Ulcerative Colitis Market and Forecast Analysis

CONTENTS

11 FORECAST: ULCERATIVE COLITIS (Published on 05 September 2017)
11 OVERVIEW
12 EXECUTIVE SUMMARY
13 MARKET OVERVIEW AND TRENDS
22 MARKET DEFINITION AND METHODOLOGY
31 ENTYVIO (VEDOLIZUMAB)
38 ETROLIZUMAB
43 FILGOTINIB
46 HUMIRA (ADALIMUMAB)
51 LT-02 (PHOSPHATIDYLCHOLINE)
52 OZANIMOD
57 REMICADE (INFLIXIMAB)
63 SIMPONI (GOLIMUMAB)
68 STELARA (USTEKIMUMAB)
72 XELJANZ (TOFACITINIB)
77 PRIMARY RESEARCH METHODOLOGY

81 TREATMENT: ULCERATIVE COLITIS (Published on 05 September 2017)
81 OVERVIEW
82 EXECUTIVE SUMMARY
84 PRIMARY RESEARCH METHODOLOGY
86 PATIENT SEGMENTATION
88 CURRENT TREATMENT OPTIONS
100 PRESCRIBING TRENDS
110 COMPLIANCE
114 UNMET NEEDS IN ULCERATIVE COLITIS
120 PRESCRIBING INFLUENCES
124 IMPACT OF BIOSIMILARS

131 EPIDEMIOLOGY: ULCERATIVE COLITIS (Published on 16 May 2018)
131 OVERVIEW
132 DISEASE BACKGROUND
135 METHODOLOGY
Disease Coverage | Ulcerative colitis 4
145 FORECAST
150 BIBLIOGRAPHY
153 APPENDIX: ADDITIONAL SOURCES

154 MARKETED DRUGS: ULCERATIVE COLITIS (Published on 05 September 2017)
154 OVERVIEW
155 EXECUTIVE SUMMARY
156 PRODUCT OVERVIEW
157 MESALAMINES
161 CORTICOSTEROIDS
166 PRODUCT PROFILE: ENTYVIO
181 PRODUCT PROFILE: HUMIRA
194 PRODUCT PROFILE: REMICADE
209 PRODUCT PROFILE: SIMPONI

219 CROHN’S DISEASE AND ULCERATIVE COLITIS PRICING AND REIMBURSEMENT (Published on 16 March 2018)
219 OVERVIEW
220 EXECUTIVE SUMMARY
221 REGULATORY LABELS
230 GLOBAL ACCESS LEVERS AND BARRIERS
240 ACCESS TO RECENTLY LAUNCHED AND PIPELINE PRODUCTS
263 VALUE AND EVIDENCE
268 US PRICING
269 US REIMBURSEMENT
301 JAPAN
303 BIOSIMILAR TNF-ALPHA INHIBITORS IN THE FIVE MAJOR EU MARKETS
314 PRICING IN THE FIVE MAJOR EU MARKETS
316 FRANCE
358 GERMANY
370 ITALY
381 SPAIN
391 UK
412 METHODOLOGY

414 PIPELINE: ULCERATIVE COLITIS (Published on 05 September 2017)
414 OVERVIEW
415 EXECUTIVE SUMMARY
416 CLINICAL PIPELINE OVERVIEW
417 COMPARATOR THERAPY
425 PRODUCT PROFILE (LATE STAGE): LT-02
429 PRODUCT PROFILE (LATE STAGE): STELARA
436 PRODUCT PROFILE (LATE STAGE): XELJANZ
448 PRODUCT PROFILE (LATE STAGE): ETROLIZUMAB
461 PRODUCT PROFILE (LATE STAGE): FILGOTINIB
468 PRODUCT PROFILE (LATE STAGE): OZANIMOD

