Crohn's Disease and Ulcerative Colitis Pricing, Reimbursement, and Access - Product Image

Crohn's Disease and Ulcerative Colitis Pricing, Reimbursement, and Access

  • ID: 4533543
  • Report
  • 204 pages
  • Datamonitor Healthcare
1 of 4

FEATURED COMPANIES

  • CVS Caremark
  • Express Scripts
  • FDA
  • Stelara
  • TNF
  • MORE

Overview

Payers view spending on inflammatory bowel disease (IBD) drugs as significant, as there is a large patient base requiring expensive biologic therapies. The market has been long dominated by the TNF-alpha inhibitors Humira and Remicade, but more recent biologic launches such as Entyvio and Stelara have focused on novel mechanisms of action. Additionally, another alpha integrin, etrolizumab, is a further biologic of interest to clinicians.

The IBD pipeline is also expecting the launches of novel oral agents such as JAK inhibitors Xeljanz and filgotinib, as well as the S1P receptor antagonist ozanimod. Payers fully expect that these pipeline agents will continue to fuel the growth of the IBD market, and that the launches of TNF-alpha inhibitor biosimilars will not do much to temper growth. Consequently, payers have been restricting the prescribing of the non-TNF-alpha inhibitors to later lines of therapy - and after the TNF-alpha inhibitors whenever possible - to ensure biosimilar savings are realized. European payers are enacting national and regional restrictions: using start-and-stop criteria, delineating therapeutic lines, and requiring discounts in exchange for access to earlier lines of treatment. US payers mandate prior authorization, with most payers requiring failures with TNF-alpha inhibitors prior to accessing Entyvio or Stelara.

Note: Product cover images may vary from those shown
2 of 4

FEATURED COMPANIES

  • CVS Caremark
  • Express Scripts
  • FDA
  • Stelara
  • TNF
  • MORE

1. OVERVIEW

2. EXECUTIVE SUMMARY

3. REGULATORY LABELS

  • Marketed Crohn’s disease products in the US, Japan, and five major EU markets
  • Marketed ulcerative colitis products in the US, Japan, and five major EU markets
  • Bibliography

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

6. VALUE AND EVIDENCE

  • Insights and strategic recommendations
  • Remission-based endpoints are key for most payers
  • Key opinion leaders and payers want longer clinical trials with extension studies
  • US and EU payers and physicians want head-to-head trials to directly assess efficacy and determine pricing

7. US PRICING

8. US REIMBURSEMENT

  • Insights and strategic recommendations
  • Medicare pays $2.9bn for Humira and Remicade at an average of over $25,000 per beneficiary
  • The inflammatory conditions segment has been the most expensive specialty drug category for eight consecutive years
  • Humira is the drug with the highest spend in the specialty category for all Express Scripts’ payers
  • Rising per member per year spend for Humira is mostly due to unit cost increases
  • Commercial formularies vary in their tier positioning for IBD drugs
  • Exclusions are more common within Medicare Part D formularies than in commercial plans
  • Medicare Part D covers first-generation biologics, but with high out-of-pocket costs for members
  • State Medicaid programs are largely in consensus on their IBD preferred drug formulary lists
  • Prior authorization is the key utilization management tool used in IBD for all payers in the US
  • Drugs with approvals in multiple inflammatory indications are favored in payer contracting
  • Five TNF-alpha inhibitor biosimilars have been approved by the FDA, but only two have launched
  • Payers continue to prefer Remicade over biosimilar infliximab
  • Larger discounts are required to promote biosimilar infliximab use
  • Bibliography

9. JAPAN

  • Pricing of launched treatments for Crohn’s disease and ulcerative colitis
  • Bibliography

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

11. PRICING IN THE FIVE MAJOR EU MARKETS

12. FRANCE

  • Insights and strategic recommendations
  • ASMR rating has an impact on pricing
  • In the absence of head-to-head trials versus TNF inhibitors, later entrants largely receive no added benefit
  • Access to Stelara and Entyvio is restricted to TNF-failure patients in CD and UC respectively
  • Entyvio gets added benefit in TNF-alpha-refractory UC patients
  • Etrolizumab’s ASMR hinges on efficacy data demonstrating absolute improvement over infliximab
  • Bibliography

13. GERMANY

  • Insights and strategic recommendations
  • A positive assessment from the G-BA will impact pricing negotiations
  • Lack of head-to-head comparisons results in no added benefit for Entyvio
  • Certain sickness funds subject TNF-alpha inhibitors to indicative budget limits, but the relevance of this may change under ongoing reforms
  • New G-BA software will make added benefit assessments and prices for competing drugs more visible to prescribers
  • Etrolizumab may have mixed pricing due to an anticipated added benefit in some patient populations
  • Stelara is expected to bypass benefit assessment in CD despite approval post-AMNOG
  • Bibliography

14. ITALY

  • Insights and strategic recommendations
  • Delays in AIFA decisions for newly launched drugs hamper regional and local access
  • Limited budgets present the greatest barrier to biologics use
  • AIFA reimburses all biologics approved for CD and UC, but with access restrictions
  • UC and CD drugs reimbursed by AIFA are found in the regional formulary of Emilia-Romagna
  • Bibliography

15. SPAIN

  • Insights and strategic recommendations
  • National reimbursement decisions are usually not a barrier to access
  • IPT restricts Entyvio in UC and CD to patients who have failed TNF-alpha inhibitors
  • IPT restricts Stelara for CD to patients who have failed on or who are contraindicated to TNF-alpha inhibitors
  • Regional access to UC and CD treatments varies in Spain
  • The Catalonian therapeutics committee has outlined a pathway for CD
  • Moving towards a flat fee per patient will incentivize use of the least expensive IBD therapy
  • Bibliography

16. UK

  • Insights and strategic recommendations
  • NICE approval is a key market access barrier
  • Entyvio is restricted to the third line in CD after failure with a TNF-alpha inhibitor, and requires a patient access scheme
  • Entyvio is reimbursed in the full patient population for UC with a patient access scheme and a one-year stopping rule
  • Remicade is reimbursed for pediatric UC patients, as per its marketing authorization, despite failing the cost-effectiveness test
  • Xeljanz’s pricing will largely be dictated by its cost in RA, which will need to be comparable to Olumiant
  • Managing spend for IBD drugs will revolve around start-and-stop criteria
  • Regional formulary decisions
  • Bibliography

17. METHODOLOGY

  • Primary research
  • Price assumptions
  • Exchange rates
  • 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

Note: Product cover images may vary from those shown
3 of 4

Loading
LOADING...

4 of 4
  • Stelara
  • FDA
  • TNF
  • CVS Caremark
  • Express Scripts
Note: Product cover images may vary from those shown
5 of 4
Note: Product cover images may vary from those shown
Adroll
adroll