Is Your Drug Launch Set Up to Avoid Commercialization Failure?
For market access leaders, launching a new product can be a high stakes challenge. With nearly two-thirds of drug launches falling short of...
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3 min read
CareMetx
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Jun 30, 2025 11:58:15 AM
For years, people living with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as Non-Alcoholic Steatohepatitis (NASH) have faced a difficult reality: the condition has been largely overlooked, with few effective treatment options available to help manage it. Diagnosis is often delayed, and for many patients, lifestyle modification has been the only option. In practice, that often meant being told to simply lose weight, with no additional support or alternatives. But lasting lifestyle change is difficult to achieve, especially at the level needed to impact this disease’s progression. In a recent study, just 51% of patients reached the recommended 7-10% weight loss, and only 34% maintained at least 10% weight loss after nine months, figures too low to meaningfully change outcomes for most people.
Thankfully, that longstanding gap in care is finally beginning to close. The FDA’s approval of the first pharmacologic treatment specifically indicated for MASH, along with a growing pipeline of late stage therapies, signals a meaningful shift in the landscape. For the first time, patients may have access to medications capable of modifying the course of their disease. But therapeutic advancement alone is not enough. To realize the full benefit of these innovations, patients will require structured, coordinated support across the care continuum- from diagnosis through treatment initiation, adherence, and ongoing monitoring.
Understanding the Emerging Burden of MASH
Roughly 5% of U.S. adults live with MASH. Many also face compounding health and social challenges such as type 2 diabetes, obesity, or barriers related to housing, income, or transportation. These factors make long-term disease management even more complex. Without proper care, which, until recently, hasn’t been available for most, MASH can progress to serious and irreversible complications. For example, 10- 12% of patients go on to develop cirrhosis, liver failure, or cancer.
But that trajectory may finally change. The approval of the first FDA-indicated pharmacologic treatment for MASH marks a significant turning point, offering patients a real therapeutic option for the first time. Early clinical data show meaningful improvements in liver health and quality of life. For patients and providers who have waited years for progress, it’s an important step forward.
Still, new treatment options alone won’t be enough. While the emergence of therapies marks real clinical progress, their high cost remains a major barrier, often costing tens of thousands of dollars per year. Even when insurance provides partial coverage, patients can still face thousands of dollars in out-of-pocket costs. Public payers may offer more predictable support, but providers consistently report administrative roadblocks, delayed authorizations, and a growing need for hands-on navigation to help patients access and afford therapy.
To address these challenges, manufacturers have introduced a range of support programs—copay savings, free drugs for uninsured patients, and referrals to charitable foundations among them. Yet each program has its own eligibility requirements, documentation hurdles, and capacity limits. For both patients and providers, the result is a fragmented and often confusing experience that’s difficult to navigate and sustain.
Designing Effective Patient Support Models
This therapeutic innovation must be matched with patient services innovation. That means embedding support early in the process: helping patients get diagnosed sooner, navigate access more easily, and stay engaged throughout treatment.
In the MASH space, effective support models must include:
These elements aren’t just operational add-ons, they’re essential to delivering on the promise of breakthrough MASH therapies. They’re what will ultimately determine whether a patient can access, afford, and stick with treatment.
Integrating Specialized Partners to Enhance Care
Success in meeting patients' needs in this therapeutic area requires multi-faceted patient access and support components; rarely all delivered by a single partner. The required innovation to effectively address the patient’s entire journey brings together best-in-class partners across the care continuum- access service leaders, experts in patient behavior and effective engagement, and affordability teams with deep experience in copay, bridge programs, and foundation support.
But even the strongest mix of partners can fall short without one essential element: integration. When these services operate in silos, patients face delays, data gets lost, and critical next steps are missed. Fragmented systems and disconnected workflows don’t just slow time to therapy; they create real risk of patients falling through the cracks.
That’s where modern infrastructure makes a difference. Seamlessly connected systems- EMRs, CRMs, specialty pharmacies- enable faster, more coordinated program execution while easing the burden on providers and supporting a more consistent experience for patients.
For a patient with MASH, these breakdowns aren’t just frustrating- they have real consequences. A delay in prior authorization can mean missing the opportunity to start therapy. A missed copay resource could lead someone to abandon treatment altogether. Without clear, connected support, patients are left to navigate a maze of forms, follow-ups, and financial decisions—often while also managing other chronic conditions. Integrated systems help remove these barriers, making it more likely that patients can access therapy, afford it, and stay on treatment long enough to see real benefit.
Laying the Groundwork for Sustainable Access
To truly change the MASH treatment landscape, commercial teams must go beyond delivering medicine. They need the infrastructure, coordination, and flexibility to support patients through every step of their journey—especially as access and affordability challenges evolve.
At CareMetx, we understand how disjointed systems and manual workarounds can stall progress and undermine patient outcomes. Our solution is designed to streamline connectivity across partners and platforms, reduce lift for your team, and keep your program moving—no matter how your ecosystem evolves.
If you're facing these challenges, we're ready to talk. Let’s explore how we can help you build a more connected, sustainable approach to patient support. Reach out to learn more.
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