Legislature(2009 - 2010)BUTROVICH 205

02/18/2009 01:30 PM HEALTH & SOCIAL SERVICES


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01:35:45 PM Start
01:36:44 PM SB10
02:29:54 PM Adjourn
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
*+ SB 10 MEDICAID/INS FOR CANCER CLINICAL TRIALS TELECONFERENCED
Heard & Held
+ Bills Previously Heard/Scheduled TELECONFERENCED
         SB 10-MEDICAID/INS FOR CANCER CLINICAL TRIALS                                                                      
                                                                                                                                
CHAIR DAVIS announced consideration of SB 10.                                                                                   
                                                                                                                                
1:36:44 PM                                                                                                                    
SENATOR PASKVAN moved to adopt  the proposed committee substitute                                                               
to SB  10, labeled  26-LS0073\E, as  the working  document. There                                                               
being no objection, version E was before the committee.                                                                         
                                                                                                                                
TOM  OBERMEYER,   aid  to  Senator   Davis  said   the  committee                                                               
substitute provides substantive definitional  changes in the body                                                               
of the  bill to  clarify sections  of the  original bill;  so the                                                               
title of the bill was changed slightly to read:                                                                                 
                                                                                                                                
     An Act requiring health care insurers to provide insurance                                                               
     coverage for medical care  received by a patient  during                                                                 
     certain approved clinical  trials designed to  test and                                                                  
     improve prevention, diagnosis, treatment, or palliation of                                                               
     cancer;..."                                                                                                              
     ... directing the Department of Health and Social Services                                                                 
     to provide Medicaid services to persons who participate in                                                                 
     clinical trials; relating to experimental procedures under                                                                 
     a state plan offered by the Comprehensive Health Insurance                                                                 
     Association; and providing for an effective date.                                                                          
                                                                                                                              
1:38:41 PM                                                                                                                    
He mentioned that Dennis Bailey, the drafter, should be online                                                                  
to answer any legal questions about the bill and then continued                                                                 
with the sponsor statement.                                                                                                     
                                                                                                                                
  Clinical trials are research studies that test how well new                                                                 
     medical approaches work in patients. Each study answers                                                                  
     scientific questions and tries to find better ways to                                                                      
     prevent, screen for, diagnose, or treat disease. Patients                                                                  
  who take part in cancer clinical trials 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, as                                                                    
     part of the U.S. National Institutes of Health, reports                                                                    
     6,000 cancer trials in the United States at any one time.                                                                  
     They include trials in prevention, screening, diagnosis,                                                                   
     treatment, quality-of-life, and genetic studies.                                                                           
                                                                                                                                
     CSSB 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, including prevention,                                                                       
     detection, treatment, and palliation (supportive care) of                                                                  
     cancer. Currently Alaska health care plans may exclude                                                                     
     coverage for routine patient-care costs while a patient                                                                    
     with cancer is enrolled in a clinical trial. Providers of                                                                  
     health care plans often conclude that money is saved by                                                                    
     excluding care while patients participate in trials. But                                                                   
     these patients, if not enrolled in clinical trials, will                                                                   
     continue to receive conventional therapy at roughly the                                                                    
     same or slightly increased costs in the short-run.                                                                         
                                                                                                                                
MR. OBERMEYER mentioned that the member packets include zero                                                                    
fiscal notes for both the Division Of Insurance and Medicaid                                                                    
Services.                                                                                                                       
                                                                                                                                
     Studies have shown that only 2 to 3 percent enroll in                                                                    
     clinical trials with a 6.5 percent increase in costs for                                                                 
     clinical trial participants compared to non-participants.                                                                
                                                                                                                              
He said the sponsor statement in the member packets was just                                                                    
updated with new National Conference Of State Legislatures                                                                      
Information on 2009, which also indicates that a growing number                                                                 
of states have instituted special agreements requiring health                                                                   
plans to pay the cost of routine medical care a patient                                                                         
receives. [See National Conference of State Legislatures,                                                                       
"Clinical Trials: What are States Doing? February, 2009 Update."                                                                
                                                                                                                              
