薬事承認取得だけでは、もはや医薬品や治療法の商業的成功は決まらないし、市場投入を保証するものでもありません。今日、各製品は、医療従事者が処方できるようになる前に、支払者や医療当局によって価値の観点から評価され、処方箋に掲載され、償還率に組み込まれ、治療計画に組み込まれなければならなりません。
Approval processes are also adapting to meet the high unmet needs of patients with rare diseases where treatment options are limited or non-existent. A disease is considered to be rare when it affects fewer than 1 in 2,000 people. Although each rare disease does not affect a large number of patients, there are estimated to be over 7,000 rare diseases.
The options for fast-track and conditional approvals for products to treat rare diseases are rapidly evolving to get medicines to patients quicker. These options include using a combination of real-world evidence (R2WE) and innovative contracting techniques to give payers confidence to reimburse a novel product. RWE is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD). Real-World Data are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources including electronic health records (EHRs); medical claims and billing data; data from product and disease registries; patient-generated data, including from in-home-use settings; and data gathered from other sources that can inform on health status such as mobile devices.
By watching this webinar, you will learn what works and what doesn’t in our rapidly changing regulatory and reimbursement world. Oliver Leatham, Vice President, Global Value & Access at Certara, discussed the following:
- Case studies of approved drugs with limited market access – What went wrong?
- Analogues of products that have successfully navigated the reimbursement landscape using innovative contracting
- How RWE can support payer confidence and market access to sustain premium pricing and drive market share
- How sponsors are approaching the changing regulatory and reimbursement environment to stay ahead of the competition
About Our Speaker
Oliver is a Market Access strategist at Analytica Laser, Certara’s Evidence and Access Group. Oliver holds a BA Hons and has over 17 years’ experience in his field. Formerly Global Head of Pricing & Market Access at PAREXEL, Oliver integrated specialist Teams across a number of functions including Real World Evidence, Late Stage Research, Regulatory, Epidemiology and Commercialization. Prior to this, Oliver was Head of Market Access at Astellas with a Team of 33, made up of data analysts, HTA experts and field market access representatives, who negotiated daily with Payers at National, Regional and Local Levels. Oliver has sat on the AWMSG (Wales HTA), written for Harvard Business Review and Chaired multiple EU Market Access Symposia. Oliver specializes in innovative contracting and has been involved in some of the earliest and most successful conditional reimbursement negotiations in Europe to date.
