With the recent patent expiry of Humira® (adalimumab) in Europe, NHS England last week published a press release reiterating their goal of realizing £300 million in annual savings through the adoption of best value biologic medicines (originator or biosimilar) by 2021. With more than 46,000 patients in the UK and an annual cost of greater than £400 million, Humira represents the largest spend on a single drug by the NHS and a significant opportunity to realize savings supposedly in the region of £150 million a year.
As first laid out in the ‘Commissioning Framework for Biological Medicines’ in 2017, NHS England are targeting the adoption of best value biologics in 90% of new patients within three months and 80% of existing patients within 12 months of a biosimilar launch. The performance of Clinical Commissioning Groups (CCGs) and Trusts will be monitored against these targets with those failing to meet them falling under review of the national healthcare authority. However, in practice these targets are highly realistic and recent biosimilar experience with infliximab and rituximab shows that CCGs and Trusts are mostly trending towards such adoption rates.
To ensure best value biologics are widely available, biosimilars are procured centrally by the Commercial Medicines Unit (CMU). This is done via a tendering process where products are grouped according to their potential for therapeutic substitution and awarded specific lots according to the offers received and their relative prices. Such a process is currently underway for adalimumab biosimilars and is expected to be completed in November ready for a 1st December launch. Thus far, four biosimilars in addition to Humira® are expected to form the initial tender: Amgevita® (Amgen), Hyrimoz® (Sandoz), Imraldi® (Samsung Biogen) and Hulio® (Mylan/Fujifilm Kyowa Kirin).
While these products are already approved for use within the UK, a relatively new group of highly influential stakeholders within the NHS England framework, the Regional Medicines Optimisation Committees (RMOC), are advising commissioners not to purchase adalimumab biosimilars before the tendering process is complete, regardless of available discounts, primarily to avoid unnecessary switching of patients.
Adalimumab is now the fifth major class of biosimilar to launch in Europe, and while uptake of these types of medicines was initially slow, recent trends in the UK and other major EU markets serve as evidence that the adoption rate is accelerating. Consequently, manufacturers of products which are either directly (products in the same class) or indirectly (other products within a treatment paradigm) affected by biosimilar launch are continuously striving to identify and implement new lifecycle strategies to minimize the financial impact of such events.
MKO Global Partners (MKO), a Two Labs Company, is a strategic global life sciences consulting firm focused on payer strategy and market access across the drug development and commercial lifecycle. We have direct experience and expertise in helping pharmaceutical and biotech companies prepare for competitor launches and mitigate risk through implementation of strategic solutions.
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