JointHealth™ express   December 7, 2010

The Common Drug Review recommends tocilizumab (Actemra®) for rheumatoid arthritis (RA) be listed on provincial drug formularies

On November 17, 2010 the Common Drug Review (CDR) recommended that when people do not have private insurance coverage, provincial drug plans cover the cost of tocilizumab (Actemra®) for reducing the signs and symptoms of moderate to severely active rheumatoid arthritis (RA) in adults. Click here to read the complete Common Drug Review recommendations.

This medication received its Notice of Compliance (licence to sell) from Health Canada on April 30, 2010.

Tocilizumab belongs to the class of medications called "biologics" (short for biologic response modifiers), which target the specific pathways responsible for causing inflammation and joint destruction. Tocilizumab is the first medication designed to specifically inhibit or slow down the body's production of IL-6 (a protein that when over produced promotes inflammation) and is effective at treating the symptoms and underlying disease process in rheumatoid arthritis.

This recommendation is good news for Canadians living with rheumatoid arthritis who have had an inadequate response to a trial of one or more disease-modifying anti-rheumatic drugs (DMARDs) and/or tumour necrosis factor (TNF)-alpha inhibitors*. This medication offers another important option for Canadians living with RA, particularly because each person living with the disease responds differently to available medications. In other words, no single biologic therapy is effective in everyone with RA. A rheumatologist and their patient must weigh the potential risks and benefits associated with each biologic treatment; therefore it is important to have public formulary reimbursement for the full range of biologics approved by Health Canada.

The CDR recommendation is that patients start tocilizumab at a dosage of 4 mg/kg (by intravenous infusion over 1 hour every 4 weeks), and that clinical response be assessed at 16 weeks. This is consistent with the Health Canada approved product monograph.

The recommendation does not provide any guidance about the 8 mg/kg dose. Tocilizumab has been studied and approved for use by Health Canada at a dose of both 4 mg/kg and 8 mg/kg. It is in the best interest of patients to have an opportunity to trial the 8 mg/kg dose if, after an assessment of response to initial therapy, their disease is not appropriately controlled based on individual treatment goals. If the provinces require an assessment of response to the medication completed at 16 weeks, it is better for patients to be allowed to increase to 8 mg/kg before this assessment is made.

Actemra can also be given as monotherapy in cases of intolerance to methotrexate or where treatment with methotrexate is not appropriate.

*Please note, the Health Canada label recommends the use of the tocilizumab on a case-by-case basis for people with RA who have not first responded adequately to combination DMARD therapies.