
As Medicare plans tighten drug lists under shifting incentives, new peer-reviewed evidence warns that restricted access to multiple sclerosis medicines is tied to more relapses.
Story Snapshot
- A national Medicare study links narrower MS drug coverage to higher relapse risk.
- Plans use prior authorization, step therapy, and exclusions that can delay or block needed treatments.
- 2025 Part D redesign caps out-of-pocket costs but may push plans to further narrow coverage.
- Monthly formulary changes and mid-year restrictions are permitted under CMS-aligned rules.
Peer-Reviewed Finding: Narrower Coverage, Higher MS Relapse Risk
JAMA Network Open published a national Medicare analysis reporting that beneficiaries with multiple sclerosis in plans with broader access to disease-modifying therapies experienced lower relapse risk than those in more restrictive plans. The study moved beyond cost or adherence proxies to a clinical endpoint—relapse episodes—establishing that coverage breadth matters for outcomes. USC’s Schaeffer Center summarized the findings and emphasized that MS treatment is highly individualized, making choice among therapies essential for stability and function.
Researchers contextualized the association with known barriers: prior authorization delays, step therapy requirements, and specialty-tier placement that raise costs and impede timely starts or switches. Clinicians often cycle patients through multiple agents before finding a workable regimen; limiting options or delaying approvals can increase disease activity months later. While observational limits apply, converging evidence on delays, adherence, and persistence supports the mechanism connecting restrictive design with worse clinical results for seniors coping with MS.
Switching from one CD20-targeting therapy to another doesn't alter their ability to lower disease activity and slow disability progression. https://t.co/2VYlAtwyrR #MultipleSclerosis #MSTreatment #MSResearch #MSNews
— Multiple Sclerosis News Today (@MSNewsToday) August 7, 2025
What’s Driving Restrictions: PBMs, Plan Liability, and Rebate Dynamics
Pharmacy benefit managers and plan pharmacy committees shape formularies, leveraging exclusions and tiering to secure rebates and control spending. That tactic can work where drugs are interchangeable, but MS therapies are not one-size-fits-all. As 2025 Part D redesign shifts more liability to plans after the $2,000 out-of-pocket cap, the study’s policy discussion warns that plans may respond by tightening coverage of high-cost MS agents to manage exposure—raising the risk of access barriers precisely for patients needing individualized options.
Advocacy groups and specialty clinicians have prepared for the redesign by advising proactive documentation, appeals, and close coordination to preserve therapy continuity. The National MS Society and clinical guidance highlight that broader access reduces the likelihood of destabilizing switches or delays. If plans shrink covered options or intensify utilization management, patients and physicians face heavier paperwork and higher odds of treatment interruptions—costs in time and health that can outweigh pharmacy savings when relapses trigger infusions, hospitalizations, or steroids.
Real-World Rules: Mid-Year Changes, Tiering, and Appeals Pathways
Medicare Advantage and stand-alone Part D plans can update formularies monthly within CMS rules, including adding restrictions or moving drugs across tiers when generics or biosimilars appear. Patients may request exceptions, but approvals depend on plan criteria, physician documentation, and persistence through multi-step appeals—an administrative gauntlet especially challenging for seniors managing a relapsing neurologic disease.
Specialty-tier placement and high coinsurance can also suppress adherence, compounding risk. Even with the 2025 cap, front-loaded costs, prior authorization lags, and step therapy can delay therapy initiation or switching after breakthrough disease. Specialty pharmacy programs may help adherence, but they cannot fix a formulary that excludes or deprioritizes the drug a patient actually needs.
Implications for Patients, Clinicians, and Policymakers
Short term, restrictive formularies correlate with more relapses and heavier administrative burdens for physicians navigating denials and step therapy. Long term, repeated relapses risk accelerated disability and rising total costs that can swamp any paper savings from excluding medicines. The evidence supports guardrails that protect physician-guided choice among MS therapies, timely approvals when patients fail first-line agents, and limits on mid-year restrictions that disrupt stability—principles aligned with individual liberty and medical decision-making at the bedside, not by opaque committees.
Sources:
USC Schaeffer Center: Narrower Medicare Coverage of MS Drugs Linked to Higher Relapse Risk
JAMA Network Open: Formulary Restrictions and Relapse Episodes in Persons With Multiple Sclerosis in Medicare
NeurologyLive: Key Takeaways for MS Providers Regarding Major Medicare Changes Expected in 2025
Solace Health: Medicare Coverage for Multiple Sclerosis Medications
Kaiser Permanente: 2025 Comprehensive Formulary (Medicare)