Social health insurance is mandatory in Switzerland and covers the costs of basic medical care. In general, with regard to medicines, the costs are only reimbursed if the drug is (1) approved by Swissmedic and (2) listed on the so-called Spezialitätenliste (SL) by the Federal Office of Public Health (FOPH). However, the SL does not include all drugs. For non-SL drugs, cost coverage is only granted under exceptional circumstances. Absence of cost coverage by social health insurance is especially problematic for patients who need access to cancer drugs, since they are often costly. Even if such cancer drugs are approved by Swissmedic, patients may still lack access to them. Therefore, access to medicines includes two aspects: (1) the availability of a drug on the market (i.e., approval of a drug) and (2) inclusion on the SL (i.e., cost coverage by social health insurance). In this study, we aim to compare the current approval regulations for oncologic precision medicines in the USA, Europe, and Switzerland; to investigate cost coverage for these drugs in Switzerland; and to develop health policy implications about how access to these drugs could be improved in Switzerland.

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在瑞士获得癌症精准药物：比较分析（美国和欧盟）和卫生政策影响

社会医疗保险在瑞士是强制性的，涵盖基本医疗保健费用。一般来说，对于药物，只有在药物 (1) 获得 Swissmedic 批准和 (2) 被联邦公共卫生局 (FOPH) 列入所谓的 Spezialitätenliste (SL) 的情况下才能报销费用。但是，SL 并不包括所有药物。对于非 SL 药物，仅在特殊情况下才给予费用保障。对于需要获得抗癌药物的患者来说，缺乏社会医疗保险的费用覆盖尤其成问题，因为它们通常很昂贵。即使此类抗癌药物获得 Swissmedic 批准，患者仍可能无法获得这些药物。因此，获得药物包括两个方面：(1) 市场上药物的可用性（即药物的批准）和（2）列入 SL（即，社会医疗保险的费用覆盖）。在本研究中，我们旨在比较美国、欧洲和瑞士目前对肿瘤精准药物的批准规定；调查这些药物在瑞士的费用覆盖范围；并制定有关如何改善瑞士获得这些药物的健康政策影响。