Multiple sclerosis (MS) is a high-cost category with an increasing number of therapies that treat the condition. To help stakeholders absorb datapoints and perceptions from all directions and synthesize those insights into a tangible strategy for MS, Zitter Insights surveys a leading panel of pharmacy and therapeutics (P&T) decision makers at payers and integrated delivery networks. The Managed Care Biologics and Injectables Index: Multiple Sclerosis combines deep payer insights with the industry standard in market access information to produce quarterly reports and insights summaries on leading specialty brands.
Payers with almost three-fourths of covered commercial lives and those with more than half of Medicare lives said they consider the management of branded MS treatments a high to very high priority. Commercial and Medicare payers covering more than half of lives said their management of branded therapies is somewhat aggressive. Payers representing more than four-fifths of commercial and Medicare beneficiaries perceive a moderate to high level of unmet need in the treatment of MS.
Payers covering three-fourths of commercial lives stated that people with MS have a high disease burden. More than half of payers said the agents used to treat the condition have a high budget impact. More than half of neurologists expressed high satisfaction with current MS treatments.
In the 12 months prior to the survey, neurologists most often prescribed Biogen’s Tecfidera (dimethyl fumarate), followed closely by Ocrevus (ocrelizumab) from Roche Group member Genentech USA, Inc. and Novartis Pharmaceuticals Corp.’s Kesimpta (ofatumumab). Least prescribed were Mavenclad (cladribine) from Merck KGaA unit EMD Serono and TG Therapeutics, Inc.’s Briumvi (ublituximab-xiiy), which launched about a month before the start of the survey. Kesimpta had the highest number of high-prescribing neurologists, which are those who prescribe a product to at least 80% of patients.
On Dec. 28, 2022, the FDA approved Briumvi for the treatment of adults with relapsing forms of multiple sclerosis (RMS) to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The agent is the first and only anti-CD20 monoclonal antibody approved to treat RMS that can be administered in a one-hour infusion after the initial dose. Almost half of neurologists said they expect that the availability of Briumvi will have some impact on their prescribing patterns with both new and current patients. More than half of the payers covering commercial lives had conducted a P&T review of the drug by the time of the survey, while almost all of those with Medicare lives had not undergone such a review. Among those payers that had not had a P&T review, those with more than half of commercial lives and those with more than two-thirds of Medicare lives said they were somewhat aware of Briumvi.
Social Determinants of Health
Among payers covering Medicare lives, the top social determinants of health initiatives for disadvantaged members with MS are educational content about healthy living — which is offered by payers with more than half of lives — free/low-cost mental health services and greater access to telehealth. Commercial payers’ top initiative was improved telehealth access, followed by educational content about healthy living and services to support health/medicine literacy. Neurologists cited socioeconomic status, occupation and job security, and familial and other support as the top non-medical factors impacting the ability of people with MS to access health care services and therapy.
Indication & Efficacy
Message: “This infusion [Ocrevus] can be given in either a doctor’s office or home. Many patients tolerate the infusion overall well. A typical amount of time is roughly four hours. There are different support systems available for patients including copay help. Patients need to understand that while some improvement may be seen, this is not a cure and will not reverse multiple sclerosis.”
Payer Thoughts: “It is important for patients to continue with their support system. Many patients will see an improvement but still may need extra help.”
Multiple Generics of Aubagio Launched in March 2023
Numerous AB-rated generics of Sanofi’s Aubagio (teriflunomide) launched on March 13. The FDA first approved Aubagio on Sept. 12, 2012, for the treatment of adults with relapsing forms of multiple sclerosis, to include clinically isolating syndrome, relapsing-remitting disease and active secondary progressive disease. In 2017, Sanofi reached settlement agreements with 20 companies who filed abbreviated new drug applications for generic Aubagio that gave the firms a royalty-free license to launch in the U.S. on March 12, 2023, the company disclosed in a Form 20-F filed with the U.S. Securities and Exchange Commission. The generics include both 7 mg and 14 mg tablets. Aubagio’s list price is $9,029.72 for a 30-day supply.
ICER Examines Cost Effectiveness, Clinical Effectiveness of Multiple Sclerosis Drugs
Three FDA-approved multiple sclerosis treatments and one MS drug that the FDA is currently reviewing are not cost effective, according to an analysis from the Institute for Clinical and Economic Review (ICER). Jon Campbell, Ph.D., ICER’s senior vice president for health economics and one of the report’s authors, also tells AIS Health that there was “insufficient evidence” to differentiate the clinical effectiveness of any of those four drugs, which are known as monoclonal antibodies.
The findings were part of a larger ICER draft evidence report published on Oct. 17, 2022, that examined the clinical effectiveness and cost effectiveness of oral and monoclonal antibody disease modifying therapies (DMTs) for relapsing-remitting MS. About 85% of the 1 million Americans with MS have the relapsing-remitting form.