Challenges Regarding Coverage for New SPMS Therapies


The managed care challenges associated with the MS care spectrum have become increasingly complicated with the influx of new therapies, particularly in relation to determining a benefits design for SPMS that balances patient access to the right treatment while accounting for high treatment costs — which are growing more rapidly than those of most other disease states. Prior to 2009, many health plans’ formularies included all MS therapies with adequate accessibility. When several new drugs were introduced to the market after 2009, pharmacy and therapeutics committees (groups responsible for determining which drugs to include in the formularies) became more selective. Agents are now chosen based on clinical trial data regarding safety, efficacy and cost/value. (4) Designated efficacy outcomes, which have evolved over time, must be evaluated against the safety of the agent. Short- and long-term safety are particularly important for consideration; however, long-term safety in newer therapies has not yet been established. Health plans must also make accommodations, as some of these therapies are associated with serious safety concerns that necessitate monitoring with administration. (25)

Regarding the increasing costs of SPMS therapy, in addition to selecting SPMS agents with a favorable cost-effectiveness ratio, health plans may offset the costs by developing formulary tiers that incentivize providers to prescribe the most affordable therapies, using generic medication, establishing arrangements with drug manufacturers to fix costs or offer discounts in exchange for a top placement in the formulary and requiring that therapy initiation or switching is preceded by authorization. (25)

Recent labeling inconsistencies among newer, approved treatments have also contributed to the complexities experienced by health plans when determining appropriate patient access. As discussed earlier, the active and nonactive designations for SPMS were established in 2013. (5) They were first included in FDA-approved indications in 2019 when siponimod, cladribine and other disease-modifying therapies entered the market. All therapies for MS have since adopted this terminology for their labeling and all are now indicated for the treatment of active SPMS. A treatment for nonactive SPMS has not yet been developed. (25) Including the active/nonactive terminology in labels can be useful for treatment selection, but standardized definitions do not exist; regulatory authorities have established differing definitions. Although U.S. regulators defined activity based on clinical relapses, European regulators required inclusion of imaging results, indicating inflammation. In addition, product labels have not been required to include a time frame within which patients experienced disease activity. Because all patients with SPMS have experienced activity at some point, any could receive an active status. This challenge may be alleviated if U.S. labels for approved MS therapies included the full definition of activity. (26)


Substantial personal and economic burdens are associated with MS. (6,10) As the second most common and debilitating form of MS, 2 SPMS necessitates attention and collaboration from health plans, healthcare providers and the health community to establish tailored, standardized management strategies and evidence-based treatment options. (4) Emerging biomarkers and screening tools may improve clinicians’ abilities to promptly and accurately diagnose SPMS, and newer therapies approved for SPMS may offer a more tailored treatment approach for patients with this condition. There are still opportunities, however, for improvement regarding SPMS diagnosis and treatment. (2,18,19) As health plans navigate an increasingly complex and costly treatment landscape, individualized care approaches and shared decision-making should be prioritized.


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