Cladribine – an innovative treatment for adults with highly active relapsing remitting MS

Challenge

Multiple Sclerosis (MS) is a condition that can affect the brain and spinal cord, leading to a range of symptoms, including problems with vision, limb movement, sensation, balance and cognition. The condition most frequently begins with relapsing neurological symptoms though can also lead to progressive and more persistent disability in some people.

In some cases, this lifelong condition can cause serious disability. The number of people living with MS is expected to increase by 2.4% every year. Around 110,000 people are living with MS in the UK.

Fortunately, there have been very significant breakthroughs in the treatment of MS with over 15 disease modifying drugs (DMTs) approved for use.

However, many MS treatments on the market require frequent monitoring from clinical teams, and must be administered by a medical professional, often with the need for a hospital admission, creating significant challenges for the patient and health services. Many MS services are under significant strain, with severe specialist nursing shortages and long waiting times for infusion treatments.

What we did

Clinical trials conducted by UCLPartners Academic Health Science Centre (AHSC) from 2010-2015 showed that Cladribine, a drug traditionally used in an injectable form to treat leukaemia and lymphoma, is an effective oral treatment for highly active MS, reducing relapses. Unlike many other MS treatments on the market, Cladribine tablets speed up the treatment time for patients as they can be prescribed more widely and be safely taken at home. This treatment also requires less monitoring by clinical teams, potentially reducing pressure on NHS services.

Cladribine is the only high efficacy disease modifying therapy (DMT) that can deliver and sustain up to four years of disease control. It can help Integrated Care Systems (ICSs) and commissioners deliver on the NHS Long Term Plan, supporting an optimal care pathway, freeing up specialist nurses, infusion capacity and wider system capacity, whilst helping to keep patients out of hospital.

In 2017, NICE licensed the drug for treating highly active relapsing-remitting MS. Following this, Cladribine was named as a ‘rapid uptake’ product to be made accessible to more patients through the Accelerated Access Collaborative. The ‘rapid uptake’ products, selected by UK health and care leaders, are products that have been identified as matching solutions to the needs of local health and care systems. As such, support was put in place by the AHSN Network to spread the use of Cladribine across the country. UCLPartners have taken a lead in this work.

Milestones from discovery to adoption and spread:

• 2010 – 2015 Clinical trials by teams at Barts and The London School of Medicine and Dentistry at Queen Mary University of London and University College London Hospitals NHS Trust discover Cladribine is an effective treatment for adults with highly active relapsing remitting MS
• 2017 NICE license Cladribine for treating relapsing –remitting MS
• 2018 Cladribine is named as a ‘rapid uptake’ product to be made accessible to more patients through the Accelerated Access Collaborative
• 2019 NICE publish technology appraisal guidance removing the requirement for a gadolinium-enhanced MRI prior
• 2018 – present Uptake of Cladribine is spread through the AHSN Network’s Innovation Exchanges, which match solutions to the needs of their local health and care systems.

Impact and next steps

To date,over 1,500 MS patients have benefitted from Cladribine tablets in the UK since launch in late 2017. 

According to NHS England data, since the accelerated access programme began in March 2019 over 1,380 prescriptions had been issued by December 2020, which significantly exceeded the predicted uptake. Jenny Turton, Deputy Director for Innovation, Research and Life Sciences at NHS England has called this ‘a great success story’.

There was a short pause in the roll out of Cladribine in March 2020 whilst investigations into the safe use of MS disease-modifying treatments (DMTs) like Cladribine during the pandemic were underway. Thanks to the work of UCLPartners, Merck and other organisations, a body of evidence was gathered that demonstrated the safety of Cladribine tablets both in terms of their impact on susceptibility to COVID-19 and outcomes of those infected with the disease.

The ongoing COVID-19 pandemic into 2021 has continued to place challenges on healthcare delivery and patients remain apprehensive about coming to hospital for investigations such as blood monitoring or for scans. In February 2021, UCLPartners provided expert advice which resulted in NHS England altering prescribing requirements for neurologists during COVID-19, removing the need for an MRI scan for patients with active MS being switched from an existing disease modifying treatment on to Cladribine, making the drug more accessible to those patients that could benefit from it. This is also helping the NHS by reducing the need for scans at a time when these facilities are needed to monitor patients with life threatening illnesses.