     Of the approximately 20 percent of cancer patients who are                                                               
     eligible to participate in clinical trials only 3 percent                                                                
     participate and less than 0.5 percent are Medicare                                                                       
  patients; so even if the enrollment increased considerably,                                                                 
     it is unlikely that the numbers will significantly impact                                                                  
     overall costs to health plans. In FY 2007 an estimated                                                                     
     4,600 patients received cancer treatments through Alaska's                                                                 
     Medicaid program at a cost of $21.5 million. The average                                                                   
     payment per beneficiary was about $4,675. The federal                                                                      
     government reimburses the state at about 50 percent of the                                                                 
  total costs. Dr, Anderson noted last year that in the 1970s                                                                   
     only 50 percent of cancer patients lived five years after                                                                  
     diagnosis. That figure is now over 2/3 in 2008.                                                                            
                                                                                                                                
1:42:10 PM                                                                                                                    
     Twenty-three or more states have passed legislation or                                                                   
  instituted special agreements requiring health plans to pay                                                                 
     the cost of routine medical care patients receive while                                                                  
     participating in clinical trials. Passage of CSSB 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 long run.                                                                                              
                                                                                                                                
                                                                                                                                
MR. OBERMEYER noted  that there are a number  of attachments that                                                               
might be  of help  to members if  they have  questions, including                                                               
documentation from  the American Society of  Clinical Oncology. A                                                               
letter  from Dr.  Mary Stewart  of the  Denali Oncology  Group in                                                               
Anchorage   indicates  that   for   many   people  with   cancer,                                                               
participation  in  a  clinical  trial  is  their  best  treatment                                                               
option,  yet  many  third-party payers  take  the  position  that                                                               
routine  patient  care  costs  should be  denied  to  anyone  who                                                               
enrolls  in  such trials.  The  sponsors  believe such  a  policy                                                               
deprives beneficiaries  of the value  of their  health insurance,                                                               
wrongly restricts  their treatment  options and  inhibits medical                                                               
progress against serious and life-threatening diseases.                                                                         
                                                                                                                                
CHAIR DAVIS  said that Jonathan  Sherwood with the  Department of                                                               
Health  and  Social  Services  (DHSS) is  online  to  answer  any                                                               
questions  that may  come up.  She  then opened  the meeting  for                                                               
public testimony.                                                                                                               
                                                                                                                                
1:44:20 PM                                                                                                                    
SENATOR ELLIS joined the meeting.                                                                                               
                                                                                                                                
MARIE  DARLIN, AARP  Capital City  Task Force,  Juneau, AK,  said                                                               
AARP is very much in favor  of this bill. Most of the significant                                                               
advances   in  cancer   treatment  that   have  become   standard                                                               
procedures began  as clinical  trials; so it  would seem  that if                                                               
persons   covered  by   insurance,   even   Medicaid,  have   the                                                               
opportunity to  participate in clinical  trials, they  should not                                                               
be denied the opportunity.                                                                                                      
                                                                                                                                
SENATOR  ELLIS mentioned  that  when his  dad  was battling  lung                                                               
cancer,  he  learned  about  clinical  trials  through  the  AARP                                                               
newsletter;  even though  he was  not  a good  candidate at  that                                                               
time, he appreciated AARP for providing the information.                                                                        
                                                                                                                                
1:46:23 PM                                                                                                                    
DR. MARY STEWART, Medical  Oncologist, President, Denali Oncology                                                               
Group, Anchorage,  AK, has been  practicing in Alaska  since 1985                                                               
and has  seen a lot of  improvement in cancer care  as the result                                                               
of dedicated  laboratory researchers  and patients, who  are very                                                               
motivated  to help  them find  better treatments.  One way  to do                                                               
that is  enrolling in a  clinical trial  to test one  strategy of                                                               
care against  another. It  is important,  she said,  to recognize                                                               
that these are real individuals  whose lives have been touched by                                                               
cancer. A nurse educator she saw  last week has had her treatment                                                               
altered because  of an Austrian  clinical trial that found  a way                                                               
to reduce the risk of  breast cancer recurrence; a local baseball                                                               
coach has just come back from  Seattle after his second stem cell                                                               
transplant for myeloma;  a young man she met today  who was newly                                                               
diagnosed  with  a curable  cancer  has  benefited from  all  the                                                               
people who enrolled in trials over the last 25 years.                                                                           
                                                                                                                                
DR. STEWART  stressed that each  trial asks a  specific question;                                                               
the study  tests the new  treatment to find  out if it  is better                                                               
than the  standard treatment, as well  as whether it is  safe and                                                               
effective. Research  and animal  models can never  duplicate what                                                               
happens in the  complex human body. When  insurance rules prevent                                                               
individuals  from enrolling  in these  trials, it  means it  will                                                               
take  longer to  find  the answers  the  medical community  needs                                                               
today. She said she is quite  sure that everyone in this room has                                                               
been touched  by cancer in  some way  and knows what  the urgency                                                               
is. She asked the committee to please pass SB 10 today.                                                                         
                                                                                                                                
