THE IMPACT ON ACCESS TO INNOVATIVE DRUGS OF THE FIRST MANAGED ENTRY AGREEMENTS IN ROMANIA
Author(s)
Chiriac ND, Radu PC, Pravat MA
Roche Romania Srl, Bucharest, Romania
Presentation Documents
OBJECTIVES: This research aims to illustrate the first results of implementing managed-entry agreements (locally developed as cost-volume/cost-volume-results contracts) on the access of patients to innovative therapies. METHODS: The authors studied, for the period July 2014 – June 2016, the HTA reports that led to the conditional inclusion of some of the drugs in the List using cost-volume/cost-volume-results contracts. Critical appraisal was done covering the public information available on these first innovative drugs included on the reimbursement List using managed entry arrangements (MEA), including the review of legislative framework for negotiating and contracting. RESULTS: Based on the prioritization criteria, in 2015, out of 45 drugs having conditional inclusion decisions, only nine were selected to negotiate a MEA. In Autumn 2015 five MEAs were signed (four for oncology, one for hepatitis C) and in Spring 2016 a further three MEAs were signed (two in oncology, one in rheumatology). The MEAs are valid for only one year and the price/volumes are confidential. There are two types of MEA, one with financial/market share provisions and another including outcomes of the therapy as well. For all therapeutic areas covered with MEA, there are a high proportion of patients not covered by treatment due to actual pitfalls of contracting legislation. CONCLUSIONS: In Romania after 2014, the access via managed entry agreements represents the only solution for new innovative drugs not dominant versus present therapies. The types of MEA are limited and the actual MEA contracting process has several problems like dis-incentivizing the targeted therapies, long delays in negotiation and reimbursement and volatile price during MEA implementation. Meanwhile, both Payer and MAHs agreed that the legislation is not satisfactory and has to be revised.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PHP358
Topic
Health Policy & Regulatory
Disease
Multiple Diseases