Confidentiality in the Pharmaceutical Managed Entry Agreements in Romania

Abstract

Background and Aim: Health technology assessment for drugs is a necessary step in developing health policies that are focused on patients and getting the best value for scarce resources. One important feature of health technology assessment is transparency. In many countries, health technology assessment is followed by negotiations between pharmaceutical companies and health authorities to determine whether a drug will be publicly funded. These negotiations often result in Managed Entry Agreements, which typically include confidentiality clauses covering the final price of the drug. Methods: We reviewed Romanian legislation starting in 2014 to assess the level of confidentiality and transparency in drug pricing and reimbursement. Results: We found that for drugs with Managed Entry Agreements, the level of discounts is confidential, the public does not know how much the government is paying for each of these drugs, the volumes (units) of drugs are not transparently published by the payer, the outcomes, in terms of patients treated by therapeutic area, therapeutic success, and resource utilization, are confidential. Conclusions: We consider that too much confidentiality can prevent the public from knowing if the government is getting good value for money, but too little confidentiality can lead to higher drug prices or a lack of drugs from the market.