Roche and pan-Canadian Pharmaceutical Alliance Finalize Ocrevus Negotiations for RRMS and Early PPMS

Roche Canada and the pan-Canadian Pharmaceutical Alliance (pCPA) have completed negotiations ultimately aiming to obtain public funding for Ocrevus (ocrelizumab) as a first-line treatment for adults with relapsing-remitting multiple sclerosis (RRMS) with active disease, and as management strategy for patients with early primary progressive MS (PPMS).

Active disease in people with RRMS is defined by clinical and imaging features, while early PPMS is determined through disease duration, level of disability, and imaging evidence of inflammatory activity.

The pCPA is set up by Canadian provinces and territories, and conducts joint negotiations with pharmaceutical companies to increase patient access to clinically relevant and cost-effective treatments, and enable lower therapy costs.

Thirteen of the 16 jurisdictions have signed on to the pCPA letter of intent on Ocrevus, including: Alberta, Saskatchewan, Manitoba, Ontario, Quebec, Nova Scotia, New Brunswick, Prince Edward Island, Newfoundland & Labrador, Yukon, Correctional Services Canada, Veterans Affairs Canada, and Non-Insured Health Benefits.

Roche Canada will continue working with the three remaining jurisdictions — British Columbia, Northwest Territories, and Nunavut — to achieve public funding for all eligible MS patients, the company says.

“We are thrilled to have completed negotiations with the pCPA as the first step in allowing public funding in Canada for the first and only approved treatment for PPMS, the most severe and debilitating form of the disease, as well as a new way to target and reduce relapses and disease progression in people living with RRMS,” Ilona Torontali, Roche Canada’s vice president, said in a press release.

According to Torontali, the company will work with each of the 13 jurisdictions “to ensure that Ocrevus is available through each of the provincial public formularies.”

Health Canada approved Ocrevus for adults with RRMS with active disease in August 2017, and for adult patients with early PPMS in February 2018.

Ocrevus’ effectiveness and safety were assessed in the pivotal OPERA I and II (NCT01247324 and NCT01412333) Phase 3 trials in relapsing MS patients, and in the ORATORIO (NCT01194570) Phase 3 study in people with PPMS.

The OPERA studies showed that long-term treatment with Ocrevus significantly reduced disease activity in relapsing MS, compared with Rebif (interferon beta-1a, by EMD Serono).

The ORATORIO trial also showed less disability worsening in PPMS patients receiving Ocrevus, compared to placebo. Ocrevus also led to a three-fold greater proportion of PPMS patients without evidence of disease progression and no signs of inflammatory disease activity after more than two years of treatment.

The therapy also delayed the relative risk of disability progression by 25% compared to placebo, and reduced the volume of chronic brain lesions as well as total brain volume loss.

Ocrevus was the first treatment approved by the U.S. Food and Drug Administration and the European Commission for both PPMS and relapsing MS.

The most common adverse side effects associated with Ocrevus in the three trials were infusion-related reactions (IRRs) — rash, urticaria, erythema (redness), hypotension (decreased blood pressure), pyrexia (fever), fatigue, headache and dizziness, among others — and respiratory tract infections.

The incidence of IRRs decreased from 27.5% in the first infusion, to less than 10% at dose 4. Most IRRs were mild to moderate.