Increased access to Mavenclad (cladribine tablets) for Multiple Sclerosis patients in Response to the COVID-19 Pandemic

Increased access to Mavenclad (cladribine tablets) for Multiple Sclerosis patients in Response to the COVID-19 Pandemic

 

• NHS England responds to the COVID-19 pandemic by simplifying eligibility requirements for patients with highly active relapsing MS starting cladribine tablets
• Amends made to Blueteq form suspend the requirement for patients with highly active relapsing MS to have an MRI before accessing cladribine tablets^†
• Reduces need for patients to visit hospital to access cladribine tablets during the Covid 19 pandemic

 

Feltham, London, 1 March 2021 – Merck, a leading science and technology company, today announced that NHS England has updated the Blueteq[*] requirements for patients with highly active relapsing MS starting cladribine tablets during the COVID-19 pandemic. Cladribine tablets can now be started without the need for a patient to have an MRI before starting treatment, if an MRI is not possible as a direct result of Covid-19.[†]

 

The decision is in response to COVID-19 and delays in access to treatment for patients with highly active relapsing MS during the pandemic. The change to the Blueteq form addresses challenges with capacity for MRI scans during the COVID-19 pandemic and provide access to DMT treatment for patients who have been shielding or are unable to visit the hospital. NHS England’s decision was supported by neurologists at several large MS specialist centres, who feel MS patients will benefit from this change to eligibility during the COVID-19 pandemic.

 

Cladribine tablets is a short-course oral treatment available in the UK for adults with highly active relapsing MS, that can help reduce relapses for up to four years with a maximum of 20 days’ oral treatment, taken in the first and second year.^4-5 Following completion of treatment in the first two years, no additional treatment is required in years 3 and 4.⁶

 

Dr Wallace Brownlee, Consultant Neurologist and MS Clinical Lead at the National Hospital for Neurology and Neurosurgery, said: “The COVID-19 pandemic has meant that some people with MS have experienced delays in starting DMT while awaiting MRI to confirm treatment eligibility. The removal of the MRI requirement for reimbursement of treatment with cladribine tablets provides access to a highly effective and convenient oral DMT option when options may be limited as a consequence of the COVID-19 pandemic.”

 

David Martin, Chief Executive Officer of the Multiple Sclerosis Trust, added: “We are very pleased that NHS England has amended criteria for access to Mavenclad. Now people with MS face one less barrier to accessing an effective MS treatment as the pandemic continues to disrupt health services.”

 

The decision by NHS England builds on previous initiatives to improve access to novel and innovative treatments. In November 2017, cladribine tablets was designated as the only ‘rapid uptake product’ in MS by the Accelerated Access Collaborative (AAC) - a cross government-industry collaboration working to remove barriers to uptake of innovations, so that NHS patients have faster access to innovations that can transform care.⁷

 

“We are pleased that NHS England has taken this decision to remove a significant barrier to patients being able to access cladribine tablets at this time. The update to Blueteq provides an opportunity for patients with highly active relapsing MS to benefit from the durable high efficacy, well-characterised safety profile and low dosing and monitoring requirements from cladribine tablets without delay,” said Doina Ionescu, Merck Managing Director & General Manager – UK & Ireland.

 

 

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About Merck

Founded in Germany in 1668, Merck is the world’s oldest pharmaceutical and chemical company. We have a significant presence in the UK, having been active here since 1883. Over 1,300 employees work in 11 UK locations across the entire operational spectrum, from manufacturing to sales and marketing, distribution and research and development (R&D).

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.

 

 

About Mavenclad (cladribine tablets)

Mavenclad is a short-course oral therapy that selectively and periodically reduces lymphocytes thought to be integral to the pathological process of relapsing MS (RMS).

 

Mavenclad received marketing authorisation from the

European Commission in August 2017 for the treatment of highly active relapsing MS in adults in the 28 countries of the European Union in addition to Norway, Liechtenstein and Iceland. Mavenclad has since then been approved in 69 countries, including Canada, Australia and the U.S.

 

 

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.8 million people have MS worldwide⁸, and 130,000 in the UK⁹. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

 

 

 

References:

1. Dimethyl Fumarate SmPC. November 2020.
2. Fingolimod SmPC. December 2020.
3. Natalizumab SmPC. October 2020.
4. Giovannoni, G et al. Mult Scler J 2018;24(12):1594-1604
5. Giovannoni G, et al., N Engl J Med 2010;362:416-26
6. Mavenclad Summary of Product Characteristics
7. National Institute for Health and Care Excellence. AAC Rapid Uptake Products. https://www.nice.org.uk/Media/Default/accelerated-access-collaborative/aac-rapid-uptake-products-list.pdf Accessed February 2021
8. MS International Foundation. Who Gets MS? https://www.msif.org/about-ms/epidemiology-of-ms/ Accessed February 2021
9. MS Trust. MS in the UK. https://www.mssociety.org.uk/care-and-support/resources-and-publications/publications-search/ms-in-the-uk - Accessed February 2021

 

[*]Blueteq is an electronic contractual prior approval system used by NHS England for range of high-cost drugs excluded from tariff

[†]An MRI is still recommended prior to initiating Mavenclad in patients with highly active relapsing MS switching from DMTs with known cases of progressive multifocal leukoencephalopathy (PML), (dimethyl fumarate, fingolimod, natalizumab),^1-3 to reduce risk of PML