‘People with Alzheimer’s Should Have the Same Opportunities as People with Other Diseases’
Next Avenue interviewed Harry Johns, CEO of the Alzheimer’s Association, on the decision to restrict coverage for the drug Aduhelm
Editor’s note: On April 7, 2022 the Centers for Medicare and Medicaid Services (CMS) announced a decision to limit the availability of Aduhelm to only those participating in clinical trials. A statement from the Alzheimer's Association has been added to the end of this story.
A clinician who cares for Alzheimer's patients was musing the other day, "just as summer follows spring," you can count on one thing in Washington: when the Food and Drug Administration (FDA) approves a drug, Medicare will always cover the cost for those they insure.
Not anymore. In January of 2022 — six months after the FDA approved the controversial Alzheimer's drug Aduhelm, the first new Alzheimer's treatment in 18 years and the first in a pipeline of promising treatments — the Centers for Medicare and Medicaid Services (CMS) made headlines and history. It blocked access to the drug to the vast majority of early stage Alzheimer's patients or those with mild cognitive impairment.
The CMS draft decision restricts coverage of Aduhelm (a monoclonal antibody that targets amyloid in the brain) and any FDA-approved drugs in this class with what's called evidence development. That means those drugs would be covered only for Medicare patients enrolled in qualifying clinical trials who can be monitored.
"We do believe in the science of this treatment. It is not a cure. Far from it."
To say this didn't sit well with the Alzheimer's Association would be a gross understatement. Its mission is to eliminate Alzheimer's disease through research and to support all those affected by the degenerative brain disease, the most common type of dementia.
Alzheimer's Association CEO Harry Johns issued a blistering statement calling the CMS decision "shocking discrimination against everyone with Alzheimer's… especially women and minorities" and that access to an Alzheimer's treatment "would now only be available to a privileged few."
Next Avenue recently spoke with Harry Johns in Chicago.
Next Avenue: Is it fair to say that many questions still surround the safety and effectiveness of Aduhelm?
Harry Johns: There is no question that the path to approval was controversial. That's undeniable. There certainly are considerations for risk, which there are for virtually all treatments for all diseases. And the first treatments for virtually any disease - whether it's an individual cancer, hypertension, HIV/AIDS - are not the best treatments. This approved treatment is far from a cure. It makes a marginal, but we believe real difference for people, potentially. And thusly, we did advocate strongly for approval, not only on the basis of the approval of the first treatment, but with the potential for the first treatment to open the door to multiple treatments in that class to follow.
Among those criticizing the Alzheimer's Association for supporting this drug is Vanderbilt University neurologist Matthew Schrag. He says the association was pushing for approval of Aduhelm when the trials showed conflicting results and a potentially high rate of side effects. He called for a new clinical trial, which he said would best serve patients. Any part of that with which you disagree?
Well, we disagree with much of that. Virtually all treatments have side effects. The referral to another trial would have delayed people who face Alzheimer's today from benefitting from a treatment that in fact did have a positive trial. And the FDA has long had the ability to approve treatments that have a positive trial with other supporting evidence.
This is not the way they ultimately chose to approve [Aduhelm]. But we are a science-driven organization and the largest funders of Alzheimer's research in the world, and we would never make a decision to advocate on behalf of our constituents if we did not believe in the science. We do believe in the science of this treatment. It is not a cure. Far from it. The treatment is now approved for people who have Alzheimer's-driven mild cognitive impairment or first stage Alzheimer's. Those people won't stay at that stage indefinitely.
So with insurers like Blue Cross/Blue Shield of Massachusetts, medical schools like Case Western Reserve, academic hospitals like the Cleveland Clinic, along with Japan, Canada and the European Union, all choosing not to approve Aduhelm for Alzheimer's patients, why has the Alzheimer's Association put all its chips on this drug?
There's never been a circumstance where CMS hasn't covered a treatment approved by the FDA. And the kind of difference and life improvement we're talking about has been covered by many types of payers for many types of cancer for limited time. I worked in cancer for a long time. People with cancer also want and need that kind of time and the access to such treatments. We strongly believe that people with Alzheimer's should have the same opportunities as people with other diseases. It's that simple.
