HEALTH TECHNOLOGY ASSESSMENT OF DIABETES COMPOUNDS- THE POLISH PERSPECTIVE

Author(s)

Adalsteinsson JE1, Czech M2, Skrekowska-Baran I3, Jasik BM11Novo Nordisk A/S, Copenhagen, Denmark, 2Novo Nordisk Pharma Sp z.o.o., Warsaw, Poland, 3Novo Nordisk Pharma Sp, Warszawa, Poland

OBJECTIVES: The AOTM in Poland was established to give MoH in Poland advice on reimbursement.  The aim of this research is to create an overview of HTA reports on diabetes compounds in Poland and the results of the decision making. METHODS: A search was conducted on the webpage of AOTM (http://www.aotm.gov.pl) for HTA reports on the following products: Rosiglitazon, Pioglitazon, Sitagliptin, Vildagliptin, Saxagliptin, Exenatide, Liraglutide, Glargine, Detemir, Aspart, Glulisene and Lispro. RESULTS: Of a total of 163 reports (published between 2007-2010), 8 reports in Polish language on diabetes were identified and assessed. Two reports can be viewed as secondary assessment of regulatory safety discussions.  The other six reports assessed the implementation of new diabetes compounds with assessment of efficacy, safety and cost effectiveness of the drugs.Two reports assessed safety concerns associated with the risk of cancer and concluded based on EMA and FDA research that no increased risk was associated with these agents. Rosiglitazone and Sitagliptin were not recommended for reimbursement due to availability of other treatments with similar efficacy. Saxagliptin, Exenatide and Liraglutide got the recommendation to be reimbursed due to expected increase in QALYs.  The final report was assessing Glulisene which got the recommendation to temporary reimburse (two years) provided that data on hard endpoints (not specified in public report) and cost effectiveness should be delivered. CONCLUSIONS: Recommendation by AOTM is supported by assessment of available RCTs, cost per life year gained, cost per QALY, estimated budget impact for 5 years and also in some cases reports from EMEA, FDA and other HTA agencies (SMC, PBAC and CADTH). The AOTM’s recommendation is not obligatory for the Polish Ministry of Health.

Conference/Value in Health Info

2010-11, ISPOR Europe 2010, Prague, Czech Republic

Value in Health, Vol. 13, No. 7 (November 2010)

Code

PDB86

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Diabetes/Endocrine/Metabolic Disorders

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