THE JOINT COMMITTEE FOR NEW DRUGS EVALUATION IN SPAIN- SIX YEARS OF EXPERIENCE
Author(s)
Collar JPharmacoeconomics & Outcomes Research Iberia, Madrid, Spain
Presentation Documents
OBJECTIVES: The Joint Committee for New Drugs Evaluation (JCNDE) was established in 2003 to improve efficiency in drug evaluation in Spain. Five Regional Drug Evaluation Centres are part of it and have common Standard Operating Procedures (SOPs) which are regularly updated and improved. The objective of this study was to analyze the drugs innovation degree scores assigned by the JCNDE and timing between the new drug commercialization and the JCNDE evaluation. METHODS: The JCNDE SOPs define a stepwise procedure with 4 key criteria for new drug innovation ratings: efficacy, safety, convenience and drug cost. The drug innovation scores range from 0 (insufficient experience with the drug) to 4 (relevant therapeutic improvement). The drug evaluation results were gathered from JCNDE reports and from the Regional Drug evaluation centre reports. The time period analyzed was from 2004 to 2009. RESULTS: Ninety drug evaluations were held, considering 86 different drugs and 11 evaluations for a new drug indication for the same drug. Seventy-eight (87%) of the evaluations were negative (scores 0-1), not finding any 0 in the last 2 years of the study. Ten and 2 evaluations were scored as 2 and 3 respectively. None of the drugs assessed were considered a relevant therapeutic improvement compared to the existing options. Five drugs not reimbursed were evaluated. Median time since commercialization to evaluation was 6 months (IQR: 2-11 months) and 32 drug evaluations were held before up to a maximum of 3 months after commercialization. CONCLUSIONS: The JCNDE has been an efficient instrument to develop new drug assessments in the Primary Care setting for the Regional Health Systems in Spain. Most of the assessments held have been negative. At present, health-economics arguments are basically focused on the daily treatment cost comparisons. About 1/3 of the evaluations are started before drug commercialization.
Conference/Value in Health Info
2010-11, ISPOR Europe 2010, Prague, Czech Republic
Value in Health, Vol. 13, No. 7 (November 2010)
Code
PHP14
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes
Disease
Multiple Diseases