After the FDA approval last June, you called for a price that would make Aduhelm accessible to all communities. It started at $56,000 per year (which helped trigger the recent 14.5% Medicare premium increase). You called that price unacceptable. Biogen halved it to $28,000 per year. Is that a price you're happy with? Would that make it accessible to all communities?
Biogen's initial price was simple unacceptable and they should at a minimum be sure that anyone who could benefit from the treatment would have access to the drug. We never advocated for a broad label. Never. Only for the type of label that is now approved. (Note: just people with mild cognitive impairment - i.e. problems with memory beyond normal aging.)
Now that the price is $28,000, do you have a sense of how much Alzheimer's patients would pay out of pocket?
I can't give you the exact number, but we know it would still be cost prohibitive for many people, which is why we said that anyone who could benefit from the treatment should have access.
[Editor's Note: Biogen, the manufacturer of Aduhelm, has contributed to the Alzheimer's Association. But Johns says corporate donations count for less than one percent of the Association's revenue and don't influence its decisions. "We don't care about the companies who donate to the Association, we care about our constituents," he says.]
Given how CMS coverage has always been in lockstep with the FDA on drug approvals, how surprised were you when CMS issued its unconventional draft ruling earlier this month?
"We absolutely and completely support gaining inclusion of all Americans in trials so there can be the appropriate confidence in the outcomes of trials based upon everyone participating."
Pretty surprised. We believe that the folks at the FDA and at CMS want to do the right thing on behalf of Americans. But we were surprised about the proposed coverage with evidence development because it's so restrictive that it's effectively a denial of coverage decision that's just inappropriate.
One of the themes of your tough statement following the draft decision to limit coverage was that it represented "shocking discrimination," how the people disproportionately impacted would include women, Blacks and Hispanics while patients in many clinical trials for new drugs are often disproportionately white.
CMS did not provide anybody to be interviewed for this story, but sent a statement about diversity in clinical trials from administrator Chiquita Brooks-LaSure:
"The national coverage determination is clear that any clinical trials must directly address past underrepresentation by requiring an unprecedented level of diversity."
Does that assuage or at least encourage you that there's now an incentive for manufacturers and trial administrators to ensure that clinical trials recruit diverse participants?
Company trials must get to the point of having appropriate representation of everyone in America in their trials, which they have not. But the draft decision by CMS would have the effect of limiting access to all people who have Alzheimer's. So it has a blanket negative effect.
We absolutely and completely support gaining inclusion of all Americans in trials so there can be the appropriate confidence in the outcomes of trials based upon everyone participating.
You are known as a guy who keeps things close to the vest, even keeled. And yet this CMS decision prompted an uncharacteristically strong public rebuke from you. What, in particular, set you off about this admittedly unorthodox draft decision by CMS? Put another way, why is this the hill you're willing to die on when so many others have for the moment rejected Aduhelm?
We are a scientific group. Our entire leadership team believes strongly that we cannot stand by and see the people who have Alzheimer's treated differently than people with other diseases. If we as an organization who have a responsibility to our constituents don't stand up for them at a moment when they could be deprived of treatments emerging from the pipeline over many years, I personally see no other choice than to take a stronger position than would be normal.
That way, people recognize just how devastating this could be if [the CMS decision] were to stand as it is for all of the treatment in the class.
Statement from the Alzheimer's Association responding to the recent CMS decision about coverage of Aduhelm
April 7, 2022 — "We are currently reviewing the CMS final decision. At initial review we are very disappointed with the immediate impact it will have on Americans living with Alzheimer's and their families today. While we note some of the recommendations provided by people living with Alzheimer's and the Alzheimer's Association have been incorporated into the CMS decision, denying access to FDA-approved Alzheimer's treatments is wrong. At no time in history has CMS imposed such drastic barriers to access FDA-approved treatments for people facing a fatal disease." — Harry Johns, Alzheimer's Association CEO