Interventions of Interest:

  • AMX0035 (RELYVRIO™, Amylyx Pharmaceuticals, Inc.)
  • oral edaravone (Mitsubishi Tanabe Pharma Development America, Inc.)

The majority of independent appraisal committee voted that the evidence is adequate to demonstrate that both AMX0035 and oral edaravone (in population narrower than its label) provide a net health benefit compared to standard of care. They also determined that at current pricing or price estimates both therapies represent a “low” long-term value for money.

AMX0035 would only achieve common thresholds for cost-effectiveness if priced between $9,100 – $30,700 per year; oral edaravone far exceeds cost-effectiveness thresholds at its market price of $171,000 per year.

Given the rapidly progressive and terminal nature of the disease, clinical experts in the Policy Roundtable felt strongly that combining ALS medications that target different potential mechanisms of action is the best way to slow loss of motor neurons.

Final Documents

ICER’s Chief Medical Officer, David Rind, MD stated:

“The votes of the Midwest CEPAC reflected the remaining uncertainties around the benefits of these therapies and the overwhelming certainty that $170,000 per year is much too high a price for either therapy despite the overwhelming need for treatments for this devastating disease.

The evidence suggests that AMX0035 extends life, and it is clear that oral edaravone is far less burdensome than its infused preparation, but prices need to be greatly reduced to align with benefits.”

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