February 2025 Clinical Recap
Jake Goll, PharmD (jake.goll@theprismhealthgroup.com) serves as the clinical consultant at Prism Health Group, where he provides end-to-end oversight of clinical strategy through in-depth data analysis, proactive consultation, and subject matter expertise. Gene Therapy: Big Talk, Slow Uptake
The Latest on Compounded GLP-1s: FDA Crackdown & Industry Shifts
GLP-1 medications continue to dominate headlines in both healthcare and pop culture, and this year’s Super Bowl only fueled the hype. Hims & Hers made waves with a bold ad promoting their compounded GLP-1 products, reigniting discussions about the clinical and sustainability concerns surrounding non-FDA-approved compounded versions of these drugs. Maybe I’m just a pharmacy nerd, but the ad prompted me to put down my plate of wings and get up on my soapbox to share unsolicited details about compounded GLP-1s with my non-healthcare friends, rambling over what was probably another touchdown from the Eagles.
Compounding of semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound) was initially permitted under FDA regulations due to drug shortages. Companies like Hims & Hers, Ro, and others seized this opportunity, compounding and aggressively marketing their own versions. However, as anticipated, the FDA has now declared these shortages resolved, triggering new restrictions on compounding.
Prism raised concerns early on about reliance on these compounded products, warning that once the FDA pulled back its allowance, patients who had started on compounded therapy, whether for cost reasons or because their employer didn’t cover GLP-1s under the pharmacy benefit, would be left with few options. That moment has now arrived.
Key Dates for Compounding Restrictions:
- Semaglutide State-licensed pharmacies & physicians (503A): No compounding after April 22, 2025 Outsourcing facilities (503B): No compounding after May 22, 2025
- Tirzepatide State-licensed pharmacies & physicians (503A): No compounding after February 18, 2025, or until a court ruling in OFA v. FDA (whichever is later). Outsourcing facilities (503B): No compounding after March 19, 2025, or until a court ruling in OFA v. FDA (whichever is later).
On February 25th, the Outsourcing Facilities Association (OFA) filed a second lawsuit, this time regarding semaglutide, alleging the FDA is “dismissing evidence that the shortage persists” in removing the drugs from its shortage list “without notice-and-comment rulemaking.” As of February 28th, there have not been any new developments regarding the OFA v. FDA cases outside of what has been noted above.
Lilly Direct Expands Zepbound Offerings – But Is It Affordable?
Almost as if responding to the end of GLP-1 compounding, Eli Lilly has expanded its direct-to-consumer Lilly Direct program offerings for Zepbound. Originally launched in 2024, the program offered Zepbound 2.5mg and 5mg vials at $399 and $549 per month, respectively. Lilly Direct products are available to cash-paying customers only and cannot be processed through the pharmacy benefit.
February 25th Pricing Updates:
- Zepbound 2.5mg price reduced to $349/month
- Zepbound 5mg price reduced to $499/month
- New dosages added: Zepbound 7.5mg: $599/month Zepbound 10mg: $699/month
- Adherence incentive for 7.5mg and 10mg strengths: Through the Zepbound Self Pay Journey program, first fills and refills (within 45 days of previous delivery) are reduced to $499/month.
Cost Comparison & Alternative Access Strategies
Lilly Direct offers a discounted cash price, but $499/month is still out of reach for many patients. Meanwhile, traditional pharmacy benefit rebate data suggests the average net price of Zepbound is $700-$750 per month.
To bridge the affordability gap, programs like RxSaveCard provide alternative access routes for weight management medications. These programs:
- Connect patients with participating pharmacies offering cash-pay discounts.
- Help patients bypass insurance barriers.
- Allow plan sponsors (employers, health plans) to load funds onto cards to offset medication costs that can be used to purchase Lilly Direct medications.
Telehealth Add-Ons for Obesity Care
Lifestyle management tactics are essential for weight management. Lilly Direct recognizes this need for a holistic approach and also partners with Form Health and 9am Health to provide telehealth solutions, including access to obesity specialists and care coordination. Individual program costs are noted below.
- Form Health: $299/month
- 9am Health: $149/month
Journavx: A New Non-Opioid Option for Acute Pain Management
On January 30th, 2025, the FDA approved Journavx (suzetrigine), a first-in-class, non-opioid pain medication from Vertex Pharmaceuticals, for the treatment of moderate to severe acute pain in adults. This approval marks the first new class of pain medication in over 20 years and was granted Breakthrough Therapy, Fast Track, and Priority Review designations by the FDA.
How Does Journavx Work?
Unlike opioids, Journavx is not a controlled substance and does not pose a risk of addiction due to its unique mechanism of action. It works by blocking pain signal transmission from peripheral sensory neurons, the messengers that carry pain signals from the body to the spinal cord and brain.
Clinical Efficacy & Labeling
Clinical trials showed Journavx significantly reduced pain compared to placebo. While it did not outperform hydrocodone/acetaminophen, it provided notable pain relief without the risks associated with opioid use. The label recommends use for the shortest duration necessary, not exceeding 14 days, as it was not studied beyond this timeframe.
