Atopic dermatitis (AD) is a chronic, pruritic inflammatory skin disease that usually affects children but can persist or start in adulthood. For many years, the treatment landscape has remained stagnant, with topical agents dominating the treatment algorithm and systemic immunosuppressants such as azathioprine and cyclosporin largely used in patients whose disease is inadequately controlled. Expected approval of Sanofi/Regeneron’s IL-4/IL-13 inhibitor dupilumab in 2018 should give moderate to severe atopic dermatitis patients a promising targeted therapy option, with AstraZeneca/Leo Pharma’s tralokinumab and Roche/Gladerma’s lebrikizumab potentially strengthening the field in 2021. However, uptake of these premium-priced agents will strongly depend on EU5 payers’ willingness to reimburse, and on country-specific prescribing controls.
Questions Answered in this Report:
- The topical agents are the mainstay of the AD market. The conventional systemics are mainly used in moderate to severe patients who respond inadequately to topicals. What are the current prescribing practices for AD in the EU5, and how, if at all, are these impacted by payer policy?
- Currently, no biologics are approved for AD; however, European AD guidelines do recommend off-label use of some biologics in severe patients if they are refractory to topicals and conventional systemics. To what extent are off-label conventional systemics such as methotrexate and off-label biologics like Novartis/Roche’s Xolair (omalizumab) used for moderate to severe AD? How do payers cover any such off-label prescribing?
- Currently available AD therapies are inexpensive and therefore payers are generally not too concerned about the cost of overall AD treatment. However, this situation will change soon with the potential entry of the first biologic in 2018. What are payer and physician perspectives on promising but costly emerging agents such as dupilumab? What key market access challenges will manufacturers of novel AD therapies face? What can they do to encourage optimal pricing and reimbursement terms, and to drive uptake?
- Markets covered: France, Germany, Italy, Spain, and United Kingdom
- Methodology: Surveys of 250 dermatologists and 10 country-specific interviews with European payers
- Indication coverage: atopic dermatitis (AD)
- Key drugs covered: prescription topical corticosteroids, topical calcineurin inhibitors, methotrexate, cyclosporin, azathioprine, mycophenolate mofetil, Toctino, dupilumab, tralokinumab, and lebrikizumab
- Key companies mentioned: Sanofi, Regeneron, AstraZeneca, Leo Pharma, Roche, and Novartis
- Atopic Dermatitis/Atopic Eczema - Access & Reimbursement - Detailed, Expanded Analysis (EU)
Author(s): Yulia Privolnev, MA; Sangha Mitra, PhD, MBA
Yulia Privolnev is a manager 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. Yulia’s specific focus is on all aspects of market access in Western and Eastern Europe, as well as external reference pricing (ERP) and managed entry agreements (MEAs) on a global scale. Yulia holds a bachelor’s degree from the University of Toronto and a master’s degree from the London School of Economics.
Sangha is a Business Insights Analyst with the immune, gastrointestinal and respiratory team at Decision Resources Group, with drug development and market access related therapeutic experience in respiratory, genitourinary, psoriasis, psoriatic arthritis, ankylosing spondylitis, and axial spondyloarthritis. In addition, she has extensive experience with biopharmaceutical industry opportunity platforms, where she has conducted therapy and company strategy analysis for companies such as GlaxoSmithKline and Allergan.
She joined DRG from a biotech start-up where her key contribution was to develop strategy and content for investor pitch deck for venture funding for a seed round of funding. During her M.B.A. at Boston University School of Management, she was involved in several strategy related consulting projects for biotech companies and non-profits in Boston area. She holds a doctoral degree in Biochemistry from Utah State University.