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Objective
This paper constitutes the first attempt to draw lessons from the recent uptake of health economic evaluation of innovative drugs in the French regulatory framework.Study Design
Taking the example of new direct-acting antivirals against hepatitis C virus, the paper asks whether and how the cost-effectiveness (CE) opinions issued by the French National Health Authority improve the information available to support the pricing decisions.Methods
The analysis compares the assessment of these drugs based on three different sources: CE opinions, clinical opinions, and the published cost-utility analyses (CUA) available in the literature and identified through a systematic review.Results
The results show that CE opinions bring to the fore three issues prone to impact the incremental cost utility ratio and those were not available to the decision maker through clinical opinions or published CUA: the stage of treatment initiation, the modeling of the disease progression, and the uncertainty around the efficacy rates.Conclusions
France has introduced the criterion of the cost per QALY gained in the pricing and regulation of innovative pharmaceuticals since 2013. Our analysis shows that the use of CUA does enhance the information available to the decision makers on the value of the treatments. 相似文献3.
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《Health policy (Amsterdam, Netherlands)》2020,124(4):404-410
BackgroundIn 2014 managed entry agreements (MEA) between Swedish health care payers (county councils), the reimbursement authority (the Dental and Pharmaceutical Benefits Agency (TLV)) and pharmaceutical companies were introduced to facilitate early and equal access to treatments. MEAs complement the value-based pricing system for out-patient drugs and enables stake-holders to negotiate risk-sharing agreements.AimThe aim of the study was to review existing agreements, describe the type of uncertainty dealt with, and to analyze incentives created using the literature on performance-based reimbursement schemes in Sweden.MethodA document review of all agreements made in the period January 2015 to August 2019 was conducted, classifying agreements by the type of uncertainty dealt with.ResultsAgreements were made for 56 products during the studied time period (45 ongoing), mainly in the fields of hepatitis C (n = 10) and oncology (n = 14). Uncertainties addressed in ongoing agreements included size of treated population (10), treatment duration (13), and effectiveness (9). The mechanism for risk-sharing was limited to refunds based on patient numbers, duration or just flat-rate refunds. The estimated refund in 2018 was 50 % of total sales.DiscussionThis review show that the main driver behind risk sharing in Sweden so far have seem to be affordability rather than managing uncertainty. 相似文献
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《Journal of Clinical Orthopaedics and Trauma》2020,11(1):73-78
BackgroundPerioperative opioid use is becoming an increasingly concerning topic in total joint arthroplasty (TJA). The current study aims to add to the paucity of prior studies that have detailed perioperative opioid use patterns and the effects of preoperative chronic opioid use among a cohort of total hip arthroplasty (THA) patients.MethodsA retrospective analysis of 256 consecutive patients who underwent a THA at our institution between February 2016 and June 2016 was performed. Two cohorts were compared: patients deemed 1) preoperative chronic opioid users, and 2) non-chronic users. Variables compared included baseline characteristics, quality metrics, and patients’ opioid use histories 3 months prior to surgery and 6 months following surgery.ResultsOf the 256 patients, 54 (21.1%) patients were identified as preoperative chronic opioid users. Baseline characteristics including age, gender, BMI, and ASA scores were similar between both cohorts. Discharge disposition, value-based purchasing (VBP) costs, length of stay (LOS), emergency room visits, and postoperative office visits were similar between the two cohorts. Readmission rates (30-day, 90-day, and 6-month) were significantly higher (p < 0.05) in the chronic opioid users cohort. By the 6-month postoperative time period, chronic opioid users were consuming approximately 100-times the morphine equivalents than non-chronic users.ConclusionsThe current study demonstrates that a substantial proportion of preoperative chronic opioid users continue to consume large amounts of opioids up to 6-months following THA surgery. Furthermore, preoperative chronic use is significantly associated with poorer quality outcomes, specifically with respect to readmission rates.Level of evidenceLevel II, Prognostic Study. 相似文献