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State Laws Concerning Clinical Trials and Off-Label Drug Use for Cancer Patients Kristianna G. Pettibone, M.S. 1 Raedell Wallace 1 Randi Field, J.D. 1.

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Presentation on theme: "State Laws Concerning Clinical Trials and Off-Label Drug Use for Cancer Patients Kristianna G. Pettibone, M.S. 1 Raedell Wallace 1 Randi Field, J.D. 1."— Presentation transcript:

1 State Laws Concerning Clinical Trials and Off-Label Drug Use for Cancer 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's 130th Annual Meeting and Exposition Philadelphia, PA November 11, The MayaTech Corporation 2 National Cancer Institute State Cancer Legislative Database Program

2 State Cancer Legislative Database Program Introduction Objective: To review state level insurance mandates for 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.

3 State Cancer Legislative Database Program Background 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.

4 State Cancer Legislative Database Program Background (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.

5 State Cancer Legislative Database Program Phases of Clinical Trials (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 ( people) to evaluate effectiveness and safety. Phase III: Study further expanded to large groups ( 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.

6 State Cancer Legislative Database Program States with Mandates for Coverage of Clinical Trials and Type of Insurer Addressed 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.

7 State Cancer Legislative Database Program Number of States Clinical 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

8 State Cancer Legislative Database Program Number of States Organizations Approved to Conduct 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 Administration NIH:National Institutes of Health NCI:National Cancer Institute DOD:Department of Defense VA:Department of Veterans Affairs

9 State Cancer Legislative Database Program Specific Conditions of Clinical Trial 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.

10 State Cancer Legislative Database Program Miscellaneous Notes on Mandated Coverage 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.

11 State Cancer Legislative Database Program States with Mandates for Coverage 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.

12 State Cancer Legislative Database Program Number of States Authorities That Must Recognize or Recommend 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 Information AMADE: American Medical Association Drug Evaluation AHFSDI: American Hospital Formulary Service Drug Information DRUGDEX: Private drug evaluation listing

13 State Cancer Legislative Database Program Medically 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.

14 State Cancer Legislative Database Program Experimental or Contraindicated Drugs 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

15 State Cancer Legislative Database Program Deductibles, Copayments, or Coinsurance Requirements for Off-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.

16 State Cancer Legislative Database Program Enforcement 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.

17 State Cancer Legislative Database Program Miscellaneous Notes on Mandated Coverage 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.


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