Redefining gMG Management: Pt III

Key Takeaways

• Coverage decisions in myasthenia gravis extend beyond drug cost and must account for route of administration, infrastructure requirements, and overall resource utilization.
• Reliance on a single metric, such as the Myasthenia Gravis Activities of Daily Living (MG-ADL) score, oversimplifies a highly heterogeneous disease and may inadvertently restrict appropriate access to therapy.
• Future access strategies should emphasize flexibility, individualized assessment, and shared decision-making rather than rigid “if this, then that” algorithms.

When evaluating newer immunotherapies, including bispecific treatments like gefurulimab, what clinical, economic, and real-world evidence most influences coverage decisions?

Amanda Hernandez, MD, PhD: That’s a great question—and it’s a nuanced one. Coverage isn’t just about how expensive a therapy is. It’s also about how that therapy is administered, what infrastructure is required, which payers cover what, and how all of those pieces fit together.

For example, if a therapy is delivered as a prefilled syringe or auto-injector that a patient can administer at home, that may be more cost-effective than an infusion that requires IV access, a nursing team, infusion center time, and facility fees. On the other hand, emerging therapies like CAR T—particularly bispecific CAR T approaches being explored in myasthenia—require significant infrastructure and coordination. That’s an entirely different level of resource utilization.

So when thinking about access, we have to consider the patient’s needs, the disease state, logistical realities, and the financial implications all at once. It’s not a single-variable equation.

We’re fortunate to now have a growing list of therapeutic options, and that list will only expand. Ideally, we would be able to prescribe what is truly in the patient’s best interest without placing them in a position where they must first try and fail something else simply to satisfy a coverage requirement.

How can payers design access policies that manage cost while preserving flexibility for disease variability and treatment response?

Dr Hernandez: When we submit a therapy for prior authorization, we send clinic notes and documentation—often including MG-ADL scores. As I mentioned earlier, insurers frequently use the MG-ADL as a hallmark metric to determine eligibility or continued coverage.

While that approach is understandable, it’s incomplete.

Coverage decisions should look beyond a single number. They should consider the patient’s clinical history, prior therapies, combination strategies, contraindications, and overall trajectory. They should account for what can and cannot be combined safely. They should consider not only symptom scores, but the broader context of the patient’s disease journey.

An informed access strategy needs to extend beyond asking, “Did the MG-ADL improve?” It should also ask: What is the provider observing? Is the improvement clinically meaningful? Is the therapy preventing hospitalizations? Is it preserving swallowing or respiratory function? Is it preventing crisis?

Those are outcomes that matter deeply to patients.

No two patients are the same. There is extraordinary heterogeneity—not just in antibody subtype, but in disease presentation, severity, immunopathophysiology, and even in how patients tolerate therapy over time.

Consider something as practical as IV access. If a patient has poor venous access, are we going to place a port solely to administer a therapy when there are injectable options that may be equally effective? Even if the injectable therapy has a different cost profile, we need to weigh the broader clinical implications.

Flexibility in coverage allows us to tailor care appropriately. Patients may require different therapies at different stages of their disease. What works today may not be what works two years from now. An access model that allows adaptation is crucial.

I worry that sometimes we distill this very complex and elegant disease into an “if this, then that” algorithm. But autoimmune disease management is rarely that linear. It’s more often, “If this—and also these other factors—then here are several possible strategies.”

That’s where shared decision-making becomes essential. When we are modifying someone’s immune system, it is a profound responsibility. Patients deserve transparency, options, and thoughtful reasoning behind therapeutic choices.

Ultimately, payer models should reflect that complexity. They should move beyond a single patient-reported outcome measure and toward a more comprehensive, informed framework—one that recognizes heterogeneity, supports flexibility, and prioritizes long-term patient outcomes over simplified thresholds.