1:48:57 PM                                                                                                                    
SENATOR DYSON  said he  has an acquaintance  who is  indigent and                                                               
who felt coerced to participate,  believing that participation in                                                               
one of these experimental regimens was  the only way he could get                                                               
care. He asked if she could comment on that.                                                                                    
                                                                                                                                
DR. STEWART said it is possible  to get medicines for free if the                                                               
medicines  are being  tested before  being FDA  approved; so  one                                                               
could  get  free  care,  depending  on  the  situation.  But  for                                                               
individuals who  are medically indigent  in general,  the medical                                                               
community  always finds  a  way to  provide  treatment for  their                                                               
cancers.                                                                                                                        
                                                                                                                                
SENATOR PASKVAN said  he understands that the  medical drug costs                                                               
are  paid  for  by  the  pharmaceutical  company;  he  asked  for                                                               
examples of the routine patient  care costs that are being denied                                                               
to patients who participate in a clinical program.                                                                              
                                                                                                                                
DR.  STEWART  answered that  patients  with  cancer have  routine                                                               
blood  tests to  check liver  and kidney  functions to  ascertain                                                               
whether they  have become anemic.  In order to monitor  the state                                                               
of  the  cancer  and  whether  it  is  responding  to  treatment,                                                               
physicians routinely  do x-rays, CT  scans, bone scans  and other                                                               
things. This  is normal care;  these are  things that have  to be                                                               
done whether or not patients are enrolled in a clinical trial.                                                                  
                                                                                                                                
1:51:38 PM                                                                                                                    
SHEILA  TALLMAN,  Premera  Blue   Cross/Blue  Shield  of  Alaska,                                                               
Anchorage, AK,  said they do not  oppose the bill but  would like                                                               
to  work   with  the  committee   on  some   amendments.  Premera                                                               
recognizes   the  importance   of  cancer   clinical  trials   in                                                               
identifying  effective  and safe  treatments  that  are based  on                                                               
evidence and  research and does  currently cover  routine medical                                                               
care for  members who are participating  in phase 2 and  3 cancer                                                               
clinical  trials. There  are  concerns  however, about  expanding                                                               
coverage to  phase 1 and 4  trials because of patient  safety and                                                               
treatment effectiveness issues. For example,  in a phase 1 trial,                                                               
the drug  or treatment is still  being evaluated and there  is no                                                               
reasonable expectation  of a theraputive  or curative  benefit to                                                               
the  member  at  that  time.  The  basic  dose  mechanisms,  drug                                                               
toxicities and  safety aspects  have not  yet been  validated; so                                                               
including  phase 1  trials may  raise significant  patient safety                                                               
concerns if  Premera is  required to cover  them in  an insurance                                                               
plan. In a phase 4 clinical  trial, the treatment will be covered                                                               
if it is medically necessary; but  there may be other known, more                                                               
effective  medical treatments  available and  Premera would  like                                                               
the  flexibility to  look at  and pay  for those  other types  of                                                               
medical  treatments,  which  may  be  more  beneficial  to  their                                                               
members.                                                                                                                        
                                                                                                                                
In  conclusion, Ms.  Tallman said,  they  believe clinical  trial                                                               
participation is  important in identifying and  testing evidence-                                                               
based care  and they  encourage this  participation while  at the                                                               
same  time  balancing  safety,  treatment-effectiveness  and  the                                                               
rising cost of health insurance.  Premera will be able to support                                                               
this bill if their amendments are included.                                                                                     
                                                                                                                                
1:53:35 PM                                                                                                                    
CHAIR DAVIS asked Dr. Stewart  to speak to Ms. Tallman's concerns                                                               
about phase 1 and phase 4 clinical trials.                                                                                      
                                                                                                                                
DR. STEWART  suggested that  Dr. Anderson may  be better  able to                                                               
speak to this.                                                                                                                  
                                                                                                                                
