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A real world example of coverage with evidence development in Australia - ipilimumab for the treatment of metastatic melanoma
BACKGROUND: Australian Government subsidisation of ipilimumab for the treatment of patients with metastatic melanoma was conditional on the sponsor entering a ‘managed entry scheme’ to assess the 2-year overall survival rate in metastatic melanoma patients who received ipilimumab in the first year o...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5810048/ https://www.ncbi.nlm.nih.gov/pubmed/29456865 http://dx.doi.org/10.1186/s40545-018-0131-4 |
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author | Kim, Hansoo Comey, Samantha Hausler, Karl Cook, Greg |
author_facet | Kim, Hansoo Comey, Samantha Hausler, Karl Cook, Greg |
author_sort | Kim, Hansoo |
collection | PubMed |
description | BACKGROUND: Australian Government subsidisation of ipilimumab for the treatment of patients with metastatic melanoma was conditional on the sponsor entering a ‘managed entry scheme’ to assess the 2-year overall survival rate in metastatic melanoma patients who received ipilimumab in the first year of Pharmaceutical Benefits Scheme listing. METHODS: All unresectable stage IIIc / IV metastatic melanoma patients treated with at least one dose of ipilimumab therapy in Australia from the PBS listing date to a time point 12 months later (i.e. from 1-Aug-2013 to 31-Jul-2014) were invited to participate. Overall survival at 2 years post treatment initiation was measured, with Cox regression analysis used to examine the relationship between survival and patient baseline characteristics. RESULTS: The evaluable population (910 patients) was on average 63.3 years old, male (70.1%) and treated in a public hospital (64.4%) in an urban area (76.5%). The majority of patients were treatment naïve (63.3%), did not have brain metastases (71.1%), and were classified as ECOG performance status 0 or 1 (90.4%). The 2 year overall survival rate was conservatively calculated to be at least 23.9% and potentially as high as 34.2%. A significant difference in overall survival at 2 years was demonstrated across the categories of ECOG performance status (p < 0.0001), M-status (p = 0.0005) and treatment status (p = 0.0114). No statistical difference in survival rate was observed when examining brain metastases vs no brain metastases (p = 0.2622), treatment at private vs public hospitals (p = 0.7601) nor treatment in the urban vs rural setting (p = 0.5048). CONCLUSIONS: The 2 year overall survival rate for all patients receiving PBS subsidised ipilimumab in Australia from the first year Pharmaceutical Benefits Scheme cohort is estimated to be between 23.9% and 34.2%, which is higher than the 23.5% observed in the key ipilimumab registrational trial. Results and learnings from the ipilimumab ‘managed entry scheme’ illustrate that early access with the promise of future evidence to confirm a medicine’s cost-effectiveness can work, but needs to be carefully considered, constructed and managed. |
format | Online Article Text |
id | pubmed-5810048 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-58100482018-02-16 A real world example of coverage with evidence development in Australia - ipilimumab for the treatment of metastatic melanoma Kim, Hansoo Comey, Samantha Hausler, Karl Cook, Greg J Pharm Policy Pract Research BACKGROUND: Australian Government subsidisation of ipilimumab for the treatment of patients with metastatic melanoma was conditional on the sponsor entering a ‘managed entry scheme’ to assess the 2-year overall survival rate in metastatic melanoma patients who received ipilimumab in the first year of Pharmaceutical Benefits Scheme listing. METHODS: All unresectable stage IIIc / IV metastatic melanoma patients treated with at least one dose of ipilimumab therapy in Australia from the PBS listing date to a time point 12 months later (i.e. from 1-Aug-2013 to 31-Jul-2014) were invited to participate. Overall survival at 2 years post treatment initiation was measured, with Cox regression analysis used to examine the relationship between survival and patient baseline characteristics. RESULTS: The evaluable population (910 patients) was on average 63.3 years old, male (70.1%) and treated in a public hospital (64.4%) in an urban area (76.5%). The majority of patients were treatment naïve (63.3%), did not have brain metastases (71.1%), and were classified as ECOG performance status 0 or 1 (90.4%). The 2 year overall survival rate was conservatively calculated to be at least 23.9% and potentially as high as 34.2%. A significant difference in overall survival at 2 years was demonstrated across the categories of ECOG performance status (p < 0.0001), M-status (p = 0.0005) and treatment status (p = 0.0114). No statistical difference in survival rate was observed when examining brain metastases vs no brain metastases (p = 0.2622), treatment at private vs public hospitals (p = 0.7601) nor treatment in the urban vs rural setting (p = 0.5048). CONCLUSIONS: The 2 year overall survival rate for all patients receiving PBS subsidised ipilimumab in Australia from the first year Pharmaceutical Benefits Scheme cohort is estimated to be between 23.9% and 34.2%, which is higher than the 23.5% observed in the key ipilimumab registrational trial. Results and learnings from the ipilimumab ‘managed entry scheme’ illustrate that early access with the promise of future evidence to confirm a medicine’s cost-effectiveness can work, but needs to be carefully considered, constructed and managed. BioMed Central 2018-02-13 /pmc/articles/PMC5810048/ /pubmed/29456865 http://dx.doi.org/10.1186/s40545-018-0131-4 Text en © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Kim, Hansoo Comey, Samantha Hausler, Karl Cook, Greg A real world example of coverage with evidence development in Australia - ipilimumab for the treatment of metastatic melanoma |
title | A real world example of coverage with evidence development in Australia - ipilimumab for the treatment of metastatic melanoma |
title_full | A real world example of coverage with evidence development in Australia - ipilimumab for the treatment of metastatic melanoma |
title_fullStr | A real world example of coverage with evidence development in Australia - ipilimumab for the treatment of metastatic melanoma |
title_full_unstemmed | A real world example of coverage with evidence development in Australia - ipilimumab for the treatment of metastatic melanoma |
title_short | A real world example of coverage with evidence development in Australia - ipilimumab for the treatment of metastatic melanoma |
title_sort | real world example of coverage with evidence development in australia - ipilimumab for the treatment of metastatic melanoma |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5810048/ https://www.ncbi.nlm.nih.gov/pubmed/29456865 http://dx.doi.org/10.1186/s40545-018-0131-4 |
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