A comparative review of Haute Autorité de Santé 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
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...
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MDPI AG
2017-01-01
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| Series: | Journal of Market Access & Health Policy |
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| Online Access: | http://dx.doi.org/10.1080/20016689.2017.1336043 |
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| author | Yasmina Iffet Eroglu |
| author_facet | Yasmina Iffet Eroglu |
| author_sort | Yasmina Iffet Eroglu |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-e783e3eded8145bbabb10742694c9805 |
| institution | OA Journals |
| issn | 2001-6689 |
| language | English |
| publishDate | 2017-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Market Access & Health Policy |
| spelling | doaj-art-e783e3eded8145bbabb10742694c98052025-08-20T02:03:52ZengMDPI AGJournal of Market Access & Health Policy2001-66892017-01-015110.1080/20016689.2017.13360431336043A comparative review of Haute Autorité de Santé 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 substitutesYasmina Iffet Eroglu0Aix-Marseille UniversiteBackground: 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.http://dx.doi.org/10.1080/20016689.2017.1336043cationic emulsioncyclosporine Aocular deliverydry eye diseasesevere keratitisophthalmologytopicaldrug compoundingcomposite end pointreimbursement |
| spellingShingle | Yasmina Iffet Eroglu A comparative review of Haute Autorité de Santé 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 Journal of Market Access & Health Policy cationic emulsion cyclosporine A ocular delivery dry eye disease severe keratitis ophthalmology topical drug compounding composite end point reimbursement |
| title | A comparative review of Haute Autorité de Santé 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 |
| title_full | A comparative review of Haute Autorité de Santé 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 |
| title_fullStr | A comparative review of Haute Autorité de Santé 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 |
| title_full_unstemmed | A comparative review of Haute Autorité de Santé 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 |
| title_short | A comparative review of Haute Autorité de Santé 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 |
| title_sort | comparative review of haute autorite de sante and national institute for health and care excellence health technology assessments of ikervis r to treat severe keratitis in adult patients with dry eye disease which has not improved despite treatment with tear substitutes |
| topic | cationic emulsion cyclosporine A ocular delivery dry eye disease severe keratitis ophthalmology topical drug compounding composite end point reimbursement |
| url | http://dx.doi.org/10.1080/20016689.2017.1336043 |
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