Early and unrestricted access to high-efficacy disease-modifying therapies: a consensus to optimize benefits for people living with multiple sclerosis

Abstract

Early intervention with high-efficacy disease-modifying therapy (HE DMT) may be the best strategy to delay irreversible neurological damage and progression of multiple sclerosis (MS). In European healthcare systems, however, patient access to HE DMTs in MS is often restricted to later stages of the disease due to restrictions in reimbursement despite broader regulatory labels. Although not every patient should be treated with HE DMTs at the initial stages of the disease, early and unrestricted access to HE DMTs with a positive benefit–risk profile and a reasonable value proposition will provide the freedom of choice for an appropriate treatment based on a shared decision between expert physicians and patients. This will further optimize outcomes and facilitate efficient resource allocation and sustainability in healthcare systems and society.

Immune responses to SARS‐CoV‐2 vaccination in multiple sclerosis: a systematic review/meta‐analysis

“…Disease‐modifying therapies (DMTs) and immune reconstitution therapies (IRTs) are used to treat patients with MS (pwMS) to decrease relapses, or new MRI lesions in the brain and spine, and to slow disability progression. 1 The coronavirus disease 2019 (COVID‐19) pandemic is concerning in pwMS due to possible increased susceptibility to COVID‐19, considering many potential interactions with the immune system, neurological complications associated with SARS‐CoV‐2 infection and the immunosuppressive effects of DMTs. 2 , 3 These complications include an increased risk of death due to COVID‐19 in pwMS who have significant neurological disability.…”

Assessment of the Treating Physicians’ First-Hand Experience With Handling and Satisfaction of Ofatumumab Therapy: Findings From the PERITIA Survey

“…A recent article by Filippi M et al mentioned that use of oral and self-administered DMTs could lead to reduction in costs for health care systems mainly in terms of hospital occupation, and in the risk of infection; additionally, it could attenuate the di culties in access to care caused by the COVID-19 pandemic. 19 Per the ofatumumab label, the rst injection of ofatumumab should be performed under the guidance of an appropriately trained HCP. Thereafter, ofatumumab is intended for patient self-administration.…”

“…13,20 In this survey, we found that 40% of the treating physicians would favour the use of ofatumumab for treatment-naïve patients; 87% prefer to use ofatumumab as rst escalation therapy and 68% prefer to use it as second escalation therapy. A recently published article determined that an early and unrestricted access to high-e cacy (HE) DMTs including ofatumumab for people living with MS in Europe, showed a positive bene t-risk pro le and improved outcomes indicating that the early use is the best strategy to delay the progression of MS. 19 HEDMTs (including alemtuzumab, ngolimod, ocrelizumab, and ofatumumab) have demonstrated improved e cacy versus interferons or teri unomide in reducing relapse rates, MRI lesions, brain volume loss, and/or delaying disease progression across several clinical programs. 13,[21][22][23] In the Phase 3 ASCLEPIOS trials, 9 ofatumumab was administered in a pre-lled syringe; however, ofatumumab is approved in Europe 12 as a pre-lled syringe and an autoinjector pen.…”

The Brave New World of Early Treatment of Multiple Sclerosis: Using the Molecular Biomarkers CXCL13 and Neurofilament Light to Optimize Immunotherapy

“…This would be particularly beneficial in pandemic times, since “high-efficacy” but higher risk IMDs interfere with immune responses to vaccines [ 32 ]. Conversely, treatment with “high efficacy” IMDs (HE IMDs) [ 33 , 34 , 35 , 36 ], with a higher risk profile, might be better suited for patients with positive neuroinflammation predictive biomarkers.…”