It’s not surprising that Alnylam’s Amvuttra (vutrisiran) received FDA approval for ATTR-CM last week, but what shocked many was Alnylam’s choice to price the drug at nearly half a million dollars per year in a segment where its incumbent competitors cost half as much.
- Amvuttra is now the third FDA-approved therapy for ATTR-CM, following Pfizer’s Vyndaqel and BridgeBio’s Attruby/Beyonttra.
- The HELIOS-B study found Amvuttra reduces all-cause mortality and cardiovascular events in ATTR-CM patients compared to placebo, supporting the FDA’s approval.
- Amvuttra was already approved for transthyretin amyloid polyneuropathy (ATTR-PN).
Alnylam claims Amvuttra’s eyewatering price stems from the drug’s “compelling and highly differentiated value for patients and physicians, as well as payers.”
- Part of this pricing argument is the slight difference in how Amvuttra works, since it’s the first ATTR-CM drug that silences the disease-causing protein rather than stabilizing it.
- Alnylam also believes patients are more likely to stick to quarterly injections of Amvuttra than remembering to take their pills every day.
- Even so, Amvuttra costs $476k annually, far surpassing the list prices for Vyndaqel ($250k) and Attruby ($244k), which have already seen scrutiny for their high costs
Amvuttra’s pricing might be part of a bigger strategy though since it’s administered through Medicare Part B (physician-administered medicines) instead of via Part D like Vyndaqel and Attruby.
- About 75% to 80% of eligible ATTR-CM patients are covered by Medicare, so doctors may be incentivized to prescribe more expensive Part B medicines.
Beyond Amvuttra’s financial strategy and its mortality and CV event improvements in the HELIOS-B study, a recent JACC study suggests the drug could help maintain or even improve functional capacity, health status, and QOL in patients with ATTR-CM.
- Compared to placebo, more patients on Amvuttra maintained or improved 6-MWT distance (>7 m [49.6% vs 33.2%], >15 m [55.5% vs 38.6%], and >35 m [68.4% vs 51.6%]).
- More patients on Amvuttra also maintained or improved their KCCQ-OS scores (>5 points [63.5% vs 46.6%], >10 points [74.6% vs 60.7%]).
The Takeaway
Amvuttra’s FDA approval now means we have a third drug for ATTR-CM that works differently than the current competitors. Whether that difference will justify Alnylam’s pricing strategy remains to be seen.
