The early inclusion of health economics in the process of developing biopharmaceuticals and biosimilars is imperative with a view to demonstrating their relative (cost) effectiveness and informing registration, pricing and reimbursement decisions, writes Professor Steven Simoens of the Katholieke Universiteit Leuven, Belgium, in the Journal of Medical Economics in 2009.
In the article he discusses health economic challenges of research and development, registration, pricing and reimbursement of biopharmaceuticals and biosimilars. Professor Simoens identified relevant studies by searching PubMed, Centre for Reviews and Dissemination databases (Database of Abstracts of Reviews of Effects, National Health Service Economic Evaluation Database, and Health Technology Assessments Database), Cochrane Database of Systematic Reviews and EconLit up to March 2009. Additionally, the bibliography of included studies was checked for other relevant studies.
Professor Simoens found that the development process of biopharmaceuticals is risky, lengthy, complex and expensive. Registration is complicated by the inherent variation between biopharmaceuticals. Also, as biopharmaceuticals are likely to be efficacious in a subgroup of the patient population, there is a need to select the most responsive target population and to identify biomarkers. To inform pricing and reimbursement decisions, the development process needs to collect comparative data to calculate the incremental cost effectiveness and budget impact of biopharmaceuticals. There is a role for innovative mechanisms such as risk-sharing arrangements to reimburse biopharmaceuticals.
Professor Simoens stresses that –given that biosimilars are similar, but not identical to the reference biopharmaceutical– the development process needs to generate clinical trial data in order to gain marketing authorisation. Although, according to him, there is no need to repeat all trials of the reference biopharmaceutical, the need to conduct some biosimilar trials enrolling several hundreds of patients involves considerable expense and time. A US study has estimated that the costs of biosimilar trials would range from US$10–40 million. This study also reported that the required investment in manufacturing processes would amount to US$250–450 million, he writes. From a health-economic perspective, the question arises whether inherent differences between biopharmaceuticals and biosimilars produce differences in safety, effectiveness and costs: to date, this question is unresolved according to him.
Professor Simoens states there is a need for an evidence-based approach that integrates health-economic considerations into the development programmes of biopharmaceuticals and biosimilars. A health-economic approach to market access for biopharmaceuticals and biosimilars would serve to aid researchers and decision makers in pharmaceutical companies and government to identify those products in the development process that are likely to be safe, effective and cost effective, and to guide the rationale for making registration, pricing and reimbursement decisions. A health-economic approach can support the implementation of safe and (cost) effective health technologies that support further health improvements, while containing health expenditure, he concludes.
Reference:
Simoens S. Health economics of market access for biopharmaceuticals and biosimilars. J Med Econ. 2009;12(3):211-8.
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