  or pharmaceutical companies because                                                               
it was their product; it did  not leave that much for the private                                                               
insurers to pay. Helping 40 percent  of the people is better than                                                               
not helping any.                                                                                                                
                                                                                                                                
2:58:18 PM                                                                                                                    
SENATOR MEYER asked her why SB 10  has to go to Finance if it has                                                               
a zero fiscal note.                                                                                                             
                                                                                                                                
SENATOR  DAVIS replied  that she  was going  to ask  to have  the                                                               
Finance referral waived.                                                                                                        
                                                                                                                                
SENATOR  BUNDE commented  that it's  important to  note that  the                                                               
major expense  for cancer treatment  is the drugs;  routine costs                                                               
are  a lot  smaller.  The state  would follow  for  the other  60                                                               
percent  if this  passed.  His  concern is  for  the people  this                                                               
affects.                                                                                                                        
                                                                                                                                
3:00:36 PM                                                                                                                    
SENATOR BUNDE  moved to report  CSSB 10(HSS) from  committee with                                                               
individual recommendations and  zero fiscal note.   There were no                                                               
objections and it was so ordered.                                                                                               
                                                                                                                                

Document Name Date/Time Subjects
CS for SB 10 Bill Packet.pdf SL&C 3/12/2009 1:30:00 PM
SB 10
SB 114 Bill Packet.pdf SL&C 3/12/2009 1:30:00 PM
SB 114
SB 125 Bill Packet.pdf SL&C 3/12/2009 1:30:00 PM
SB 125
SB 114 Proposed Amendment.pdf SL&C 3/12/2009 1:30:00 PM
SB 114