Note: Rejections calculated among new patients within each brand’s first 12 months post-launch; rejections in analysis are classified by remaining unapproved for 30 days after an initial rejection
Source: IQVIA LAAD pharmacy claims; US Market Access Strategy Consulting

Each selected GLP-1 brand tells a different access story, but in all three instances, the use of transitional assistance to overcome payer restrictions is clear. When Ozempic initially launched in 2017, less than a third of new patients were able to get commercial insurance to cover their prescriptions. However, some patients that were rejected did manage to fill prescriptions using a transitional assistance program. Eventually Ozempic’s access improved, resulting in 70% paid commercial new starts after 12 months.

For Wegovy and Mounjaro, access has stayed comparatively low since launching. Even after a year on the market, only a quarter of new patient attempts filled their prescriptions for Wegovy with commercial insurance. This was slightly higher for Mounjaro (35%), which may have been related to its diabetes indication as opposed to Wegovy’s indication for weight loss. The two brands differ even more when evaluating the utilization of transitional assistance.

In the case of Wegovy, transitional assistance utilization declined over the course of a year despite minimal in access. Transitional assistance for Mounjaro, on the other hand, accounted for nearly a quarter of new patient attempts at month 11.

Note: Status based on a 30-day look-forward from initial attempt
Source: IQVIA LAAD pharmacy claims; US Market Access Strategy Consulting

Some new patients get access through transitional assistance before attempting to fill with insurance. This increases patients’ speed to treatment but may be an unnecessary application of transitional assistance if payer coverage would have otherwise covered the treatment. Such dynamics are particularly challenging for brands like Mounjaro where as much as 16% of new, commercial patients use transitional assistance on a first attempt. There are implications for overall revenues and support sustainability.

Long-term sustainability of transitional assistance

Some transitional assistance programs tend to snowball and can be difficult to scale back. While a voucher is designed for one-time use, denial conversion and bridge programs might ultimately leave manufacturers to cover several months, if not a whole year or more, of patients’ prescriptions. In the case of Mounjaro after 11 months on the market, transitional assistance accounts for a quarter of all commercial new starts and more than half of all commercial claims as continuing patients become repeat beneficiaries of transitional assistance. As a result, Mounjaro is subsidizing more than 50% of its own commercial revenue.

Mounjaro is not unique. While the new therapy is exceptional in its volume trajectory and market potential, many launch brands are faced with the challenge of balancing patient access, payer coverage, and transitional assistance impact to margin. One way to ensure transitional assistance is being allocated where needed is to convert patients to payer coverage, making the most of any contract wins as soon as possible.

This is the case for Ozempic, in which over 50% of patients that initiated treatment using transitional assistance were able to convert to payer coverage¹, and thus its commercial volume is made up mainly of continuing patients with payer coverage. Still facing payer access challenges, Wegovy and Mounjaro have much lower conversion rates – around 25% and 30%, respectively. Patients who initiated treatment for both brands using transitional assistance continued to be subsidized by the manufacturer as they refilled their prescriptions.

Source: IQVIA LAAD pharmacy claims, PlanTrak projected pharmacy claims; US Market Access Strategy Consulting

Transitional assistance utilization is partly a function of demand – fueled by formulary restrictions, for example – as well as the result of program design and implementation. Manufacturers and the vendors they work with can design transitional assistance many ways that affect patient eligibility, how long patients may use a program, how often benefit verifications occur for re-enrollment, and how efficiently patients are converted from transitional assistance to payer coverage. In this way, manufacturers are able to boost and pull back on transitional assistance depending on patient need and budget availability.

Manufacturers must balance their volume and access goals with the gross-to-net impact that transitional assistance creates. By scaling back such programs, brands may see improvements to profitability and budgets but may also cede share to other brands. For launch products looking to establish efficacy and confidence with providers and patients, market share can be a powerful asset.

Starting in December 2022, Mounjaro began to pull back some of its marketing (including transitional assistance)²  and focused on diabetes patients as opposed to all patients which included weight loss patients. This led to a sharp decline in new-to-brand volume as weight loss patients who were less likely to have payer coverage and thus required transitional assistance were now excluded from eligibility. While transitional assistance remained available to all continuing patients, new patient volume moved to Wegovy and Ozempic.

Source: IQVIA LAAD pharmacy claims, PlanTrak projected pharmacy claims; US Market Access Strategy Consulting

GLP-1s in the wake of weight loss innovation

Transitional assistance allows patients to access treatment when they otherwise would not be able to. While this can be critical for early uptake at launch, it is also strategically necessary that brands account for the long-term implications. A transitional assistance strategy, especially for a launch drug, includes:

• Clear definitions of short- and long-term success
• Robust, gross-to-net forecasts that account for both payer access and demand
• Plans and strategies to move patients from transitional assistance to coverage

As IQVIA will explore in a forthcoming blog, Mounjaro’s launch transformed the GLP-1 market by driving demand for highly effective treatments that patients were largely able to acquire for free through transitional assistance. Though only currently indicated for diabetes, the combined HbA1c and weight loss benefits make Mounjaro a standout in the class, creating a level of demand that has significantly grown the size of the overall GLP-1 market. Even as Mounjaro’s transitional assistance reduced and supply shortages began, new patients are finding solutions in Ozempic and Wegovy and are changing the face of the market as they do.

The Mounjaro story is part of a larger, consumer-driven wave of demand where patients are taking possession of their own access wherever possible. In the case of GLP-1s, patients are operating outside their insurance and even a drug’s current indication to get the treatment they want. Transitional assistance opens the door for patients that might not have access to new, innovative therapies. Pharmacy discount cards, online discount pharmacies, and telehealth-based pharmacy subscriptions are other facets of this emerging trend. In an ever-evolving market, biopharmaceutical manufacturers must consider the more direct role patients may play in defining value and even launch uptake.

References:

1. IQVIA LAAD pharmacy claims data, US Market Access Strategy Consulting analysis
2. Eli Lilly Tightens Access to Diabetes Drug, Frustrating Some People with Obesity, STAT News