March 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
Novo Nordisk Enters the GLP-1 Direct-to-Consumer Space
Novo Nordisk has officially entered the direct-to-consumer weight management market, joining Eli Lilly with the launch of the NovoCare® Pharmacy. This follows Eli Lilly’s recent announcement to expand the available dose range of Zepbound through their Lilly Direct® program, alongside a new pricing structure. Patients enrolled in Lilly’s Zepbound Self Pay Journey Program who consistently refill every 45 days or less can access treatment at a reduced cash price of $499 per month.
To bridge the affordability gap, programs like RxSaveCard provide alternative access routes for weight management medications by connecting patients with participating pharmacies offering cash-pay discounts, helping patients bypass insurance barriers by allowing plan sponsors (employers, health plans, etc.) to load funds onto cards that can be used to purchase Lilly Direct® or NovoCare® medications.
These developments coincide with the FDA’s crackdown on compounded versions of GLP-1 medications, which will end access to non-FDA-approved versions. As of March 19, compounded tirzepatide products (Lilly’s Zepbound and Mounjaro) will no longer be permitted, followed by compounded semaglutide products (Novo’s Wegovy and Ozempic) on May 22.
In response, NovoCare® now also offers a streamlined solution for patients seeking reliable access to authentic, FDA-approved Wegovy at a flat rate of $499 per month. Like Lilly Direct, NovoCare® operates as a self-pay program, meaning insurance cannot be used. Patients who are prescribed Wegovy can conveniently schedule direct-to-home delivery through the NovoCare® platform.
Wegovy and Zepbound pricing is comparable, both maxing out at the same value. And while the two direct-to-consumer programs share many similarities, there are key distinctions. A detailed comparison is included in the table below.
On March 27, Eli Lilly announced an expansion of its “pharm to table” model, this time targeting Alzheimer’s disease (https://lillydirect.lilly.com/memory-and-thinking). Under the Lilly Direct® umbrella, the company is offering connections to in-person and telehealth care options for individuals in the U.S. experiencing memory and cognitive issues. This follows recent expansions of Lilly’s Zepbound program and Novo Nordisk’s NovoCare® offering for Wegovy.
While this new initiative doesn’t yet include direct-to-consumer medication, Lilly’s portfolio includes Kisunla for early symptomatic Alzheimer’s, suggesting a focus on streamlining access to care and enabling earlier treatment initiation, with potential to include direct-to-consumer access to Kisunla in the future.
Access delays in Alzheimer’s care are significant. In 2025, wait times to see a dementia specialist are expected to exceed a year, with even longer delays in rural and underserved areas. Lilly aims to address this through their partnership with Synapticure, which can connect patients to a care navigator within one day and a neurologist within two weeks.
Though still in their infancy, these direct-to-consumer programs offer an innovative approach to tackling healthcare access and cost issues. By bypassing traditional wholesalers and PBMs, manufacturers can offer medications (like GLP-1s) at prices that undercut PBM net costs after rebates. They are also showing how they can expedite access to care, largely via telehealth models.
These programs are surfacing in therapeutic areas where the patient experience is often fragmented or delayed, Alzheimer’s and obesity being prime examples. While easier access raises valid concerns about potential inappropriate use or overuse, these efforts reflect a bold reimagining of pharma’s role in care delivery. It’s a space to watch cautiously, but with optimistic curiosity.
Tremfya Expands GI Market Reach with Crohn’s Disease Approval
On March 20, 2025, Johnson & Johnson’s Tremfya received FDA approval for Crohn’s Disease (CD), its fourth indication, just months after gaining approval for ulcerative colitis (UC) in September 2024. This rapid expansion highlights Tremfya’s growing competitiveness in the inflammatory bowel disease (IBD) space among the interleukin (IL) drugs (e.g., Skyrizi, Stelara). Notably, J&J highlights that Tremfya is the first and only IL-23 inhibitor with both subcutaneous and intravenous induction options for Crohn’s Disease, offering increased flexibility for prescribers and patients.
With this latest indication, Tremfya now mirrors the full slate of approvals held by both Stelara and Skyrizi, covering plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease. J&J is also making a strategic case for Tremfya’s superiority over its own Stelara in Crohn’s Disease, positioning Tremfya as a preferred IL agent as Stelara’s market share faces pressure from biosimilar competition.
The IL inhibitor class is becoming increasingly competitive. While drug selection remains highly individualized based on patient characteristics, agents like Tremfya and Skyrizi are gaining ground as front-runners due to their impressive efficacy. Still, Stelara remains a clinically effective option, and the launch of biosimilars adds another layer of value through potential cost savings, creating a compelling case for Stelara as a first-line option from both a clinical and economic perspective.
The table below provides a snapshot comparison of Tremfya, Skyrizi, and Stelara, highlighting key differences in administration, clinical attributes, and cost.
GLP-1’s Show Clinical Promise but Miss Mark on Cost-Effectiveness
A new economic evaluation published in JAMA Health Forum on March 14, 2025, has reignited concerns around the cost-effectiveness of GLP-1 therapies for weight loss. The study concluded that semaglutide (Wegovy) and tirzepatide (Zepbound) remain priced too high to meet commonly accepted cost-effectiveness thresholds, echoing earlier findings from the Institute for Clinical and Economic Review (ICER) in 2022, but now based on updated clinical outcomes and net cost estimates.
The analysis reaffirmed that these medications provide meaningful long-term health benefits, particularly in sustained weight loss and cardiovascular outcomes. However, their high acquisition costs continue to outweigh the projected healthcare savings over time, leading the authors to suggest that manufacturers must significantly lower prices before these therapies make both clinical and financial sense for broader coverage.
Importantly, the study did not include potential benefits in related conditions such as obstructive sleep apnea and nonalcoholic fatty liver disease (NASH/MASH), which may further bolster the clinical value of GLP-1s in future models. That said, the microsimulation used by the researchers did account for maximum sustained weight loss and cardiovascular benefit over a lifetime horizon, so authors feel that adding these two disease states into consideration would not significantly change outcomes.
A detailed comparison of clinical outcomes and cost-effectiveness estimates from the study is included in the table below. Additionally, some observations regarding the study’s data:
1) Prism independently verified net costs with data from IPD Analytics, LLC, which tracks wholesale acquisition costs and estimated rebates.
2) The study acknowledged that it estimated rebate data for Zepbound (tirzepatide) based off how Mounjaro’s (tirzepatide) rebate compares to Ozempic (semaglutide) in the diabetes category. Prism relied on IPD Analytics’ estimated rebate for Zepbound (tirzepatide), which is determined by comparing gross vs. net sales reports from manufacturers.
