Incyte the latest to fall victim to JAK scrutiny as FDA pushes back Jakafi review

 The entire JAK inhibitor family of medicines is feeling the ripple effects from a safety signal flagged for Pfizer’s Xeljanz. Now, the first marketed drug in the class is encountering increased scrutiny from the FDA.

The FDA has pushed back a decision for Incyte’s application for Jakafi in steroid-refractory chronic graft-versus-host disease (GVHD) by three months, the company said Tuesday. The new target action date is Sept. 22.

The delay came after Incyte submitted additional data in response to a recent request by the agency. The FDA views the update as a major amendment to the previous package, so it now needs more time to review it, the drugmaker said.

Jakafi is only the latest in the JAK drug class to face an FDA delay. Previously, the FDA postponed its verdict on Eli Lilly’s Incyte-partnered Olumiant and Pfizer’s investigational abrocitinib in moderate-to-severe atopic dermatitis. The agency also held up Xeljanz’s filing in ankylosing spondylitis by three months. Before that, the agency delayed two AbbVie filings for Rinvoq in eczema and psoriatic arthritis.

The extra hurdles stemmed from a safety problem observed in a post-marketing trial of Xeljanz in rheumatoid arthritis. The study linked an increased risk of dangerous heart-related side effects to the Pfizer JAK inhibitor compared with traditional TNF blockers in patients who were at least 50 years old with at least one existing cardiovascular risk factor.

Jakafi was the first JAK inhibitor to reach the market with an FDA go-ahead for the bone marrow disease myelofibrosis in late 2011. The drug has been allowed in patients with steroid-refractory acute GVHD since May 2019.

The company's latest application in chronic GVHD comes off positive results from the phase 3 REACH3 trial. At week 24, the drug triggered a response in 49.7% of patients. For patients on best available treatments, 25.6% responded.

“We remain confident in the data from the REACH3 trial supporting our sNDA submission for [Jakafi] and look forward to continued dialogue with the FDA throughout the remainder of the review process,” Incyte’s chief medical officer, Steven Stein, M.D., said in a statement.

Currently, Jakafi is given at different strengths twice daily. Incyte is evaluating a once-daily formulation with a potential approval expected by the end of 2022.

In a more important regulatory decision for Incyte, the company is also awaiting a verdict for a cream product with the same ruxolitinib active ingredient as used in the oral Jakafi for the treatment of atopic dermatitis. It used a priority review voucher for that application to secure an early decision date that’s scheduled for June 21.

Incyte didn’t respond to a request for comment on whether the FDA has raised any questions regarding the topical drug’s filing. Last month, when asked about the increased JAK scrutiny at the FDA, Sten said the company is “very comfortable where we are with the review.” 

https://www.fiercepharma.com/marketing/incyte-latest-to-fall-victim-to-jak-scrutiny-as-fda-pushes-back-jakafi-review-gvhd

How will insurers cover a new Alzheimer’s drug?

 Federal regulators have approved the first new drug for Alzheimer’s disease in nearly 20 years, leaving patients waiting to see how insurers will handle the pricey new treatment.

Health care experts expect broad coverage of the drug, which was approved Monday. But what that means for patients will vary widely depending on their insurance plan. In some cases, that could mean coming up with several thousand dollars to pay for what the insurer didn’t cover.

And there’s no guarantee that every case will be covered.

Here’s what you need to know:

WHAT WAS APPROVED?

The Food and Drug Administration said it granted approval to a drug from Biogen based on clinical research results that seemed “reasonably likely” to benefit Alzheimer’s patients.

It’s the only drug that U.S. regulators have said can likely treat the underlying disease, rather than just manage symptoms. The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse mental decline. It slowed it in one study.

The FDA’s decision came despite the conclusion of its advisory committee that there wasn’t enough evidence that the drug slowed the brain-destroying disease.

WHAT DOES IT DO?

It aims to help clear harmful clumps of a protein called beta-amyloid from the brain. The medication will be marketed as Aduhelm and is to be given as an infusion every four weeks.

WHAT WILL IT COST?

Biogen said the drug would cost approximately $56,000 for a typical year’s worth of treatment, and it said the price would not be raised for four years.

