NHS England partners with Merck allowing people with MS immediate access to cladribine

NHS England has announced a commercial agreement that allows NHS patients in England immediate access to the innovative new multiple sclerosis (MS) treatment, cladribine tablets (Mavenclad).¹

NHS England and Merck, the manufacturer of cladribine tablets, have partnered on the commercial access agreement, representing an example of a “win-win-win” for the NHS, patients and industry at a time of intense financial pressure on the NHS.

Alleviating pressure on NHS services is critical, as the MS population has outgrown the services available and MS as a condition is costing the UK economy between £3.3bn-£4.2bn each year.²

Speaking at the FT Global Pharmaceutical and Biotechnology Conference in London, NHS chief Simon Stevens said: “These innovative deals are concrete examples of how NHS England is now successfully working with the life sciences industry to make treatments available for patients while securing fair value for taxpayers. “Today’s announcement shows that for companies who are willing to work with us, there are real gains for them, for the NHS and most importantly for patients able to get new and innovative drugs.”

Elisabeth Prchla, Merck UK general manager, said: “We are delighted with the NHS England decision on this commercial agreement, which will see patients in England access the treatment immediately. This is a first of its kind in multiple sclerosis, which can also be a benchmark for the future, bringing together the NHS, government and industry to achieve faster access for patients, in line with the UK’s Life Sciences Industrial Strategy.”

She continued, “This milestone underscores our commitment to unmet needs in the MS community – we have been working closely with NHS England to find a solution that not only provides access to our medicine as early as possible but will also save the NHS money at a time of immense financial pressures.”

This commercial agreement follows the recent positive recommendation from the National Institute for Health and Care Excellence (NICE).³ Last week, NICE issued a Final Appraisal Determination (FAD) that recommends cladribine tablets as an option for treating highly active MS in adults. Use of cladribine tablets is recommended only if a person has rapidly evolving severe relapsing-remitting multiple sclerosis, that is, at least two relapses in the previous year and at least one T1 gadolinium-enhancing lesion at baseline MRI or relapsing-remitting multiple sclerosis that has responded inadequately to treatment with disease-modifying therapy, defined as one relapse in the previous year and MRI evidence of disease activity.³

This is the first MS disease-modifying therapy that has gone straight to a positive final recommendation in the NICE appraisal process, involving just one committee meeting. In the FAD, NICE concluded that cladribine tablets are less costly than other treatments and require less frequent dosing and monitoring requirements. The recommendation in the FAD forms the basis of NICE’s final guidance (Technology Appraisal Guidance, TAG), anticipated in early 2018, and once this is published the NHS must provide funding within 90 days.³

“Merck is committed to improving the lives of patients with MS through the delivery of innovative medicines and patient support programmes. We are delighted that cladribine tablets are now available for certain patients with highly active relapsing-remitting MS and proud to have worked together with NICE and NHS England to deliver this treatment as early as possible,” said Marco Lyons, Head of Medical Neurology and Immunology at Merck.

Cladribine tablets are taken for a maximum of 10 days in the first year and a maximum of 10 days in the second year, with no additional treatment needed in years three and four. Patients can take cladribine tablets at home from the first dose as treatment does not require hospital administration.⁴ Monitoring is limited to the first two years only, meaning that cladribine tablets have the lowest administration and monitoring burden of all available high efficacy disease-modifying therapies.^4-8

Cladribine tablets received marketing authorisation from the European Commission in August 2017 based on an extensive 12-year clinical trial programme.^9-13 The comprehensive dataset has informed the treatment regimen and monitoring requirements. The most clinically relevant adverse reactions are lymphopenia and herpes zoster (shingles). Pre-treatment assessments are required before initiating treatment and lymphocyte counts must be assessed before, and during, treatment in the first two years. Cladribine tablets should not be taken by certain people, including immunocompromised patients and pregnant women.⁴

REFERENCES

¹ Commercial agreement for cladribine tablets (MAVENCLAD®). NHS England November 2017

² MS Society, Multiple Sclerosis – an urgent need. Available at: https://www.mssociety.org.uk/vote-for-us. Last accessed November 2017

³ NICE. Final Appraisal Determination cladribine tablets for treating relapsing-remitting multiple sclerosis. 2017 Available at: https://www.nice.org.uk/guidance/gid-tag392/documents/final-appraisal-determination-document. Last accessed November 2017

⁴ Summary of product characteristics, Mavenclad 2017. Available at: https://www.medicines.org.uk/emc/medicine/34044. Last accessed November 2017

⁵ Summary of product characteristics, Gilenya 2017. Available at: https://www.medicines.org.uk/emc/medicine/24443. Last accessed November 2017

⁶ Summary of product characteristics, Lemtrada 2017. Available at: https://www.medicines.org.uk/emc/medicine/28917. Last accessed November 2017

⁷ Summary of product characteristics, Tysabri 2017. Available at: https://www.medicines.org.uk/emc/medicine/18447. Last accessed November 2017

⁸ Summary of product characteristics, Tecfidera 2017. Available at: https://www.medicines.org.uk/emc/medicine/28593. Last accessed November 2017

⁹ Giovannoni G, et al., N Engl J Med 2010;362:416-26

¹⁰ Giovannoni, G et al. Mult Scler J 2017 doi: 10.1177/1352458517727603. [Epub ahead of print]

¹¹ Leist T et al. Lancet Neurol 2014; 13: 257–67

¹² Montalban X, et al., Neurology 2016;86(16):P3.029

¹³ Clinicaltrials.gov, PREMIERE safety registry, 2017; Available at: https://clinicaltrials.gov/ct2/show/NCT01013350?term=NCT01013350&rank=1. Last accessed November 2017