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CASE STUDY PROPOSAL EXAMPLE

Title (capital letters)

REQUIREMENT OF COST-EFFECTIVENESS ANALYSIS STUDY: CREATING A TOOL TO ASSIST NATIONAL DRUG SELECTION DECISION MAKING IN THAILAND

Authors (author’s last name, followed by first initial)

institution(s), city, state, country

Tangcharoensathien V1, Yoongthong W2, Kulsomboon V3
 

1International Health Policy Program (IHPP), Nonthaburi, Thailand, 2Food and Drug Administration, Nontaburi, Thailand, 3Chulalongkorn University, Bangkok, Thailand

Organization
(The organization where the case study took place)

ORGANIZATION: Health Economics Working Group for National Essential Drug Selection Committee.

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: National essential drug selection committee is directly responsible for selecting effective, safe, high quality medicines to be included in national essential drug list. In the past, the selection was made mostly based on evidences related to efficacy and safety of drugs. In the last decade, there have been strong interest in taking cost-effectiveness and budget impact information into account but the use of such information was not obligated. In order to support an efficient use of resources under budget constraints, Health Economics Working Group for National Essential Drug Selection Committee has been formed and assigned a role of designing how to best use value for money and budget impact information during drug selection process.

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: To design how to best use cost-effectiveness and budget impact information during national drug selection process.

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: The cost-effectiveness data will be required as part of dossier submission for some pharmaceutical products. As a result, pharmaceutical companies owning the products will be responsible for the submission of local cost-effectiveness study, while a decision whether to submit budget impact analysis remained belong to the company.

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

IMPLEMENTATION STRATEGY: All pharmaceutical companies will be requested to attend a meeting and be informed about the requirement of cost-effectiveness data and Thai Pharmacoeconomics guideline.

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

RESULTS: The decision was made during several roundtable meetings of Health Economics Working Group in March-July 2010. Some pharmaceutical products will be chosen to require cost-effectiveness data. Out of those chosen products, the top 12 products will be selected for non-profit research organizations to conduct a local cost-effectiveness study. The tentative selection criteria developed to rank the importance of studies include burden of disease, multisource product, life-saving product, breakthrough product, and potential inequity of product access. The products, other than the top 12 products, will have to be left responsible by the owning pharmaceutical companies to submit a dossier containing cost-effectiveness data. Tentatively, pharmaceutical companies will be given 20 weeks to submit a dossier after being informed about the need of cost-effectiveness study from the National essential drug selection committee.  For the time being, our tentative reviewing process is to have the cost-effective dossier be reviewed by 3 external and 2 internal reviewers. The detailed description of drafted standard operating procedures (SOP) for the whole process is under development.

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

LESSONS LEARNED: Thailand has become another country requiring cost-effectiveness data to be submitted by pharmaceutical companies. Adopting a rigorous reviewing process may ensure reliability and applicability of findings to Thai context. Other countries may consider applying the cost-effectiveness requirement at the national level. More research needs to be undertaken to assess the implications of such requirement.

 


 

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