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After the Centers for Medicare & Medicaid Services (CMS) released its guidance for the Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act of 2022 (IRA) on June 30, John Murphy, Chief Policy Officer for the Biotechnology Innovation Organization (BIO), made the following statement:
“As we have stated in the past, the Medicare price setting provisions of the IRA will have a profound and lasting negative impact on innovative medicine development and access in the U.S. Nothing in the final guidance released today will change that. Unfortunately, patients—and their loved ones—will be robbed of the future medical innovation that they’re so desperately waiting for as this law rolls out.
“CMS took some limited steps in the final guidance that will modestly improve the environment around transparency. Although much more could have been done.
“Notably, we were pleased to see CMS take the reasonable position of allowing affected manufacturers to control some of their own disclosures and confidentiality protections surrounding the negotiation process.
“Similarly, CMS clarified the ability of interested parties and patients to have a voice in the negotiation process. Moreover, Part D plans are now on notice that MFP-selected drugs are going to have to be accessible to patients once negotiated. Although, it remains unclear how much CMS will increase formulary review to ensure unreasonable utilization management is not implemented as a barrier to access.
“Yet the Agency missed the opportunity to repair damage to the rare disease community and support more meaningful investment in orphan research by allowing new but unapproved orphan designations to retain the orphan exclusion. We believe CMS has the authority and discretion to make this clarification and to support rare disease patients.
“BIO and our members will continue to pursue all avenues available to protect patient access to medicines and to ensure the U.S. remains an open market for innovation and investment.”
