In the first week of February, Astellas Pharma made two big moves surrounding its hot flash treatment, Veozah.
First, it announced a new version of its Veozah ad would air during the Super Bowl, when 30-second ad spots were selling at a reported cost of about $7 million.
Four days later, Astellas lowered 2023 sales expectations for Veozah from $375 million to $50 million, blaming lower-than-expected demand.
Veozah’s May 2023 FDA approval was hailed as a game-changer for women who can’t or don’t want to take hormones to treat their vasomotor symptoms, more commonly known as hot flashes and night sweats. Veozah is a non-hormonal, neurokinin 3 (NK3) receptor antagonist, the first in a class of drugs that targets the neural activity that causes hot flashes in menopause.
The potential market for Veozah — and an in-development rival from Bayer — is huge. As many as 80% of women in the U.S. report experiencing hot flashes and other vasomotor, and even in severe cases, these symptoms remain untreated, according to Dr. Tabby Khan, medical director for Komodo Health, which analyzes healthcare claims data for more than 330 million unique patients in the United States.
“Six thousand people enter menopause every day,” Khan said. “Symptoms last seven to 10 years.”
So why wasn’t Veozah a hit out of the gate?
The answer seems to be a complicated mix of curbing payer reluctance and educating women and providers that not only this treatment exists, but that menopause symptoms are worth treating in the first place.
For instance, Komodo Health analyzed Veozah uptake and found that from May to October last year, 34% of prescriptions came from ob/gyns.
“But we also saw a significant number of prescriptions from nurse practitioners, family medicine doctors and physician assistants,” said Khan.
That’s important because of the chokehold of parameters under which some payers are willing to cover Veozah. For instance, Kaiser Permanente’s Kaiser Foundation Health Plan of the Northwest will only pay for new Veozah prescriptions if it’s prescribed by an ob/gyn, according to its criteria for drug coverage.
That’s not the only coverage hurdle. Kaiser requires patients to have tried several other non-hormonal treatments first, including antidepressants. Patients also need a specific diagnosis and a liver function test.
That payer reluctance trickles down to providers, which don’t want to prescribe a drug their patients’ insurance won’t cover. Astellas said as much in its downward sales revision, saying that “[b]ased on market research, [healthcare providers’] perception of the current payer coverage progress is ‘insufficient to actively prescribe Veozah’ which is impacting the uptake.”
Shaking the misconception
Requiring patients to try other treatments first reflects a general attitude about menopause treatment.
“We’ve kind of just been throwing the kitchen sink at [vasomotor symptoms],” Khan said. “Do antidepressants help? Does gabapentin help? Can we do non-pharmaceutical adjunct therapies, lifestyle, exercise?”
“Menopause symptoms have historically been overlooked. There’s this general sentiment … that menopause is not a disease that needs to be treated."
Dr. Tabby Khan
medical director, Komodo Health
The question is, what will it take for the market to move away from the “kitchen sink” approach to menopause treatment?
Astellas believes an ad blitz and patient education is one answer, especially since a large barrier in the menopause space is the belief that vasomotor symptoms are a normal part of aging that must be endured.
“Menopause symptoms have historically been overlooked,” Khan said. “There’s this general sentiment … that menopause is not a disease that needs to be treated, that it doesn’t automatically require any treatment. It’s just part of women aging and going through different phases of life.”
Veozah’s Super Bowl spot took aim at that sentiment, contrasting the distress of hot flashes with the comfort and ease of “not flashes,” touting the drug as “100% hormone free” and “the first and only prescription treatment that directly blocks the source of hot flashes and night sweats.”
The Super Bowl campaign was the culmination of an ad blitz in which Astellas spent a reported $24.1 million during the NFL season. However, the Super Bowl ad’s performance was a bit underwhelming. It was 64th in consumer engagement in a ranking of 96 ads by EDO, which analyzes Super Bowl ads.
The most recent Komodo Health data has shown a steady rise in Veozah prescribing since launch. January 2024 had more than double the amount of prescriptions as October 2023, and prescriptions from January and February 2024 comprised more than 40% of all-time Veozah prescriptions.
According to an earlier analysis of Komodo Health’s claims data, Veozah prescriptions numbered just under 900 in June, then rose to more than 5,000 by October. Although these numbers don’t likely represent the whole market, they do show a steady upward trend.
Khan also believes new entrants to the market will also help, not only with an uptick in Veozah prescriptions, but with awareness and prescribing overall.
“I would hypothesize that the introduction of new drugs to the space is actually going to lead to new patients and new markets as well,” she said.
She pointed to Bayer’s elinzanetant, which just hit a major phase 3 milestone in relieving vasomotor symptoms, setting the stage for the drug to go head-to-head with Veozah. Like Veozah, elinzanetant targets the neural activity that leads to hot flashes, but acts on NK1 as well NK3. Veozah is only an NK3 receptor antagonist.
Despite Veozah’s slow uptake — and the fact that Bayer didn’t release specific data about elinzanetant’s performance — Bayer seems to have high hopes about the drug.
Stefan Oelrich, head of Bayer’s pharmaceutical division, called elinzanetant a “potential blockbuster” that could be “capable of transforming the way menopausal symptoms are treated.”
Veozah and elinzanetant aren’t alone. A handful of other companies have non-hormonal menopause drugs in development, including VistaGen, which is developing a neuroactive nasal spray that showed promising phase 2a results for hot flashes, and Daré Bioscience, which is developing a non-hormonal treatment for vulvar and vaginal atrophy.
Still, Veozah uptake and the menopause drug development landscape overall hasn’t been as promising as the size of the market itself. Ultimately, success will depend on whether companies can overcome the triple hurdles of payer hesitance, prescriber reluctance and sluggish consumer demand.
