The CMS has renewed its position on Alzheimer’s future drugs that also target the amyloid proteins that are likely to cause the disease. If these drugs undergo a traditional approval process rather than an accelerated approval process, patients will not need to be in a randomized, controlled trial.
Instead, they may be on a patient register that monitors how patients behave while taking medication. Unlike randomized trials, none of the patients needed a placebo.
“We’re really looking at real-world data to make sure all patients have the same benefits,” said Tamara Sirek Jensen, CMS Clinical Standards and Quality Office Coverage and Analysis Team Leader.
The decision takes effect immediately, which means that patients who want to take Aduhelm must pass FDA-tested testing. Biogenic plans Start screening patients in May for a post-marketing trial that may meet CMS coverage standards.
Wallpaper: For the final definition, the CMS reviewed more than 10,000 comments and 250 peer-reviewed reviews.
At the time it was proposed, critics from the pharmaceutical industry and patient advocacy groups – some of whom receive a small percentage of funding from pharmaceutical companies – Said the narrow coverage offered by Medicare Aduhelm effectively discourages the most qualified patients from taking the drug, which costs about $ 28,000 annually due to stringent clinical trial requirements.
They also cited the fact that the CMS decision functionally violates FDA approval. Medication. Aduhelm, also known by the scientific name aducanumab, received accelerated approval last summer. Conditional approval requires Biogen to conduct a fourth, post-market randomized study to prove that the drug is beneficial to patients.
Რa is the following: Biogen is set Start screening patients His mandate is for a Phase IV trial for Aduhelm next month, in addition to two ongoing trials underway on the drug. One of these trials is observational, while the other is a continuation of the late-stage clinical trial.
Medicare will cover Adhelm only for those enrolled in clinical trials
Source link Medicare will cover Adhelm only for those enrolled in clinical trials