A503areas covered with MEA, there are a high proportion of patients not covered by treatment due to actual pitfalls of contracting legislation. ConClusions: In Romania after 2014, the access via managed entry agreements represents the only solution for new innovative drugs not dominant versus present therapies. The types of MEA are limited and the actual MEA contracting process has several problems like disincentivizing the targeted therapies, long delays in negotiation and reimbursement and volatile price during MEA implementation. Meanwhile, both Payer and MAHs agreed that the legislation is not satisfactory and has to be revised.
A27Objectives: Cost effectiveness analyses play a critical role in determining coverage of novel drugs and devices. Increasingly, payers are demanding subgroup analyses to determine indications which would be covered by the national health system or insurance agency. MethOds: To understand and review trends in the use of subgroup cost effectiveness analysis, we analyzed NICE HTAs for products approved between 2011-2012. Manufacturer submissions for CEA were compared to final review and decision by HTA agency. Analogs were identified and case studies were developed to further understand the use of subgroup analyses and cost effectiveness models. Results: Decisions made by NICE in 2011-2012 show increasing trends towards the use of subgroup analysis for determining indications for coverage by national payer bodies. Between 2011-2012, 80% of the assessments included subgroup analyses. Approximately half of them included cost effectiveness analyses for various subgroups. Interestingly, the ICER values estimated by NICE for the same subgroups showed a large variation (1X-3X fold difference) compared to ICER values estimated by manufacturers. Selected case studies highlighted that for several products, NICE is recommending treatments only for subgroups whose ICER values are within the cost effectiveness threshold. cOnclusiOns: New products need robust broader population and subgroup analyses for insurance coverage.
A911contrária, mas o juiz deferiu a liberação do medicamento. ConClusions: Apesar da Recomendação N° 31 de 2009 e a Resolução N° 238 de 2016, do Conselho Nacional de Justiça, a proporção de conformidade entre as decisões judiciais e as NT/RTR encontrada no presente trabalho foi baixa. O estudo também encontrou menor influência das NT em comparação as RTR nas decisões judiciais.
In 2011, the Federal Prosecution Service filed a lawsuit intending the dispensing of long and rapid-action insulin analogues by public health care for patients with T1DM. A federal judge ordered Federal Government and the State of Santa Catarina to provide the drugs. At the appellate level, the issue was re-examined by the Federal Court, and scientific information was requested to the Ministry of Health, which sent the the CONITEC's analysis that recommended do not incorporate the insulin analogues into the health system, because the scientific studies available were not enough to ensure that insulin analogues are either similar or superior in efficacy, safety and cost-effectiveness. So, the judges of Federal Court were convinced in 2014 that the current clinical guideline, which provides human insulin NPH and regular is effective for most patients and unstable or difficult T1DM cases. ConClusions: The CONITEC's HTA Report about insulin analogues was important for judges sentencing decision. Thereby, the decision of the lower court judge was reformed by the appeal court, which decided in favor of the Federal Government, realieving the public health system to incorporate insulin analogues. The insulins analogues are not cost-effective and could reduce the access of treatment with the standards insulin. The budget impact analysis would be huge, about US$ 1 billion per year, if the insulin analogues were incorporated. They conclude that the creation of a new clinical guideline aimed to provide analogues of insulin is typical convenience and opportunity choice of Public Administration, unreachable by the Judiciary.
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