DR.  JEANNE  ANDERSON,   representing  herself,  Katmai  Oncology                                                               
Group, Anchorage, AK, explained that  phase 4 clinical trials are                                                               
generally conducted to get more  experience with a drug, to learn                                                               
about very  rare side effects  that can  only be picked  up after                                                               
many thousands  of patients have been  treated. Cancer physicians                                                               
would only recommend that a patient  enroll in a phase 4 study if                                                               
it is a  drug that has been  SEA approved, if they  believe it is                                                               
the most effective  treatment and if it is in  the best interests                                                               
of the  patient. She disagreed  with Premera's position  that the                                                               
insurer should have the ability to  choose which drug is the most                                                               
effective; the  oncologist is  the person  most informed  and the                                                               
one  who  should make  that  decision.  She  stressed that  if  a                                                               
patient goes  into a phase  4 study,  there is no  increased cost                                                               
[to the  patient or the  insurance company];  additional tracking                                                               
and monitoring costs are born by the pharmaceutical company.                                                                    
                                                                                                                                
DR.  ANDERSON   admitted  that  phase  1   studies  are  somewhat                                                               
contentious.  Medicare, which  has provided  coverage since  2000                                                               
for  all Medicare  beneficiaries  who are  on qualified  clinical                                                               
trials,  requires  that  studies have  "therapeutic  intent"  and                                                               
there  are differences  of opinion  across the  country regarding                                                               
whether or not  phase 1 studies have therapeutic  intent. Phase 1                                                               
studies are  testing what is the  best dose to give  to a patient                                                               
who has  cancer, but they  are using background  information that                                                               
was  obtained from  pre-clinical  data, studies  done in  animals                                                               
and/or laboratory testing;  these may be drugs that  were used on                                                               
patients with  other types of  cancers. A  phase 1 study  is only                                                               
conducted if  there is  an expectation that  the drugs  will have                                                               
some therapeutic benefit.  Doctors do not want to give  a drug in                                                               
phase 1 that they believe has no potential to help the patient.                                                                 
                                                                                                                                
She agreed that  a critical part of phase 1  trials is looking at                                                               
safety, but physicians  only recommend these trials  if they have                                                               
a  plausible  reason  to  believe there  will  be  a  therapeutic                                                               
benefit to the  patient. Patients are monitored  very closely and                                                               
safety is  always of the  utmost concern;  so she does  not think                                                               
the insurance companies need to worry about patients' safety.                                                                   
                                                                                                                                
1:57:00 PM                                                                                                                    
DR. ANDERSON  thanked the  committee for  hearing this  bill. She                                                               
said that approximately 2600 Alaskans  were diagnosed with cancer                                                               
last year.  Decades ago only  about 50 percent of  patients lived                                                               
five years from  diagnosis, but as of last year,  2/3 of patients                                                               
were predicted to  survive five years. She  hopes that continuing                                                               
to advance physicians' knowledge  in cancer care through clinical                                                               
trials will increase  that 66 percent to even  higher cure rates.                                                               
Even so, she  knows that many Alaskans die every  day from cancer                                                               
and that there need to  be improvements. Physicians in Alaska are                                                               
committed to providing the best  care possible for their patients                                                               
to relieve suffering and reduce  death from cancer. In caring for                                                               
their patients, they often turn to  a clinical trial as, in their                                                               
opinion, providing the best treatment  for an individual patient.                                                               
Dr.  Anderson stressed  that  clinical trials  are  a formal  and                                                               
scientific  way to  test  whether  a new  treatment  is safe  and                                                               
effective and better than existing treatments.                                                                                  
                                                                                                                                
DR.  ANDERSON said  the  physicians and  hospitals  in Alaska  do                                                               
support clinical  trials; they  have over 50  trials open  in the                                                               
state  for patients  but, as  has been  mentioned, only  about 40                                                               
patients per year  enroll. There are many  reasons why enrollment                                                               
is low;  some include lack of  knowledge or interest on  the part                                                               
of either the  patient or the physician, or  lack of availability                                                               
of  an appropriate  trial for  the patient.  However, a  critical                                                               
barrier also  is lack of  insurance coverage or fear  by patients                                                               
that they will  lose coverage if they enroll in  a study. Passage                                                               
of this bill  will clearly remove an important  barrier to access                                                               
to  clinical  trials;  it will  result  in  physicians  providing                                                               
improved care to  their patients, reduce the burden  of cancer in                                                               
the population and help patients  to stay in Alaska for state-of-                                                               
the-art care.                                                                                                                   
                                                                                                                                
She referred members to a  position paper published by the Denali                                                               
Oncology Group for additional information.                                                                                      
                                                                                                                                
