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Understanding the impact of state statutes on payer coverage for cancer treatments is important as treatment landscapes continue to evolve. Statutes are enacted state laws that may authorize administrative regulations. As of April 2024, 41 states have statutes related to coverage of oncology treatments. These statutes have a direct effect on a variety of stakeholders, including patients, providers, and payers. Policymakers in the majority of states have enacted statues that require coverage of off-label uses of drugs/biologics when specific criteria are met.

One critical aspect of the statutes discussed in the report is the use of clinical compendia as the basis for determining the medical appropriateness of off-label cancer treatments. As there is no federal law regarding coverage of off-label uses of medications in the commercial payer space, commercial payers’ coverage criteria (e.g., prior authorization use) varies across the states where payers operate. Payer policies may align with state statute, expand beyond statute, or be more restrictive. It may be complicated to keep track of where state statute would conflict with, and therefore, override a payer coverage policy. Statutes may refer to compendia using reference or authoritative language, or by name (e.g., American Hospital Formulary Service Drug Information, National Comprehensive Cancer Network [NCCN]: NCCN Drugs & Biologics Compendium [NCCN Compendium®]).

What Is in the report?

Avalere’s report provides an overview of state statutes on commercial payer coverage of drugs/biologics that have been (1) approved by the Food and Drug Administration and (2) recognized for additional off-label use in authoritative reference compendia for the treatment of cancer. Publicly available information current as of April 4, 2024, were used to review and analyze statutes in all 50 states, the District of Columbia, and Puerto Rico that apply to the process of how compendia are considered for determining coverage. It highlights how these statutes can vary, detailing which compendia are mentioned and any cancer-specific language.

The State Statute Drug Coverage Report answers key questions, including:

• Which states have statutes related to the use of compendia to determine coverage?
• Which states have cancer-specific statutes?
• Which compendia are recognized by each state in determining coverage and reimbursement?

The report provides an overview of state statutes in which coverage requirements are mentioned, and identifies if language confirms application to cancer, which compendia are used, how compendia are used, and if NCCN is referenced. This report serves as a supplement to other payer coverage tracking of drugs/biologics, as the statutes in this report may override individual drug/biologic policy coverage criteria. The goal of this report is to support reimbursement and coverage for drug/biologic therapies when used for the treatment of cancer; it may be of interest to life science companies who are supporting providers in patient cases of appeal for declined coverage.

This report is not an interpretation of individual treatment decisions, nor is it a recommendation for off-label usage or a guarantee of payer coverage. Notably, these are state-regulated statutes only and do not apply to self-funded ERISA plans. It does not constitute legal advice or opinion; rather, it is for general informational purposes only. This report can serve as an educational tool, providing insights into off-label oncology treatment policies from state perspectives. It is intended to help stakeholders navigate the complexities of using compendia to support coverage and reimbursement of cancer treatments.

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Avalere’s experts in commercialization, regulatory, and policy  strategy can help manufacturers, patient advocacy organizations, and other stakeholders analyze the statutes and access implications to off-label treatments and help develop strategies to mitigate delays in patient access to oncology treatments. This report offers comprehensive analysis along with recently updated state legislation.