HOW WILL INSURERS COVER IT?

They will likely request some documentation first that the patient needs the drug. Many plans will require doctors to submit records and other paperwork justifying the treatment before they agree to cover it.

Insurers also will likely require pre-approval for brain scans needed to determine that the patient is a candidate for treatment, said Lance Grady of Avalere Health consultants.

He noted that some plans also may want to see the results of a scan before they decide to cover the next infusion, which could delay treatment.

IS COVERAGE GUARANTEED?

Medicare is widely expected to cover the treatment. Insurers that offer private or commercial coverage also will pay for care that doctors deem medically necessary.

That may not mean every case, though. If the treatment is proposed for a patient with advanced Alzheimer’s, and research shows the drug isn’t effective in that population, then the insurer may not pay for it.

“That happens all the time with drugs,” said Robert Laszewski, a health care consultant and former insurance executive. “Just because the FDA says its safe doesn’t mean it’s appropriate for everybody.”

WHAT WILL PATIENTS PAY?

That’s impossible to say broadly.

It can depend on the person’s coverage and their out-of-pocket maximum, which is a plan’s limit for how much a patient pays in a year for in-network care before insurance picks up the rest of the bill.

Some patients who are already receiving a lot of care may not wind up with a huge added expense from the drug before they hit that limit.

Patients who have a supplemental plan for their Medicare coverage also may wind up with few out-of-pocket costs for the drug.

Patients with Medicare Advantage coverage, which is run by private insurers, or individual health insurance could pay several thousand dollars before they hit their plan’s annual limit, depending on the plan.

“That could be very burdensome for someone, especially if a person is looking at this cost every single year, and they don’t have an option to get a better health plan,” said Stacie Dusetzina, an associate professor at Vanderbilt University and drug pricing expert. “It can add up.”

ARE THE DRUGMAKERS HELPING?

Cambridge, Massachusetts-based Biogen plans to begin shipping millions of doses within two weeks.

The company says it will help patients figure out their options for financial assistance and find providers and care infusion sites. The drugmaker also is offering programs to help reduce the out-of-pocket cost for some patients with commercial coverage.

But people with Medicare and Medicare Advantage coverage cannot get drugmaker discounts like that. Health care researchers say most of the people who will need this drug will have some form of Medicare coverage.

https://apnews.com/article/alzheimers-drug-aduhelm-aducanumab-insurance-cost-929cead08a792217a258e278e9cef97d

Idorsia to present new Phase 3 data on daridorexant in insomnia at SLEEP 2021

 Idorsia Ltd (SIX: IDIA) today announced that nine abstracts for

daridorexant, the company's investigational dual orexin receptor 
antagonist for the treatment of adults with insomnia, will be presented 
at SLEEP 2021. The annual joint meeting of the American Academy of Sleep 
Medicine and the Sleep Research Society is conducted virtually from June 
10-13. 
 
   Antonio Olivieri, Senior Vice President, Head of Global Medical Affairs 
of Idorsia commented: 
 
   "As a company with a strong scientific core rooted in innovative small 
molecules, Idorsia aims to transform the horizon of therapeutic options. 
We look forward to presenting new data from our Phase 3 clinical program 
and other important new data on daridorexant. This reflects our 
commitment to advance research for insomnia, a condition that can 
substantially impact the physical and mental health of patients and 
remains an area with great unmet need." 

https://www.marketscreener.com/quote/stock/IDORSIA-LTD-35837944/news/Press-Release-nbsp-Idorsia-to-present-new-Phase-3-data-on-daridorexant-in-insomnia-at-SLEEP-2021-35553251/

FDA OKs Pfizer PREVNAR 20 Pneumococcal 20-valent Conjugate Vaccine for Ages 18 Up

 Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet in October to discuss and update recommendations on the safe and appropriate use of pneumococcal vaccines in adults.

