Evidence map›Paper›PMID 29556491›Full record

ArticleFrontiers in public health2018

An Overview of the Reimbursement Decision-Making Processes in Bulgaria As a Reference Country for the Middle-Income European Countries.

Maria Kamusheva, Mariya Vassileva, Alexandra Savova, Manoela Manova, Guenka Petrova

Abstract read
In one paragraph

Article in Frontiers in public health, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Maria KamushevaFaculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria.
Mariya VassilevaNational Council on Prices and Reimbursement, Sofia, Bulgaria.
Alexandra SavovaFaculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria.
Manoela ManovaFaculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria.
Guenka PetrovaFaculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPolicy makers face a lot of challenges in the process of drug reimbursement decision-making, especially in the context of entering the market of more and more innovative medicinal products (MPs). The aim of the current study is to make an overview of the reimbursement system development and to evaluate the access of innovative medicines, which have entered the EU-market in the period 2015-2017, in Bulgaria as reference example for middle-income European country.

methodsA literature and a legislative systematic review regarding the Bulgarian reimbursement system as well as a defining the number of available innovative reimbursed MPs in 2017 in Bulgaria was made.

resultsThe reimbursement legislation in Bulgaria is quite unstable due to constant changes, which have been made, especially in the recent years. Despite this fact, the reimbursement process in Bulgaria is in accordance with the Transparency Directive. Bulgarian patients have a relatively delayed access to innovative medicines as only 5% of centrally authorized MPs in 2017 are available in the positive drug list (PDL), 16% of all in 2016 and 18%-in 2015. This could be explained by the long procedure for their appraisal in Bulgaria: the first step is issuing an opinion by the HTA Committee, followed by negotiation of discounts between the marketing authorization holder and the National Health Insurance Fund and making a final decision by the National Council on Prices and Reimbursement (NCPR) for the inclusion into the PDL.

conclusionOptimization of the procedure for issuing reimbursement status for innovative MPs is needed, such as improvements in the process of conducting HTA reports and their appraisal, incorporation of adequate systems for following the effectiveness and safety of MPs in the real-world conditions, value-based pricing implementation, and increasing the financial control over the health insurance system.

Indexed as

accessaffordabilityBulgariainnovative medicineslow and middle-income Balkan countriespositive drug listreimbursement

Identifiers

PMID29556491
PMCPMC5845108

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