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

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.

José is a science news writer with a PhD in Neuroscience from Universidade of Porto, in Portugal. He has studied Biochemistry also at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario, in London, Ontario. His work ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimer’s disease.
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José is a science news writer with a PhD in Neuroscience from Universidade of Porto, in Portugal. He has studied Biochemistry also at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario, in London, Ontario. His work ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimer’s disease.
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7 comments

  1. LuAnn Sullivan says:

    Please clarify what the rates of reduced disease progression were with Ocrevus and active RRMS (not compared to Rebif) and the rate of disease reductio when used Ocrevus vs placebo on PPMS

  2. Keri says:

    I would like to know what the provinces in Canada will be charged for each dose of Ocrevuz. Just reviewed my latest insurance EOB for my treatment in December in the US….

    I was billed OVER $82,000. YES, NEARLY $83k for one of two yearly treatments!! Wondering if Canada allows drug cos to charge such ridiculous prices! (Fyi, my insurance paid out over $72,000 for that one dose. This is why the US healthcare system is diseased!)

    • LuAnn Sullivan says:

      Thanks for your input Keri. I had no idea what Ocrevus cost. I have an appointment next week with my neurologist to discuss starting treatment. My opinion is that this medication better have and excellent track record for reducing disease/disability progression for charges like that. Problem is the material that I have read does not clearly state the success rate.

    • LuAnn Sullivan says:

      Was it worth $83,000? Did you benefit from the treatment is what I am getting at. I do not see any concrete numbers published regarding the reduction in disability or disease progression.

  3. Senator says:

    Is it worth the cost of Ocrevus is a fair question. I have been on Ocrevus now for two years. It has enabled me to discontinue Solumedrol treatments which were 1,000mg x 5days every three months. It replaced it because my pain in calves and feet were alleviated, along with increased strength in legs. It also calmed my jittery hands, and allowed me to sweat again. The renewed ability to sweat gave me the ability to tolerate heat better like take warmer showers, and stay outside longer on warm days. I`m glad that Ocrevus has been finally approved for PPMS patients, and that every jurisdiction will approve it. On to UK and hope they can see themselves to approve Ocrevus for PPMS patients.

  4. John says:

    Ocrevus cost $65,000 for 1 year of treatment ( 4 vials) in the US, that is published price from the drug company. If your infusion center charges more than that, they are over charging you and insurance company what they have to pay.

  5. Ellen says:

    From what I understand this drug will be available through public funding in NS, but I can’t grasp any kind of timeline for this. Does anyone know how long these things usually take?

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