— Current evidence suggests that suzetrigine may provide a net health benefit when compared to no systemic treatment, opioid analgesics, and NSAIDs; at expected pricing, treatment is likely to be cost-effective in the long run —
BOSTON, February 5, 2025 – The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of suzetrigine (Vertex Pharmaceuticals) for the treatment of acute pain.
“It has been a long time since we have had a new class of drugs for acute pain,” said ICER’s Chief Medical Officer David Rind, MD. “Suzetrigine has a different mechanism of action from prior oral therapies, and this creates options for treatment alone or in combination with existing medications. The overall value of this new drug is linked to the risk of a one-week course of opioids leading to opioid use disorder. If that level of risk is near zero and suzetrigine proves to be safe, suzetrigine will likely be a cost-effective alternative from a long-term perspective. Longer term data will help define the appropriate role of suzetrigine in practice, but a pain medicine with a new mechanism of action will create options for patients and clinicians.”
This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC on February 28, 2025. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report and voting questions reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.
Key Clinical Findings
Rates of development of opioid use disorder (OUD) after short-term administration of opioids for acute pain are uncertain, as are rates of NSAID adverse effects (e.g., acute kidney injury, gastrointestinal bleeding, acute coronary syndrome) when used in the post-operative setting. There are also uncertainties in assessing the efficacy of suzetrigine because of lack of data on use of rescue medication in the Phase III trials, which studied the drug’s use after surgery, as well as the use of imputation for pain scores after rescue medication was used in the clinical trial.
The above uncertainties inform ICER’s ratings that the evidence for suzetrigine for the treatment of acute pain in comparison with no systemic treatment, in comparison with opioid analgesics, and in comparison with NSAIDs are all promising but inconclusive (P/I), meaning moderate certainty of a small or substantial net health benefit, with a small likelihood of a negative net health benefit.
Key Cost-Effectiveness Findings
The FDA approved suzetrigine for acute pain on January 30, 2025. The manufacturer announced a US price of approximately $232.50 for a one-week course of treatment for acute pain.
When compared to treating with opioids, ICER expects the treatment to be cost-saving from a lifetime perspective because of cost offsets due to fewer patients developing OUD.
About ICER
The Institute for Clinical and Economic Review (ICER) is an independent, non-profit research institute that conducts evidence-based reviews of health care interventions, including prescription drugs, other treatments, and diagnostic tests. In collaboration with patients, clinical experts, and other key stakeholders, ICER analyzes the available evidence on the benefits and risks of these interventions to measure their value and suggest fair prices. ICER also regularly reports on the barriers to care for patients and recommends solutions to ensure fair access to prescription drugs. For more information about ICER, please visit www.icer.org.