Mavenclad (cladribine tablets, 10 mg) was one of the seven medicinal and medical technology products selected by the Accelerated Access Collaborative (AAC) as a “rapid uptake product” — a U.K. recognition that aims to bring life-changing technologies into the country’s National Health System (NHS), and to patients, more quickly, easily, and cost-effectively.
The AAC’s decision follows National Institute for Health and Clinical Excellence (NICE) decision to recommend Mavenclad for eligible patients with highly active relapsing-remitting multiple sclerosis (RRMS) followed in the NHS. That decision was announced in November 2017.
Merck KGaA, the therapy’s manufacturer, and NHS England have also partnered on a commercial agreement to ensure that MS patients in England are among the first to gain access to this disease-modifying therapy.
“The journey that cladribine tablets (Mavenclad) has had to get to people with MS is a truly remarkable story. The fact that it has now been selected as one of the innovations of the accelerated access collaborative initiative is a testament to the perseverance of Merck and the MS community,” Gavin Giovannoni, PhD, professor at Barts and the London School of Medicine and Dentistry, Queen Mary University of London, said in a release provided by Merck to Multiple Sclerosis News Today.
A collaboration between representatives of the U.K.’s healthcare organizations and the those of the pharmaceutical health technology industry, the AAC aiming to speed the process to moving innovative and potentially transformative products to the market.
According to the AAC, Mavenclad’s selection was supported by its “novel mode of action, high efficacy, and a low treatment and monitoring burden.”
“With NHS support to promote wider access and adoption of cladribine tablets could transform the treatment of multiple sclerosis in the UK,” Giovannoni said.
AAC’s goal in selecting these seven products is “on overcoming barriers to make their use across the NHS more widespread,” the announcement states. However, a start date for inclusion is not given.
Mavenclad is a short course oral therapy that targets immune T- and B-cells that trigger relapsing MS and is designed to do so without suppressing the entire immune system. Taken for a maximum of 20 days over two years, this therapy has been shown to help patients remain relapse-free for up to four years, while supporting the “reset” of the immune system.
Extensive clinical data collected in three Phase 3 clinical trials — CLARITY (NCT00213135), CLARITY EXTENSION (NCT00641537), and ORACLE-MS (NCT00725985) — and an ongoing registry study (PREMIERE, NCT01013350) have demonstrated the efficacy of Mavenclad in more than 2,700 patients involved, with some followed for up to 10 years, Merck recently reported.
“We are delighted that Mavenclad has, yet again, been recognised as an innovative medicine which has the potential to offer benefits to both patients and carers as well as value for money to the NHS,” said Liz Henderson, the company’s executive vice president for Global Manufacturing & Supply.
“Merck is committed to working in partnership with the AAC to address barriers to uptake and increase system efficiencies to ensure all eligible U.K. patients can benefit from this innovation,” she added.
Mavenclad is available in several countries worldwide, including Canada, Europe, Australia, Argentina, Israel, and the United Arab Emirates. In Canada, it is under review for possible inclusion in that country’s public health system (Quebec has a separate review).
The U.S. Food and Drug Administration accepted for review EMD Serono’s resubmitted new drug application (NDA) for cladribine tablets in July, seven years after it was first denied. EMD Serono is the biopharmaceutical business in the U.S. and Canada of Merck KGaA, based in Darmstadt, Germany.
Mavenclad is recommended for patients who fail to respond adequately, or are unable to tolerate, other therapies. It should not be used by patients who have a compromised immune system or women who are pregnant.