LIST OF FIGURES
14 Figure 1: Ulcerative colitis sales across the US, Japan, and five major EU markets, by country, 2016–25
15 Figure 2: Ulcerative colitis sales across the US, Japan, and five major EU markets, by class, 2016–25
16 Figure 3: Sales of Humira, Remicade, and their biosimilar versions in the US, Japan, and five major EU markets, 2016–25
18 Figure 4: Sales of key marketed drugs in ulcerative colitis across the US, Japan, and five major EU markets, 2016–25
20 Figure 5: Forecast sales of late-phase therapies in ulcerative colitis across the US, Japan, and five major EU markets, 2016–25
25 Figure 6: Datamonitor Healthcare’s ulcerative colitis forecast methodology
28 Figure 7: Price sources and calculations, by country
34 Figure 8: Entyvio sales forecast for ulcerative colitis in the US, Japan, and five major EU markets, by country, 2016–25
40 Figure 9: Etrolizumab sales forecast for ulcerative colitis in the US, Japan, and five major EU markets, by country, 2016–25
44 Figure 10: Filgotinib sales forecast for ulcerative colitis in the US, Japan, and five major EU markets, by country, 2016–25
48 Figure 11: Humira sales forecast for ulcerative colitis in the US, Japan, and five major EU markets, by country, 2016–25
54 Figure 12: Ozanimod sales forecast for ulcerative colitis in the US, Japan, and five major EU markets, by country, 2016–25
60 Figure 13: Remicade sales forecast for ulcerative colitis in the US, Japan, and five major EU markets, by country, 2016–25
65 Figure 14: Simponi sales forecast for ulcerative colitis in the US, Japan, and five major EU markets, by country, 2016–25
70 Figure 15: Stelara sales forecast for ulcerative colitis in the US, Japan, and five major EU markets, by country, 2016–25
74 Figure 16: Xeljanz sales forecast for ulcerative colitis in the US, Japan, and five major EU markets, by country, 2016–25
87 Figure 17: Severity of diagnosed ulcerative colitis patients, by country
100 Figure 18: Mean percentage of ulcerative colitis patients receiving pharmacological therapy versus non-pharmacological therapy, by country
102 Figure 19: Mean percentage of drug-treated ulcerative colitis patients in the US, Japan, and five major EU markets treated with monotherapy versus combination therapy, by line of therapy
104 Figure 20: Mean percentage of drug-treated ulcerative colitis patients across the US, Japan, and five major EU markets receiving each drug class, by line of therapy
105 Figure 21: Mean percentage of drug-treated ulcerative colitis patients receiving anti-TNF therapy, by country and line of therapy
107 Figure 22: Mean percentage use of biologic therapies for the treatment of ulcerative colitis patients, by line of therapy
111 Figure 23: Mean compliance rates for drug-treated ulcerative colitis patients, by formulation type
117 Figure 24: Top treatment challenges in ulcerative colitis
128 Figure 25: Summary of future usage of biosimilars at one year and three years post-launch
129 Figure 26: Physician confidence in prescribing biosimilars for ulcerative colitis approved on the basis of indication extrapolation, by country
149 Figure 27: Trends in diagnosed prevalent cases of ulcerative colitis in the US, Japan, and five major EU markets, by country, 2017–37
158 Figure 28: Mesalamines for ulcerative colitis – SWOT analysis
163 Figure 29: Corticosteroids for ulcerative colitis – SWOT analysis
174 Figure 30: Entyvio for ulcerative colitis – SWOT analysis
175 Figure 31: Datamonitor Healthcare’s drug assessment summary of Entyvio for ulcerative colitis
176 Figure 32: Datamonitor Healthcare’s drug assessment summary of Entyvio for ulcerative colitis
188 Figure 33: Humira for ulcerative colitis – SWOT analysis
189 Figure 34: Datamonitor Healthcare’s drug assessment summary of Humira for ulcerative colitis
190 Figure 35: Datamonitor Healthcare’s drug assessment summary of Humira for ulcerative colitis
202 Figure 36: Remicade for ulcerative colitis – SWOT analysis
203 Figure 37: Datamonitor Healthcare’s drug assessment summary of Remicade for ulcerative colitis
204 Figure 38: Datamonitor Healthcare’s drug assessment summary of Remicade for ulcerative colitis
205 Figure 39: Mean percentage of patients receiving branded biologics in the US, Japan, and five major EU markets, by lines of therapy
214 Figure 40: Simponi for ulcerative colitis – SWOT analysis
215 Figure 41: Datamonitor Healthcare’s drug assessment summary of Simponi for ulcerative colitis
216 Figure 42: Datamonitor Healthcare’s drug assessment summary of Simponi for ulcerative colitis
412 Figure 43: Price sources and calculations for the US and EU, by country
432 Figure 44: Stelara for ulcerative colitis – SWOT analysis
433 Figure 45: Datamonitor Healthcare’s drug assessment summary of Stelara for ulcerative colitis
434 Figure 46: Datamonitor Healthcare’s drug assessment summary of Stelara for ulcerative colitis
442 Figure 47: Xeljanz for ulcerative colitis – SWOT analysis
443 Figure 48: Datamonitor Healthcare’s drug assessment summary of Xeljanz for ulcerative colitis
444 Figure 49: Datamonitor Healthcare’s drug assessment summary of Xeljanz for ulcerative colitis
456 Figure 50: Etrolizumab for ulcerative colitis – SWOT analysis
457 Figure 51: Datamonitor Healthcare’s drug assessment summary of etrolizumab for ulcerative colitis
458 Figure 52: Datamonitor Healthcare’s drug assessment summary of etrolizumab for ulcerative colitis
464 Figure 53: Filgotinib for ulcerative colitis – SWOT analysis
465 Figure 54: Datamonitor Healthcare’s drug assessment summary of filgotinib for ulcerative colitis
466 Figure 55: Datamonitor Healthcare’s drug assessment summary of filgotinib for ulcerative colitis
471 Figure 56: Ozanimod for ulcerative colitis – SWOT analysis
472 Figure 57: Datamonitor Healthcare’s drug assessment summary of ozanimod for ulcerative colitis
473 Figure 58: Datamonitor Healthcare’s drug assessment summary of ozanimod for ulcerative colitis