While Journavx is approved for moderate to severe pain, real world efficacy will be interesting to monitor, considering it did not outperform hydrocodone/acetaminophen, which is on the lower end of potency in the opioid class.
Cost & Payer Considerations
One major challenge with Journavx is cost. At $15.50 per 50mg tablet, a 14-day course totals approximately $450.
Payer management strategies will likely depend on whether P&T committees view Journavx as addressing an unmet need for acute pain while reducing opioid abuse risks.
- Prior authorization (PA) or step therapy (ST) requirements could delay access to a medication intended for immediate pain relief, potentially burdening both providers and patients.
- If covered, plans should implement quantity limits (QL) as a safeguard, which will avoid delaying therapy when prescribed according to FDA guidelines.
Utilization Management Recommendations
To ensure appropriate use without disrupting therapy, a QL of 14 days (29 tablets per prescription) and 1 prescription per 6 weeks aligns with FDA-approved indications. This schedule accounts for patients undergoing common surgeries like knee arthroplasties or bunionectomies on both sides, typically spaced six weeks apart. As payers evaluate coverage, balancing accessibility, cost, and opioid-sparing potential will be key considerations.
Stelara Biosimilars Enter Market Rapidly: Capitalizing on Cost Savings
The biosimilar landscape for Stelara is evolving much faster than Humira’s, with multiple competitors launching shortly after the release of Wezlana on 1/1/25. Unlike Humira biosimilars, which saw a slow, staggered rollout and limited initial price competition, Stelara biosimilars are immediately driving down costs, creating a prime opportunity for PBMs and plan sponsors to act quickly.
PBM Formulary Landscape (as of February 28th):
- OptumRx continues to cover Stelara alongside its white-label biosimilar, Wezlana (Amgen/Nuvaila), available in: High-WAC option: 5% discount off Stelara’s WAC Low-WAC option: 81% discount off Stelara’s WAC
- MedImpact continues to cover Stelara while adding: Selarsdi (Alvotech/Teva): 85% discount off Stelara’s WAC Yesintek (Biocon): 90% discount off Stelara’s WAC
For reference, Stelara’s annual WAC is $126,326 for psoriasis and psoriatic arthritis; $189,484 for Crohn’s disease and ulcerative colitis, assuming a 90mg dose. A 45mg dose is used for psoriasis and psoriatic arthritis for those weighing under 100kg, which reduces annual WAC to $63,163.
The rapid entry of multiple biosimilars for Stelara presents a stark contrast to the slow rollout of Humira biosimilars. When Amjevita launched on January 31, 2023, it entered the market with only a 55% WAC discount, and no additional Humira biosimilars were available until July of the same year. In contrast, Stelara’s biosimilar competition is arriving at steep discounts right from the start, immediately creating significant cost-saving opportunities for PBMs and plan sponsors. With these aggressive price reductions, plans that move swiftly to prefer biosimilars can take advantage of lower upfront costs without having to rely on rebates for savings.
The potential annual savings per patient depend on Stelara’s net cost after rebates, drug strength (45mg vs. 90mg), and its dosing regimen, which varies by indication. For psoriasis and psoriatic arthritis, the medication is dosed every 12 weeks, while for Crohn’s disease and ulcerative colitis, it is dosed every 8 weeks. With immediate price erosion and multiple biosimilars offering substantial discounts, PBMs and payers have a unique opportunity to drive down specialty drug costs faster than seen with Humira biosimilars. The chart below assumes a 90mg dose.
GLP-1s and Colonoscopy Prep: What Patients and Providers Need to Know
A recent meta-analysis published in the American Journal of Gastroenterology examined whether GLP-1 medications impact colonoscopy preparation. As part of their mechanism of action, GLP-1s delay gastric emptying, prolonging the amount of time food spends in the digestive system. With colonoscopies requiring an empty, clean colon in order to provide an accurate evaluation, concerns have been raised about GLP-1s delaying gastric emptying and thus, preventing an adequate assessment of colon health.
Study Findings
The meta-analysis reviewed five studies with 10,833 subjects, assessing:
- Inadequate Bowel Preparation (IBP) rate as the primary outcome
- Boston Bowel Preparation Scale (BBPS) scores as the secondary outcome
Key results:
- Higher IBP rates in patients taking GLP-1s
- Lower BBPS scores in the GLP-1 group
- Statistically significant risk of inadequate bowel prep for GLP-1 users, as supported by higher IBP rates and lower BBPS scores
These findings are clinically significant, as poor preparation increases the likelihood of needing a repeat colonoscopy, adding costs and inconvenience for both patients and plan sponsors.
Current Recommendations
The American Society of Anesthesiologists currently recommends holding GLP-1 therapy for one week before a colonoscopy. However, patient-specific recommendations may vary, making early communication with a gastroenterologist essential. Physicians can provide personalized guidance on bowel preparation strategies and whether temporarily stopping GLP-1s is necessary.
With the growing use of GLP-1s for diabetes and weight loss, these findings highlight an important clinical and cost consideration for both healthcare providers and payers.
