Value-based contracting for biopharmaceuticals is in its early stages, and the consensus from experts convened by NEHI is that thoughtful experimentation of these contracts should proceed. This NEHI white paper recommends a combination of strategies to foster innovation and experimentation, address operational challenges, and advance policy measures, including appropriate legislative or regulatory relief.
Among the recommendations:
Various stakeholders, including the oncology community, payers, and biopharmaceutical manufacturers, should expedite efforts to improve collection of data and should develop patient-reported outcomes measures for cancer care.
The U.S. Food and Drug Administration should finalize guidance on the exchange of health care economic information on new, not-yet-approved products. NEHI also recommends that the FDA consider publishing specific guidance to allow communication about of off-label uses for cancer drugs, given the likelihood that drugs approved for use in one type of cancer are likely to be used for other cancer indications.
The Inspector General of the U.S. Department of Health and Human Services should create new safe harbors to the federal Anti-Kickback Statute to allow for various activities that can support value-based contracting. These activities, such as when biopharmaceutical companies help to ensure that patients adhere to medication, should not be construed as illegal inducements and should be allowed through value-based contracts without threat of legal sanction.
The Centers for Medicare and Medicaid Services should make appropriate exemptions under Government Best Price and related federal health program rules to allow for value-based contracting without triggering other price cuts and unreasonable losses for biopharmaceutical manufacturers. If CMS cannot achieve a regulatory solution, Congress should step in and revise the law accordingly.
Congress should direct the National Academy of Medicine to investigate new, long-term approaches to financing high-cost therapies for cancer and other diseases, as value-based contracting by itself will not address that the challenges that high-cost drugs pose for the financial sustainability of health care.
Following the release of this paper, NEHI hosted a webinar, Value-Based Contracting in Oncology: A Discussion on New Payment Arrangements, moderated by NEHI President and CEO Susan Dentzer and featuring Claire Brunken, Executive Director of Outcomes Projects at Novartis, and Dr. Michael Sherman, Chief Medical Officer, at Harvard Pilgrim Healthcare.