LIST OF TABLES
23 Table 1: Summary of drug classes and brands included in Datamonitor Healthcare’s ulcerative colitis patient-based forecast
29 Table 2: Exchange rates used for calculating prices
33 Table 3: Datamonitor Healthcare’s pricing assumptions for Entyvio, by country
35 Table 4: Entyvio sales for ulcerative colitis across the US, Japan, and five major EU markets, by country ($m), 2016–25
41 Table 5: Etrolizumab sales for ulcerative colitis across the US, Japan, and five major EU markets, by country ($m), 2016–25
45 Table 6: Filgotinib sales for ulcerative colitis across the US, Japan, and five major EU markets, by country ($m), 2016–25
48 Table 7: Datamonitor Healthcare’s pricing assumptions for Humira, by country
49 Table 8: Humira sales for ulcerative colitis across the US, Japan, and five major EU markets, by country ($m), 2016–25
55 Table 9: Ozanimod sales for ulcerative colitis across the US, Japan, and five major EU markets, by country ($m), 2016–25
59 Table 10: Datamonitor Healthcare’s pricing assumptions for Remicade, by country
61 Table 11: Remicade sales for ulcerative colitis across the US, Japan, and five major EU markets, by country ($m), 2016–25
64 Table 12: Datamonitor Healthcare’s pricing assumptions for Simponi, by country
66 Table 13: Simponi sales for ulcerative colitis across the US, Japan, and five major EU markets, by country ($m), 2016–25
69 Table 14: Datamonitor Healthcare’s pricing assumptions for Stelara, by country
71 Table 15: Stelara sales for ulcerative colitis across the US, Japan, and five major EU markets, by country ($m), 2016–25
73 Table 16: Datamonitor Healthcare’s pricing assumptions for Xeljanz, by country
75 Table 17: Xeljanz sales for ulcerative colitis across the US, Japan, and five major EU markets, by country ($m), 2016–25
78 Table 18: Gastroenterologists surveyed for the ulcerative colitis primary research study, 2016
84 Table 19: Gastroenterologists surveyed for the ulcerative colitis primary research study, 2016
89 Table 20: Treatment guidelines: initial treatment of active ulcerative colitis, by severity
94 Table 21: Treatment guidelines: maintenance of medically induced remission of ulcerative colitis and other therapy recommendations
98 Table 22: Summary of key classes and products included in Datamonitor Healthcare’s ulcerative colitis survey
101 Table 23: Ulcerative colitis patients receiving pharmacological therapy versus non-pharmacological therapy, by country (%)
103 Table 24: Mean percentage of drug-treated ulcerative colitis patients receiving monotherapy versus combination therapy, by line of therapy and country
106 Table 25: Mean percentage of drug-treated ulcerative colitis patients receiving anti-TNF therapy, by country and line of therapy
112 Table 26: Compliance rates for ulcerative colitis patients, by formulation type and country (%)
115 Table 27: Relative importance of treatment challenges in ulcerative colitis, by country
121 Table 28: Relative importance of factors that influence gastroenterologists’ prescription of biologics and aminosalicylates in ulcerative colitis, by country
125 Table 29: Initial usage of biosimilar infliximab, according to respondents using biosimilar infliximab at the time of the survey, by country (%)
126 Table 30: Expected usage of biosimilar infliximab, according to respondents who did not prescribe biosimilar infliximab at the time of the survey, by country (%)
133 Table 31: Inflammatory bowel disease risk factors
136 Table 32: Sources used for ulcerative colitis analysis in the US, Japan, and five major EU markets
142 Table 33: Ulcerative colitis data processing methods in the US, Japan, and five major EU markets, by country
146 Table 34: Diagnosed prevalent cases of ulcerative colitis in the US, Japan, and five major EU markets, 2017–37
156 Table 35: Key marketed drugs for ulcerative colitis
157 Table 36: Branded mesalamines class overview
162 Table 37: Branded corticosteroids overview
167 Table 38: Entyvio drug profile
169 Table 39: Entyvio pivotal trial data in ulcerative colitis
171 Table 40: Entyvio ongoing late-phase trials in ulcerative colitis
182 Table 41: Humira drug profile
184 Table 42: Humira pivotal trial data in ulcerative colitis
187 Table 43: Humira ongoing late-phase trials in ulcerative colitis
195 Table 44: Remicade drug profile
