Embed Size (px)
Citation preview
State Laws Concerning Clinical Trials State Laws Concerning Clinical Trials and Off-Label Drug Use for and Off-Label Drug Use for Cancer PatientsCancer Patients
Kristianna G. Pettibone, M.S.1
Raedell Wallace 1
Randi Field, J.D. 1
Regina el Arculi, M.A. 2
Presented at the American Public Health Association's130th Annual Meeting and Exposition
Philadelphia, PA November 11, 2002
1 The MayaTech Corporation 2 National Cancer Institute
State CancerLegislative
Database Program
State CancerLegislativeDatabase Program
IntroductionIntroduction
Objective: To review state level insurance mandatesfor coverage of participation in clinical trials and off-label drug use.
Methodology: Data from the National Cancer Institute’s State Cancer Legislative Database (SCLD) were analyzed to determine the scope and content of state legislation addressing coverage of clinical trials and off-label drug use. State-level laws enacted by June 30, 2002 were analyzed.
State CancerLegislativeDatabase Program
BackgroundBackground
Clinical Trials
• According to the National Institutes of Health, a clinical trial is a research study to determine the safety and effectiveness of new drugs and therapies or to determine new ways to use existing treatments.
• Our research will focus on cancer treatment trials which are designed to test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
• In 1994, Rhode Island was the first state to enact a law requiring coverage of costs associated with participating in a clinical trial.
State CancerLegislativeDatabase Program
BackgroundBackground (continued)(continued)
Off-Label Drug Use
• According to the National Cancer Institute, off-label drug use refers to the use of an approved drug for any purpose, or in any manner, other than what is described in the drug’s labeling.
• A 1991 study by the U.S. General Accounting Office found that one-third of all drug administrations to cancer patients are off-label and more than half of cancer patients received at least one drug for an off-label indication.
• In 1989, Michigan was the first state to enact a law requiring coverage of off-label prescription drug use.
State CancerLegislativeDatabase Program
Phases of Clinical TrialsPhases of Clinical Trials (NIH, 2002)(NIH, 2002)
Phase I: Study testing a new drug/treatment for the first time in a small group (20-80 people) to determine safety, safe dosage range, and side effects.
Phase II: Study expanded to a larger group (100-300 people) to evaluate effectiveness and safety.
Phase III: Study further expanded to large groups (1000-3000 people) to confirm effectiveness, monitor side effects, compare it to common treatments, and collect information to enable safe use of drug/treatment.
Phase IV: Post-marketing studies conducted to gather additional information including drug risks, benefits, and optimal use.
State CancerLegislativeDatabase Program
States with Mandates for Coverage of States with Mandates for Coverage of Clinical Trials and Type of Insurer Clinical Trials and Type of Insurer AddressedAddressed
Individual and group insurers required to provide coverage.
Managed care and individual and group insurers required to provide coverage.
All states with laws addressing coverage of clinical trials require insurers to provide coverage of clinical trials. The type of insurer addressed by the law varies by state.
State CancerLegislativeDatabase Program
Phase I Phase II Phase III Phase IV0
2
4
6
8
10
12
Number of
States
Clinical Trial Phases CoveredClinical Trial Phases Covered
Coverage of certain phases of clinical trials varies by state.
* New Hampshire (Phase I and II) and Virginia (Phase I) require that coverage for certain clinical trials be decided on a case-by-case basis. These states are included in the counts above.
AZ
CA
MD
NH
VA
AZ
CA
GA
IL
LA
MD
NH
NM
RI
VA
AZ
CA
CT
GA
IL
LA
MD
NH
NM
RI
VA
AZ
CA
IL
LA
MD
NH
NM
RI
VA
State CancerLegislativeDatabase Program
Number of
States
Organizations Approved to Organizations Approved to Conduct Clinical TrialsConduct Clinical Trials
Each state requires that clinical trials be conducted by specified organizations in order to qualify for coverage.
AZ
CA
CT
GA
IL
LA
MD
NH
NM
RI
VA
AZ
CA
CT
IL
LA
NH
NM
RI
CT
GA
MD
RI
VA
AZ
CA
CT
LA
NM
AZ
CA
CT
LA
MD
NH
NM
RI
VA AZ
FDA: Food and Drug AdministrationNIH: National Institutes of HealthNCI: National Cancer Institute
DOD: Department of DefenseVA: Department of Veterans Affairs
State CancerLegislativeDatabase Program
Specific Conditions of Clinical Specific Conditions of Clinical Trial CoverageTrial Coverage
Personnel providing treatment are doing so within their scope of practice, experience, and training AND no clearly superior, non-investigational treatment exists AND data provide a reasonable expectation that the treatment will be at least as efficacious as a non-investigational treatment.