1:59:25 PM                                                                                                                    
KRISTA  RANGITSCH, representing  herself,  is  a cancer  research                                                               
nurse  at Providence  Alaska Medical  Center, Anchorage,  AK, and                                                               
supports  SB 10.  Patients  are  referred to  her  office when  a                                                               
clinical  trial  is  recommended  by  a  physician  as  the  best                                                               
treatment option; part  of her discussion with  the patient about                                                               
the study  includes informing them  that their  insurance company                                                               
may not  cover some or all  of the routine costs  associated with                                                               
treating their  cancer while  on the  study. Her  office strongly                                                               
encourages  all  patients  to find  out  what  their  [insurance]                                                               
policy says about clinical trial  coverage, but this is the stage                                                               
at which  she finds  they encounter the  majority of  barriers to                                                               
enrollment. She  added that people  go through a  lot emotionally                                                               
and financially  when they  are diagnosed  with cancer;  the last                                                               
thing they should have to  worry about is whether their insurance                                                               
will cover a clinical trial that  the physician feels is in their                                                               
best interests. One of the  ever-increasing reasons that patients                                                               
are not enrolling  in clinical trials is the lack  of coverage or                                                               
the fear  that they will not  be covered. In many  instances, due                                                               
to the  severity of the  cancer and  the need to  begin treatment                                                               
immediately, there just isn't enough  time to investigate whether                                                               
an insurance company  will cover the costs or to  get through the                                                               
carrier's determination process.                                                                                                
                                                                                                                                
In closing,  she said,  if insurance  companies were  mandated to                                                               
cover routine  care costs associated  with a clinical  trial, she                                                               
is  pretty confident  that  many  more people  would  be able  to                                                               
participate  in the  clinical trials,  which  would increase  the                                                               
likelihood of  improved cancer treatments, maybe  someday leading                                                               
to a cure.                                                                                                                      
                                                                                                                                
2:01:45 PM                                                                                                                    
DOUGLAS  BLAYNEY, Medical  Oncologist, President  Elect, American                                                               
Society  of  Clinical  Oncology (ASCO),  Professor  of  Medicine,                                                               
University of Michigan, Ann Arbor,  MI, thanked the committee for                                                               
allowing him  to testify. He said  he knows both Dr.  Stewart and                                                               
Dr.  Anderson  and believes  Alaska  is  fortunate to  have  such                                                               
articulate  and  caring  physicians.  He wanted  to  address  two                                                               
questions that  came up today,  the first by Senator  Dyson about                                                               
denied  routine  care  costs.  At  ASCO they  see  a  variety  of                                                               
questions  that  come  in from  members  throughout  the  states.                                                               
Sometimes when a patient is known  to be on a clinical trial, the                                                               
insurance company  or third-party carrier will  deny coverage for                                                               
things such as pain medicines,  radiation therapy, which might be                                                               
used to  reduce pain  or fluid collection  that may  be necessary                                                               
for lung cancer patients. These  routine things physicians do for                                                               
cancer patients whether they are  involved in a clinical trial or                                                               
not, are sometimes  denied. He thinks it is  important to include                                                               
the provision in  the bill that requires carriers  to continue to                                                               
pay for the  routine patient care costs for  patients on clinical                                                               
trials.                                                                                                                         
                                                                                                                                
He also  mentioned that phase  4 clinical studies are  often used                                                               
for  drugs that  are  approved and  widely  used like  Tamoxifen,                                                               
which has  been approved  for use  in breast  cancer for  over 20                                                               
years. ASCO was recently involved  in a clinical study that found                                                               
certain   antidepressants  negate   the  effects   of  Tamoxifen.                                                               
Tamoxifen  needs  to  be  converted  in the  body  to  an  active                                                               
substance and  some antidepressants, but not  others, prohibit or                                                               
impede  this  conversion,  which renders  Tamoxifen  ineffective.                                                               
Without  the  use  of  a  phase 4  study,  they  would  not  have                                                               
discovered  that;  so he  strongly  encouraged  the committee  to                                                               
consider coverage of phase 4 studies.                                                                                           
                                                                                                                                
Finally,  regarding  phase 1  clinical  trials,  he reminded  the                                                               
members that they  are talking about patients  with cancer; phase                                                               
1  drugs  being   tested  in  cancer  patients   are,  almost  by                                                               
definition, being  given with  therapeutic intent.  He encouraged                                                               
them to  retain the provision for  coverage of phase 1  trials in                                                               
SB 10.                                                                                                                          
                                                                                                                                
