Transcript International Experience in Pharmaceutical Services for

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
[email protected]
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
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
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
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
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.
Pharmaceutical Logistics and
Supply Systems
• Pharmaceutical Ordered from
– Manufacturer
– Wholesale distributor
• Pharmaceutical Payment
– Catalogue “List” price
– Group purchase
• Pharmacies
• Hospitals
– Tendering
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
Prescribed Pharmaceutical Expenditure by Source of
Finance, Canada
1985 to 2001
Source : Canadian Institute for Health Information, Statistics Canada
Pharmaceutical Products
Reviewed for Provincial Formulary
• New interchangable (generic) products
• New strengths of approved products
• Reformulated products
• New pharmaceutical products
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
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
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
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