PREVNAR 20 includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD),8,9,10,11,12 and have been associated with high case-fatality rates,13,14,15,16 antibiotic resistance,4,17,18 and/or meningitis.19,20

"Today’s approval of PREVNAR 20 marks a significant step forward in our ongoing fight to help address the burden of pneumococcal disease, including pneumonia in adults, and broadens global protection against more disease-causing serotypes than any other pneumococcal conjugate vaccines," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. "With a single injection, PREVNAR 20 provides adults with strong and meaningful protection against serotypes responsible for the majority of circulating pneumococcal disease around the world."

https://finance.yahoo.com/news/u-fda-approves-prevnar-20-231200834.html

Drop in convalescent plasma use at US hospitals linked to higher COVID-19 mortality rate

 A new study from researchers at Johns Hopkins Bloomberg School of Public Health and colleagues suggests a slowdown in the use of convalescent plasma to treat hospitalized COVID-19 patients led to a higher COVID-19 mortality during a critical period during this past winter's surge.

U.S. hospitals began treating COVID-19 patients with convalescent plasma therapy—which uses antibody-rich blood from recovered COVID-19 patients—in the summer of 2020 when doctors were looking to identify treatments for the emerging disease. By the spring of 2021, doctors in the United States had treated over 500,000 COVID-19 patients with convalescent plasma. The use of convalescent plasma started declining late in 2020 after several large clinical trials showed no apparent benefit.

The researchers' analysis suggests that the decline in convalescent plasma use might have led to more than 29,000 excess COVID-19 deaths from November 2020 to February 2021.

The study was published online June 4 in the journal eLife.

"Clinical trials of convalescent plasma use in COVID-19 have had mixed results, but other studies, including this one, have been consistent with the idea that it does reduce mortality," says study senior author Arturo Casadevall, MD, Ph.D., Alfred and Jill Sommer Professor and Chair of the Department of the Molecular Microbiology and Immunology at the Bloomberg School.

The study was done in collaboration with researchers at Michigan State University and the Mayo Clinic. Casadevall and colleagues observed that while plasma use was declining late last year, the reported COVID-19 patient mortality rate was rising. That led them to hypothesize that the two phenomena were related.

In the study, the researchers compared the number of units of plasma distributed to U.S. hospitals from blood banks, on a per patient basis, to the number of reported COVID-19 deaths per hospital admission across the country.

One finding was that while the total use of plasma peaked last December and January during the winter surge in new COVID-19 patients, the use per hospitalized patient peaked in early October 2020—just as deaths per COVID-19 hospital admission bottomed. Thereafter, in the wake of reports of negative results from clinical trials, use of plasma per hospitalized patient fell sharply—and deaths per COVID-19 hospital admission rose.

The researchers analyzed the relationship between these two datasets and found a strong negative correlation, higher use rate being associated with lower mortality and vice versa. They also grouped periods of plasma use into five "quintile" groupings from lowest-use weeks to highest, and found a graded relationship between less use and higher mortality.

A model the researchers generated to fit the data suggested that the COVID-19 case fatality rate decreased by 1.8 percentage points for every 10-percentage point increase in the rate of plasma use. That model implied that there would have been 29,018 fewer deaths, from November 2020 to February 2021, if the peak use rate of early October had held. Moreover, it suggested that the use of plasma on the whole, as limited as it was, prevented about 95,000 deaths through early March of this year.

The researchers analyzed, and then rejected, the possibility that several other factors could explain away the link between less plasma use and more mortality. These factors included changes in the average age of hospitalized patients, and the emergence of new variants of the COVID-19-causing coronavirus.

As for why some clinical trials found no benefit for plasma use, the researchers note in their paper that many of the clinical trials with negative results had used plasma—mainly considered an antiviral treatment—relatively late in the course of COVID-19, when patients may have been too ill to benefit, and when the disease is driven mainly by immune-related responses rather than the coronavirus itself.

Casadevall notes that convalescent plasma remains under FDA Emergent Use Authorization in the U.S., and that it is readily available. "We hope that physicians, policymakers, and regulators will consider the totality of the available evidence, including our findings, when making decisions about convalescent plasma use in individual COVID-19 patients," Casadevall says.

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Explore further

US halts trials of plasma transfusions for COVID patients

https://medicalxpress.com/news/2021-06-convalescent-plasma-hospitals-linked-higher.html

Enabling smart watches to monitor lockdown lifestyles

 In a first-of-its-kind study, researchers from Tel Aviv University and the Academic College of Tel Aviv-Yaffo used smart watches and a dedicated app to monitor 169 subjects before and during Israel's second COVID-19 lockdown (October 2020). The watches and app provided the researchers with accurate daily data for measuring quality of life parameters, such as mood, stress, duration and quality of sleep, heart rate at rest, meeting others and physical exercise.

