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Minimum requirements for HTA analyses

The minimum requirements are the requirements to be met by clinical, economic and budgetary analyses of the entity obliged to finance the services from public funds, which are submitted by the responsible entity in the reimbursement process. Detailed requirements are set out in the Regulation of the Minister of Health of 2 April 2012 on the minimum requirements to be met by the analyses included in the applications for inclusion in the reimbursement and determination of the official sales price and for raising the official sales price of a drug, a foodstuff for special nutritional uses, a medical device, which does not have a reimbursed equivalent in the indication.

In case the analyses submitted in the reimbursement proceedings do not meet the minimum requirements, the President of the Agency calls the applicant to supplement the analyses using the System for Reimbursement List Services (SOLR), setting 21 days to supplement the documentation. The deadlines for performing verification analyses during that time are suspended.