Background. The goal of this report is to address the key issues that patients, providers, and payers face when making decisions about PCSK9 inhibitor therapy and to support the dialogue needed for successful action to improve the quality and value of health care for all patients. The scope for this assessment utilizes the PICOTS (Population, Intervention, Comparators, Outcomes, Timing, and Settings) framework. The evidence review is based on 25 clinical trials and two published systematic reviews and meta-analyses. The results were cross-checked with the manufacturers' FDA submission documents and the FDA's briefing documents. Topic in Context. In summarizing the contextual considerations for appraisal of a health care intervention, we seek to highlight the four following specific issues: (1) Is there a particularly high burden/severity of illness? (2) Do other acceptable treatments exist? (3) Are other, equally or more effective treatments nearing introduction into practice? (4) Would other societal values accord substantially more or less priority to providing access to this treatment for this patient population?
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