Novartis secures listing on Scottish NHS for self-injected MS therapy, move tracks NICE endorsement

By Jane Byrne contact

- Last updated on GMT

© GettyImages/koto_feja
© GettyImages/koto_feja

Related tags: Multiple sclerosis, autoinjector, Mhra, EU Commission

Scotland will soon have access to the Novartis drug, Kesimpta, (ofatumumab), the first self-administered, targeted B-cell therapy for patients with relapsing remitting multiple sclerosis (RRMS).

The Scottish Medicines Consortium (SMC) published its final advice yesterday ​recommending ofatumumab for the treatment of RRMS with active disease defined by clinical or imaging features.

“Ofatumumab has the potential to reduce relapse rates, slow disease progression and improve quality of life. Offered as a monthly self-injection, this treatment option may minimize the treatment burden for many people with relapsing-remitting MS and reduces the need for regular hospital visits,”​ found that agency.

Scotland has the highest average incidence rate of MS​ in the UK, with about 15,750 people living with the disease, with a higher rate in women than in men. There are about 130,000 people with MS in the UK.

Patients with RRMS in Scotland have previously been unable to access a high efficacy, B-cell therapy through the NHS without regular visits to a clinic or hospital for treatment.

The SMC’s decision follows a similar recommendation on ofatumumab [in April] from the UK’s National Institute for Health Care and Excellence (NICE), the agency that decides which drugs and treatments should be available on the NHS in England.

EU and UK licensing

Novartis also received green lights in April this year from both the EU Commission and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to market that MS therapy.

Ofatumumab is designed to be self-injected once a month using the Sensoready autoinjector pen.

The drug is a fully human anti-CD20 monoclonal antibody (mAb); it works by binding to a distinct epitope on the CD20 molecule, inducing potent B-cell lysis and depletion, according to the company.

In clinical trials, ofatumumab delivered on the primary endpoint significantly reducing relapses by more than 50% when compared to teriflunomide, a commonly prescribed oral disease modifying therapy for RRMS, said Norvartis.

Chinmay Bhatt, MD UK, Ireland and Nordics for Novartis Pharmaceuticals, commented: “We know this past year has been a huge challenge for patients with MS in Scotland, with many regularly making long journeys into hospital for treatment in the middle of a pandemic. Ofatumumab will give patients access to a highly effective therapy from the comfort of their own homes, after initial guidance from a doctor or nurse.”

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