ICER: Potential New Pain Medication Offers Small Savings

Suzetrigine, a non-opioid currently being reviewed by U.S. regulators to treat acute pain, would provide small savings and help patients avoid the use of opioids, according to a draft evidence report from the Institute Clinical and Economic Review (ICER).

Suzetrigine is a new class of pain medicine. It targets a specific receptor, NaV1.8, that plays a role in pain signaling. Suzetrigine is designed to prevent pain signals from reaching the brain.

The FDA is currently reviewing Vertex Pharmaceuticals’ new drug application for suzetrigine to treat moderate-to-severe acute pain. Regulators have set a Prescription Drug User Fee Act (PDUFA) target action date of Jan. 30, 2025.

ICER officials assessed two phase 3 randomized trials comparing suzetrigine with placebo and with the opioid hydrocodone in combination with acetaminophen. One trial included patients after bunionectomy and the other after abdominoplasty. Across both trials, 873 patients received suzetrigine, 879 patients received hydrocodone/acetaminophen, and 439 patients received placebo.

In the trials, patients treated with suzetrigine had greater and faster reductions in pain than those treated with placebo. Suzetrigine appeared to have similar efficacy to hydrocodone/acetaminophen for abdominoplasty, but slower onset of pain relief for bunionectomy, ICER officials noted in their report. Adverse effects of suzetrigine were similar to placebo and nausea appeared less common than with hydrocodone/acetaminophen.

ICER’s model was primarily driven by the risks of opioid use disorder from a short course of an opioid analgesic, David M. Rind, M.D., chief medical officer at ICER, said in an interview.

“We thought [opioid use disorder] was the appropriate way to look at the cost-effectiveness of this product,” he said. “We focused heavily on this report on cost-effectiveness compared with opioids, assuming that there’s some risk to opioid use disorder, addiction, even from short courses. There’s tremendous disagreement on that.”

Using a placeholder price for suzetrigine of $420 for a one-week course, ICER found the lifetime savings of suzetrigine would be $200 compared with opioids, saying the evidence is promising but inconclusive.

Rind pointed that there are still uncertainties about the safety of suzetrigine. “When we have a treatment for acute pain, we really want to know it’s safe,” he said. “But we’re not going to know the rare or lowlevel risks until this is on the market and being used by lots of people over time. And that's just a reality of releasing drugs with a new mechanism of action.”

Although the savings are expected to be small, Rind says there is opportunity for a non-opioid pain medication. “There are people who absolutely shouldn’t get opioids and or NSAIDs [nonsteroidal anti-inflammatory drugs] because of prior gastrointestinal bleeds or diabetic kidney disease or heart disease. That’s not a minor issue. Having something that might be safer than NSAIDs would be nice.”

Vertex officials appear to be positioning suzetrigine as an alternative to opioids, with a launch focus on hospitals and hospital systems and key specialties, including orthopedic, general and plastic surgery, anesthesiologists, pain specialists and those in the emergency department, according to a recent company presentation.

In a survey the company conducted last year, 78% of healthcare providers said they were concerned about the risk of opioid addiction among their patients with acute pain, and 88% said their patients prefer to manage pain without a prescribed opioid. Patients also are looking for a non-opioid pain reliever, with 52% of patients in the Vertex survey saying they are looking for a pain medication with fewer side effects.

Vertex is also studying suzetrigine in phase 3 trials to treat patients with diabetic peripheral neuropathy and in phase 2 trials to treat patients lumbosacral radiculopathy.

ICER is accepting public comment on the draft report through Jan. 13, 2025. A revised report will be available by Feb. 5, 2025, with a public meeting held on Feb. 28, 2025 and a final report will be released March 27, 2025.