Comparing Patient Access to Pharmaceuticals in the UK and US
Comparing Patient Access to Pharmaceuticals in the UK and US
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DOI：
10.2165/00148365-200605030-00004
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发表时间：
2006-09-01
影响因子：
3.6
通讯作者：
Faden, Laura
中科院分区：
文献类型：
--
作者：
Cohen, Joshua;Cairns, Catherine;Faden, Laura
背景：关于获得新药的辩论集中在申请批准和批准上市之间的时间间隔。这一拖延被确定为患者获得新药的第一个障碍，包括安全性、有效性和质量方面的障碍。自那以后，又发现了更多障碍。这些涉及已批准药物的报销和定价，即所谓的第四和第五个障碍。方法：我们回顾了1999年4月至2005年4月期间进行的38项国家健康与临床卓越研究所(NICE)指导评估。这些评估包括71种最近批准的药物，被认为具有较高的临床或成本影响。对于每一种药物，我们首先由英国药品保健品管理局(MHRA)或欧洲药品评估机构(EMEA)确定其上市批准日期。其次，我们确定了每种药物是否得到了美国FDA的批准上市，如果是的话，它被批准的日期。第三，我们考虑了NICE是否以及何时建议每种药物报销和使用，以及报销条件是否适用。第四，对于FDA批准的药物子集，我们检查了七个为联邦医疗保险受益人提供服务的美国领先第三方支付者使用的三级处方的处方放置、成本分担和报销条件。第五，我们审查了每一项NICE建议，以确定评价文件或最后建议中是否提到了成本效益数据。第六，我们询问了每个美国支付方的发言人，成本效果评估或回扣是否在确定我们样本中的药物处方放置方面起到了作用，以及任何涵盖的药物在上市批准和报销之间是否存在滞后。结果：在38项良好指导评估的71种药物中，美国FDA批准了。平均而言，药物的子集在美国获得营销授权的时间早于英国。平均而言，美国的计划覆盖了所用药物的87%，与推荐用于NHS报销和使用的药物的比例相同。美国的成本分担明显高于英国，不同计划之间的差异更大。平均而言，美国覆盖的药物的报销条件(15%)低于NICE提供条件的药物的百分比(46%)。在上市批准后，美国的计划比NICE更快地决定偿还药物。结论：美国提供了更快、更灵活的途径，可以获得我们样本中大多数(但不是全部)英国批准的药物。然而，美国患者的费用分担比英国高，覆盖范围在人口中的分布也不太均匀。从政策的角度来看，我们的研究结果证实了支持NICE快车道倡议的必要性，以减少评估某些新药所需的时间。此外，研究结果表明，在美国，有必要仔细监测计划对与联邦医疗保险药品福利有关的法规的遵守情况，特别是在处方限制和费用分担限制方面。
Background: The debate on access to new drugs has focused on the time lag between applications for approval and granting of marketing authorisation. This delay was identified as the first barrier with respect to patient access to new drugs, encompassing the hurdles of safety, efficacy and quality. Additional barriers have since been identified. These pertain to reimbursement and pricing of approved drugs, the so-called fourth and fifth hurdles.Methods: We reviewed 38 National Institute for Health and Clinical Excellence (NICE) guidance appraisals carried out between April 1999 and April 2005. These appraisals included 71 recently approved drugs considered to have either high clinical or cost impact. For each drug we first determined its marketing approval date by the British Medicines Healthcare Products Agency (MHRA) or European Medicines Evaluation Agency (EMEA). Secondly, we determined if each drug was approved by the US FDA for marketing and, if so, the date when it was approved. Thirdly, we considered whether and when each drug was recommended for reimbursement and use by NICE, and whether conditions of reimbursement applied. Fourthly, for the subset of FDA-approved drugs, we examined formulary placement, cost sharing and conditions of reimbursement on three-tier formularies used by seven leading US third-party payers serving Medicare beneficiaries. Fifthly, we reviewed each NICE recommendation to determine if cost-effectiveness data were referred to either in the appraisal documentation or in the final recommendation. Sixthly, we asked a spokesperson from each US payer whether cost-effectiveness assessments or rebates played a role in determining formulary placement of drugs in our sample, and whether there was a lag between marketing approval and reimbursement for any of the covered drugs.Results: Of the 71 drugs contained in 38 NICE guidance appraisals, the US FDA approved 64. On average, the subset of 64 drugs received marketing authorisation in the US prior to the UK. On average, US plans covered 87% of the 64 drugs, the same percentage of drugs recommended for NHS reimbursement and use. Cost sharing in the US was significantly higher than in the UK, with wider variation across plans. On average, drugs covered in the US had fewer conditions of reimbursement (15%) than the percentage of drugs given conditions by NICE (46%). US plans were quicker to decide to reimburse drugs following marketing approval than NICE.Conclusions: The US provides faster, more flexible access to most, but not all, of the UK-approved pharmaceuticals in our sample. However, US patients have higher cost sharing than the UK and coverage is less evenly spread across the population. From a policy perspective, our study findings confirm the need to bolster the NICE fast-track initiative to decrease the amount of time it takes to appraise certain new pharmaceuticals. Also, the study findings point to the need in the US for careful monitoring of plan compliance with regulations pertaining to the Medicare drug benefit, particularly with respect to formulary restrictions and limits on cost sharing.