Thesystemic lupus erythematosus (SLE)therapy market in the five major pharmaceutical markets in Europe (EU5) is mostly served by off-label therapies.Benlysta is the only drug approved for SLE in more than 50 years, but uptake of Benlysta IV has been tempered by its high price in a largely generic market, physician perceptions of its modest efficacy, a slow onset to action, and an inability to be used in patients with severe, life-threatening organ involvement. Benlysta SC, which offers a more-convenient mode of administration,recently began to launch across the EU5, and several novel therapies are in late-stage development for SLE, including anifrolumab, atacicept, and voclosporin. In addition, both Orencia and Benlysta are being studied in lupus nephritis (LN). As these emerging agents become available, EU5 payers and prescribers must carefully balance clinical efficacy with cost-effectiveness, and drug marketers must be well equipped to navigate a complex road to reimbursement.
- How do reimbursement terms for Benlysta IV and Benlysta SC vary across the EU5? How do payers regulate use of these premium-priced agents?
- How do prescribing patterns for key SLE therapies differ between and within EU5 countries, and to what extent does payer policy impact uptake?
- What restrictions are imposed on SLE therapies, and how, if at all, do these restrictions influence physician prescribing practices?
- What key market access challenges do emerging SLE agents face? What lessons have been learned, and what market access levers can drug developers use to optimize the positioning of their products?
Access & Reimbursement provides in-depth insight regarding the impact of payer policy on physician prescribing behavior so that clients can build their market access strategy and optimize their brand positioning.
- Markets covered: France, Germany, Italy, Spain, United Kingdom.
- Methodology: Survey of 253 rheumatologists and country-specific interviews with 10 payers.
- Indication: SLE, including LN.
- Key drugs covered: Benlysta, MabThera, Orencia, hydroxychloroquine, CellCept, Myfortic, anifrolumab, atacicept, voclosporin
- Actionable recommendations to optimize market access.
- Market access successes and stumbles.
- Market access roadblocks.
- Reimbursement dynamics.
- The impact of pricing and reimbursement, policy, and coverage on prescribing.
- Market access outlook for emerging therapies.
- Key stakeholders influencing reimbursement decisions.
- Systemic Lupus Erythematosus - Access & Reimbursement - Detailed, Expanded Analysis: Systemic Lupus Erythematosus (including Lupus Nephritis): EU5
- EU5 Access & Reimbursement Systemic Lupus Erythematosus
Author(s): Anna Reyes, MSc; Mohit Nasa, MBA
Anna Reyes is an analyst on the Global Market Access Insights team at Decision Resources Group, primarily focusing on European market access. She is responsible for monitoring, analyzing, and reporting on global market access through the production of DRG’s Global Market Access Solution (GMAS) and Access & Reimbursement products. Anna’s specific focus is on all aspects of market access in the EU5, as well as in select LatAm countries. Anna holds a bachelor’s degree from the University Rovira i Virgili and a master’s degree in bioengineering from IQS Barcelona.
Mohit Nasa is a Lead Insights analyst on the Immune and Inflammatory team at Decision Resources Group and has authored content for indications like asthma and rheumatoid arthritis.
He holds a Bachelor’s degree in Pharmacy and has earned his MBA in marketing and CRM from Amity Business School. Prior to joining DRG, Mohit worked as a Senior Business analyst at Novartis where he was responsible for end to end market assessment, reporting analytics and related projects for Novartis’s asthma brand Xolair. Mohit has also worked as Brand Manager at Ozone pharma and an Account Manager for IMS Health.