Promoting A Newly Approved Indication Against Established Competitors
By Ben Comer, Chief Editor, Life Science Leader
There are lots of reasons why physicians and patients (and payers) might prefer one drug over another for the treatment of a given disease. Efficacy and safety are paramount, of course, but there are other factors, including drug price (and rebates), administration method, drug mechanism, an individual’s unique patient profile and history, as well as personal preferences for specific drug benefits or safety risks, compared with others.
On a recent episode of the Business of Biotech, Tolga Tanguler, Alnylam’s EVP and chief commercial officer, talked up the importance of adherence to therapy as a competitive differentiator, particularly in light of (at the time of the podcast recording) a pending supplemental FDA approval for Amvuttra (vutrisiran), for patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM).
On March 20, Alnylam received that anticipated ATTR-CM approval, putting Amvuttra in direct competition with Pfizer’s Vyndamax (tafamidis) and BridgeBio’s Attruby (acoramidis). To find out how the launch is going, and what Alnylam is hearing from physicians and patients, I recently reconnected with Tanguler, who is — no surprise — quite bullish about Amvuttra’s potential in the category.
Both of Amvuttra’s competitors are daily, oral formulations (Vyndamax’s recommended dose is once daily, and Attruby’s is twice daily) compared to Amvuttra’s once-quarterly dosage, or every three months, via subcutaneous injection. The Amvuttra injection is given by a healthcare professional and covered by a health insurance medical benefit, while Vydamaz and Attruby are taken by patients and processed through a drug benefit, an important distinction when it comes to out-of-pocket costs.
Although Amvuttra’s list price is substantially higher than Vyndamax’s or Attruby’s prices, Tanguler says the drug is “already getting great access,” and that 70% to 75% of patients have a $0 copay. Because ATTR-CM is a rare and severe disease, patients are already being monitored by their physicians, which includes periodic office visits. Amvuttra’s administration and dosing regimen — a subcutaneous injection every three months — fits in well with the provider care ATTR-CM patients already receive, explained Tanguler, and provides a key benefit versus competing therapies. “We know that the utilization of any pill product is 60% at best in terms of adherence,” said Tanguler. Among providers, many of whom also treat hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN) patients — Amvuttra’s first approved indication — there are “already a lot of believers in first-line therapy with Amvuttra.”
Amvuttra’s prior approval in hATTR-PN also helps set the table for value-based agreements with payers in the ATTR-CM indication, said Tanguler. Details of the value-based contracts are proprietary, but “we keep them simple” and focused on meeting the expected patient outcomes. Payer experience with value-based contracts for Amvuttra in the hAATR-PN indication also help to extend and validate similar contracts in ATTR-CM, said Tanguler, adding that such contracts must be renewed annually.
Amvuttra represents “a step change in terms of how this category is evolving, and we're excited to be offering the very first silencer into a category where we believe we're going to make a true difference,” said Tanguler. For more about Alnylam’s approach to commercializing RNAi therapeutics, watch episode 252 of the Business of Biotech.