Minimum requirements for HTA analyses

Minimum requirements are the requirements imposed on clinical and economic analyses, as well as analyses of impact on the budget of the entity obliged to finance healthcare services from public funds, which are submitted by the marketing authorization holder as part of the reimbursement process. Detailed requirements are set forth in the Regulation of the Minister of Health dated 2 April 2012 on the minimum requirements for the analyses included in applications for providing reimbursement and establishing an official selling price and increasing an official selling price for a medicinal product, foodstuff for particular nutritional purposes or medical device that has no reimbursed equivalent for the particular indication.

Should the analyses submitted under the reimbursement procedure be found not to meet the minimum requirements, the President of the Agency shall request that the applicant supplement the analyses using the Reimbursement List Service System (RLSS) and designate a 21-day deadline for supplementing the documentation. Deadlines for the verification analysis are suspended during this period of time.