Canada Publishes Budget Impact Analysis Guidelines Under New PMPRB Amendments

Country: CANADA-ONTARIO | Region: NORTH AMERICA | Type: Policy | Keywords: #budgetimpactanalysis #cadth #guidelines #newdrug #pmprb #referencepricing #reimbursement


PRICENTRIC BRIEF:
  • The Government of Canada has published “Budget Impact Analysis Guidelines” for conducting pharmaceutical budget impact analyses for submission to public drug plans in Canada, as part of the new amendments to the Patented Medicine Prices Review Board (PMPRB)
  • Budget impact analyses (BIAs) will focus on the financial impact of a drug; therefore, these guidelines are specifically designed to assist those who develop, submit, and evaluate BIAs in determining the financial impact and affordability of listing a new drug for reimbursement by the Canadian Agency for Drugs and Technologies in Health (CADTH), as well as participating local or national drug plans
  • The analytic framework under the BIA recommendations will consider perspective, time horizon, population, drug costs, and discounting and inflation, among other factors, while input and data source recommendations will consider estimations of the current market size, relevant comparators, and forecasting of the market under reference and new drug scenarios, plus additional information

 

THE DETAILS

OTTAWA, Canada – The Government of Canada has published “Budget Impact Analysis Guidelines” for conducting pharmaceutical budget impact analyses for submission to public drug plans in Canada, as part of the new amendments to the Patented Medicine Prices Review Board (PMPRB).

Due to the COVID-19 pandemic, the new amendments are now set to take effect on January 1, 2020, six months later than anticipated.

Budget impact analyses (BIAs) will focus on the financial impact of a drug. As such, these guidelines are specifically designed to assist those who develop, submit, and evaluate BIAs in determining the financial impact and affordability of listing a new drug for reimbursement by the Canadian Agency for Drugs and Technologies in Health (CADTH), as well as participating local or national drug plans.

These new guidelines supersede guidelines published by the PMPRB back in May 2007, because previous guidelines no longer reflect best business practices – as such, an update was necessary to ensure developments in Canadian BIA methods align with international guidelines.

The analytic framework under the BIA recommendations will consider perspective, time horizon, population, scenarios to be compared, drug costs, discounting and inflations, model design, characterizing uncertainty, and validation.

Similarly, input and data source recommendations will consider estimations of the current market size, relevant comparators, forecasting of the market under reference and new drug scenarios, estimating drug costs, and interactive budget impact model.

 

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