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Market Research Report

Psoriatic Arthritis Pricing, Reimbursement, and Access

Published by Datamonitor Healthcare Product code 365153
Published Content info 177 Pages
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Psoriatic Arthritis Pricing, Reimbursement, and Access
Published: June 24, 2016 Content info: 177 Pages
Description

An absence of head-to-head trials, along with biosimilar launches, provide payers with leverage to demand favorable pricing for branded products in exchange for formulary access.

This report addresses the following questions:

  • What access controls are payers imposing on interleukins in psoriatic arthritis?
  • What discounts and market access levers will be required to drive uptake of interleukins and second-generation TNFalpha inhibitors?
  • How do US and European payers view the launch of oral small molecules in psoriatic arthritis?
  • What impact will biosimilar entry have on pricing and reimbursement of branded biologics?
Table of Contents
Product Code: DMKC0161763

TABLE OF CONTENTS

EXECUTIVE SUMMARY

MARKET CONTEXT

  • 1. Market growth due to price increases and rising prevalence will be offset by biosimilar entry
  • 2. Marketed psoriatic arthritis products in the US, Japan, and five major EU markets
  • 3. Pipeline psoriatic arthritis treatments in late-stage development
  • 4. Bibliography

GLOBAL PAYER INSIGHTS

  • 5. Insights and strategic recommendations
  • 6. Spend on psoriasis and psoriatic arthritis drugs is moderate, but may vary depending on the patient population
  • 7. Recently launched agents struggle to compete with TNF-alpha inhibitors
  • 8. Dosing frequency and route of administration act as differentiating factors for TNF-alpha inhibitors
  • 9. US and EU payers and physicians want head-to-head trials to assess efficacy directly and determine pricing
  • 10. Longer clinical trials with statistically and clinically significant results are favored by both US and EU payers
  • 11. The psoriatic arthritis pipeline suffers from a dearth of promising candidates
  • 12. Varying dosing and method of administration are important for patients, but oral formulation does not warrant a higher price
  • 13. Bibliography

US PRICING

US PAYER INSIGHTS

  • 14. Insights and strategic recommendations
  • 15. Drugs with approvals in multiple inflammatory indications are favored in payer contracting
  • 16. Psoriasis is usually approved first, but expanding to psoriatic arthritis is beneficial for pipeline and marketed drugs
  • 17. Inflectra, the first TNF-alpha biosimilar, is approved by the FDA, but launch could take years due to legal battles
  • 18. Bibliography

US REIMBURSEMENT

  • 19. Insights and strategic recommendations
  • 20. Trends in psoriatic arthritis drug expenditure
  • 21. Bibliography

JAPAN

  • 22. Price premiums are awarded for added benefit or innovation
  • 23. Pricing of launched psoriatic arthritis treatments
  • 24. Bibliography

FIVE MAJOR EU MARKETS PRICING

FIVE MAJOR EU MARKETS PAYER INSIGHTS

  • 25. Insights and strategic recommendations
  • 26. Access to biologics is mostly restricted in the five major EU markets, with a variety of tools used to curb access

BIOSIMILAR TNF-ALPHA INHIBITORS IN THE FIVE MAJOR EU MARKETS

  • 27. Insights and strategic recommendations
  • 28. Uptake of biosimilar TNF-alpha inhibitors varies across UK markets as the EMA does not determine interchangeability
  • 29. Most physicians and payers consider biosimilars to be interchangeable, and an opportunity to reduce costs, but worries around indication extrapolation remain
  • 30. Payers use biosimilars to pressure originators on pricing
  • 31. Hospitals continue to procure both biosimilars and originators; dynamic pricing environment observed
  • 32. Biosimilars will be used as price benchmarks for pipeline agents
  • 33. Payers are unlikely to implement strong incentives to drive uptake of biosimilar infliximab due to limited use of the drug
  • 34. Bibliography

FRANCE

  • 35. Insights and strategic recommendations
  • 36. ASMR rating has an impact on pricing
  • 37. Access restrictions for biologics are minimal, and are largely determined by national Transparency Committee guidelines
  • 38. Both IL-17s Cosentyx and Taltz are likely to get ASMR V from the TC
  • 39. Bibliography

GERMANY

  • 40. Insights and strategic recommendations
  • 41. Positive assessment from the G-BA will impact price negotiations
  • 42. Certain sickness funds subject TNF-alpha inhibitors to indicative budget limits, but the relevance of this restriction may change under ongoing reforms
  • 43. The G-BA follows IQWiG recommendation, and Otezla receives evaluation of no added benefit for psoriatic arthritis
  • 44. IQWiG determines Cosentyx to offer no added benefit in psoriatic arthritis
  • 45. Taltz is unlikely to get an added benefit assessment in psoriatic arthritis from the G-BA
  • 46. Bibliography

ITALY

  • 47. Insights and strategic recommendations
  • 48. Delays in AIFA decisions for newly launched biologics hamper regional and local access
  • 49. Access to psoriatic arthritis medications is controlled for specialist use, but a more restrictive barrier is limited budget allocation
  • 50. Emilia-Romagna outlines therapeutic strategy for biologics in psoriatic arthritis
  • 51. Taltz will be placed in later lines of therapy in psoriatic arthritis
  • 52. Bibliography

SPAIN

  • 53. Insights and strategic recommendations
  • 54. National reimbursement decisions are not a barrier to access
  • 55. Regional access to psoriatic arthritis drug treatments varies in Spain
  • 56. Budget limitations and formulary restrictions are quoted as access barriers, with differences between hospitals
  • 57. Risk-sharing agreements and local negotiations are used to control expenditure for biologics
  • 58. Taltz's positioning in psoriatic arthritis remains speculative
  • 59. Bibliography

UK

  • 60. Insights and strategic recommendations
  • 61. NICE approval is a key market access barrier
  • 62. Patient population restrictions and brand preference in regional formularies are the main access levers in psoriatic arthritis
  • 63. UK physicians reserve the use of biologics as a last resort for psoriatic arthritis patients
  • 64. Use of Stelara in psoriatic arthritis is reserved for after failure with TNF-alpha inhibitors
  • 65. Later biologic entrants require patient access schemes to have an acceptable ICER
  • 66. NICE does not recommend Otezla for psoriatic arthritis due to lower effectiveness than TNFalpha Inhibitors
  • 67. Biosimilars present the greatest threat to Cosentyx's chances of NICE recommendation for first-line biologic use
  • 68. Taltz is likely to receive a similar NICE recommendation to Cosentyx
  • 69. Regional formulary decisions
  • 70. SMC approves Otezla for psoriatic arthritis contrary to NICE decision due to differences in treatment sequencing
  • 71. SMC supports use of lower dose of Simponi, but higher dose is not deemed to be cost effective
  • 72. Bibliography
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