THE ANALYSIS OF THE RELATION BETWEEN THE DURATION OF ADMINISTRATIVE PROCEDURES AND THE METHODOLOGICAL ACCURACY AND REVIEWABILITY AS WELL AS THE RESULTS OF THE SUBMITTED PHARMACOECONOMIC ANALYSES
Author(s)
Zizalova J, Rrahmaniova D, Vrubel F, Davidova T
Ambruz & Dark Deloitte Legal, Prague 8, Czech Republic
Presentation Documents
OBJECTIVES: According to the law, the State Institute for Drug Control (SUKL) should decide the maximum price, amount, and conditions of reimbursement of a new drug within 165 days in line with the Transparency Directive. In reality, this deadline is often exceeded, especially in case of innovative drugs. We analyzed whether the duration of the administrative procedure is related to methodological accuracy and reviewability of pharmacoeconomic analyses submitted by marketing authorization holder (MAH) and their results. METHODS: Ten administrative procedures, which assessed innovative not interchangeable drugs decided in 2016 were analyzed. In two cases, no cost utility analysis was submitted due to the character of the new intervention. The duration from the SUKL’s first written assessment (WA) to its final decision (Duration) was recorded. The relation between Duration and ICER and budget impact of CUA and BIA as well as the occurrence of objections to the published methodological rules raised by SUKL in WA were analyzed and considered. RESULTS: No relation between results of CUA and BIA and Duration was observed. Methodological concerns were expressed in WA in two cases; the average Duration was 320 days then. In cases where no methodological concerns arose in WA, the average Duration was 115 days. In three cases, SUKL addressed some methodological questions to MAH already before WA was published. If they were explained successfully by MAH, the average Duration was 171 days. CONCLUSIONS: The average Duration observed was 166 days. Methodological errors identified in WA prolonged the Duration almost two-times whereas timely and effective communication between SUKL and MAH led almost to the compliance with the Directive. When ICER and budget impact meet the threshold by the decision-making practice, their exact values do not influence Duration. On the other hand, not even the cost-saving result means a fast track.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PHP284
Topic
Health Policy & Regulatory
Topic Subcategory
Approval & Labeling
Disease
Multiple Diseases