The study was conducted by a group of experts from the Iby and Aladar Fleischman Faculty of Engineering at Tel Aviv University led by Dr. Erez Shmueli, Dr. Dan Yamin, Shay Oved and Merav Mofaz, in collaboration with TAU's Prof. Noga Kronfeld Schor of the School of Zoology at the George S. Wise Faculty of Life Sciences and the Sagol School of Neuroscience, and Dr. Anat Lan and Prof. Haim Einat of the Academic College of Tel Aviv-Yaffo. The study was recently published at the leading Journal of the Royal Society Interface.

The data collected in the study indicate that, in general, during the lockdown the subjects slept more (6:08 vs. 6:01 hours) met fewer people face to face (11.5 vs. 7.8 daily encounters), exercised less (30 vs. 27 minutes), walked less (daily step count of 8,453 vs. 7,710) felt less happy (0.87 vs. 0.76 on a scale of -2 to 2) and exhibited a lower heart rate at rest (62.6 vs. 62.1 beats per minute).

Among the young participants, a more substantial drop was registered in the daily step count: from 9,500 steps before to 8,200 steps during the lockdown. In comparison, the average daily step count in the 60+ age group decreased from 7,500 to 7,200.

The lockdown was also very detrimental to the younger subjects' mood. On a scale of -2 to 2, their average score declined from 0.89 before to 0.72 during the lockdown, while older subjects reported only a small decrease—from 0.85 to 0.8.

Interestingly, when zooming in on the younger age group, the increase in sleep-duration was mainly expressed in late chronotypes (7:05 hours before vs. 7:24 during the lockdown). Late chronotypes, especially in the age of our younger group which usually work or study and have younger children (also in our study), normally suffer sleep loss. With no need to wake up the children or go to everyday obligations, the more relaxed social schedule induced by the lockdown could allow them to wake up later without using an alarm clock and increase their sleep duration. In contrast, when zooming in on the older age group, the increase in sleep-duration was mainly expressed in early chronotypes (6:48 hours before vs. 6:58 during the lockdown). It is possible that this population could not perform some early social activity like group sports, but other explanations may also be possible.

Analysis by gender revealed that while men's stress level decreased from -0.79 before to -0.88 during the lockdown, women's stress rose from -0.62 to -0.52. The researchers suggest several possible explanations for these findings:

First, according to the Israeli Ministry of Finance, more women lost their workplace (fired or sent to unpaid vacation) than men. Second, schools and daycares were closed during lockdowns and parents to young children had to stay with them at home. Several studies reported that during lockdowns, men were more concerned about paid work while women were more worried about childcare. Third, according to Israeli Police data, domestic violence against women increased during lockdowns.

Moreover, the lockdown was more 'effective' in keeping women from meeting others face to face. While for men, the number of such encounters decreased from 11 to 9, women reported a sharper decline from 12 to 7 daily encounters on average. Face to face encounters, even a random meeting with a neighbor or a public transportation driver, are known to improve people's mood and reduce depression and anxiety.

"During lockdowns women were more secluded and stressed than men, and generally their welfare and mental health were significantly more affected than men's," adds Dr. Shmueli.

"We were lucky," says Dr. Shmueli. "Roughly two years before the outbreak of the pandemic, we planned a large-scale experiment with the goal of providing earlier and improved diagnosis of infected diseases, by integrating multiple sources of data such as self-reported questionnaires and smart watches. Clearly, we didn't have COVID-19 in our mind back then, but the running experiment allowed us to monitor subjects for a relatively long period before and during the second lockdown in Israel."

"The findings of our study are important by themselves and suggest that certain subpopulations should receive more attention than others during lockdowns. However, in addition to the direct negative effects of lockdowns on wellbeing, lockdowns may also indirectly affect our immune system—it is well known that mood, stress, physical activity and sleep duration and quality have a major effect on our immune system. Paying more attention to the affected subpopulations may therefore help in coping better with the virus, and even improve the effectiveness of vaccines."

