To review clinical guidelines, recent HTA decisions, and the influence of economic analyses in HTA decisions related to biologic therapies in UC. MethOds: A literature review and targeted research provided information on clinical treatment guidelines (US and Europe) and HTAs (Europe) related to biologics in UC. Economic models in UC were identified and reviewed to determine how these affected HTA decisions. Results: Since several biologics were approved after the last version of the US treatment guidelines, the US guidelines only address the use of infliximab for the treatment of moderate or severe UC. In the UK, NICE has recommended infliximab, adalimumab, and golimumab as possible treatments for adults with moderate to severe UC in whom conventional therapy hasn't worked or isn't suitable. A recent NICE HTA recommends vedolizumab as an option for treating moderately to severely active UC in adults only if the company provides vedolizumab with the discount agreed in the patient access scheme. The Scottish Medicines Consortium (SMC) recommends vedolizumab for the treatment of adult patients with moderate-to-severe UC and an inadequate response, lost response, or intolerance to conventional therapy or a TNFα antagonist; this advice is "contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower." Earlier SMC advice did not recommend adalimumab, golimumab or infliximab for use within NHS Scotland due to lack of robust economic analyses. The SMC advice is superseded by the NICE HTA decisions. cOnclusiOns: In the UK and Scotland, more than 9 HTA have been performed in the 10 years since biologics have become available for the treatment of moderate-to-severe UC. Differential cost-effectiveness among specific indications, lines of treatment, and countries have resulted in a variety of recommendations as to their use which supplement clinical guidelines in UC.
A477value-based pricing, which reflects disease burden, therapeutic innovation, and social values, is suggested. This study attempts to measure the importance of costeffectiveness and other values for a new anticancer drug. Methods: Through literature reviews and experts' advices, eight health insurance benefit criteria were selected: disease severity, size of population affected by disease, pediatric medicine, alternative drugs, innovativeness, clinical benefit, cost-effectiveness, and budget impact. Preference for the criteria was investigated by using Discrete Choice Experiments(DCE), Analytic Hierarchy Process (AHP), swing weighting (SWING), and direct point allocation (DIRECT). The survey was conducted in three hundred general population through face to face interview. Respondents were selected using stratified random sampling by age, sex and region. The conditional logistic regression for DCE was conducted with STATA ver.12. Results: In the preference investigation using DCE, people preferentially considered disease severity (OR: 1.837, 95% CI: 1.673 to 2.017), alternative drugs (OR: 1.556, 95% CI: 1.458 to 1.661), and size of population affected by disease (OR: 1.408, 95% CI: 1.285 to 1.543). According to the results by using AHP, respondents considered clinical benefit to be the most important, followed by cost-effectiveness and disease severity as the main evaluation items. As estimated by SWING and DIRECT, clinical benefit was also evaluated as the most important item. There was no difference in the first to third priority evaluation items between SWING and DIRECT. ConClusions: The priorities derived from all methodologies show that clinical benefit and disease severity were more important than cost-effectiveness in general terms. In the situation where decision-making is mostly centered on cost-effectiveness, our results may be seen as the social demand that clinical benefit and the influence of applicable disease should be reflected appropriately in the insurance coverage.
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