2:06:02 PM                                                                                                                    
HANNAH BRYCE SMITH, a Cancer  Research Nurse working at Fairbanks                                                               
Memorial  Hospital, Fairbanks,  AK,  was authorized  to speak  on                                                               
behalf of one of her patients  about a situation they bumped into                                                               
with her  insurance company. The  patient was diagnosed  with and                                                               
treated for  breast cancer  and was  looking for  alternatives to                                                               
prevent the recurrence of her  breast cancer. Researching online,                                                               
she found quite  a few clinical trials that were  open; she spoke                                                               
with her  physician about it  and her physician  recommended that                                                               
she enroll for  one in particular. The  physician's office called                                                               
her insurance  company and was told  that any tests and  any care                                                               
given to  her while on the  clinical trial would not  be covered.                                                               
The physician's  office sent the  insurance company  the protocol                                                               
and  called  again to  explain  that  they  were not  asking  the                                                               
insurer to pay  for any drugs or anything  experimental, but were                                                               
again told that  her insurance would not pay for  anything if she                                                               
elected  to  participate  in  a clinical  trial.  After  a  third                                                               
unsuccessful  attempt, the  physician called  Ms. Smith's  office                                                               
and told  her that the patient  would not be able  to participate                                                               
because she needed her insurance  coverage to pay for the routine                                                               
tests.                                                                                                                          
                                                                                                                                
When Ms.  Smith called  and tried to  explain the  situation more                                                               
thoroughly, they  refused yet again,  saying that  their policies                                                               
do not  pay for  any experimental  procedures. She  repeated that                                                               
they were not being asked  to pay for anything experimental, that                                                               
this was a phase 3 trial  testing the efficacy of three different                                                               
types  of  drugs;  she  was referred  to  their  case  management                                                               
service, which also refused to  authorize payment. At that point,                                                               
she asked the  company to submit that denial to  her in a written                                                               
statement that  she could  use as  part of  the evidence  she was                                                               
putting together for the legislature  about barriers to patients'                                                               
participation in  clinical trials. Two days  later they contacted                                                               
her  to ask  for more  information about  the clinical  trial and                                                               
then  came back  with  an authorization  to pay  for  all of  the                                                               
patient's  routine  standard-of-care   tests.  The  patient  then                                                               
enrolled in  the clinical trial  and moved forward; but  when she                                                               
considers the amount of time  that went into getting approval for                                                               
her to do this, it is  clear that insurance issues present a huge                                                               
barrier.                                                                                                                        
                                                                                                                                
MS.  SMITH said  she  was  born in  Fairbanks  and  is trying  to                                                               
convince patients that  they can stay in Fairbanks  and still get                                                               
state-of-the-art  cancer care,  but  lack of  access to  clinical                                                               
trials is a huge barrier to keeping people in the interior.                                                                     
                                                                                                                                
2:10:17 PM                                                                                                                    
PAULA  CALL, representing  herself,  is a  breast cancer  patient                                                               
involved in  a phase 3  trial. Her insurance company  has covered                                                               
most  of her  routine treatment;  she could  not have  considered                                                               
participating without their agreement to  do so. She is comforted                                                               
to know she  has been receiving the best  drug treatment possible                                                               
to prevent  a recurrence  of her cancer  and feels  strongly that                                                               
this  bill must  be  passed.  Her situation  would  have taken  a                                                               
different  course if  her  insurance company  had  not agreed  to                                                               
cover this.                                                                                                                     
                                                                                                                                
ANGELA  VER  PLOEG, representing  herself,  is  a cancer  patient                                                               
involved  in  a clinical  trial.  She  was first  diagnosed  with                                                               
breast  cancer  25  yrs  ago;  since  that  time,  her  brothers'                                                               
daughters  have had  breast cancer.  Ms. Ver  Ploeg's cancer  has                                                               
returned  and she  is  afraid that  her nieces  will  have to  go                                                               
through it  too, that their  cancers will return. She  hopes that                                                               
by  that time,  through  clinical trials  and research,  medicine                                                               
will have better  answers for them than it has  for her. She very                                                               
much wants  to encourage the  continuation of clinical  trials to                                                               
promote research so they can find a cure for cancer.                                                                            
                                                                                                                                
