Today, Health Services Minister George Abbott announced the provincial government has expanded the treatment options for the wet form of age-related macular degeneration to include two additional drugs: Lucentis and Avastin. But what his ministry's news release doesn't mention is on December 16, 2008, Avastin's manufacturer, in consultation with Health Canada, advised health professional the drug "was specifically developed to treat cancer by injection into the veins" not the eye. Indeed, "the use of Avastin in the eye has not been reviewed or authorized by Health Canada."
In response, ministry communications director Michelle Stewart advised in an email, "The decision to use Avastin for non-approved uses is not illegal. In fact, the off label use of many drugs is quite common in medicine and is done at the discretion of the physician."
Moreover, according to Ms. Stewart, Avastin "has been used successfully for managing AMD for many years throughout the world," having been "prescribed extensively by retinal specialists in B.C. and elsewhere."
This morning, the Canadian Broadcasting Corp.'s Jeff Davies broke the news the government was planning to cover the cost of new drugs used to treat macular degeneration. At the time, Mr. Davies reported Avastin hasn't been licensed in Canada to treat the condition.
The following is a complete copy of Ms. Stewart's email.
Avastin became the standard of care for three main reasons:
(1) Physicians who used it have observed excellent results in their patients, including vision improvement;
(2) It works through the same mechanism-of-action as Lucentis;
(3) It is very cost-effective. The decision to use Avastin for non-approved uses is not illegal. In fact, the off label use of all drugs, not just Avastin, is quite common in medicine and is done at the discretion of the physician who weighs the risks vs. benefits
* There is clinical evidence to support its use, as well as many ongoing studies. That includes a 1,200-patient clinical trial sponsored by the National Eye Institute of the United States, comparing Avastin to Lucentis.
* Many patients who are being prescribed Avastin now are benefiting from the drug. The ministry is funding Avastin to provide physicians a cost-effective option when Lucentis or Visudyne do not work for a patient.
* Using cost-effective medications where possible is in the best interest for tax payers. Avastin is a small fraction of the cost for Lucentis (less than 10 per cent).
* The decision to use Avastin for non-approved uses is not illegal. In fact, the off label use of many drugs is quite common in medicine and is done at the discretion of the physician, who weighs the risks vs. benefits
* We will continue to work with specialists and monitor new clinical evidence regarding these treatments, as well as new AMD therapies that may emerge in the future.