• Matusewicz W
  • Baran J
  • Farkowski M
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ORGANIZATION: Agency for Health Technology Assessment in Poland (AHTAPol) serves as an advisory body to support the Minister of Health and relevant policy makers in the decision-making process in the public sector of health care in a 38 million people country. PROBLEM OR ISSUE ADDRESSED: During 2007 in Poland, patients with metastatic renal cell carcinoma (mRCC), seventh-leading cause of death in men and in ninth-leading cause in women due to cancer, had access only to immunomodulatory therapy. GOALS: Necessity of providing access to cost-effective new treatments in the first line of therapy of mRCC. OUTCOMES ITEMS USED IN THE DECISION: Clinical efficacy, safety, evidence from different levels of reliability (RCT, RCT interim analysis, patient registry), quality of life, cost-effectiveness/ cost-utility IMPLEMENTATION STRATEGY: Consultative Council (CC) of AHTAPol debated on the subject multiple times and given a new decision after each manufacturer's submission comprised of a new HTA report updated as soon as the newest evidence was published RESULTS: In 2008-2009, CC debated over 3 claims for the reimbursement of sunitinib and one for the reimbursement of bevacizumab in the indication: first line treatment of mRCC. The first submission on sunitinib, was based on an interim analysis of an international multicenter III phase randomized controlled trial (RCT) and 4 observational studies. The claim was rejected, on April 1, 2008, on the grounds of insufficient data on overall survival (OS) and inacceptable level of costeffectiveness of app. USD 330 thousand per LYG, much higher than three-fold GDP recommended by WHO. The second submission, containing evidence from the first submission together with final results of the III phase trial available as conference presentation and abstract, was also rejected by CC on October 28, 2008. Claiming that a conference presentation and abstract are not sufficiently reliable evidence, CC concluded that no new evidence was presented and cost-effectiveness remained unacceptably high. Meanwhile, August 6, 2008, CC rejected submission of bevacizumab on the grounds of unacceptably low level of submitted HTA report, especially in the sections comprising safety issues and economical analysis. Third and final submission on sunitinib was debated on March 2, 2009. CC was presented the evidence from two previous submissions and a newly published data of BC Cancer Registry-a registry of patients with mRCC. This data on practical effectiveness showing prolongation of OS, rather that unreliable evidence on efficacy derived from conference materials, persuaded CC to recommend reimbursement of sunitinib for Polish patients. After that crucial decision, National Health Fund created a dedicated therapeutic program for patients with mRCC with sunitinib as a first line treatment. On December 12, 2009 CC rejected second submission of bevacizumab because there was no evidence of its superiority over already reimbursed sunitinib. LESSONS LEARNED: Utilizing evidence from different levels can broaden decision maker's perspective and justify coverage of sometimes expensive but socially demanded new treatments. In certain cases, there is a lack of evidence from the irrefutably well designed and conducted clinical controlled trials and thorough analysis of observational studies can give enough additional data to issue an informed decision. Data from large patient registries can be crucial to the decision-making process




Matusewicz, W., Baran, J., & Farkowski, M. (2011). PCASE1 UTILIZING EVIDENCE FROM DIFFERENT LEVELS IN THE REIMBURSEMENT PROCESS OF NEW MEDICAL TECHNOLOGIES-ADVANCED RENAL CELL CARCINOMA FIRST LINE THERAPY IN POLAND 2008-2009. Value in Health, 13(3), A217. https://doi.org/10.1016/s1098-3015(10)73062-x

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