PHARMACOECONOMIC GUIDELINE FOR POSITIVE DRUG LIST APPLICATION PURPOSES IMPLEMENTED IN BULGARIA

Author(s)

Savova A1, Stoimenova A1, Manova M1, Zidarova B2, Petrova G1, Danchev N2
1Medical University Sofia, Faculty of Pharmacy, Sofia, Bulgaria, 2National Council of prices and reimbursement of medicinal products, Sofia, Bulgaria

OBJECTIVES: The economic evaluation of new medicines is substantial for allocating the limited healthcare budgets. In Bulgaria, according to the legislation for pricing and reimbursement of medicinal products applied to be included in the Positive Drug List, pharmacoeconomic assessment shall be performed according to the criteria based on efficacy, therapeutic effectiveness, safety, and pharmacoeconomic parameters. However, until recently there were no detailed guidelines for applicants available and in April 2015 methodological recommendations were implemented. The objective of methodological recommendations is to achieve optimal assessment of candidate medicinal products applying for the PDL inclusion. METHODS: A working group of representatives from National Council for Pricing and Reimbursement of medicinal products, Bulgarian Drug Agency, and experts from academia developed a guideline, following the good practices of other countries to provide standardized approach to economic evaluation of medicinal products in Bulgaria. RESULTS: The guideline is structured in five sections including requirements for provided data for efficacy, therapeutic effectiveness and safety, as well as pharmacoeconomic parameters. Applicants need to prepare their applications according to the requirements provided by these methodological recommendations.There should be a clear and unambiguous conclusion about the benefits of the medicinal product, subject to evaluation over the existing alternatives, the clinical significance and its place in therapy. If there is an economic evaluations conducted with a candidate medicinal product for other health systems or published by HTA agencies in Europe it is necessary to be provided with respective motives for positive or negative decision.  CONCLUSIONS: The implemented pharmacoeconomic guideline will facilitate the appraisal of medicinal products based on objective and transparent information which will allow the decision makers to justify the reimbursement of new medicinal products based on scientific evidences and available resources.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PHP194

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Multiple Diseases

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