Therapeutics Initiative A SHORT HISTORY

Therapeutics Initiative A SHORT HISTORY

Therapeutics Initiative, 1994 (10 individuals) Mission: To provide physicians and pharmacists with up-to-date, evidence-based, practical information on prescription drug therapy. First Task: To become expert in assessing evidence from clinical trials of new drugs in Canada, and to provide the evidence to Pharmacare. First policy decision: No conflicts of interest were allowed.

What happened? We became expert in critical appraisal and assessment of evidence from clinical trials. We got involved in the Cochrane Collaboration and learned their methodology. We hired experts in Health Technology Assessment and Systematic Review.

Interventions implemented Therapeutics Letter 6 times per year posted on website and mailed to physicians and pharmacists in BC. Letters provided the best available evidence about the benefits and harms of drugs and drug classes. Letters provided drug cost information.

What did the clinicians think about the Letter? ANSWERED BY REGULAR SURVEYS

What was the impact on prescribing of the first 20 Letters? ANSWERED USING A RANDOMISED CONTROLLED TRIAL.

Effect of periodic letters on evidence-based drug therapy on prescribing behaviour: a randomized trial Dormuth CR, Maclure M, Bassett K, Jauca C, Whiteside C, Wright JM (CMAJ 2004; 171(9): 1057-61) The Therapeutics Initiative is funded by a grant from the Government of British Columbia 8

Methods Physicians: -Study population included 499 physicians from 24 local health areas in British Columbia, Canada Communities: -Paired according to the number of physicians. -One in each pair was randomly assigned to the intervention group and the other to the control group Source databases: -Physician service records and drug claims records from the British Columbia Ministry of Health 9

Methods Analyses: -Incidence of newly treated patients was measured -For each drug group studied, patients were classified as being newly treated if none of the drugs in the group were dispensed to them in the previous year. 10

Results Table: Characteristics of treatment and control physicians Treatment Control Characteristic Group (n=258) Group (n=241) Physicians: % General Practitioners 89.9 90.4 Average age 45.6 46.2 % Males/Females 89/11 83/17 Patients: Average age 35.5 (75.2) 35.0 (75.3) % Males/Females/Unknown 46/52/2 (44/52/4) 46/52/2 (44/52/4) Avg. no. visits / MD 6402 (1322) 6660 (1340) Results in brackets are for subset of patient population 65 and older. 11

Source: Dormuth CR, Maclure, et al. CMAJ 2004; 171(9): 1057-61 12

Interpretation Printed letters distributed as a series regularly from a trusted source has a modest desirable impact on prescribing to new patients. Further work needs to be done to determine the sustainability of prescribing changes, and to determine what aspects of printed letters elicit prescribing changes 13

What policies were implemented? Outcomes based coverage. 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.

Examples of drug classes affected by this policy Non-steroidal anti-inflammatory drugs (Cox-2 selective NSAIDs). Oral hypoglycemic drugs (glitazones and others). Cholinesterase inhibitors for Alzheimers Disease.

What other policies were implemented? Reference based pricing of equivalent drugs within a drug class. Restricted access based on special authority criteria. Therapeutic substitution

Reference based pricing January 1, 1997 least expensive ACE inhibitors fully covered (captopril, quinapril, ramipril). More expensive ACE inhibitors covered up to a maximum of $27 per month (benazepril, cilazapril, enalapril, fosinopril, lisinopril). Patients on more expensive ACEI could pay the difference or switch.

Outcomes of reference pricing for angiotensin-convertingenzyme inhibitors SCHNEEWEISS S, WALKER AM, GLYNN RJ, MACLURE M, DORMUTH C, SOUMERAI SB. N ENGL J MED 2002;346:822-9

No increase in Emergency Hospitalizations due to RP 19 Schneeweiss et al. N Engl J Med 2002

Pharmacy savings in prevalent ACEI users 20 $60 Projected prepolicy trend $50 $40 $30 $20 $10 $0 Apr-96 May-96 Jun-96 Jul-96 Aug-96 Sep-96 Oct-96 Nov-96 Dec-96 Jan-97 Feb-97 Mar-97 Apr-97 May-97 Jun-97 Jul-97 Aug-97 Sep-97 Oct-97 Nov-97 Dec-97 Jan-98 Feb-98 Mar-98 Apr-98 Average monthly anti-hypertensives ingredient expenditures per patient 12 month savings: $6,700,000 Month Schneeweiss et al. J Can Med Assoc, 2002

Reference pricing for ACEI conclusions 18% of patients switched to lower cost alternative. Not associated with changes in physician visits, hospitalizations or mortality. Cost savings to drug funder of approximately $6 million per year.

What was the impact of these policies on drug utilization and costs?