2:14:39 PM                                                                                                                    
DR. MICHAEL  J. O'CONNELL, Associate Chairman,  National Surgical                                                               
Adjuvant Breast  and Bowel Project,  Pittsburg, PA,  Professor of                                                               
Oncology  Emeritus  at  the  Mayo  Clinic  College  of  Medicine,                                                               
Rochester, MN ,  has practiced medical oncology for  33 years. He                                                               
said the previous  testimony by all of the  medical personnel was                                                               
extremely articulate and very accurate  and he agreed with all of                                                               
the points  that had been  made; he  wanted to briefly  expand on                                                               
three of those points for the committee's consideration.                                                                        
                                                                                                                                
First,  a statement  was made  that clinical  trials provide  the                                                               
best  treatment for  cancer  patients and  that  is something  he                                                               
definitely believes. The clinical  trials involve a protocol that                                                               
outlines the specific eligibility  criteria, in other words, what                                                               
types of  patients would be  best suited for treatment  with that                                                               
particular  regimen;  in addition,  they  outline  the dosing  of                                                               
chemo-therapy or  radiation therapy and dose  modifications based                                                               
upon the  side-effects that might  occur. So  it is not  a single                                                               
physician  who is  making these  judgments; because  of the  peer                                                               
review  process  that goes  on  in  the development  of  clinical                                                               
trials,  there is  actually an  improvement in  the selection  of                                                               
patients,  the methods  of treatment  and the  evaluation of  the                                                               
outcomes.  Scientific peer  review is  an important  component of                                                               
why clinical trials  do provide the best  treatment. In addition,                                                               
patient safety  is paramount and  is also subjected to  review by                                                               
institutional review  boards consisting  not only  of physicians,                                                               
but of lay  personnel and others to ensure  that the risk/benefit                                                               
ratio  of  any particular  clinical  trial  is in  the  patients'                                                               
favor.  As has  been  commented previously,  clinical trials  may                                                               
represent  the  only  treatment option  available  once  standard                                                               
therapy  has failed  to be  effective  for a  given patient  with                                                               
cancer.                                                                                                                         
                                                                                                                                
DR. O'CONNELL  continued; the second point  regards the statement                                                               
that  the  standard  care  for most  cancers  has  actually  been                                                               
established  by  the  results  of clinical  trials  and  this  is                                                               
definitely true. They provide scientific  evidence with regard to                                                               
the  side-effects  associated   with  those  treatments.  Another                                                               
important point is that clinical  trials have indicated that some                                                               
treatments  are  very toxic  or  ineffective  and some  of  these                                                               
treatments are  very expensive and  have contributed to  the rise                                                               
in health  care costs. He said  one example he would  point to is                                                               
the use of high-dose chemo-therapy  and bone marrow transplant in                                                               
the treatment  of patients with  metastatic breast  cancer, which                                                               
was  practiced  in the  United  States  for  a number  of  years.                                                               
Through  randomized  clinical  trials comparing  this  toxic  and                                                               
expensive treatment  to more standard  therapies, it  was clearly                                                               
shown that there  was no benefit with the  bone marrow transplant                                                               
and  high-dose chemo-therapy;  as a  result the  treatment is  no                                                               
longer used, thus saving patients the toxicity and expense.                                                                     
                                                                                                                                
Finally,  he   believes  that   from  the   insurance  companies'                                                               
standpoint, it  is very important  that they only be  required to                                                               
pay expenses that would normally  be incurred in routine clinical                                                               
practice. Tests  and procedures that are  considered experimental                                                               
and non standard-of-care  must be funded by  research dollars and                                                               
the  studies' sponsors  and  not passed  along  to the  insurance                                                               
companies. This  is accomplished by incorporating  designation of                                                               
any  experimental aspects  of  the protocol  in  the peer  review                                                               
process  and  he  fully  supports   not  passing  along  research                                                               
expenses to the insurance industry.                                                                                             
                                                                                                                                
In conclusion,  he said,  he also agrees  that lack  of insurance                                                               
coverage for routine  costs of cancer clinical trials  is a major                                                               
barrier that prevents  patients from receiving the  best care and                                                               
contributing to  knowledge that will improve  future outcomes and                                                               
he  strongly supports  the legislation  before  the committee  to                                                               
require  insurance  coverage under  the  conditions  he has  just                                                               
discussed.                                                                                                                      
                                                                                                                                
