10/24/2011 02:15 EDT | Updated 12/24/2011 05:12 EST

Fewer drugs green-lighted by provincial plans after drug review begun: study

TORONTO - The number of new prescription medications covered by provincial and territorial insurance plans dropped substantially after a national review body began assessing the cost-effectiveness of drugs in 2003, a study has found.

Researchers also discovered that newly approved drugs were listed for coverage more quickly in several of the smaller provinces following the formation of the Common Drug Review, which also looks at the efficacy and safety of new drugs before recommending that they be added to public plans.

Formularies are government-funded insurance plans that cover some or all of the cost of prescription medications for certain segments of the population, often seniors and people on social assistance.

The study by University of Alberta researchers compared the number of medications listed by provincial, territorial and some federal plans in the five years prior to the start of the Common Drug Review process to the number in the five years following the agency's inception.

Almost 200 new drugs were approved in Canada over the 10 years, of which 53 were green-lighted by the CDR.

In the period before the review process began, drug plans across the country listed between 47 and 66 per cent of new drugs that came on the market; in the subsequent five years, the number of new drugs accepted fell to between 12 and 40 per cent.

"So there has been a reduction in the number of drugs, but it's probably a multifactorial effect of why there are fewer drugs getting onto the formulary systems beyond just the Common Drug Review," said Dean Eurich, a professor of public health at the University of Alberta and the study's principal investigator.

"I don't know that it's actually a detriment to the public that we've seen a reduction in the number of drugs being approved onto the formulary," Eurich, who is also a practising pharmacist, said from Edmonton.

In many medication categories — for instance, blood pressure drugs or antidepressants — there may be five or six similar versions already on the market, and adding another and typically more expensive brand of these "me-too" drugs may not be in the public interest, he said.

"So from a formulary perspective, that's not good value to the public."

The study, published Monday in the Canadian Medical Association Journal, found as well that the time to get newly marketed medications listed on various formularies also dropped dramatically after the CDR began its work.

Before the CDR process began, the overall average time to listing on formularies was 778 days, or more than two years. After 2003, the average time-to-listing fell overall for Canada, but varied by the size of province. For instance, Ontario's average time rose to 692 days from 443 days, while in P.E.I., the 3 1/2-year gap between a drug being approved by Health Canada to its listing on the formulary was almost cut in half.

Eurich said the process appears to have benefited at least some Canadians by helping to speed up decision-making by provinces and territories about medications recommended by CDR experts as both beneficial and cost-effective.

"The drug is getting onto the formulary quicker, which means they have access to it far sooner than they may have prior to the Common Drug Review, or at the very least they have access in terms of having a health plan cover it for them," he said.

Commenting on the study, health policy researcher Steve Morgan said the CDR should not be seen as a culprit in any disparities in patient access to medications that exist from one province or territory to another.

"I think there's a story within the story," said Morgan of the University of British Columbia. "And I wouldn't want the Common Drug Review to come off as appearing that it may have done harm in the Canadian policy context, when in fact there is stuff going on in the background that probably confounds any such conclusion."

For one thing, far fewer drugs are being approved for use by government bodies in the United States and Europe compared with a decade ago, and the same trend is being seen in Canada — so there are fewer to be considered for formularies.

An integral factor is also the pharmaceutical industry itself, which has changed dramatically in the last decade or so.

Big pharma has shifted its focus from primary-care medications for such ailments as heart disease, high blood pressure, depression and gastrointestinal disorders to more complex and specialized drugs, including those targeting various cancers and rare diseases, Morgan said Monday from Vancouver.

"The drugs that are coming to market may still be valuable, but they're for very specialized types of care," he explained, adding that such products are often exorbitantly expensive.

While one province may be able to cover drugs with hefty price tags, others may find a drug's high cost unaffordable and refuse coverage. Political priorities can also affect a decision to include or refuse a medication on a formulary.

Morgan said the CDR does affect patients' access to new drugs, but from a health-economics, evidence-based perspective, which is what it should do, he said. The CDR also provides a single, standardized recommendation for government decision-makers across the country.

"It does its job, it levels that evidence playing field, but it cannot level other aspects of the playing field," he said."