James Wright. Managing Director and Chair, Therapeutics Initiative. University of British Columbia. Vancouver (Canadá).BackgroundThe Therapeutics Initiative was established in 1994 with two main mandates: 1) to provide physicians and pharmacists with up-to-date, evidence-based, practical information on prescription drug therapy, and 2) to advise the Ministry of Health on the best available evidence of benefits and harms of new and existing prescription drugs. In the beginning we had the privilege of working with a small number of enlightened individuals within Pharmacare in the Ministry. Pharmacare and the Therapeutics Initiative had the common goal of optimizing use of prescription drugs and appreciated that prescribing practices in general were far from optimal.
Policies implemented1. Therapeutics Letter 6 times per year to provide physicians and pharmacists with the best available evidence about the benefits and harms of drugs and drug classes.
2. Letters provide drug cost information for physicians.
3. Funding of new drugs was based on the best available evidence; a new drug only became a full benefit if it represented a therapeutic advantage or a cost advantage over appropriate alternatives (outcomes based coverage).
4. Reference based pricing of equivalent drugs within a drug class.
5. Restricted access with exemptions in special cases.
Reasons why the policies were successful 1. The Therapeutics Initiative did not allow anybody with a conflict of interest to participate in decision-making about assessment of evidence.
2. Setting up the questions for systematic review was an interactive process.
3. The drug assessment working group followed Cochrane methodology and improved their skills at critical appraisal and assessing risk of bias over time.
4. Independent researchers were contracted to evaluate the impact of the policies on drug utilization and health outcomes.
5. Ministry of Health personnel remained committed to outcomes based coverage despite political pressures.
Outcomes1. The Therapeutics Initiative (TI) and Letter (TL) had a high acceptance rate based on a 2006 survey: >80% of general practitioners and >90% of pharmacists felt the TI was meeting its mandate. TL 64 Your opinions of the Therapeutics Letter. The 2006 Survey. http://www.ti.ubc.ca/letter64 full report. http://ti.ubc.ca/PDF/Survey2006Report.pdf
2. Drug utilization and drug costs are substantially lower in BC for most classes of drugs as compared to the rest of Canada. TL 72 Prescription drug costs. BC vs Canada. http://www.ti.ubc.ca/letter72
3. The different policies were shown to NOT have an adverse effect on health care utilization or health outcomes (eg. Outcomes of reference pricing of angiotensin-converting-enzyme inhibitors. N Engl J Med 2002;346:822-9)
4. Enormous pressure was put on the government to abolish the Therapeutics Initiative and drug policies.
5. No new drug classes (eg. Statins) have been subjected to the reference based pricing policy since 1998.
ConclusionI will end my talk by a discussion of:
1. The lessons learned by the Therapeutics Initiative during the last 16 years.
2. What is wrong with the global system of prescription drug discovery, clinical drug trials, drug marketing, and drug regulation?
3. Ways in which the system could be improved.
Therapeutics Letter diciembre de 2008The Canadian Rx AtlasTherapeutics Letter mayo de 2007OUTCOMES OF REFERENCE PRICING FOR ANGIOTENSIN-CONVERTING–
ENZYME INHIBITORS