Is the Common Drug Review just about the bottom line?

More expensive drugs less likely to make it on the formulary.
Docs and patients pay the price

By Tokunbo Ojo

In June, the Canadian Expert Drug Advisory Committee (CEDAC) of the newly minted Common Drug Review (CDR) — the new process for evaluating which drugs should end up on Canada's drug formularies — recommended that gefitinib not be listed. Among the reasons cited are a lack of randomized controlled trials to prove the drug's effectiveness and the drug's high cost. Gefitinib costs about $2,200 per month.

ONE DRUG'S JOURNEY
"The drug is expensive, there's no question," says Dr Peter Macleod, a respirologist who works with lung cancer patients at Ottawa Hospital. "It's not a cure, but it can buy quality survival for a select group of patients who have failed standard treatment with chemotherapy and cannot be operated on. I've seen very pleasant results of the drug in patients and I'm disappointed that the government isn't ready to make it available to these patients."

Another doctor who's disappointed by the gefitinib decision is Dr Natasha Leighl, medical oncologist at Princess Margaret Hospital in Toronto. Though she agrees in principle with the CEDAC recommendation, Dr Leighl still believes this decision leaves patients in limbo because gefitinib is the only available drug for patients now after chemotherapy.

"I understand why the expert committee said they wanted better evidence," she says. "I think that's to make sure that Canadian taxpayers are not just paying for everything that the drug companies come up with. But on the other hand, it does leave our patients behind, especially the economically challenged ones. Because the other drug, erlotinib, that has done all the right randomized controlled studies might not be available in Canada till next year, even though the FDA in the US has just approved it."

CDR NUTS AND BOLTS
When the CDR was initiated by the federal, provincial and territorial health ministers (apart from Quebec's) back in September 2001, hopes were high that it would streamline the review process. Evaluations started in April and so far 13 drugs have been through the entire process — eight of which have been non-recommended.

The CDR's expert panel, CEDAC, is made up of experts in drug therapy and evaluations from across the country. The committee has also made recommendations on several other drugs in the past few months, including the controversial non-recommendation of two drugs to treat rare and fatal inherited Fabry disease, a glycosphingolipid storage disorder.

CEDAC evaluates drugs only after Health Canada approval has been granted. The CDR then reviews the clinical data of new drugs approved for marketing by Health Canada, and a decision is made.

If a drug is recommended, it's up to the participating publicly funded drug plan to decide whether or not to accept the recommendation. But since the system's still so new, it's too early to tell if the provinces and territories are taking CEDAC's advice. This information won't be available until a formal review of the CDR process is done next year.

MIXED MESSAGES
Doctors will no doubt be eagerly awaiting next April's review of the CDR process, particularly to see if it reached its goal of achieving consistency for Canadian drug approval. Until then a number of questions remain. For one, why don't Health Canada and the CDR agree on what drugs are worthwhile? Health Canada's approval of gefitinib was conditional upon completion of a randomized controlled trial to confirm its clinical benefit. But then the CDR rejected it. Are these mixed messages really the stuff of a 'single process'? But perhaps the biggest question is what effect CDR recommendations will have on the formularies, and how doctors will react. If your province accepts a CDR non-recommendation, what will you do?

Q: Doctors, we want to know what you think. Will the CDR process change the way you advocate for your patients? Fax or email us your thoughts: 514-397-0228/[email protected]