Redefining gMG Management: Pt II

Key Takeaways

• The Myasthenia Gravis Activities of Daily Living (MG-ADL) scale and Quantitative Myasthenia Gravis (QMG) score are valuable tools, but each has limitations and must be interpreted with clinical context.
• Increasingly, payers are using MG-ADL scores to make coverage determinations—sometimes misinterpreting improvement as a reason to discontinue effective therapy.
• The marked heterogeneity of autoantibody profiles in myasthenia gravis necessitates therapeutic flexibility, including formulary access to targeted agents in both outpatient and inpatient settings.

What clinical and functional outcomes matter most in assessing treatment response—and how should payers incorporate symptom burden and quality of life into value assessments?

Amanda Hernandez, MD, PhD: When we think about functional outcomes in myasthenia gravis, the most commonly used measure is the MG-ADL score. We see it consistently across clinical trials, and in my clinic, every patient completes an MG-ADL at each visit. It’s a patient-reported outcome measure, which I value tremendously.

That said, the MG-ADL captures symptom burden at a specific moment in time. It tells us how the patient is feeling, but it doesn’t always carefully delineate symptom frequency or variability. There’s still a fine balance we’re trying to strike between what the patient is reporting, what we observe clinically, and what other measures—like the QMG, which is more physician-reported—are telling us.

As clinicians, we rely heavily on our patients to give us a clear lens into how symptoms are affecting their day-to-day lives. But I do think there’s room for improvement in how we assess disease activity in clinical practice.

In clinical trials, the consistent use of measures like MG-ADL does allow for relative comparability across studies. That parity is helpful when evaluating efficacy signals. However, in real-world practice, these scores need to be interpreted thoughtfully and with nuance.

What role does coverage flexibility play in enabling personalized treatment decisions in a heterogeneous condition like gMG?

Dr Hernandez: One issue I’ve encountered is that insurance companies are increasingly using MG-ADL scores to determine whether they will continue covering a therapy.

For example, I had a patient who started a newer infusion therapy with an MG-ADL score of 11. After treatment, their score improved to 2—which is remarkable. But the insurer argued that because the score improved so substantially, they no longer needed to cover the therapy.

Of course, the reason the score improved is because the patient is on the therapy. Discontinuing it would not be in their best interest.

That highlights a broader issue: how are we educating payers about chronic autoimmune diseases like myasthenia? This is not necessarily a condition that is “cured.” While remission is possible, sustained control often depends on continued therapy. When something is working, maintaining that therapy is frequently the best course of action.

If payers don’t fully understand how to interpret these measures, it places the burden on providers to appeal denials or pursue peer-to-peer reviews. That process delays care and can delay meaningful care. I believe there’s an opportunity for deeper education so that coverage decisions reflect the clinical realities of the disease.

How do formulary design and utilization management strategies influence prescribing?

Dr Hernandez: The heterogeneity of myasthenia gravis is extraordinary. Even within antibody-defined subgroups, patients are not the same.

We know that roughly 80% of patients have antibodies associated with significant complement engagement—but those same antibodies can have other pathogenic mechanisms as well. Not every patient’s disease is predominantly complement-driven. For some, a complement inhibitor may not be the most rational choice.

In those cases, I may prefer a therapy that antagonizes FcRn or one that depletes certain B-cell populations. The decision should be based on the pathophysiologic mechanism most relevant to that individual patient.

If payer policies create a rigid, stepwise expectation that does not account for that heterogeneity, patients can end up on therapies that are not optimally aligned with their disease biology. That limits our ability to practice precision medicine.

Flexibility in coverage is essential—not only for clinical outcomes, but also for shared decision-making. When I tell my patients that modifying their immune system is both an honor and a privilege, I mean that. It requires transparency, education, and buy-in. Patients should understand why we are choosing one therapy over another, and what alternatives exist if the initial strategy does not produce the desired outcome.

I’ve seen formulary design influence prescribing in both outpatient and inpatient settings. On the outpatient side, having infusion or injection therapies on formulary within an institution can make access easier. That said, patients may also receive therapy at standalone infusion centers or even via home infusion, depending on the treatment and resources available. So there is some degree of flexibility.

On the inpatient side, however, formulary restrictions can be more cumbersome. IVIG and plasma exchange remain the most commonly used rescue therapies. But some of our newer targeted agents may offer clinically meaningful improvement in certain patients, potentially even more rapidly.

If those therapies are not on formulary, obtaining them requires non-formulary requests and administrative processes that can be time-consuming and costly for the institution. I’ve had to navigate that process twice in the past week for hospitalized patients. I’m fortunate to have a supportive team, but not every institution has those resources.

At smaller centers, lack of formulary access could lead to unnecessary prolongation of an exacerbation simply because a patient cannot receive the most appropriate therapy in a timely manner.

Ultimately, access—whether through payer flexibility or formulary inclusion—directly affects patient outcomes. As our therapeutic toolkit expands, our systems of coverage and hospital policy need to evolve in parallel to ensure that patients truly benefit from the advances we’ve made.