A comparative review of Haute Autorite de Sante and National Institute for Health and Care Excellence health technology assessments of Ikervis to treat severe keratitis in adult patients with dry eye disease which has not improved despite treatment with tear substitutes.
A comparative review of Haute Autorite de Sante and National Institute for Health and Care Excellence health technology assessments of Ikervis to treat severe keratitis in adult patients with dry eye disease which has not improved despite treatment with tear substitutes.
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DOI：
10.1080/20016689.2017.1336043
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发表时间：
2017-01-01
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通讯作者：
Eroglu, Yasmina Iffet
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作者：
Eroglu, Yasmina Iffet
背景：2015年，Ikervis成为ema唯一批准的环孢素A （CsA）滴眼液，用于治疗成人干眼病患者的严重角膜炎，尽管使用泪液替代品治疗，但仍未改善。自20世纪80年代以来，CsA已在兽医学上用于眼部疾病，然后用于人类。然而，其极低的水溶性导致其在植物油中使用，其特点是眼内利用度低，眼内穿透性差，耐受性差，保质期短。浓度从0.05%到2%以工业规模复合，并在整个欧洲报销。在法国，Ikervis已被has授予5分的ASMR评分，而在英国，NICE认可其使用。目的：回顾干眼病的环境、挑战和可用的治疗方案，并比较NICE和HAS的评估，以质疑HAS在缺乏证据的情况下维持复方CsA制剂的全额报销，而ema批准的药物的报销率为15%的决定。方法：广泛检索PubMED。结果：比较国的选择、综合评分评估和CE模型的使用是关键的区分因素。结论：在局部配方中，对载体的改进是能够带来显著效益的关键创新。继美国之后，欧洲也需要一个复利法案。
Background: In 2015, Ikervis became the only EMA-approved cyclosporine A (CsA) eye-drop for the treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes. Since the 1980s, CsA has been used empirically for ocular conditions in veterinary medicine then in humans. However, its extremely low aqueous solubility led to its administration in vegetable oils, which is characterized by low ocular availability, poor intraocular penetration, poor tolerability and short shelf-life. Concentrations from 0.05% to 2% are compounded on an industrial scale and reimbursed throughout Europe. In France, Ikervis has been granted an ASMR score of 5 by HAS, whereas in UK NICE endorsed its use. Objective: To review the dry eye disease environment, its challenges and available treatment options, and compare the NICE and HAS assessments to question HAS' decision to maintain full reimbursement of compounded CsA formulations in the absence of evidence, while reimbursing the EMA-approved drug at 15%.METHOD: extensive search on PubMED. Results: Comparator selection, composite score assessment and use of CE model are key differentiators. Conclusion: In topical formulations, improvements to the vehicle are key innovations that can bring significant benefits. After the USA, a Compounding Act is needed in Europe.