THE CONFIDENTIALITY REGARDING DRUGS PRICING AND REIMBURSEMENT IN ROMANIA

Author(s)

Paveliu M1, Radu P2
1Titu Maiorescu UNIV, Bucharest, B, Romania, 2Roche Romania SRL, Bucharest, Romania

Health Technology Assessment for drugs emerged as a necessity to develop health policies that are patient focused and seek to achieve best value for scarce resources, one characteristic of it being the transparency of the process. Following or part of the Health Technology Assessment in a lot of countries there is a practice of negotiations with health authorities to get access at public financing. The contracts which results from these negotiations (Managed Entry Agreements) have often a common denominator, respectively the confidentiality covering the final price of the drug, generally as a mean to avoid price decrease in other countries. The authors performed a critical review of the Romanian legislation from the last 10 years looking for the confidentiality and transparency aspects covering the pricing and reimbursement of drugs. The results showed that: (1) the List prices are publically available in the Official Gazette, (2) the reimbursement prices paid by the Payer have a specific legislation, but the methodology for calculation is not transparent, (3) for innovative drugs there is a specific methodology to get discounts based on cost-volume/cost-volume-results contracts, but the level of discounts is confidential, (4) the budgets allocated to thesecost-volume/cost-volume-results contracts are confidential, (5) the volumes (units) of drugs are not transparently published by the Payer and (6) the outcomes, in terms of patients treated by therapeutic area and the resources utilization, are confidential. Confidentiality could represent an incentive or a disincentive for drugs access on the market, according with the decision made by the health authorities. Too much confidentiality could restrict access of new drugs and very limited confidentiality could lead the Payer to miss the opportunity for getting lower prices within the country, in exchange of granting access of the drugs for the patients.

Conference/Value in Health Info

2018-11, ISPOR Europe 2018, Barcelona, Spain

Value in Health, Vol. 21, S3 (October 2018)

Code

PCP37

Topic

Health Policy & Regulatory

Disease

Multiple Diseases

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