The company is seeing higher-than-expected demand for Relyvrio, management said during a launch update.

“Interest and demand for Relyvrio are well above our pre-launch expectations,” said Justin Klee, Amylyx co-CEO, during an investor presentation Tuesday morning. “As a result, we expect to meaningfully exceed fourth-quarter and full-year 2022 Wall Street research analyst consensus estimates for net revenue.

The reception from payers has also been “better than we thought,” said Klee, echoing a filing with the Securities and Exchange Commission also posted Tuesday. “More people have already gained access to Relyvrio through their insurer than we had anticipated through this point in our launch.” 

While time-consuming, especially for ALS clinics, Klee said patients with ALS who are prescribed the drug are getting it via the medical-exception process, even while plans are still determining coverage policies. Additionally, about 80% of medical prior-authorization requests for Relyvrio are approved on the first submission.

Insurers representing about a quarter of covered lives in the U.S. have published coverage policies providing broad access to Relyvrio. So far, there’s been just one exception. Commercial insurer Cigna decided not to recommend approval for medical necessity. The insurer last week justified its decision as being due to a lack of clinical efficacy data and unclear clinical benefit. 

Asked about the refusal by analyst Marc Goodman of SVB Securities, which hosted the investor update, Klee pointed out that Cigna represents “only about” 3% of covered lives in the U.S. He said the payer is “clearly an outlier” compared to other plans providing broad access. 

“So Cigna, they’re an island,” Klee said. Moreover, if a Cigna member wants the drug, they may still get coverage on a one-off basis, he noted.

Nevertheless, the insurer’s decision clearly spawned some market skepticism. In an investor note titled “AMLX – I disagree with Street buzz,” Evercore ISI analyst Umer Raffat cited “a ton of confusion in the marketplace.”

One popular assertion, the analyst said, has been that Cigna’s negative decision on Relyvrio portends that other insurance may follow suit. As it turns out, the insurer contradicted itself. 

As Raffat went on to explain, Cigna said Amylyx’s drug has an unclear clinical benefit due to its 2-point differential on the ALSFRS, a scale designed to assess patient function. Meanwhile, Cigna deemed “medically necessary” another ALS drug with a similar benefit, Mitsubishi Tanabe Pharma’s infusion drug Radicava (edavarone).

“Cigna couldn’t have been more inconsistent, in my view,” Raffat posited. 

Two other assertions seized upon by market speculators concerning Relyvrio’s launch included an alleged high discontinuation rate and a duration of therapy of less than one year. Raffat argued against both rumors.

“Is there a high discontinuation rate on Relyvrio? Nope,” Raffat added, explaining that this is not something supported by prescription data. Likewise, the duration of therapy argument is misplaced given calls he’s conducted with physicians and data modeling so far.

Based on calls with doctors and other channel checks, he estimates that about 2,000 patients may be on Relyvrio. “I feel very confident in [the] launch and remain very constructive,” the analyst wrote.

Relyvrio received approval from the Food and Drug Administration for treating ALS in September. Since then, the drug has been plagued by ongoing concerns over its clinical efficacy as well as its steep price point. 

Amylyx set the wholesale acquisition cost of the drug at $158,000 per year, which is slightly lower than the $160,000 cost of Radicava. 

In the months following the drug’s approval, patients have had to contend with the $158,000 price tag, leading to insurance delays, denials or massive out-of-pocket expenses, according to the Associated Press.

Klee said Tuesday that the company continues to engage with payers and educate those that have not formalized coverage decisions and that it expects the majority of payers to set their coverage policies during the first half of this year. 

The company added that it also expects a decision from European regulators during first-half 2023 and is engaged with government payers. 

To fund the Relyvrio rollout, Amylyx announced it was offering 6 million shares of common stock as part of a public offering.

https://www.mmm-online.com/home/channel/amylyx-counters-wall-street-noise-cites-demand-for-als-drug/