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CASE STUDY PROPOSAL EXAMPLE

title (capital letters)

DRUG ELUTING STENTS - AN EXAMPLE OF THE TRANSITION FROM EVIDENCE TO POLICY THROUGH THE ONTARIO COMPREHENSIVE APPROACH TO THE DIFFUSION OF HEALTH TECHNOLOGIES

author’s last name, followed by first initial, institution(s), city, state, country

Levin L1, Goeree R2

1Ontario Ministry of Health and Long-Term Care, Toronto, ON, Canada; 2McMaster University, Hamilton, ON, Canada

Organization:
The organization where the case study took place.

Organization: Ontario Ministry of Health and Long-Term Care
Program for the Assessment of Technologies in Health Research Institute

Problem or Issue Addressed:
The problem that prompted the initiative (e.g., rapidly rising pharmacy budget for cancer; poor outcomes after knee replacement surgery)

Problem or Issue Addressed: In 2002, the Ontario Ministry of Health and Long-Term Care (MOHLTC) was advised that drug eluting stent (DES) would present a diffusion pressure since approximately 10,000 stents were being used per year and the differential cost between bare metal stents (BMS) and DES was $2,200-$3,840 per stent. An initial review of the literature by the Medical Advisory Secretariat (MAS) found that in low-risk patients the restenosis rates for BMS were 20-30% compared to 0-5% for DES. However, issues of generalisability to the Ontario health system were raised in the MAS analysis, and a concern that there would be creep to off-label use in high-risk patients.

Goals:
What did the organization hope to accomplish? Include numerical goals if appropriate (e.g., 20% decrease in the cancer pharmacy budget while maintaining cancer care quality)

Goals: Establish through a pragmatic study whether results published from randomized controlled trials on DES are generalisable to Ontario and to use this as a basis for long-term funding decision making.

Outcomes items used in the decision: The measures that were used in the decision process (e.g., cost-effectiveness data from the literature, a survey such as the SF-36).

Outcomes items used in the decision: One year restenosis and mortality rates according to whether the stents used were bare metal or drug eluting

Implementation Strategy:
What was done at the organization to meet the goals specified?

 

Implementation Strategy: A Conditionally Funded Field Evaluation (CFFE) approach to diffusion was adopted. MOHLTC conditionally provided $12 million annually for DES to be used exclusively within a pragmatic study conducted by the Program for the Assessment of Technologies in Health (PATH) Research Institute with the goal to assess the cost-effectiveness of DES in the Ontario context. Using a large registry of over 20,000 patients, the PATH Research Institute collected information on the number and type of stents, rates of revascularization procedures and mortality over a 1 year follow-up period. PATH reported back the findings from the study in early 2007 to the Ontario Health Technology Advisory Committee (OHTAC) whose advice to MOHLTC was used to make a long-term funding decision.

Results:
A description of what happened after implementation. Numerical data are encouraged but not required

Results: It was found that the effectiveness of DES varied widely across patients with different risk factors and that DES were not cost-effective in a number of patients. The results of the cost-effectiveness study, which have not been previously published, were used by OHTAC to make a recommendation for DES funding in high risk patients only which, compared to a more open diffusion policy, resulted in an estimated $22million annual savings to the health care system. These results differed from efficacy data from published RCTs. Reasons for this discrepancy cannot be provided with certainty but possibilities include differences in the use of ant-platelet drugs and the use of a more current bare metal stent.

Lessons Learned:
Recommendations to similar organizations or academic researchers – recommendations can be positive or negative

Lessons Learned: This example of a pragmatic effectiveness study used to inform decision making demonstrates how an evidence-based approach to health technology assessment can, and should, influence policy decision making when faced with concerns of generalizability and decision uncertainty.


 

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