Prime Therapeutics and EMD Serono ink value-based agreement on MAVENCLAD® (cladribine) tablets

EAGAN, Minn., June 8, 2020 /PRNewswire/ -- Prime Therapeutics LLC (Prime), a leading pharmacy benefit manager (PBM) serving more than 30 million members nationally, signed a value-based agreement with EMD Serono for its oral multiple sclerosis (MS) therapy, MAVENCLAD^® (cladribine) tablets, which was approved by the Food and Drug Administration (FDA) in 2019 for the treatment of adults with relapsing forms of MS, including relapsing-remitting MS (RRMS) and active secondary progressive disease. The arrangement aims to provide financial compensation for Blue Plans that is dependent on the rate at which their members discontinue the two-year treatment with MAVENCLAD or switch to a different MS therapy at any point over the typical course of treatment.

Many specialty drugs for complex conditions, such as MS, are available at a premium compared to standard medications. MS drugs rank in Prime's top ten commercial drug spend and will likely remain a concern as new pipeline drugs come to market. Therefore, Prime seeks additional financial compensation for its Blue Plan clients when these therapies don't provide the intended value.

"Real-world patient data is the cornerstone of Prime's highly-evolved contracting strategy," said Kelly McGrail-Pokuta, vice president, pharmaceutical trade relations at Prime. "Prime's health outcomes data on members clearly show us which drugs provide the highest value relative to their cost. We build our value-based agreements using a patient-centered approach that seeks to lower cost of care while improving the quality of therapies Blue Plans pay for and their members receive."

MS is a progressive, autoimmune disease affecting one million people in the U.S., and more than 2.3 million people worldwide.¹ It is the most common non-traumatic, disabling neurological disease in young adults. Eighty-five percent of people living with MS are initially diagnosed with RRMS, characterized by attacks of new or increasing neurological symptoms.² Most people with RRMS will eventually transition to a secondary progressive (SPMS) course in which there is a progressive worsening of neurologic function over time. SPMS can be further characterized at different points as either active (with relapses and/or evidence of new magnetic resonance imaging [MRI] activity) or not active.

MAVENCLAD is the first and only FDA-approved treatment for RRMS and active SPMS that provides two years of proven efficacy with a maximum of 20 days of oral treatment, over 96 weeks.

Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS, and MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS). The MAVENCLAD label includes a boxed warning for malignancies and the risk of teratogenicity.  The most common adverse reactions are upper respiratory tract infection, headache, and lymphopenia.  

"Ensuring broad access to MAVENCLAD for patients is a top priority for EMD Serono," said Robert Truckenmiller, Head of Market Access & Customer Solutions, Fertility & Endocrinology at EMD Serono. "We are pleased that an industry leader like Prime Therapeutics recognizes the value of covering MAVENCLAD. This innovative contract provides value-based payment upon patients discontinuing or changing therapies, which supports our patient-centric mission."

Prime's 2018 real-world study showed patient adherence to MS disease-modifying drugs was associated with a significant decrease in relapses. Prime's real-world data indicates insurers should consider implementing value-based agreements on high-cost therapies to help lower costs and develop clinical programs to improve use of medicines as prescribed.

1. Multiple Sclerosis: Just the Facts. National MS Society. https://www.nationalmssociety.org/nationalmssociety/media/msnationalfiles/brochures/brochure-just-the-facts.pdf. Accessed 6/2/2020.
2. McKay, K., Kwan, V., Duggan, T. and Tremlett, H., 2020. Risk Factors Associated with The Onset of Relapsing-Remitting and Primary Progressive Multiple Sclerosis: A Systematic Review. National Institutes of Health.

About Prime Therapeutics
Prime Therapeutics LLC (Prime) makes health care work better by helping people get the medicine they need to feel better and live well. Prime provides total drug management solutions for health plans, employers, and government programs including Medicare and Medicaid. The company processes claims and offers clinical services for people with complex medical conditions. Prime serves more than 30 million people. It is collectively owned by 18 Blue Cross and Blue Shield Plans, subsidiaries or affiliates of those plans. For more information visit www.primetherapeutics.com or follow @Prime_PBM on Twitter.

About EMD Serono, Inc.
EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada - is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. www.emdserono.com. For more information on MAVENCLAD, please see the prescribing information including the boxed WARNING, at www.MAVENCLAD.com. 

SOURCE Prime Therapeutics LLC