Data provide a reasonable expectation that the treatment will be at least as efficacious as a non-investigational treatment
No clearly superior, non-investigational treatment exists AND data provide a reasonable expectation that the treatment will be at least as efficacious as a non-investigational treatment.
Institutional Review Board (IRB) approval is required.
The laws in eight states explicitly require that certain conditions be met before coverage for clinical trials is provided.
State CancerLegislativeDatabase Program
Miscellaneous Notes on Mandated Miscellaneous Notes on Mandated Coverage of Clinical TrialsCoverage of Clinical Trials
• Rhode Island’s law is the only one that does not specifically require coverage of routine patient care costs, which typically include any costs or services usually covered by the policy.
• Reimbursement must be considered payment in full in Arizona and New Mexico.
• Georgia only requires coverage of clinical trials for dependent children.
• Vermont was not included in these data. The state has in place requirements similar to those addressed here, but has implemented them through regulation rather than legislation.
State CancerLegislativeDatabase Program
States with Mandates for States with Mandates for Coverage of Off-Label Drug UseCoverage of Off-Label Drug Use
Individual and group insurers and managed care insurers are required to provide coverage, if they provide coverage for prescription drugs in general.
Individual and group insurers and managed care insurers are required to provide coverage. Coverage is not contingent on the insurer providing coverage for prescription drugs in general.
Individual and group insurers are required to provide coverage, if they provide coverage for prescription drugs in general.
Twenty-six states have laws addressing cancer-specific off-label drug use.
State CancerLegislativeDatabase Program
USPDI AMADE AHFSDI DRUGDEX Medical Literature0
5
10
15
20
25
Number of
States
Authorities That Must Recognize or Authorities That Must Recognize or Recommend the Off-Label TreatmentRecommend the Off-Label Treatment
• Michigan, New Hampshire, and Oklahoma do not specify inclusion of a drug in a reference compendium as a condition of coverage.
USPDI: U.S. Pharmacopeia Drug InformationAMADE: American Medical Association Drug EvaluationAHFSDI: American Hospital Formulary Service Drug InformationDRUGDEX: Private drug evaluation listing
State CancerLegislativeDatabase Program
Medically Necessary ServicesMedically Necessary Services
Seventeen states require that insurers also provide coverage of any related, medically necessary services.
Medically necessary services covered.
Medically necessary services not covered.
State CancerLegislativeDatabase Program
Experimental or Contraindicated Experimental or Contraindicated Drugs Not CoveredDrugs Not Covered
Experimental and/or contraindicated drugs not covered.
Contraindicated drugs not covered.
No restrictions.
Twenty states do not require coverage of experimental and/or contraindicated drugs. Three states do not require coverage of contraindicated drugs. Three states have no restrictions
State CancerLegislativeDatabase Program
Deductibles, Copayments, or Deductibles, Copayments, or Coinsurance Requirements for Coinsurance Requirements for Off-Label Drug Use and Clinical TrialsOff-Label Drug Use and Clinical Trials
Deductibles, copays, or coinsurance requirements for off-label drug use may apply.
Deductibles, copays, or coinsurance requirements for clinical trials may apply.
Deductibles, copays, or coinsurance requirements for both off-label drug use and clinical trials may apply.
* Although Georgia’s law does not distinguish among deductibles, copayments, or coinsurance, the state has been included here, because its law states that general “cost-sharing arrangements” may apply.
Eleven states have laws that indicate that cost-sharing may apply to coverage of off-label drug use or clinical trials. Cost-sharing is not addressed in the legislation of the other states.
State CancerLegislativeDatabase Program
Enforcement and ReviewEnforcement and Review
• Four states—Arizona, Georgia, Louisiana, and New Mexico—that mandate coverage of clinical trials and seven states—Alabama, Georgia, Illinois, Indiana, Kansas, Kentucky, and Minnesota—that mandate coverage of off-label drug use indicate that a State Commissioner of Insurance (or similar entity) is responsible for enforcement of these provisions.
State CancerLegislativeDatabase Program
Miscellaneous Notes on Mandated Miscellaneous Notes on Mandated Coverage of Off-Label Drug UseCoverage of Off-Label Drug Use
• Eight states—California, Colorado, Maryland, Nevada, New
Jersey, North Dakota, Oregon, and Tennessee—have enacted off-label drug use laws that do not explicitly address cancer treatment; instead they refer to life-threatening conditions or generic off-label indications. Because they are not cancer-specific, they fall outside the scope of the SCLD Program and are not included in this analysis.
• Ohio has off-label drug use laws that address both cancer-specific use and generic use.
