Private insurer policies are making it difficult for some scleroderma patients in Quebec to receive the treatment their physician has prescribed. With the support of The Arthritis Society, a patient-led regional committee in Sherbrooke is working to change that.
The Scleroderma Medical Assistance Committee of Sherbrooke was launched in September 2014 with the goal of facilitating access to private insurance coverage for off-label prescription of medications. (“Off-label” refers to the use of a drug for a purpose other than that for which it has been approved for use by Health Canada.)
An example of off-label prescription is the use of the drug tadalafil for treatment of Raynaud’s phenomenon.
More than 90% of people with scleroderma are also affected by Raynaud’s, which is a narrowing of the small blood vessels in the skin, particularly in the extremities. In severe cases, digital ulcers (open sores in the fingers or toes) can occur as skin tissue breaks down. Digital ulcers are very painful and the healing process is often very long.
Conventional treatment for Raynaud’s involves the use of calcium blockers such as nifedipine or amlodipine, which relax the blood vessels and can help repair skin ulcers. For “refractory patients” (people who do not respond to a given treatment), however, another drug called tadalafil has been shown to be very effective in recent studies.
Tadalafil is a special kind of vasodilator called a PDE-5 inhibitor. You might know it better by the trade names it is sold under: Viagra, Cialis, It relaxes blood vessels and increases blood flow, which is why it can be effective in treating Raynaud’s. However, the drug was originally designed to treat erectile dysfunction, so its prescription for patients with scleroderma and digital ulcers is technically considered to be “off label”, even though its use for this purpose is widely accepted by the medical community.
As is often the case with rare diseases, the manufacturer has not applied to Health Canada to have Raynaud’s phenomenon be added to the drug’s list of approved indications, citing costs of the application process compared to the number of people who would receive prescriptions for that indication.
Coverage for these drugs is evaluated individually by public and private insurers. Under Quebec’s public health insurance program, the RAMQ, tadalafil is always covered when scleroderma patients present digital ulcers that fail to respond to first-line treatment with calcium blockers.
Private insurers, however, often refuse to cover off-label prescriptions, adding stress for patients and delaying access to effective treatment. Cost may be one reason why private insurers are reluctant to approve off-label use of tadalafil, as it can be very expensive. The consequence of that decision, however, is that patients are required to stay on an ineffective treatment, putting their health and quality of life in jeopardy.
With the support of The Arthritis Society, the Scleroderma Medical Assistance Committee of Sherbrooke is advocating with private insurers to cover off-label use of this medication. This would bring the private institutions’ policies in line with the position of the public health insurance program, and more importantly would help preserve quality of life for those Quebeckers affected.
This effort also has the support of:
How you can help
To support this advocacy, the Committee will need to present examples of patients who have been prescribed tadalafil to treat Raynaud’s phenomenon, and whether they were approved or rejected for coverage by either public or private insurers.
If tadalafil has been prescribed to treat your Raynaud’s phenomenon, please contact the Scleroderma Medical Assistance Committee of Sherbrooke to discuss your experience : firstname.lastname@example.org.