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Congress is back—and so is Good Day BIO, with the biggest headlines from last week: CMS released revised guidance on the Inflation Reduction Act drug price controls, and FDA granted traditional approval to LEQEMBI. (689 words, 3 minutes, 26 seconds) |
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CMS price controls guidance a ‘missed opportunity’ for innovation, patients |
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Centers for Medicare & Medicaid Services (CMS) released revised guidance on the Drug Price Negotiation Program—and BIO explained why it’s a missed opportunity.
Catch up: The Inflation Reduction Act (IRA) permits CMS to “negotiate” the prices of certain drugs covered by Medicare, but the terms make it clear the agency will actually be establishing price caps. After soliciting comments from stakeholders (including BIO), CMS released revised guidance on June 30.
The revised guidance includes small improvements—such as “limited steps” giving manufacturers some confidentiality during the process and patients a chance to weigh in, says BIO Chief Policy Officer John Murphy. The guidance also says Part D plans must provide access to selected drugs.
But: CMS “missed the opportunity to repair damage to the rare disease community and support more meaningful investment in orphan research,” continues Murphy.
The IRA exempts orphan drugs for rare diseases—but only if they’re used for one indication. Researchers often find new cures by using orphan drugs for other indications, but they'll essentially be penalized if they do that now.
BIO’s overall assessment: “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,” says Murphy. “Patients—and their loved ones—will be robbed of the future medical innovation that they’re so desperately waiting for.”
What’s next: “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,” according to Murphy.
Read the full statement. |
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FDA grants traditional approval to Alzheimer’s drug LEQEMBI |
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The decision sets the stage for broader Medicare coverage of the groundbreaking Alzheimer’s treatment, though the registry requirement remains.
The news: The Food and Drug Administration (FDA) granted traditional approval to LEQEMBI, the Alzheimer’s drug developed by Eisai and Biogen. The drug was granted accelerated approval in January.
Why it matters: LEQEMBI is the first in a new class of Alzheimer’s drugs to receive traditional approval. The decision follows clinical trials showing LEQEMBI reduced cognitive decline by 27% in early-stage Alzheimer’s patients.
A first step toward access: The decision sets the stage for as many as 1 million Alzheimer’s patients to access the treatment. Centers for Medicare and Medicaid Services (CMS) recently confirmed Medicare would only cover drugs in this class if they receive traditional approval and patients participate in a registry, and CMS announced expanded coverage of the drug.
But: Medicare coverage is still conditional on physicians entering patient data in a registry— “an unnecessary and potentially harmful barrier,” according to the Alzheimer’s Association.
What they’re saying: “Today marks a breakthrough in the treatment of Alzheimer’s,” said Biogen CEO Christopher Viehbacher. “We are proud that the results of Eisai’s Alzheimer’s disease research over the past 40 years have been recognized and delivered to people living with this disease,” said Eisai CEO Haruo Naito.
What’s next: LEQEMBI is administered intravenously after specific tests, and Eisai is assisting with training for these tests and patient access to enable 100,000 Americans to receive LEQEMBI by 2026. |
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