OBJECTIVES : As non-TNF-α biologics targeting moderate-to-severe ulcerative colitis (UC) seek to compete with entrenched TNF-α brands and their biosimilar counterparts, our research explored the reimbursement and prescribing landscape for this increasingly complex disease in cost-constrained France, Germany, Italy, Spain, and the UK.

METHODS : Across countries, 10 payers who influence reimbursement nationally or regionally were interviewed, and 251 gastroenterologists were surveyed on their prescribing patterns.

RESULTS : Interviewed payers demand unequivocal proof of added benefit, via flawless clinical trial design (including comparator selection), if optimal reimbursement terms and prime product positioning are to be attained in the crowded UC market. First-in-class CAM inhibitor vedolizumab’s unexceptional HTA results and modest uptake, primarily in TNF- α inhibitor-refractory patients, among surveyed gastroenterologists (11-17% of biologics-treated UC patients) reflect this requirement. Furthermore, one-third of surveyed physicians report that their vedolizumab prescribing is restricted to patients who have failed one or more TNF-α inhibitors, and, by year-end 2021, when classmate etrolizumab, JAK inhibitor tofacitinib, and additional TNF- α biosimilars will have launched, respondents expect to use vedolizumab even less. Conversely, payers praised etrolizumab’s strategy, which assesses potential predictive biomarkers and includes a head-to-head trial design, and launch-year-predicted biologics-treated patient share among surveyed gastroenterologists is encouraging, at 6-8%. First-in-class tofacitinib is also well-positioned; almost all survey respondents expect to prescribe within one year of availability, albeit biologics-treated patient share of 7-9% by year-end 2021 indicates later-line positioning.

CONCLUSIONS : Non-TNF-α biologics look set to secure reimbursement and somewhat rapid uptake, but largely in TNF-α refractory/non-responding UC patients. Biomarker-driven prescribing of new brands has been identified by stakeholders as a compelling strategy which would provide cost-conscious payers with value for money, especially as more TNF-α biosimilars emerge. Overall, strategic tactics will be required if emerging agents are to maximize return on investment and challenge the first-line dominance of the TNF-α inhibitors.