"The COVID-19 crisis has channeled substantial resources to the wellbeing and welfare of the elderly, and rightly so, since they are more exposed than the younger population to the health hazards of the disease itself. But our study shows that emphasis should also be placed on the mental health of young people—who paid a heavier price for measures like social distancing and lockdowns."

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Explore further

COVID-19 pandemic led to increased screen time, more sleep problems

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More information: Shay Oved et al, Differential effects of COVID-19 lockdowns on well-being: interaction between age, gender and chronotype, Journal of The Royal Society Interface (2021). DOI: 10.1098/rsif.2021.0078

https://medicalxpress.com/news/2021-06-enable-smart-lockdown-lifestyles.html

Alzheimer's drug raises heavy questions around who will and won't get it

 Geri Taylor knew, perhaps better than most, that what she was experiencing was cause for alarm. A former nurse and healthcare executive, Taylor had come face to face with Alzheimer's disease throughout her career and recognized its early signs. She was having a tough time remembering, and not just things like where she set her keys. In a defining moment in 2012, Taylor, then 69, looked in the mirror and didn't recognize her reflection.

She and husband Jim Taylor soon went to see a neurologist, who gave a diagnosis of early cognitive impairment. But it wasn't until they tried enrolling her in a clinical trial for an experimental drug that Geri learned she indeed had Alzheimer's.

Much has changed in the years since. To Geri, the disease's most noticeable effect is that words now remain just out of reach. "I have these wonderful thoughts. And on my way to putting words together, I can't remember what they were about." Jim, meanwhile, admits he's had a "much more challenging" time adjusting to this new normal than his wife.

Geri is one of roughly 6 million people in the U.S. living with Alzheimer's, a disease that steadily breaks down memory as well as the brain and body. Until this week, patients and their caregivers had no treatments for the disease, only a handful of drugs that could help alleviate some of its symptoms.

But in a historic and controversial decision, the Food and Drug Administration approved a new medicine on Monday that's meant to slow the cognitive decline caused by Alzheimer's, despite conflicting evidence about whether it's truly effective. Developed by the companies Biogen and Eisai, the medicine — now known as Aduhelm — is the first new Alzheimer's treatment approved in nearly 20 years.

For the Taylors, Aduhelm has long been a source of hope. The trial Geri applied to, the one that confirmed her Alzheimer's, was an early study of Aduhelm, and Geri ended up on the high dose that would ultimately gain FDA approval.

Aside from about an 18-month period between when that study ended and a different, so-called “extension” one began, Geri has been receiving hour-long infusions of Aduhelm each month. She believes it's helping combat her disease.

"It’s the lifeline," she told BioPharma Dive. "Every time I get a shot, as soon as it's over, I’m sure I feel better. That's what I've got. That's all I've got."

Many patients feel the same. Yet, with Aduhelm now headed to market, there are outstanding questions about how they'll be able to afford and access the drug. Biogen set the average price for Aduhelm at $56,000 per year, which is far above what some stakeholders had expected. According to The Wall Street Journal, Cigna, one of the nation's largest health insurers, estimates some eligible patients may end up paying $10,000 or more in annual out-of-pocket costs.

Sticker shock could be felt widely, as the FDA cleared Aduhelm with hardly any restrictions to its use. The Institute for Clinical and Economic Review, a prominent watchdog group for drug pricing, sharply criticized Biogen for the price it set as well as the FDA for approving a drug with known safety concerns but unclear benefits to such a large population.

"Alzheimer's disease has a tremendous impact on patients and loved ones, and no one can be insensitive to the hopes and the fears that are part of their daily lives," ICER said in a statement. "But no one should assume that approving a drug with such conflicting and uncertain evidence will necessarily help patients and families."

In conference calls with analysts and in an interview with BioPharma Dive, Biogen executives defended the drug's price, which they compared to specialty drugs for cancer and inflammatory diseases.

"We believe that this price is really fair," said Chirfi Guindo, head of global product strategy and commercialization, in an interview. "It is sustainable and we remain open-minded."

More broadly, there aren't enough neurologists to diagnose what could be a dramatic influx of patients looking to be treated. Biogen estimates between 1 million and 2 million people could test positive for the toxic protein its drug targets, a figure that some providers fear would overwhelm treatment centers.

