Kesimpta for RRMS Now Available in Scotland at Low or No Cost

Adults in Scotland with active relapsing-remitting multiple sclerosis (RRMS) will now have access at low or no cost to Kesimpta (ofatumumab), the first self-administered, at-home B-cell-targeting therapy for people with the neurodegenerative disease.

The Scottish Medicines Consortium (SMC) recommended that the Novartis therapy be available through the country’s National Health System (NHS) to patients with active RRMS, defined by the presence of clinical relapses or imaging evidence of MS activity.

“This is excellent news! The approval of Kesimpta in Scotland increases the choices for people with relapsing MS,” David Martin, the CEO of the U.K.’s MS Trust, said in a press release.

“An expanding range of [therapies], working in different ways and with different benefits and risks, means more people can find the treatment that is best for them,” Martin said.

Importantly, Martin noted, patients can administer this therapy themselves, at home.

“Kesimpta offers access to an effective treatment which doesn’t require regular hospital visits,” he said.

The decision follows a similar recommendation by the National Institute for Health and Care Excellence — the agency that decides which therapies are added to the NHS in England and Wales. Patients in those two countries also now have access to Kesimpta at low or no cost.

The SMC’s recommendation comes three months after Kesimpta was approved in the U.K. for relapsing forms of multiple sclerosis (MS). A great majority of MS patients — around 85% — are diagnosed first with the relapsing-remitting form of the disease.

The therapy also is available for adults with active RRMS in the E.U., the U.S., Canada, Switzerland, Singapore, Australia, Japan, Argentina, the United Arab Emirates, Albania, and India.

Kesimpta is an antibody that binds to the CD20 protein receptor at the surface of B-cells — a type of immune cell involved in the abnormal immune responses that drive MS — promoting their death.

As such, the therapy is expected to lessen neuroinflammation, and ultimately prevent disease relapses and slow disease progression.

While other B-cell-targeting therapies used in MS are delivered directly into the bloodstream at hospitals or specialist infusion centers, Kesimpta can be self-administered under the skin, at home, using the Sensoready autoinjector pen. This gives patients a more convenient method of taking the medication.

Kesimpta’s regimen includes three initial weekly doses, followed by monthly injections; the first injection must be performed under the guidance of a healthcare professional.

The SMC’s decision was based on data from the ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231) Phase 3 clinical trials. Those trials tested Kesimpta against Sanofi Genzyme’s Aubagio (teriflunomide) in a total of 1,882 people with relapsing forms of MS.

An oral treatment for these types of the disease, Aubagio works by blocking the activity of  B-cells and T-cells, another type of immune cell involved in MS.

Findings from both trials showed that Kesimpta significantly reduced patients’ annual relapse rates by more than half as compared with Aubagio. The participants’ relative risk of disability progression after three months also was cut by more than 30% relative to Aubagio.

Kesimpta also was associated with fewer brain lesions on MRI scans, indicating less extensive brain damage among those taking the therapy. Moreover, nearly nine of 10 Kesimpta-treated patients continued to show no evidence of disease activity in their second year of treatment.

The two therapies were found to have comparable safety profiles. The most frequent adverse events among participants on Kesimpta were mild to moderate injection-related reactions, which mainly occurred with the first injection and were rapidly resolved on their own.

Other adverse events that occurred in at least 10% of Kesimpta-treated patients included head colds, headache, lower respiratory tract infections, and urinary tract infections.