Alnylam prices heart drug at premium to rivals

 Alynlam Pharmaceuticals will sell its drug for a life-threatening heart disease at almost double the cost of other treatments available for the condition, company executives said Thursday.

The price of the drug, Amvuttra, was revealed on a Thursday evening conference call discussing the Food and Drug Administration’s decision to clear the treatment in people with transthyretin amyloidosis, or ATTR, cardiomyopathy. Alnylam already markets the medicine for people with a form of the condition that affects the nerves, but has long looked to an approval in cardiomyopathy as the kind of revenue driver that can help it turn a consistent profit.

Alnylam will begin selling Amvuttra as two other treatments, Pfizer’s tafamidis and BridgeBio Pharma’s Attruby, are already accessible. Both tafamidis and Attruby are taken orally, while Amvuttra is injected. Although none of the drugs have been tested directly against another and cross-trial comparisons come with caveats, Amvuttra’s benefits also don’t appear to be clearly superior to its rivals.

Investors and Wall Street analysts were therefore paying close attention to the FDA’s labeling as well as Amvuttra’s price tag. Both could shape how doctors, insurers and patients decide which treatment they prefer moving forward. Tafamidis sales surpassed $5 billion last year, while Attruby’s early prescription numbers have outpaced investor expectations. The market is expected to grow in the coming years, as Alnylam believes the majority of an estimated 150,000 patients in the U.S. remain undiagnosed.

Amvuttra’s label is largely similar to its competitors. The drug was approved to reduce hospitalizations or death resulting from heart complications, as tafamidis and Attruby are. But the label also included mention of urgent care visits for heart failure, something Alnylam’s Chief Medical Officer Pushkal Garg highlighted on Thursday as “unique” to the company’s drug.

Alnylam priced Amvuttra at its current cost in the polyneuropathy form of the condition, which equals about $476,000 for a year’s supply. That figure far surpasses the list prices for tafamidis and Attruby, which are respectively about $250,000 and $244,000.

Prior to the announcement, analysts and investors had debated whether Alnylam might cut the price of Amvuttra in cardiomyopathy to boost access, Stifel analyst Paul Matteis wrote in an investor note. However, on Thursday’s call, Chief Commercial Officer Tolga Tanguler said the company believes its drug “offers a compelling and highly differentiated value for patients and physicians, as well as payers.”

One reason, Tanguler said, is that Amvuttra is the first medicine of its kind for ATTR cardiomyopathy, working by “silencing” the misfolded protein implicated in the disease rather than stabilizing it as others do. It’s also the only one cleared for both forms of the condition, and showed benefits in a study involving many people who were less sick and on other medicines, including tafamidis.

Tanguler suggested patients are more likely to stick to quarterly injections of Amvuttra than remembering to take their pills every day. He said Alnylam has seen over 95% treatment adherence rate in ATTR polyneuropathy, and believes that dosing regimen will give clinicians, health insurers and patients “peace of mind.”

Alnylam intends to gradually cut Amvuttra’s price through rebates and pay-per-performance deals as patient uptake increases, Tanguler added. He didn’t detail the thresholds for doing so, however.

While Amvuttra’s initial price is much higher than that of its rivals, Stifel’s Matteis wrote that the company’s strategy “makes a lot of sense.” A key reason why: Amvuttra is administered through Medicare Part B, which covers physician-administered medicines, instead of via Part D like tafamidis and Attruby. Medicare accounts for about 75% to 80% of eligible patients, and doctors may have a financial incentive to write prescriptions for more expensive Part B medicines.

The program also involves less administrative hurdles than private plans, meaning people may be less likely to have to try other drugs before getting Amvuttra.

“We believe very firmly that in the majority of cases we will not be ‘stepped through’ tafamidis or any other stabilizer,” Tanguler told analysts.

Still, because of its much higher price, Amvuttra may face “significant payer headwinds to commercial uptake,” according to Leerink Partners analyst Mani Foroohar. In his own client note, Foroohar indicated that the benefit related to hospitalizations and urgent heart failure visits on Amvuttra’s label is “well below” what’s written into Attruby’s prescribing information. He argues that Wall Street’s “elevated” projections for market share “skew risk to the downside” for Alnylam’s stock over the next year or so.

Alnylam expects initial uptake to be slow before accelerating later this year. It’s predicting $1.6 billion to just over $1.7 billion in sales in 2025 for its ATTR business, which also includes an older drug it sells for polyneuropathy. That business generated a little more than $1.2 billion last year.

https://www.biopharmadive.com/news/alnylam-amvuttra-price-ttr-cardiomyopathy-competition/743175/