- Email: [email protected]
Current status, issue and future perspectives for biosimilars in Japan from the viewpoint of cost-effectiveness
Annals of Oncology 30 (Supplement 6): vi36, 2019 doi:10.1093/annonc/mdz329
SYMPOSIUM 11 : THE APPROPRIATE SELECTION OF ANTI-CANCER DRUGS ACCORDING TO COST EFFECTIVENESS SY11
1
The NICE reimbursement process for pharmaceuticals in the UK. Are cancer drugs a special case?
NICE was set up in 1999 and publishes guidance to the NHS in England and Wales. Although not specifically set up as a fourth hurdle in the drug and device approval process, NICE is centrally involved in informing reimbursement decisions for new and costly drugs including those in oncology. NICE has successfully addressed so called postcode prescribing variations, but has been challenged by the number and cost of new drug applications particularly in oncology. Since July 2016 the Cancer Drugs Fund has acted to provide short term access to promising drugs which have not achieved sufficient evidence to support their use although there is a reasonable prospect of this being achieved in the future. In this presentation I will describe the history and development of NICE and provide a synthesis of how it operates. The interplay between the regulators and NICE is particularly relevant, and the roles that both have adopted will be discussed. I will address the strengths and limitations of the current structure of the organisation, and consider what future changes may be appropriate. I will illustrate the talk with a range of relevant examples drawn from the literature and personal experience.
SY11
5
Current status, issue and future perspectives for biosimilars in Japan from the viewpoint of cost-effectiveness
Yoshihiro Nanbu The Japan Biosimilar Association, Nippon Kayaku CO. LTD In Japan, maintaining the universal health insurance system has become a major social issue in our rapidly aging society with soaring expense of social security contributions and skyrocketing medical costs, etc.
C The Author(s) 2019. Published by Oxford University Press on behalf of the European Society for Medical Oncology. V
All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_6/mdz329.001/5582847 by guest on 28 October 2019
Nick Freemantle Institute of Clinical Trials and Methodology, University College London, United Kingdom
Nowadays generic medicines have become standard therapeutic medicines even in the field of cancer treatment. In terms of cost-effectiveness, biosimilars are expected to enhance patients’ access to beneficial treatment and so contribute to patients’ quality of life as well as reducing the economic burden and total medical expenses while providing equivalent therapeutic outcomes inexpensively compared to the original biologics. Regarding the approval requirements of biosimilars, unlike generic products, they need a Phase III clinical trial in addition to the characterization study which proves similarity to the originals. Biosimilars have been approved through a review process of an application package which is similar to that of new drugs. However, in Japan, biosimilars have not become standard therapeutic choices yet. Approvals of biosimilars and their prevalence in the medical front have been proceeding in Europe and those products have grown in popularity as standard therapeutic choices. In European countries, the European Medicines Agency, academic societies and governmental authorities in each country have implemented a variety of measures to facilitate use of biosimilars. As part of such efforts, the EMA published a guideline on similar biological medicinal products containing G-CSF in 2006. In overseas ASCO and ESMO have already issued a position paper and statement on biosimilar products. In Japan, the Japan Society of Clinical Oncology recommends the biosimilars in its guideline for acceptable use in 2013. This presentation covers the initiatives for biosimilars in Europe and the US, the situation and the challenges in Japan as well as the activities of the Japan Biosimilar Association.
SYMPOSIUM 11 : THE APPROPRIATE SELECTION OF ANTI-CANCER DRUGS ACCORDING TO COST EFFECTIVENESS SY11
1
The NICE reimbursement process for pharmaceuticals in the UK. Are cancer drugs a special case?
NICE was set up in 1999 and publishes guidance to the NHS in England and Wales. Although not specifically set up as a fourth hurdle in the drug and device approval process, NICE is centrally involved in informing reimbursement decisions for new and costly drugs including those in oncology. NICE has successfully addressed so called postcode prescribing variations, but has been challenged by the number and cost of new drug applications particularly in oncology. Since July 2016 the Cancer Drugs Fund has acted to provide short term access to promising drugs which have not achieved sufficient evidence to support their use although there is a reasonable prospect of this being achieved in the future. In this presentation I will describe the history and development of NICE and provide a synthesis of how it operates. The interplay between the regulators and NICE is particularly relevant, and the roles that both have adopted will be discussed. I will address the strengths and limitations of the current structure of the organisation, and consider what future changes may be appropriate. I will illustrate the talk with a range of relevant examples drawn from the literature and personal experience.
SY11
5
Current status, issue and future perspectives for biosimilars in Japan from the viewpoint of cost-effectiveness
Yoshihiro Nanbu The Japan Biosimilar Association, Nippon Kayaku CO. LTD In Japan, maintaining the universal health insurance system has become a major social issue in our rapidly aging society with soaring expense of social security contributions and skyrocketing medical costs, etc.
C The Author(s) 2019. Published by Oxford University Press on behalf of the European Society for Medical Oncology. V
All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_6/mdz329.001/5582847 by guest on 28 October 2019
Nick Freemantle Institute of Clinical Trials and Methodology, University College London, United Kingdom
Nowadays generic medicines have become standard therapeutic medicines even in the field of cancer treatment. In terms of cost-effectiveness, biosimilars are expected to enhance patients’ access to beneficial treatment and so contribute to patients’ quality of life as well as reducing the economic burden and total medical expenses while providing equivalent therapeutic outcomes inexpensively compared to the original biologics. Regarding the approval requirements of biosimilars, unlike generic products, they need a Phase III clinical trial in addition to the characterization study which proves similarity to the originals. Biosimilars have been approved through a review process of an application package which is similar to that of new drugs. However, in Japan, biosimilars have not become standard therapeutic choices yet. Approvals of biosimilars and their prevalence in the medical front have been proceeding in Europe and those products have grown in popularity as standard therapeutic choices. In European countries, the European Medicines Agency, academic societies and governmental authorities in each country have implemented a variety of measures to facilitate use of biosimilars. As part of such efforts, the EMA published a guideline on similar biological medicinal products containing G-CSF in 2006. In overseas ASCO and ESMO have already issued a position paper and statement on biosimilar products. In Japan, the Japan Society of Clinical Oncology recommends the biosimilars in its guideline for acceptable use in 2013. This presentation covers the initiatives for biosimilars in Europe and the US, the situation and the challenges in Japan as well as the activities of the Japan Biosimilar Association.