Canadian Rx atlas 2007 Overall per capita spending by province

Canadian Rx atlas 2007 Non-steroidal anti-inflammatory drugs

Canadian Rx atlas 2007 Oral diabetes drugs

Canadian Rx Atlas 2007 Cholinesterase inhibitors

How much did BC save on prescription drug costs in 2007? If BC's drug utilization was the same as the Canadian average in 2007, total spending in our province would have been $701 million higher. $455 million of this saving was due to BC residents purchasing fewer drugs, while $208 million reflects the savings from choosing lower-cost treatment options.

Why were the policies successful? The TI did not allow any conflicts of interest. Establishing questions for review was an iterative process. Drug Assessment Working Group (DAWG) followed Cochrane methodology. DAWG improved critical appraisal skills and assessing risk of bias over time.

Why were the policies successful? Researchers were contracted to independently evaluate the impact on drug utilization and health outcomes. Ministry of Health personnel remained committed to outcomes based coverage and other policies despite political pressures.

What did the TI team learn? All drugs with any effect have both benefits and harms. Drugs are less effective than what we thought was true. Drugs are more harmful than what we thought was true. In many instances we were shocked that Health Canada had approved the drugs for market. In most instances drugs are marketed without knowing that the benefits outweigh the harms in many if not all the clinical settings where they are used.

Who were happy about this program? Ministry of Health Taxpayers Most doctors PATIENTS

Who were unhappy about the program? The elephants. Some doctors (specialists) who are friends of the elephants.

What should of happened? Expansion of the reference based program to new classes of drugs eg. Statins. Continued development of the international reputation of BC as a drug policy innovator. Increased funding to the Therapeutics Intiative to increase the expertise and ensure the long-term future.

What Happened? In October 2007 a Pharmaceutical Task Force was announced by BC Health Minister with the following objectives: 1. Identify and strengthen patient care and choice; 2. Optimize the decision-making process for what drugs are covered under PharmaCare; 3. Improve the effectiveness of the Common Drug Review process; 4. Enhance the effectiveness, transparency and future role of the Therapeutics Initiative.

Nine member Pharmaceutical task force Chair, Don Avison, President of the University Presidents Council. Board member LifeSciences BC. Robert Sindelar, Dean, Faculty of Pharmaceutical Sciences, UBC. Board member LifeSciences BC. Russell Williams, president of Canada s Researchbased Pharmaceutical Companies (Rx&D). Susan Paish, Q.C., chief executive officer, Pharmasave Drugs (National) Ltd. David M. Hall, chief compliance officer and senior vice president of Community Relations, Angiotech Pharmaceuticals. 2 Ministry of Health members. 2 others.

PSF recommendations for TI April 2008 #4 The Ministry of Health should establish a new Drug Review Resource Committee to carry out the drug submission review role currently performed by the Therapeutics Initiative. #12 Subject to Recommendation #4, if the Therapeutics Initiative is maintained, action must be taken in the following areas: improve the governance, membership and accountability standards; renew and revitalize the panel of expert reviewers;

THE MINISTER OF HEALTH ACCEPTED ALL THE RECOMMENDATIONS OF THE PHARMACEUTICAL TASK FORCE AND SET UP A MECHANISM FOR THEIR IMPLEMENTATION.

Academic review of TI http://www.pharmacology.ubc.ca/ 3 member external panel reviewed the TI over 2 days in October 2008. Validated the roles and activities of the TI in drug assessment, pharmacoepidemiology and education. Recommendations: Stable funding must be ensured. The present funding is inadequate. 3 new permanent University F-slots should be established.

What has happened? The TI s advisory role to the BC Ministry of Health has been severely curtailed. The TI s funding from the BC Ministry of Health has been reduced to $550,000 per year for the Therapeutics Letter and Pharmacoepidemiology work. The University has not created any new positions in response to the Academic Review recommendations.

What has happened? In November 2009, Don Avison confirmed that he was recently appointed as the Canadian representative on Pfizer s Global International Advisory Board. He did not respond to an e-mail asking what he will be paid. Don Avison received a Leadership award from LifeSciences BC for his role as Chair of the Pharmaceutical Task Force.

What has happened? In the spring of 2012 an investigation into data access is initiated by the BC Ministry of Health. In June, 2012, TI data access is cut off as a result of the investigation. In October, 2012, TI funding is suspended by the Ministry as a result of the investigation. In October, 2013, the Ministry of Health announces that TI funding and data access will be restored.

What is wrong with the prescription drug system? The elephants (Brand Name drug companies) are too wealthy and powerful. Recommended reading: The Corporation: The pathological pursuit of profit and power by Joel Bakan (UBC Professor). It is not the fault of the corporations. Governments established the system that got us here and must bring in regulations to correct it.

Ways to improve the system. Support present independent groups investigating the benefits and harms of prescription drugs. New money for new groups and to support networking between groups internationally. Continue to educate prescribers and patients about the benefits and harms of prescription drugs.

Questions????