The introduction of the new non-opioid drug Suzetrigine could benefit from the No Pain Act

Pharmaceutical company Vertex presented positive Phase 3 data at the American Society of Anesthesiologists annual meeting last month, highlighting the potential of its investigational oral non-opioid painkiller suzetrigine as a first-in-class treatment. The data showed good safety, tolerability and effectiveness. The Food and Drug Administration is expected to decide whether to approve the drug in January 2025. At the same time, the No Pain Act could help increase suzetrigine adoption by mandating Medicare coverage for non-opioid pain treatment in ambulatory surgery centers and hospital outpatient clinics effective January 1.

Suzetrigine's Phase 3 program consisted of three studies: two randomized, double-blind, placebo-controlled studies and a single-arm safety and efficacy study. While the first two studies evaluated suzetrigine after abdominoplasty and bunionectomy surgery, respectively, the third study enrolled patients with a variety of surgical and non-surgical acute moderate to severe pain conditions to assess the safety and effectiveness of the product in various settings evaluate. Here, the most common surgical procedures were orthopedic and plastic procedures, as well as those on the ear, nose, throat and adjacent parts of the head and neck. The most common nonsurgical conditions were sprains and strains of the upper and lower extremities. No serious adverse events were reported. More than five out of six study participants rated the effectiveness of suzetrigine in treating pain as good, very good or excellent.

Although prescription opioids are effective for pain relief, their use can lead to substance use disorders in some patients. In 2021, 1.1 million Medicare beneficiaries were diagnosed with an opioid use disorder and 50,000 experienced an overdose with illicit opioids, prescription opioids, or both.

The provisions of the No Pain Act are intended to expand access to non-opioid pain treatment in ambulatory surgery centers and hospital outpatient clinics. including evidence-based treatments such as non-opioid medications and physical therapy.

Currently, hospitals receive the same payment from Medicare regardless of whether a doctor prescribes an opioid or a non-opioid. Therefore, hospitals typically prefer opioids to be dispensed by a pharmacy upon a patient's discharge, at little or no cost to the hospital.

This situation will change after the passage of the No Pain Act, at least in the outpatient surgical and hospital outpatient settings. The Centers for Medicare and Medicaid Services has issued guidance on which non-opioid drugs would be subject to expanded access legislation beginning January 1, 2025. For example, Exparel (liposomal bupivacaine) and Zynrelef (bupivacaine/meloxicam) are two of six currently approved non-opioid treatment alternatives.

However, there will continue to be challenges for commercial and Medicaid insurers because these payers are not covered by the law's provisions. And even in Medicare, health plans can choose to impose coverage restrictions such as patient cost-sharing and other utilization management practices. Medicare Part D (outpatient) often directs pain patients to the most cost-effective options, which are usually generic opioids.

Building on the No Pain Act, Senators Thom Tillis (R-NC) and Mark Kelly (D-AZ) introduced the Alternatives to Pain Act. The goal of this bipartisan legislation is to provide seniors and people with disabilities increased access to non-opioid treatments for pain management. If passed, this bill would limit patient sharing of costs for patients receiving non-opioid pain medications under Medicare plans that cover outpatient therapeutics; ban the use of step changes that require patients to try a cheaper prescription drug before switching to a more expensive drug, such as a non-opioid alternative; Promote shared decision-making between patients and their healthcare providers regarding preferences when selecting pain treatment.

There are currently several non-opioid treatment alternatives on the market and others, such as suzetrigine, in the pipeline, sponsors of the already passed No Pain Act and the Alternatives to Pain bill introduced in Congress. Act and hope that a level playing field in access will help reduce the prevalence of opioid use disorder.