1. International Experience in Pharmaceutical Services for Promoting Access to Medicines: Canada, Cuba, England, Mexico International Seminar on the Challenges for Comprehensive Pharmaceutical Services Brasilia, Brazil October 1st, 2002 Erwin Friesen, Pharm.D, FCSHP efriesen@cha.ab.ca

2. Presentation Outline Overview of Health and Pharmaceutical System in Canada Canadian pharmaceutical price regulation Distribution system for pharmaceuticals Evaluation and selection of pharmaceuticals paid for by public financing Questions for discussion

4. Canada Health Overview All citizens are covered by the government for a wide range of services (e.g. hospitals, physicians) regardless of financial status People have access to health care regardless where you happen to be or live in Canada. Health care system is publicly administered through tax revenues not by private business Provinces and territories administer their own publicly funded drug programs

5. Canada Federal Government Responsibility Health Canada Approve pharmaceutical for market based on –Safety and efficacy data –Good Manufacturing Practice data Review package and monograph labeling Determine bioequivalence standards –Review bioequivalence of generic drugs Determine who can prescribe drug and how pharmaceutical is distributed –e.g. Narcotic control, prescription only, non prescription Coordinate Adverse Drug Reaction Program Patent Medicine Review Board Administer and monitor patent laws Approve and monitor unit cost of pharmaceuticals

6. Patented Medicine Prices Review Board (PMPRB) Established 1987 as a independent, federal board that regulates the prices of patented pharmaceuticals. Ensures that prices charged by manufacturers of patented pharmaceuticals are not excessive –compares new pharmaceuticals to the range of prices for existing Canadian pharmaceuticals used to treat the same disease –limit prices of drugs to the median of the prices charged for the pharmaceuticals in the seven industrialized countries listed in the Patented Medicines Regulations (France, Germany, Italy, Sweden, Switzerland, U.K and U.S.) –adjusts prices relative to inflation rate

7. Patented Medicine Prices Review Board (PMPRB) Can impose financial penalties to pharmaceutical companies Since 1987 more than 100 cases where pharmaceutical companies have been forced to adjust their prices to comply with PMPRB guidelines. Estimated adjustments saved consumers almost $33 million in 1995, for total savings of more than $100 million since 1990 PMPRB does not it govern how a pharmaceutical is prescribed or how it is paid for by public or private health plans.

8. Pharmaceutical Logistics and Supply Systems Pharmaceutical Ordered from –Manufacturer –Wholesale distributor Pharmaceutical Payment –Catalogue “List” price –Group purchase Pharmacies Hospitals –Tendering

9. Public Funding of Pharmaceuticals Provincial Responsibility Positive list (Essential drugs?) of funded pharmaceuticals listed in a Formulary Provinces not bound by federal regulations, so provinces vary in design including the specific drugs and the amount of “cost sharing” for some pharmaceutical programs” Most provinces have independent review committees (ie. physicians, pharmacists, pharmacokineticists, government representatives) that advise Ministers of Health regarding changes in Formulary

10. Prescribed Pharmaceutical Expenditure by Source of Finance, Canada 1985 to 2001 Source : Canadian Institute for Health Information, Statistics Canada

11. Pharmaceutical Products Reviewed for Provincial Formulary New interchangable (generic) products New strengths of approved products Reformulated products New pharmaceutical products

12. Types of Formulary Decisions Interchangeable (Generic) Pharmacokinetically similar drugs New pharmaceuticals –No restrictions –Restricted (Special authorization) Guidelines/Restrictions –Reference based pricing Therapeutically equivalent drugs –“Drug lag ” or No decision awaiting more scientific efficacy or effectiveness data Old pharmaceuticals –Delisting Over the counter drugs Medically not necessary

13. Elements of Formulary Decision Clinical Data: –Preclinical data (pharmacology, pharmacokinetic and pharmacodynamic data) –Clinical trial data (efficacy and safety) –“Level” of evidence (randomized controlled trials, meta-analysis, consensus reports, expert opinion) –Comparisons with relevant comparators (identification of alternatives or place in therapy) Economic Data: –Pharmacoeconomic evaluation –Budget impact assessment

14. Possible Future Developments in Canadian Pharmaceutical Programs National Pharmaceutical Public Funding program administered by Federal government –Have started Federal “Common Pharmaceutical Review” More restrictive criteria/guidelines for high expenditure drugs Pharmaceutical utilization programs - examples –“counter detailing” –review on why and how pharmaceuticals are prescribed –“trial” prescriptions

15. Closing Allowing public access to pharmaceuticals in Canada currently includes Federal and Provincial approaches. Current main approaches are: –Price regulation –Defined infrastructure and process to decide which drugs will be publicly funded on the Formulary