Pharmacare: be careful what you wish for
Almost 60 per cent of respondents to a recent poll thought that a national Pharmacare program would be good for Canadians. National Pharmacare appears to be regarded by many as a panacea for the woes of the present hodgepodge of provincial drug plans, but some provinces seem to view it as an opportunity to alleviate the strain on their drug budgets.
Restricting access, rather than creating better programs, appears to be the direction provincial governments are looking to go. The current issue with three drugs (Lucentis, Eylea and Avastin) used to treat retinal conditions such as wet age-related macular deterioration (the main cause of blindness in seniors) demonstrates this trend.
The safety and efficacy of Lucentis and Eylea for intravitreal use for retinal conditions have been approved by Health Canada. Avastin has received approval for several oncology indications but is not approved for retinal conditions. Moreover, its product monograph has a serious black-box warning explicitly stating that the drug is “not formulated and has not been authorized for intravitreal use.” Avastin also has a serious warning about gastrointestinal perforation as well as other cautions about heart attack, stroke, hypertension, heart failure and death.
Nevertheless, Avastin is effective in treating retinal conditions and being used off-label in Canada. Off-label use for an unapproved condition, dosage or course of administration is an accepted medical practice, especially in the treatment of children or situations where unusual measures are required. However, it’s typically only for medical reasons, whereas off-label Avastin retinal use is encouraged because the drug is cheaper than Lucentis and Eylea. In two provinces, government payments to retinal specialists are reduced if they do not prescribe Avastin to 75-80 per cent of their patients. Consequently, patients already at risk for thromboembolic events who have a retinal condition (i.e. elderly overweight diabetics) are shouldering a greater risk to reduce provincial costs.
Earlier this year, provincial governments requested the Canadian Agency for Drugs and Technologies in Health (CADTH) to conduct a therapeutic review of the use of Lucentis, Eylea and Avastin for retinal conditions. A therapeutic review is an evidence-based assessment of publicly available information about a therapeutic category to support drug-listing and policy decisions and to encourage optimal therapy. Up to now, these reviews have been performed to provide recommendations at the time of a new drug submission to CADTH, but CADTH changed its rules to allow a review to be done at any time and to extend the scope to include “evidence-based expanded use (i.e. for a clinical indication not included in an approved Health Canada product monograph).”
CADTH only included randomized clinical trials in its review. Randomized trials have shown that Avastin and Lucentis have similar efficacy for retinal conditions, but they are too small to provide guidance about safety risks. Some real-world studies that included thousands of patients suggest greater safety risks with Avastin. The exclusion of real-world studies predisposes CADTH’s review to produce the conclusion that Avastin and Lucentis have similar efficacy and safety. This conclusion would justify a recommendation that Avastin can be used to treat retinal conditions which, in turn, may lead to more provinces setting quotas for retinal specialists to prescribe Avastin.
The approach taken by CADTH circumvents the regulatory approval process established to assess the efficacy and safety of medications. Any potential restriction of access to Lucentis and Eylea resulting from CADTH’s review is a concern for patients. While the issue is troubling now, it would be even greater if a national Pharmacare program was in place because all provinces would likely be recommended to use Avastin over Lucentis and Eylea.
National Pharmacare is a policy issue that continues to gain momentum which, for many Canadians, has become synonymous with better drug access. However, if cost-containment objectives are paramount, a national program could mean reduced access to medications. The new federal government’s election platform included respect for evidence-based science in government decision-making and greater transparency. A national Pharmacare system should be founded on appropriate and transparent scientific and economic evidence with the objective of improved patient access to drugs.
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