OBJECTIVES : The diabetic macular edema (DME) market in France, Germany, Italy, Spain and the UK is competitive, dynamic, and convoluted, with branded treatment choices impacted by the reimbursement environment and budgetary capabilities in each country, and not just by clinical considerations. As biosimilars loom large on the horizon, this research explored the evolving impact of payer policy on prescribing.

METHODS : Across countries, 10 payers who influence reimbursement nationally or regionally were interviewed, and 252 ophthalmologists were surveyed.

RESULTS

: Surveyed ophthalmologists’ patient share for key DME brands would increase by a maximum of 5-13 percentage points if reimbursement/access hurdles were removed. The impact is least in France and greatest in Italy—a country where regional autonomy has a strong bearing on prescribing. Of Italian respondents, 32-39% said regional guidelines/directives/reimbursement at least somewhat restrict their prescribing of dexamethasone, ranibizumab, and aflibercept, while prescribing of fluocinolone acetonide and bevacizumab is severely restricted for 33% and 47%, respectively. Of note elsewhere, approximately one-quarter of German ophthalmologists reported that >10% of their patients do not receive most labeled IVTs due to Richtgroben/similar state prescribing budgets, with 18% and 22% of respondents citing this factor as reason for not prescribing ranibizumab and fluocinolone acetonide, respectively, to >25% of their patients. Clearly impacting use of DME brands currently, payer further indicate that future policies will discourage the uptake current and emerging brands following anti-VEGF biosimilar availability, with interviewed payers across countries set on promoting uptake that surveyed ophthalmologists translated into mean maximum patient share of 35-53%.

CONCLUSIONS : Payer policy undoubtedly restricts prescribing of all DME brands across the top 5 European markets, and the expected arrival of biosimilars will further constrain brand uptake. In the cost-conscious European markets, regionally relevant budget impact modelling and well-considered pricing strategies will be essential to maximize return on investment for current and emerging brand biologics.