Approach to Uncertainty in Health Technology Assessment in a Central and Eastern European Country: Appraisal of Cancer Drugs by a Polish HTA agency in presence of high Crossover Rates in Clinical Trials.

• Autorzy: Anna Panasiuk , Monika Homa , Dariusz Pawlik , Patrycja Prząda-Machno , Marcin Kaczor
• Języki publikacji: EN

Abstrakty

EN

Background: Health technology assessment (HTA) plays an important role in reimbursement decision making in Poland and its principles are similar to those used in other countries. However, specific inter-country differences, such as substantial divergence in budgetary resources, may lead to variation in actual HTA practices, e.g. in the approach to uncertainty. Cancer drug reimbursement is a decision-taking area associated with substantial uncertainty. One of its important sources is the presence of crossover (treatment switching) in clinical trials. Objectives: To review the appraisal processes completed for cancer drugs by the Polish HTA agency (AOTMiT) and to compare AOTMiT to the British, Australian and Canadian HTA bodies with respect to strategies of addressing crossover-related uncertainty. Methods: Cancer drug assessment processes in AOTMiT, where a substantial crossover took place were reviewed and subsequently matched with the assessments conducted by NICE, PBAC and pCODR. Ways to approach the crossover-related uncertainty, the influence of uncertainty on the recommendation and uncertainty management strategies were examined. Results: 29 HTA processes related to 6 drugs were included. The crossover rate ranged from 51% to 85% and ITT analyses did not show statistically significant survival benefit. AOTMiT more often yielded negative recommendation, showed less consistent approach to crossover-related uncertainty and a narrower scope of adopted uncertainty management strategies. Conclusions: Crossover constitutes a vital source of uncertainty in the assessments of new cancer therapies. The lack of consistent standards decreases the transparency of assessment processes and can contribute to undertaking suboptimal reimbursement decisions.(original abstract)

Słowa kluczowe

EN

Medical technology; Medications

PL

Technologia medyczna; Leki

• Czasopismo: Journal of Health Policy and Outcomes Research
• Rocznik: 2016
• Numer: nr 2
• Strony: 17--34

Twórcy

autor

Anna Panasiuk

• Aestimo s.c., Kraków, Poland

autor

Monika Homa

• Aestimo s.c., Kraków, Poland

autor

Dariusz Pawlik

• Aestimo s.c., Kraków, Poland

autor

Patrycja Prząda-Machno

• Pfizer Poland, Warsaw, Poland

autor

Marcin Kaczor

• Aestimo s.c., Kraków, Poland;Jagiellonian University Medical College, Kraków, Poland

Bibliografia

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Identyfikatory

DOI

10.7365/JHPOR.2016.2.2