The latest — and perhaps last — blow to the once-promising Alzheimer’s drug Aduhelm is its makers, Biogen says It will stop collecting data on patients who are using it. Biogen said it was a result of Medicare and Medicaid severely limiting coverage to the point that there were no large numbers of patients to follow. Even after Biogen halved its original $56,000-a-year price, there were few recipients of the drug, which is designed to attack a protein that some scientists believe is linked to cognitive decline, whether at public payments. is also a commercial payer.
Unless something changes, we’ll never know whether this drug — or the more promising beta-amyloid-directed monoclonal antibodies currently in late stages of development — could help the thousands with Alzheimer’s disease of Americans. Many people who do qualify for Aduhelm also can’t get it anymore, because Medicare and Medicaid will only cover it if patient data is collected — which is exactly what Biogen says it will stop doing.
Narrow, more risky than Aduhelm: With more and more new drugs, including life-saving gene therapies, the danger that these drugs will never actually reach the people who need them is increasing, as Medicaid, Medicare and others did not pay their high costs.
But the door to change is opening; recently, a rule limiting Medicare and Medicaid Set a price for each drug, should disappear; institutions are allowed to set price ranges. This means they can more easily start entering into value-based drug purchase agreements, where there is a link between compensation and performance.
While it may be too late for Ahuhelm, this arrangement could still be used for other, more promising beta-amyloid-directed monoclonal antibodies, which are currently in late stages of development. This may be the only way to ensure access to these drugs and the patients they can help.
Currently, the Centers for Medicaid and Medicare Services is the federal program that runs Medicare and operates the Medicaid program in partnership with the states, declared If approved by the FDA, the entire class of beta-amyloid-directed monoclonal antibodies would be subject to restricted reimbursement like Aduhelm. For example, all accelerated approvals are subject to post-market clinical trials, similar to the stringent requirements imposed on Aduhelm. Even beta-amyloid-targeted Alzheimer’s drugs that pass the routine approval process must enter into “evidence development coverage” protocols, which means that data collection in patient registries after approval will be mandatory.
But all this does is put more barriers in front of the patient, and it doesn’t actually do anything effective with the data that will be collected.
Value-based pricing, on the other hand, will measure cognitive decline or progress in Alzheimer’s patients with the drug, so adjustments can be made to the acceptable price range for the product. Payers like Medicaid and Medicare can also get reimbursed from drug companies if the patient’s life doesn’t improve.
That’s a big departure from the Boston-based nonprofit Institute for Clinical and Economic Review and others that claim to embrace value-based pricing. Last year, ICER conducted a preliminary analysis of Aduhelm based on clinical trial data. ICER concluded that cost-effective price benchmark Prices for early Alzheimer’s patients range from $3,000 to $8,400 a year, well below the current price of $28,000. But ICER’s assessment is not based on real-world evidence outside of clinical trials, as is the case with any true value-based pricing agreement.
Aduhelm’s ship may have sailed with the baggage of the FDA approval controversy, the recent departure of Biogen’s CEO and now the end of tracking patient data. However, the value-based arrangement could work well for other beta-amyloid-directed mAbs, including Biogen/Eisai’s Lecanemab, Roche’s donanemab and Roche’s gantenerumab — all of which are currently in human trials.
There is no doubt that this will be a major undertaking, especially logistically. Also, getting Medicare and Medicaid to buy isn’t easy. However, there is precedent for institutions looking to pursue value-based agreements.This Center for Medicare and Medicaid Innovation The right to test models that modify Medicare payments for certain high-priced drugs.
And, to further illustrate, in 2017 when the FDA approved the CAR-T therapy Kymriah (tisagenlecleucel) — for acute lymphoblastic leukemia — it was accompanied by the announcement of a new outcomes-based agreement with Medicare and Medicaid, in The agencies will only pay for Kymriah if the patient responds by the end of the first month. Medicare and Medicaid without disclosing the reason Quietly withdrew from that agreement.
Perhaps the large unmet need in Alzheimer’s disease will prompt Medicaid and Medicare to consider alternative reimbursement methods. No one should pay for things that don’t work, including taxpayers and people taking these drugs. Value-based pricing prevents this.
Value-based pricing could have shown us with more certainty the actual level of effectiveness of Aduhelm. Maybe it’s worth paying some for that; and value-based contracts are the only way to get around this.
We are at the beginning of a huge drug pipeline, including gene therapy and other life-changing medicines, for diseases that were long considered incurable. Having a contract model with pricing based on outcome data is the only way to ensure that those who really need these drugs get them — and only continue to take them if they work.
