Decision Resources Group, a provider of best-in-class, high-value data, analytics and insights products and services to the healthcare industry, recently conducted a survey of rheumatologists across EU5 (France, Germany, Italy, Spain, and the United Kingdom) and learned that over 30% of patients with rheumatoid arthritis who are just about to begin treatment are likely to receive the biosimilar version of a drug within its first year of availability. According to interviewed payers, concerned agencies will most likely be urged to take steps to recommend or require use of biosimilars, particularly in treatment-naive patients.
This mandated switch from branded medication to their biosimilar versions, however, is not expected until rheumatologists and payers gather more clinical experience dealing with biosimilars and their long-term efficacy and safety profiles. Surveyed payers expect upcoming RA medications to face a challenging market, especially with the recent launch of biosimilar infliximab, and soon-to-be-released biosimilar counterparts of etanercept, rituximab, and adalimumab in the coming years.
The following are notable findings from the EU5 Physician & Payer Forum report entitled “EU5 Market Access Opportunities and Challenges in Rheumatoid Arthritis”:
- Interviewed payers emphasize that emerging therapies must demonstrate superiority over the standard of care TNF-alpha inhibitors in head-to-head trials for optimal pricing and reimbursement negotiations. Without this data, emerging therapies will likely be priced at the same level, or lower, than the marketed agents including biosimilars.
- Given the availability of the lower-cost biosimilars, interviewed payers report that negotiating discounts, rebate contracts, and risk-sharing schemes will be key market access levers for the uptake of new agents in the crowded RA market.
- The majority of surveyed rheumatologists indicate that they would urge local or regional payers to reimburse an oral Jak kinase inhibitor, a novel drug class in RA. However, they also anticipate that Xeljanz, an emerging Jak inhibitor, will only achieve moderate uptake by year-end 2018 and most likely be prescribed in the later lines of therapy.
“Given the increasingly constrained reimbursement environment across the EU5 and in the absence of superiority data to an active comparator, it may be difficult for Xeljanz to gain access to a broad patient population if prices are on par with Humira. Payers believe Xeljanz will need to be priced at a discount to marketed biologics for use in the earlier lines of treatment”, commented Decision Resources Group Analyst Ronnie Yoo, Ph.D. “Payers note the challenges emerging agents face with the large number of effective RA agents with established safety profiles. Biosimilar availability will further heighten the bar for cost-effectiveness, which is a key to EU5 reimbursement and market access”, he added.