MARKET AUTHORIZATION (MA) AND REIMBURSEMENT- ANALYSIS OF THE POST-MA TIMELINES AND THE ACCESS TO NEW MEDICINES IN BELGIUM
Author(s)
Francis Arickx, Pharmacist, Pharmacist, Mireille Pierlet, MSc, Economist, Els Soete, Pharmacist, Pharmacist, Ellen VanHaeren, Pharmacist, Pharmacist, Peter Verplanken, PharmacoEconomis, Expert, Philippe Van Wilder, Pharmacist, Head of DepartmentRIZIV INAMI National Health Insurance Agency, Brussels, Belgium
OBJECTIVES: The study aim was to investigate the time delays between market authorization, reimbursement submission and reimbursement authorization and to analyze whether the type of submission affects these delays for new products. METHODS: Data were extracted from the Riziv administrative database. A total of 613 reimbursement files were handled between January 1, 2002 and December 31, 2007. The three submission types were: added (n = 104) or similar (n = 480) therapeutic value or orphan status (n = 29). The following variables were computed: TTS = time between market authorization and reimbursement submission; TSA = time between reimbursement submission and authorization; TMR = time between market authorization and reimbursement authorization.Resubmissions of unapproved claims were excluded to maintain the independency between files. All statistical analyses were executed in SAS EG. RESULTS: The median (25th – 75th percentile)delays (in days) were respectively 137 (46-308), 258 (235-294) and 421 (307-633) for TTS, TSA and TMR. There was no significant difference in TTS (p = 0.11) between submission types: TSA and TMR were significantly longer (p<0.05) respectively for added value and orphan submissions as compared to claims for similar value. CONCLUSIONS: The median delay between marketing authorization and actual reimbursement of new medicines is 421 days in the 2002-2007 period. However the local applicant needs a median of 137 days before a reimbursement claim is submitted: the reimbursement process needs a median of 258 days between submission and authorization, overestimating the time needed because it includes any suspension period requested by the applicant during the procedure. There was no significant difference in TTS between submission types indicating that the need for pharmaco-economic data for added value claims is not jeopardizing TTS. TSA for added value and TMR for orphan submissions were significantly longer indicating the more complex evaluation process which precedes the reimbursement decision.
Conference/Value in Health Info
2008-11, ISPOR Europe 2008, Athens, Greece
Value in Health, Vol. 11, No. 6 (November 2008)
Code
PHP13
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
Multiple Diseases