197 Table 45: Remicade pivotal trial data in ulcerative colitis
201 Table 46: Remicade late-phase trial data in ulcerative colitis
210 Table 47: Simponi drug profile
212 Table 48: Simponi pivotal trial data in ulcerative colitis
222 Table 49: Marketed products and approved indications for Crohn’s disease drugs in the US, Japan, and five major EU markets
226 Table 50: Marketed products and approved indications for ulcerative colitis drugs in the US, Japan, and five major EU markets
235 Table 51: Levers impacting access to IBD drugs in the US and five major EU markets, by country
268 Table 52: US pricing of key marketed IBD drugs, 2017
270 Table 53: Top anti-inflammatory drug prescriptions filled by Medicare beneficiaries participating in Part B and D programs, 2015
271 Table 54: Specialty drug spend by Express Scripts commercial members (inflammatory diseases market), 2016
272 Table 55: CVS Caremark and Express Scripts’ formulary exclusions for IBD drugs, 2016–18
274 Table 56: Formulary placement of IBD medications in selected commercial formularies
279 Table 57: Formulary placement of IBD medications in selected Medicare formularies
283 Table 58: Selected formulary practices of top 10 Medicare Part D and Medicare Advantage IBD drugs
284 Table 59: Formulary placement of IBD medications in selected state Medicaid formularies
286 Table 60: Prior authorization criteria for Crohn’s disease drugs with major health insurers and pharmacy benefit managers
289 Table 61: Prior authorization criteria for ulcerative colitis drugs with major health insurers and pharmacy benefit managers
301 Table 62: Japan – pricing premiums given to medicines that can demonstrate benefit over comparators
302 Table 63: Pricing of key marketed Crohn’s disease and ulcerative colitis drugs in Japan, 2017
311 Table 64: Market access tools used to promote biosimilar TNF-alpha inhibitor uptake in the five major EU markets, by country
314 Table 65: Pricing of key Crohn’s disease drugs in the five major EU markets, by country, 2017
315 Table 66: Pricing of key ulcerative colitis drugs in the five major EU markets, by country, 2017
317 Table 67: Transparency Committee’s ASMR ratings and pricing implications
317 Table 68: Transparency Committee’s SMR ratings and pricing implications
318 Table 69: Transparency Commission’s assessment of Crohn’s disease treatments
335 Table 70: Transparency Commission’s assessment of ulcerative colitis treatments
360 Table 71: G-BA assessment of key Crohn’s disease therapies
362 Table 72: G-BA assessment of key ulcerative colitis therapies
366 Table 73: Spending regulations for TNF-alpha inhibitors in the five largest physicians’ associations in Germany
372 Table 74: Reimbursement conditions for Crohn’s disease treatments in Italy
375 Table 75: Reimbursement conditions for ulcerative colitis treatments in Italy
378 Table 76: Italian regional formulary decisions for Crohn’s disease drugs
378 Table 77: Italian regional formulary decisions for ulcerative colitis drugs
382 Table 78: Therapeutic positioning reports for IBD drugs in Spain
386 Table 79: Spanish Society of Hospital Pharmacy ratings
387 Table 80: Regional MADRE assessments for Crohn’s disease drugs
389 Table 81: Regional MADRE assessments for ulcerative colitis drugs
393 Table 82: NICE assessments of key Crohn’s disease therapies
401 Table 83: NICE assessments of key ulcerative colitis therapies
413 Table 84: Exchange rates used for calculating drug prices
416 Table 85: Phase III pipeline candidates under development for ulcerative colitis
418 Table 86: Remicade drug profile
420 Table 87: Remicade pivotal trial data in ulcerative colitis
426 Table 88: LT-02 drug profile
428 Table 89: Ongoing pivotal trials of LT-02 in ulcerative colitis
430 Table 90: Stelara drug profile
431 Table 91: Stelara Phase III trials in ulcerative colitis
437 Table 92: Xeljanz drug profile
439 Table 93: Xeljanz Phase III data in ulcerative colitis
441 Table 94: Xeljanz late-phase trials in ulcerative colitis
449 Table 95: Etrolizumab drug profile
451 Table 96: Etrolizumab Phase III trials in ulcerative colitis
455 Table 97: Etrolizumab ongoing Phase III trials in ulcerative colitis
462 Table 98: Filgotinib drug profile
463 Table 99: Filgotinib Phase III trials in ulcerative colitis
469 Table 100: Ozanimod drug profile
470 Table 101: Ozanimod Phase III trials in ulcerative colitis