Since Medicare planned to severely restrict coverage of the controversial Alzheimer’s medicine Aduhelm, the agency has received a torrent of passionate appeals from all corners of the country.
Patient advocacy organisations urged that the medicine be covered by the government insurance programme. Many Alzheimer’s researchers and clinicians expressed concern about the widespread use of a drug that has an unknown benefit and significant safety implications.
Medicare authorities made their final decision on Thursday, according to a press release. Despite the fact that Aduhelm has been authorised for use in about 1.5 million individuals by the Food and Drug Administration, Medicare will only reimburse it for patients who get it as participants in a research study.
C.M.S. Administrator Chiquita Brooks-LaSure said the decision was made to protect patients while gathering data to determine whether Aduhelm, an expensive monoclonal antibody given as a monthly infusion to patients with Alzheimer’s disease, could actually benefit them by slowing the pace of their cognitive decline. “We believe that Aduhelm has the potential to help patients,” Brooks-LaSure said.
It is the responsibility of the Civilian Medical Services to ensure that the procedure is appropriate and required, Ms. Brooks-LaSure said in an interview on Thursday. Her organisation received around 10,000 comments on its website, with “the great majority” in support of “truly restricting coverage of Aduhelm to a fairly constrained area so that we could continue to review its suitability for the Medicare population,” she added.
A key concern for Medicare has been how to cope with additional Alzheimer’s medications that were comparable to Namenda, some of which are expected to be evaluated for FDA approval in the near future. Medicare had said in a proposal in January that it would cover them in the same manner as it covered Aduhelm since it normally made coverage decisions for whole classes of pharmaceuticals.
However, in response to concerns expressed by both specialists and advocacy organisations, Medicare officials said on Thursday that they would not automatically apply the same limits to each new medicine. If, unlike in the case of Aduhelm, the Food and Medicine Administration concludes that there is compelling evidence that a prescription might benefit patients, Medicare would pay the drug for all eligible patients with the sole stipulation that the patients’ experiences be documented.
This is a very rare choice for Medicare, which nearly typically automatically pays for pharmaceuticals that have been authorised by the Food and Drug Administration, at least for the medical conditions listed on the labels.
Aduhelm’s journey, on the other hand, has been somewhat peculiar. During its approval of Aduhelm in June, the Food and Medicine Administration noted that it was uncertain if the drug was useful. The drug is intended for adults with mild Alzheimer’s-related cognitive loss.
According to Tamara Syrek Jensen, the director of coverage and analysis for the Medicare agency’s Center for Clinical Standards and Quality, “the manufacturers will have to come to us with how they’re going to include all patients that represent the Medicare population, and how they’re going to ensure that all of these patients are receiving appropriate medical treatment and monitoring.
The Food and Medicine Administration has also ordered Biogen to run another clinical study to assess if the drug showed any indication of benefit. However, the agency has said that Aduhelm will remain accessible to patients throughout the years it will take for the experiment to be completed. Participants in Biogen’s clinical study would be reimbursed for their expenses under the terms of Thursday’s ruling.
The FDA’s full approval of another drug in that class, which typically requires two convincing clinical trials, would signal to Medicare officials that there is compelling evidence that the drug can benefit patients and its benefits outweigh its risks, according to the officials. If another drug in that class were to win full, or traditional, FDA approval, which typically requires two convincing clinical trials, that would signal to Medicare officials that there is persuasive evidence that the drug can help patients and that its benefits outweigh its risks, the officials said.
According to Ms. Jensen, “if a drug were approved under traditional approval tomorrow, we would be ready.” She went on to say, “such a medication would be available “in a real-world setting” and that patients who received the medication would be enrolled in a registry or another programme that would allow Medicare to monitor whether they were benefiting from the medication.
In the words of Ms. Brooks-LaSure, Medicare’s administrator, “there is such a need to truly understand what is occurring that we want to make sure that we are giving all of that extra or necessary clinical care.” The researchers will ensure that they keep track of what is occurring in order to further improve the evidence for a therapy, they said.