4. GLOBAL ACCESS LEVERS AND BARRIERS
- Insights and strategic recommendations
- Biologics comprise the majority of spend in IBD; new agents will continue to increase spend
- Payers restrict access to IBD medications
- IBD drugs are managed as part of the wider inflammatory class of drugs
- The largest unmet need in UC and CD is severe patients at later lines of therapy, where options are limited
5. ACCESS TO RECENTLY LAUNCHED AND PIPELINE PRODUCTS
- Insights and strategic recommendations
- Payers are unimpressed by Stelara’s placebo-controlled trials
- Superiority data against infliximab are unlikely to push etrolizumab to be a first-line biologic
- Oral compounds may struggle to achieve differentiation against one another due to the lack of head-to-head trials
- Otezla’s experience in dermatology could provide the best example for how oral IBD drugs will fare
- Payers are skeptical that oral therapies can bridge the gap before biologics
- Access for JAK inhibitors hinges on pricing strategy
- A better safety profile matters to physicians, but is unlikely to move the needle from an HTA or payer perspective
- Ozanimod’s approval in UC could prove problematic for approval in MS
- Some payers may elect to contract for selected oral inhibitors
10. BIOSIMILAR TNF-ALPHA INHIBITORS IN THE FIVE MAJOR EU MARKETS
- Insights and strategic recommendations
- The uptake of biosimilar TNF-alpha inhibitors varies across EU markets, as the EMA does not determine interchangeability
- Payers resort to biosimilar quotas to promote uptake
- High quotas requiring biosimilar use prompt many physicians to switch patients
- Switching costs have led to reservations among some payers, meaning switching among multiple biosimilars is unlikely
- Discounts are not the only strategy to facilitate switching among biosimilars
- Payers use tenders, physician incentives, and formulary exclusions to drive biosimilar uptake
- Payers are willing to implement more aggressive measures to promote biosimilar uptake
- Bibliography
List of Figures
Figure 1: Price sources and calculations for the US and EU, by country
List of Tables
Table 1: Marketed products and approved indications for Crohn’s disease drugs in the US, Japan, and five major EU markets
Table 2: Marketed products and approved indications for ulcerative colitis drugs in the US, Japan, and five major EU markets
Table 3: Levers impacting access to IBD drugs in the US and five major EU markets, by country
Table 4: US pricing of key marketed IBD drugs, 2017
Table 5: Top anti-inflammatory drug prescriptions filled by Medicare beneficiaries participating in Part B and D programs, 2015
Table 6: Specialty drug spend by Express Scripts commercial members (inflammatory diseases market), 2016
Table 7: CVS Caremark and Express Scripts’ formulary exclusions for IBD drugs, 2016-18
Table 8: Formulary placement of IBD medications in selected commercial formularies
Table 9: Formulary placement of IBD medications in selected Medicare formularies
Table 10: Selected formulary practices of top 10 Medicare Part D and Medicare Advantage IBD drugs
Table 11: Formulary placement of IBD medications in selected state Medicaid formularies
Table 12: Prior authorization criteria for Crohn’s disease drugs with major health insurers and pharmacy benefit managers
Table 13: Prior authorization criteria for ulcerative colitis drugs with major health insurers and pharmacy benefit managers
Table 14: Japan - pricing premiums given to medicines that can demonstrate benefit over comparators
Table 15: Pricing of key marketed Crohn’s disease and ulcerative colitis drugs in Japan, 2017
Table 16: Market access tools used to promote biosimilar TNF-alpha inhibitor uptake in the five major EU markets, by country
Table 17: Pricing of key Crohn’s disease drugs in the five major EU markets, by country, 2017
Table 18: Pricing of key ulcerative colitis drugs in the five major EU markets, by country, 2017
Table 19: Transparency Committee’s ASMR ratings and pricing implications
Table 20: Transparency Committee's SMR ratings and pricing implications
Table 21: Transparency Commission's assessment of Crohn’s disease treatments
Table 22: Transparency Commission's assessment of ulcerative colitis treatments
Table 23: G-BA assessment of key Crohn’s disease therapies
Table 24: G-BA assessment of key ulcerative colitis therapies
Table 25: Spending regulations for TNF-alpha inhibitors in the five largest physicians’ associations in Germany
Table 26: Reimbursement conditions for Crohn’s disease treatments in Italy
Table 27: Reimbursement conditions for ulcerative colitis treatments in Italy
Table 28: Italian regional formulary decisions for Crohn’s disease drugs
Table 29: Italian regional formulary decisions for ulcerative colitis drugs
Table 30: Therapeutic positioning reports for IBD drugs in Spain
Table 31: Spanish Society of Hospital Pharmacy ratings
Table 32: Regional MADRE assessments for Crohn’s disease drugs
Table 33: Regional MADRE assessments for ulcerative colitis drugs
Table 34: NICE assessments of key Crohn’s disease therapies
Table 35: NICE assessments of key ulcerative colitis therapies
Table 36: Exchange rates used for calculating drug prices