2:20:15 PM                                                                                                                    
EMILY  NENON,  Alaska  Government  Relations  Director,  American                                                               
Cancer Society,  Cancer Action Network,  Anchorage, AK,  spoke in                                                               
support  of  SB 10.  As  an  organization,  their mission  is  to                                                               
eliminate cancer  as a major  health problem and  clinical trials                                                               
are  a  key part  of  realizing  that  mission. She  thanked  the                                                               
committee for  taking the time  to get so much  information about                                                               
this issue on the public record;  the bill that is before them is                                                               
a  comprehensive education  effort to  increase participation  in                                                               
clinical trials  in Alaska  and removing this  one barrier  is an                                                               
important step. This bill will  apply to a significant percentage                                                               
of the insured population in the state; Medicare and some self-                                                                 
insured  plans already  provide  this coverage.  In closing,  she                                                               
mentioned  that the  cost of  routine care  provided in  clinical                                                               
trials is comparable to the  cost in traditional therapy and said                                                               
she would  be happy  to share  a fact sheet  put together  by the                                                               
American  Cancer  Society, which  looks  at  a number  of  cross-                                                               
studies that have been done on this issue.                                                                                      
                                                                                                                                
2:22:54 PM                                                                                                                    
CLAIRE WADDOUP, representing herself, is  a cancer patient in the                                                               
care of  Dr. Jeanne  Anderson. She feels  that she  has benefited                                                               
from the results of previous clinical  trials and wants to pay it                                                               
back   by  participating   in  clinical   trials.  She   strongly                                                               
encouraged the legislature  to pass SB 10  including coverage for                                                               
all phases of clinical trials.                                                                                                  
                                                                                                                                
2:24:03 PM                                                                                                                    
CHAIR  DAVIS  closed public  testimony.  She  said she  does  not                                                               
intend  to  pass the  bill  out  at this  time  but  is ready  to                                                               
entertain discussion.                                                                                                           
                                                                                                                                
CHAIR DAVIS thanked  all of the people who testified  on the bill                                                               
and expressed  her hope that  the legislature will  be successful                                                               
in passing it this year.                                                                                                        
                                                                                                                                
2:25:05 PM                                                                                                                    
SENATOR  DYSON said  this issue  seems  like a  "no brainer"  and                                                               
wants to  understand why the  insurance companies have  taken the                                                               
position that  they seem  to have  taken. He said  he is  glad to                                                               
support this  bill, but feels as  if he is missing  something and                                                               
would  like  to  hear  from   representatives  of  the  insurance                                                               
industry.                                                                                                                       
                                                                                                                                
CHAIR  DAVIS  said  the  bill  has referrals  to  the  Labor  and                                                               
Commerce  and  the Finance  committees;  so  maybe the  insurance                                                               
industry will choose to testify  for one of those committees. She                                                               
noted that there is no fiscal note with the bill.                                                                               
                                                                                                                                
SENATOR  THOMAS  responded to  Senator  Dyson's  query about  the                                                               
insurance companies. He said when he  was sitting as a trustee on                                                               
the board  of a health  plan, the only  reason he ever  heard for                                                               
the  insurance industry's  reluctance  to pay  for  this type  of                                                               
thing was their belief that  the medical community wanted as much                                                               
covered  by insurance  as possible  because insurance  pays more,                                                               
which brings in money to build more hospitals and centers.                                                                      
                                                                                                                                
2:27:49 PM                                                                                                                    
SENATOR DYSON  suspects there are  a lot of  financial incentives                                                               
for things;  but he  is interested  that the  insurance companies                                                               
would deny payment  for routine things they have to  pay for even                                                               
if a  person is not  on a clinical  trial. He suspects  that they                                                               
don't  want  to  take  fiscal responsibility  for  any  potential                                                               
adverse  effects; which  would indicate  that  the industry  must                                                               
think  there is  a  record of  people  participating in  clinical                                                               
trials  who  have  had  some  bad results  that  had  a  negative                                                               
financial impact  on the carrier. He  said he would like  to know                                                               
if there is some track record.                                                                                                  
                                                                                                                                
2:29:32 PM                                                                                                                    
CHAIR DAVIS closed testimony on the  bill and said she will bring                                                               
SB 10 back on Friday with bills previously heard.                                                                               

Document Name Date/Time Subjects
Letters for or against.PDF SHSS 2/18/2009 1:30:00 PM
SB 10
Backup doc for sb 10.PDF SHSS 2/18/2009 1:30:00 PM
SB 10