By Beckie Fenrick, PharmD, MBA; Emily Crisano, PharmD, RPh; and Jason Peterson, RPh
The first quarter of 2025 has brought several notable drug approvals from the U.S. Food and Drug Administration (FDA), including Stelara biosimilar launches and new drug approvals impacting pain management, Parkinson’s disease and a rare neurological disorder. As new therapies enter the market, plan sponsors must prepare for potential cost implications, implementation of utilization management strategies and formulary adjustments.
Journavx (suzetrigine): A New Option for Acute Pain Management
Pain management remains one of the costliest areas of healthcare, with acute and chronic pain carrying a combined annual economic burden of over $1.4 trillion. Journavx (manufactured by Vertex Pharmaceuticals) is the first non-opioid pain medication of its kind in over two decades.
Clinical trials show its effectiveness in reducing pain, making it a promising option for short-term pain management. However, it is not approved for chronic pain.
Management Strategies & Plan Sponsor Considerations
- Utilization Management: Prior authorization, step therapy, age restrictions, quantity limits, and days’ supply limits should be employed to prevent unnecessary utilization and off-label use beyond the approved treatment period.
- Cost Impact: Journavx is significantly more expensive than generic pain medications, with a wholesale acquisition cost (WAC) of $450 for a 14-day course ($15.50 per tablet). If widely adopted, pharmacy costs could rise substantially, making cost-control strategies essential.
- Clinical Considerations: Journavx should be used for the shortest duration possible, not to exceed 14 days. Its long-term effectiveness beyond acute pain remains unproven, so it should not be included on a maintenance drug list. Trials for chronic pain management are ongoing.
Onapgo (apomorphine hydrochloride): A Breakthrough for Parkinson’s Disease
Parkinson’s disease affects nearly one million Americans, with diagnoses expected to reach 1.2 million by 2030. Onapgo (manufactured by Supernus Pharmaceuticals) provides symptom control through a continuous subcutaneous infusion pump, helping patients manage “off” periods more effectively than traditional apomorphine treatments. This delivery system could improve quality of life for those with advanced Parkinson’s disease.
Management Strategies & Plan Sponsor Considerations
- Utilization Management: Given its high cost and position as a non-first-line treatment, Onapgo should require prior authorization and step therapy to ensure use in appropriate patients.
- Cost Impact: At an annual cost of up to $105,000, broader adoption will likely drive higher pharmacy expenditures. Strategic formulary management will be crucial.
Clinical Considerations: Onapgo may provide improved symptom control for patients who are unresponsive to other Parkinson’s medications, but its high cost necessitates careful patient selection.
Gomekli (mirdametinib): Expanding Treatment for NF1-PN
NF1 is a rare genetic disorder with significant health complications, including nerve-related tumors. Until the FDA approval of Gomekli (manufactured by SpringWorks Therapeutics), treatment options have been limited.
Gomekli’s approval marks a milestone as the first therapy available for both adults and children, providing an alternative to Koselugo, which is only indicated for pediatric patients.
Management Strategies & Plan Sponsor Considerations
- Utilization Management: Prior authorization should be required, along with renewal criteria based on therapy response, as treatment duration is expected to range from one to two years.
- Cost Impact: With an annual wholesale acquisition cost (WAC) ranging from $225,225 for pediatric patients to $450,450 for adults, Gomekli represents a significant financial consideration for plan sponsors. As new patient populations become eligible for treatment, pharmacy costs could rise substantially.
- Clinical Considerations: Gomekli provides a new option for adult patients ineligible for surgery, but its long-term impact on NF1-PN progression is still being evaluated.
Stelara Biosimilar Market Update
Six biosimilars of Stelara were launched in early 2025, offering significant cost-saving opportunities in the biologic drug space. With Stelara generating $17 billion in sales in 2024, its biosimilars could reshape formulary strategies, particularly in the management of Crohn’s disease and ulcerative colitis.
| Biosimilar | Manufacturer | Discount vs. Stelara WAC |
| Wezlana | Amgen | High WAC: 5%, Low WAC: 81% |
| Selarsdi | Alvotech/Teva | 86% |
| Pyzchiva | Samsung Bioepis/Sandoz | 80% |
| Yesintek | Biocon Biologic | 90% |
| Otulfi | Fresenius Kabi | 86% |
| Steqeyma | Celltrion | 86% |
New drug approvals and biosimilar launches in 2025 are driving significant shifts in cost, utilization management and formulary strategies. With high-cost therapies entering the market and PBMs adjusting their formularies, plan sponsors need to stay proactive in managing pharmacy spend, ensuring appropriate utilization, and adapting to evolving coverage landscapes. Understanding these changes now will be key to optimizing both costs and patient access.