"They're aware of the amount of trouble this will cause if it becomes FDA-approved, with hundreds of thousands of patients calling their clinics to get the treatment," said Thomas Wisniewski, director of the Center for Cognitive Neurology at NYU Langone Health, in an interview early this year.  

Even if there were enough specialists, one of the tests used to diagnose Alzheimer's — known as a positron emission tomography, or PET, scan — is costly, and often not covered by insurance. The FDA is also requiring that patients on Aduhelm be monitored via magnetic resonance imaging, or MRI, for symptoms of the drug's more worrisome side effects, which may create another logistical challenge.

"I'm quite concerned that the data doesn't support its use, and even practically, that we don't have a good plan for how it could be used safely," said Mary Sano, director of the Alzheimer's Disease Research Center at Mount Sinai School of Medicine.

For Biogen, addressing these concerns will critical. The Cambridge, Massachusetts-based company bet heavily on Aduhelm, hoping that a first-of-its-kind Alzheimer's drug could offset problems elsewhere in its business. Now that approval is in hand, the potential insurance and diagnosis obstacles must be addressed for Aduhelm to live up to Biogen's multibillion-dollar sales expectations.

The company has been preparing for Aduhelm's debut for months. Executives have laid out plans to spend $600 million on its launch, and in a presentation Tuesday, they said 900 or so Alzheimer's treatment centers appear ready to administer the drug.

Biogen also said it's been pressing insurers to cover PET scans, while at the same time running its own testing program for that crucial protein, called amyloid. The company announced Monday a partnership with CVS Health that will make cognitive screenings available in 14 metropolitan areas, through the latter's Project Health initiative.

The Taylors noted to BioPharma Dive that one of the major advantages of participating in Biogen's studies has been the required brain scans are paid for.

"We personally aren't concerned. We're assuming we will continue on in the trial, because they’ll want to know about the long-term impacts," Jim said. "But it is something to be concerned about."

Another new partnership, with Cigna, will attempt to improve access by tying costs to how well a patient performs on Aduhelm.

Biogen claims it's trying to reach underserved communities, too, with other programs promoting equitable access and financial assistance. Recent reporting from STAT has detailed how, despite being more likely to develop Alzheimer's and other dementias, Black and Hispanic people are far less likely to be diagnosed and, in turn, properly treated.

"The expense is really quite high, and I'm not even talking about the drug," said Sano. "Just to have something delivered the way this is delivered, and require the imaging that it requires. It's really expensive."

Aduhelm's cost is all the more in focus given the continued debate about whether the drug's effect on amyloid actually translates to cognitive and functional benefits.

The main clinical trial supporting Aduhelm's approval found patients on the high dose declined about four tenths of a point less on a cognitive scale compared to those who got placebo. Doctors who spoke to BioPharma Dive said that, to have a meaningful impact on patients' daily lives, a drug would likely need to at least slow cognitive decline by one or two points.

Those findings, however, contrasted with results from a separate, identically designed trial that saw placebo-treated patients do marginally better than those given high-dose Aduhelm. The contradictory results, combined with the ways Biogen analyzed them, led FDA advisors and the agency's own statisticians to strongly oppose Aduhelm's approval.

That the FDA still cleared Biogen's drug was a surprise to many, among them Michael Sherman, chief medical officer of the New England-based insurer Harvard Pilgrim.

Sherman told BioPharma Dive ahead of Monday's decision that, unlike with other drugs with the potential to have large budget impacts, his team wasn't doing as much modeling for Aduhelm, in part because they didn't expect it to get approved.

Sherman noted, though, that in the event of an approval, he'd consider a price tag of $10,000 or more to be "expensive." ICER, the nonprofit cost watchdog, previously estimated a price between $2,500 and $8,300 a year could be considered cost effective, if the drug's apparent benefits were assumed to be true and not a false positive. 

"It's hard to answer what I think the drug is worth if we don't think it should be approved in the first place," Sherman said.

https://www.biopharmadive.com/news/a-first-of-its-kind-alzheimers-drug-raises-heavy-questions-around-who-will/601434/