Recently, NEHI recently published a whitepaper outlining how the healthcare system can utilize value-based partnerships (VBPs) to create value for patients, payers, and drug manufacturers throughout the advent of new, highly targeted and successful oncology drugs. The report is a major milestone in the on-going debate about the cost of prescription drugs not only because it recommends a very clear path forward to implement VBPs more broadly, but also because the framework was agreed to by payers, drug companies, and PBMs. The latter point is an amazing feat as the public dialog gives no hints that these three parties are ever in agreement when it comes to drug pricing.
MassBio is a strong supporter of implementing VBP’s where appropriate as a means to ensure patients have access to breakthrough therapies and that drug manufacturers are rewarded for the decades of innovation and billions of dollars spent on R&D. We continue to advocate on the state level for new solutions that encourage VBPs between companies and payers here and believe this white paper can be a model.
The recommendations contained in this report from NEHI are worth exploring closely. NEHI’s release on the recommendations recaps them nicely:
- 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 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.
We understand that VBPs are not appropriate for every drug on the market, but for those that do warrant this approach, it’s clear we need to change some institutional processes both within biopharma companies and government to support their widespread adoption. We applaud NEHI for the leadership they’ve taken on this very important issue and are committed to continuing the conversation within the industry in Massachusetts. The Commonwealth has always been a pioneer in challenging the status quo, from gay marriage to universal healthcare, and we’re confident the industry here will continue that trend.
Stay tuned for more from us on this issue – it’s certainly going to be a topic of discussion at our Annual Meeting in March 2018 and throughout the year.