REVIEW OF HTA RECOMMENDATIONS FOR DRUG THERAPIES IN POLAND ISSUED FROM SEPTEMBER 6, 2007 UNTIL OCTOBER 28, 2008 BY THE CONSULTATIVE COUNCIL (APPRAISAL COMMITTEE) OF AHTAPOL IN POLAND
Author(s)
Katarzyna Kolasa, PhD, Health Economics ScientistsAstraZeneca, sÖDERTÄLJE, Sweden
Presentation Documents
OBJECTIVES Review of HTA recommendations issued by the Consultative Council of AHTAPol in Poland. METHODS Fifty-nine drug recommendations, January 2007-58/16/2008, from September 2007 until October 2008, available online, were analyzed. Appraisals were grouped into positive and negative recommendations. The clinical and non-clinical reasons for rejection of use were studied. The positive guidances were divided into recommendations with major, minor and without restrictions. RESULTS Thirty-two HTA reports received negative recommendations; 26 on the grounds of clinical evidence and 6 because of non-clinical issues. Among 26 recommendations, insufficient clinical effectiveness data was the most frequently stated reason (18 cases). In other eight guidances, the argument of poor efficacy or safety was raised. Among non-clinical aspects, unacceptable cost-effectiveness ratio was given four times. The unacceptable budget impact and risk of off-label use were mentioned each one only once. Twenty-seven HTA reports received positive recommendations, of which 18 for use with major restrictions, 7 with minor restrictions and 2 without additional restrictions. Among those 18 recommendations, several restrictions were imposed simultaneously. The most common was prescription restricted to specific subpopulations (15 cases), followed by the need for an improvement of cost-effectiveness (6 cases), use as second line (5 cases), use if intolerant to other treatment (3 cases), reimbursement within specific period (2 cases). Among recommendations with minor restrictions, lowering price was mentioned five times and use by specialist twice. The appraisal of cost-effectiveness analysis was included more frequently in positive rather than negative quidances; 63% vs. 57%. The study revealed that an ICER was above WHO threshold, accepted by AHTAPoL, in 65% of positive recommendations. An ICER was below threshold in 44% of negative recommendations. CONCLUSIONS The negative and positive HTA guidances with major restrictions prevailed in Poland. Clinical rather than pharmacoeconomic aspects were the most common reason for an appraisal recommendation.
Conference/Value in Health Info
2009-05, ISPOR 2009, Orlando, FL, USA
Value in Health, Vol. 12, No. 3 (May 2009)
Code
PHP85
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Multiple Diseases