Canadian regulator considers changes in new drug pricing plan


TORONTO (Reuters) – Canada's drug pricing agency is contemplating significant changes in the way it will apply new regulations to reduce costs, as Reuters has known, as drug manufacturers are not happy with the delay of the policy of introducing new drugs in the country and blaming him for job cuts.
Canada approved new regulations for medicines under patent protection in August despite strong lobbying of drug manufacturers that can lose billions in revenue.

The new rules base the prices of Canadian medicines on those of a group of countries with lower prices than the reference group currently used to establish maximum prices, and give regulators the power to review new medicines based on profitability .
In response, Swiss pharmacist Roche withdrew his Tecentriq immunotherapy last month from the evaluation as a treatment for breast cancer, citing a "significant uncertainty and complexity" around the new regulation. Merck & Co said in November that it would cut 145 jobs, 30% of its Canadian staff, blaming the new policy.

Canadian reforms have attracted the attention of the industry for fear that lower prices will spill in its most lucrative market, the United States, where policymakers floated by importing less expensive Canadian drugs or basing some prices on the costs of medicines in other countries, including Canada.

The impact of the regulations will depend on how the Canada Patentate Drug Price Review Board (PMPRB) ultimately applies them through its pricing guidelines, which could be revised.
"The draft guidelines remain just that, a draft," the regulator said in a statement. "The PMPRB is contemplating significant changes in the document in the light of comments from interested parties."
PMPRB Executive Director Doug Clark told Reuters companies that they could be granted a grace period of 18 months to comply with parts of the regulation, and that cost-effectiveness measures could be applied to fewer treatments.

When asked if the changes under consideration were the result of withdrawn requests and objections from the pharmaceutical industry, Clark said, "absolutely not."
There is no evidence that lower prices reduce access to new medicines, as the industry has argued, he said.
Despite withdrawing his request for coverage from the government, Roche said he will make Tecentriq available for free through a patient support program. Such programs are generally used as a temporary bridge while waiting for public coverage.

The PMPRB said that companies' threats to withdraw products when faced with price controls in Germany in 2011 caused few withdrawals.

"No guarantee can be expected to convince the pharmaceutical industry to support these reforms, given that the inevitable end result will still be lower maximum prices for many patented drugs in Canada," PMPRB said in a statement.

The oncology division of the Canadian Agency for Drugs and Health Technologies (CADTH) had previously rejected Tecentriq for small cell lung cancer because it was too expensive because of the benefits it provides.

Innovative Medicines Canada, the industry's main pressure group, said at least seven drug launches have been delayed due to new regulations since August, but declined to identify them.

US pharmacist Eli Lilly and Co said he delayed an application, while Britain's AstraZeneca Plc said he delayed new treatments for hairy cell leukemia and for neurofibromatosis genetic disorder.

Drug manufacturers have been especially critical of the PMPRB plan to consider the profitability of a new drug, a common practice in some other countries, and the size of the patient population when making pricing decisions.

While the draft guidelines would subject most of the new drugs to this analysis, Clark said that was never the intention. Instead, the agency can focus on medications with a particular risk of being overpriced.

Another change under consideration would be to abandon the new measures for routine price approvals, and only use them in litigation. The PMPRB signs most drug prices without incident, but some go to an internal court and then to a federal court.

Clark said the final decision on any change rests with the agency board, and that the staff is still analyzing the comments.

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