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A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data

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Published on: December 9, 2015

Formulary Restrictions and Relapse Episodes in Persons With Relapsing-Remitting Multiple Sclerosis.

Barbara Blaylock¹, Karen Van Nuys², Geoffrey Joyce^2,3

¹Blaylock Health Economics LLC, Reno, Nevada.

JAMA Network Open

|August 1, 2025

Summary

Broader formulary coverage for multiple sclerosis (MS) disease-modifying therapies (DMTs) was linked to fewer relapses. This suggests tailoring formulary restrictions to patient needs, not solely cost management, is crucial for better MS care.

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Area of Science:

Health Services Research
Pharmacoeconomics
Neurology

Background:

Narrow formularies are utilized to negotiate higher rebates and control spending on expensive medications in the US.
Understanding the impact of formulary breadth on patient outcomes is essential for healthcare policy.

Purpose of the Study:

To investigate the association between the extent of formulary coverage for multiple sclerosis (MS) disease-modifying therapies (DMTs) and the occurrence of MS relapses.
To evaluate how formulary design in Medicare Part D plans influences clinical outcomes for MS patients.

Main Methods:

A retrospective cohort study using 100% Medicare administrative data from 2018-2022.
Analysis included beneficiaries with stand-alone prescription drug plans (PDPs) and Medicare Advantage Prescription Drug plans (MA-PDs), focusing on those with relapsing-remitting MS and DMT use.
Formulary breadth was categorized as low or high coverage based on the median coverage of MS DMTs or drug classes over four quarters.

Main Results:

The study analyzed 50,162 beneficiaries in PDPs and 34,708 in MA-PDs.
Higher formulary coverage was associated with lower MS relapse rates: 9.5% in high-coverage PDPs vs. 10.6% in low-coverage PDPs, and 6.9% in high-coverage MA-PDs vs. 7.8% in low-coverage MA-PDs.
Multivariable analyses indicated that broader formulary coverage was significantly associated with reduced odds of MS relapse (adjusted ORs ranging from 0.88 to 0.94).

Conclusions:

Broader formulary coverage for MS DMTs is associated with a reduced risk of MS relapse in Medicare beneficiaries.
These findings suggest that formulary decisions should prioritize patient needs and clinical outcomes over solely managing drug costs and utilization.
Optimizing formulary design can lead to improved management of multiple sclerosis and potentially reduce healthcare expenditures associated with relapses.