{"title":"罗马尼亚药品管理进入协议中的保密问题","authors":"M. Paveliu, C. P. Radu, Bogdan C. Pana","doi":"10.55453/rjmm.2024.127.3.7","DOIUrl":null,"url":null,"abstract":"Background and Aim: Health technology assessment for drugs is a necessary step in developing health policies that are \nfocused on patients and getting the best value for scarce resources. One important feature of health technology assessment is \ntransparency. In many countries, health technology assessment is followed by negotiations between pharmaceutical companies \nand health authorities to determine whether a drug will be publicly funded. These negotiations often result in Managed Entry \nAgreements, which typically include confidentiality clauses covering the final price of the drug. Methods: We reviewed Romanian \nlegislation starting in 2014 to assess the level of confidentiality and transparency in drug pricing and reimbursement. Results: We \nfound that for drugs with Managed Entry Agreements, the level of discounts is confidential, the public does not know how much \nthe government is paying for each of these drugs, the volumes (units) of drugs are not transparently published by the payer, the \noutcomes, in terms of patients treated by therapeutic area, therapeutic success, and resource utilization, are confidential. \nConclusions: We consider that too much confidentiality can prevent the public from knowing if the government is getting good \nvalue for money, but too little confidentiality can lead to higher drug prices or a lack of drugs from the market.","PeriodicalId":21298,"journal":{"name":"Romanian Journal of Military Medicine","volume":null,"pages":null},"PeriodicalIF":0.1000,"publicationDate":"2024-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Confidentiality in the Pharmaceutical Managed Entry Agreements in Romania\",\"authors\":\"M. Paveliu, C. P. Radu, Bogdan C. Pana\",\"doi\":\"10.55453/rjmm.2024.127.3.7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background and Aim: Health technology assessment for drugs is a necessary step in developing health policies that are \\nfocused on patients and getting the best value for scarce resources. One important feature of health technology assessment is \\ntransparency. In many countries, health technology assessment is followed by negotiations between pharmaceutical companies \\nand health authorities to determine whether a drug will be publicly funded. These negotiations often result in Managed Entry \\nAgreements, which typically include confidentiality clauses covering the final price of the drug. Methods: We reviewed Romanian \\nlegislation starting in 2014 to assess the level of confidentiality and transparency in drug pricing and reimbursement. Results: We \\nfound that for drugs with Managed Entry Agreements, the level of discounts is confidential, the public does not know how much \\nthe government is paying for each of these drugs, the volumes (units) of drugs are not transparently published by the payer, the \\noutcomes, in terms of patients treated by therapeutic area, therapeutic success, and resource utilization, are confidential. \\nConclusions: We consider that too much confidentiality can prevent the public from knowing if the government is getting good \\nvalue for money, but too little confidentiality can lead to higher drug prices or a lack of drugs from the market.\",\"PeriodicalId\":21298,\"journal\":{\"name\":\"Romanian Journal of Military Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.1000,\"publicationDate\":\"2024-01-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Romanian Journal of Military Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.55453/rjmm.2024.127.3.7\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Romanian Journal of Military Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.55453/rjmm.2024.127.3.7","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Confidentiality in the Pharmaceutical Managed Entry Agreements in Romania
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.