is a long-lasting autoimmune disease, which is characterized by patches of abnormal skin. It is a non-curable disease; however, treatment options will help to control the disease for many patients. This study provides information on the current reimbursement situation with biological agents in various European countries, which are part of the treatment plans of middle to severe Psoriasis. MethOds: The international HTA database Prismaccess® includes all decisions by market access authorities, among others from England, Scotland, France, Germany and Sweden. All decisions on therapies for Psoriasis launched in these countries since 2011 were considered for a systematic reimbursement analysis. Results: In total, there were 57 decisions considered. France with the Transparency Committee is leading with 22 decisions, followed by Sweden's TLV with 12, the Scottish SMC with 10 and German's G-BA and IQWiG with 2 and UK's NICE with 4 recommendations. The level of added benefit differs in extent and between countries. In France, 2 subgroups obtained a ASMRs of IV, while majority reached an ASMR V, which means no added benefit. SMC recommended 2 therapies, 7 as restricted and did 1 not recommended; TLV rated 8 as recommended and 4 as restricted. NICE evaluated 3 drugs as recommended and 1 as not accepted. In Germany G-BA/IQWiG evaluated 4 drugs: 2 therapies received no added benefit and 2 received an added benefit in at least one subgroup. Overall, different decisions of the respective HTA bodies could be identified for 9 treatments. They differ in appropriate comparator therapy, patient population or economic data. cOnclusiOns: The analysis showed differences in the assessment of Psoriasis drugs between different market access authorities in Europe. Reasons vary hugely and need to be taken into account in future market access submissions. SY3 How will PaYerS Manage tHe CoSt of new, advanCed BiologiC and onCologiC agentS aS tHeraPY areaS BeCoMe Crowded witH drugS witH SiMilar MeCHaniSMS of aCtion?
OBJECTIVES: Surrogate endpoints can support early access to novel therapies. In trial-level endpoint validation studies, the association between treatment effect e.g., the hazard ratio (HR) on both the surrogate and hard endpoint can be estimated. We aimed to review studies reporting an association between HRs of surrogate time-to-event endpoints and overall survival (OS) in advanced/metastatic cancers. METHODS: A systematic review was conducted using Medline and Embase. We included full reports assessing the association between HRs of surrogate time-to-event endpoints and OS in advanced/metastatic cancer indications. The following information was extracted: study characteristics, association measure, use of weighted analyses, logarithmic transformation of HRs, use of multivariate analysis, evaluation of crossover impact, use of IQWiG framework, estimating surrogate threshold effect (STE), and reported results and/or regression equations. RESULTS: Forty-five studies were included. Retrieved studies were conducted in 16 different cancer indications. Different methods were used to assess associations, including Spearman's/Pearson's correlation coefficient and linear regression analysis. Weighted analyses, logarithmic transformation of HRs and multivariate analysis were implemented in 35, 26 and 10 studies, respectively. Few studies assessed the crossover impact on the association (8 studies) and implemented IQWiG framework and STE assessment (11 studies and 3 studies, respectively). Detailed results are extracted, summarized and will be presented. CONCLUSIONS: There is inconsistency in conducting/reporting of trial-level endpoint validation studies in advanced/metastatic cancers. Future studies would benefit from building a structured data analysis checklist. Also, trial-level surrogacy was not assessed in all advanced/metastatic cancers and the strength of association varied across indications. The generalizability of results from one indication to another is limited.
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