The new drug Alduhelm manufactured by Biogen has recently gained approval from the Food and Drug Administration (FDA) for usage in the USA
However, the high price of the drug, $56,000, has already sparked significant controversies as its effectiveness is not yet been proved in slowing down the deterioration of the brain and cognitive function associated with Alzheimer’s.
The new $56000 Alzheimer’s Drug Alduhelm Might Actually Be Costlier; Experts Look For Answers
The price of Alduhelm is only a small portion of what the patients and the insurance companies have to pay to get access to the initial phases of Alzheimer’s treatment.
The real cost of treatment:
As per the explanation of the experts, patients will need to undergo multiple expensive tests to detect the presence of the protein accumulation in their brain, which is the main target for the drug to show its effectiveness.
Moreover, there are other costs associated with the treatment that will accrue. These include the fees of the doctors, the bills from the medical facilities that will administer the drug via IV mode, and bills from the imaging centers that will carry out the MRI and scans required to keep a watch on the side effects of treatment like swelling and bleeding of the brain.
There are numerous questions on how people will bear the expenditures of testing and medications that require clarification while the drug is all set to venture into the market in the following weeks.
Issues regarding the insurance;
There are speculations of disagreement occurring among the drug manufacturing company Biogen, the providers responsible for billing the patients, the Centers for Medicare and Medicaid Services (CMS), the private insurance companies, and the patients who actually pay the money.
The agency responsible for the monitoring of Medicare pays for all the drugs that are approved by the FDA, however, evaluation is required to determine the necessity and reasonability of the treatment and the diagnostic tests.
Prioritizing accessibility and affordability:
The effectiveness of Alduhelm was seen during the clinical trials.
It was successful in removing the sticky amyloid beat protein plaque accumulation in the brain, the characteristic feature of Alzheimer’s.
However, mixed results were obtained from two clinical trials that aimed at studying the effectiveness of the drug in slowing down the progression of the disease.
Currently, 6.2 million Americans are suffering from Alzheimer’s disease and the FDA has approved the use of the drug for all Alzheimer’s patients.
It is important to note that the approval does not exclude the use of monoclonal antibodies for those in the initial stages of dementia, identified as mild cognitive impairment.
This route of treatment was also studied by the manufacturer in the clinical trials of Alduhelm and it means that it is on the doctors to decide who receives the drug and who receives monoclonal antibody treatment.
At present, the speculations are that the private insurance companies and the CMS can limit the eligibility of such testing to the ones who are most likely to benefit from the tests.
The stance of the insurance companies:
The private health insurance companies follow the policy of the CMS while deciding whether or not to extend coverage for any new drug, tests, or medical procedures.
A spokesperson of the CMS states that the coverage for Alduhelm and the related tests are presently under review of the agency and soon, more information will be available.
According to David Allen, the spokesperson of America’s Health Insurance Plans, families pay more for the coverage of medicines prices that are very high.
Allen further emphasizes prioritizing accessibility and affordability that will be guided by experts and based on clear and concise clinical and scientific evidence.
The approval of the FDA does not clarify if the patients who seek the drug should first undergo screening for the accumulation of amyloid-beta in their brain, hence the decision for testing lies with doctors suggesting the drug, Medicare, and the private insurance companies