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Rheumatoid Arthritis: Payer Insight 2016

Product Code:
Publication Date:
November 2016

Latest Update

This edition presents payer views on recent developments in the rheumatoid arthritis (RA) market. Topics include; recent biosimilar launches in the US such as Pfizer’s Inflectra (infliximab-dyyb) and how this has impacted payer decisions and formulary management of other branded products for RA so far; the publication of pivotal biosimilar switching study results (NOR-SWITCH), and payer opinions on the US FDA’s guidelines on biosimilar interchangeability; the regulatory approval of Eli Lilly’s JAK1/2 inhibitor Olumiant (baricitinib) in the EU, and how payers view this new drug class.

*Latest* Update 1: February 2017
Original Publication: Nov 2016
*Purchase of this report includes all updates*

Latest Update

  • What do US payers think about the recent launch of Pfizer’s Inflectra (biosimilar infliximab)?
  • Is the net price differential between Remicade and Inflectra sufficient to facilitate switching?
  • Have any formulary changes been incorporated to accommodate the launch of Inflectra?
  • What strategies could Johnson & Johnson (J&J) employ to protect originator brand Remicade?
  • How much adoption do payers envisage for Inflectra and other biosimilars in RA?
  • What are payer opinions on large biosimilar switching studies in RA, such as the recently completed NOR-SWITCH trial in Norway?
  • How do payers view the FDA’s guidelines on biosimilar interchangeability?
  • With Eli Lilly’s JAK1/2 inhibitor Olumiant (baricitinib) obtaining regulatory approval in the EU, what do the payers think about this new drug class and its place in the treatment paradigm?

Original Publication: Price war imminent as anti-TNF biosimilars finally hit the US. Get the payer perspective

Price war imminent as anti-TNF biosimilars finally hit the US. Get the payer perspective 

Manufacturers are gearing up for a price war as biosimilar rheumatoid arthritis (RA) therapies finally hit the US, and continue to gain approval in the EU. Can payers leverage competition between originators and biosimilar manufacturers to maximize cost savings?

Find out in Payer Insight: Rheumatoid Arthritis.

We interviewed 12 US and EU payers with expertise in formulary management and drug reimbursement to get the short- to medium-term outlook for the RA market.

You’ll learn how payers are making key reimbursement and market access decisions, what biosimilar manufacturers need to do to win over stakeholders, how originators are defending their market share, and whether pipeline therapies have any hope of breaking into this fiercely competitive space.

Plus payers’ candid advice for manufacturers, and a list of key clinical trials to watch.

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See the Top Takeaways >

 “The main event will be how biosimilars will be used and it is clearly the important question mark about this market. If there are new drugs that are innovative it will change the landscape but we will see. Generally speaking, I don’t think there is major change aside from biosimilars coming.”
 Health Economics Expert, previous member of HAS, France 

Top Takeaways:

  • Biosimilars will define the RA market: Already in use in Europe, and now poised to launch in the US, anti-TNF biosimilars represent the best chance for substantial—and much needed—cost savings. Even the market leaders, Humira and Enbrel, will face threats, payers say.
  • US payers in wait-and-see mode: They say they won’t make any key decisions about changes to formularies until biosimilars actually launch in the US. What lessons can they draw from Europe’s experience with biosimilars?
  • It’s all about price: Payers stress that cost is the key driver of biosimilar adoption. But what influence will extrapolation of indications, patient switching, pharmacy-level substitution and real-world evidence factor have?
  • Whatever works: Payers expect serious discounts, but do they care where those come from? How do they view discounts from biosimilar manufacturers compared to rebates from originators? What kind of discounts do they expect?
  • Incumbency has its perks: Aggressive rebates aren’t the only tool originators can use to fend off biosimilars. Approval across a wide variety of indications may help protect their position on formularies. How will this affect payers’ decision making?
  • Education is critical: Widespread uptake of biosimilars hinges on educating patients, payers, and rheumatologists, but whose job is it exactly? How do payers view the role of regulators, manufacturers, and patient advocacy groups?
  • A tough market for new entrants: Launching in the middle of a price war, novel therapies must show clear clinical superiority, and be priced aggressively if they hope to succeed. Why are some payers saying that widespread biosimilar adoption could help these therapies secure a foothold in the treatment algorithm?

Expert insight into the issues facing payers

  • Complex PR and MA decisions ahead: Pricing, reimbursement, and market access decisions for biosimilars loom large in the near term. What factors are shaping payers’ thinking?
  • Healthcare reforms: How have the US’ “Obamacare,” Germany’s AMNOG law, France’s formal health assessments, and other reforms affected pricing and market access in RA?
  • Patient switching: Biosimilars will be used in treatment-naïve patients first, but established patients represent the bulk of potential savings in RA. Do payers expect they’ll be switched as well?
  • New contracting opportunities: Payers see potential for outcomes-based risk-sharing contracts, but they’re not without reservations. What concerns them most?

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A payers’ eye view of the rheumatoid arthritis treatment landscape

  • Drugs Summary: Get a breakdown of approved RA drugs, as well as payers’ thoughts about new interleukin-6 (IL-6) monoclonal antibodies, JAK inhibitors, and other oral DMARDs in the pipeline.
  • Coverage and access recap: Learn how coverage and access decisions are made in the US and several EU countries, and get an in-depth look at seven key factors influencing reimbursement.
  • Clinical trials to watch: A comprehensive list of important upcoming trials for approved and pipeline products gives you a window into how the treatment landscape may evolve.
  • Advice for pharma: Payers warn manufacturers to expect fierce competition and discuss key success factors for new and existing therapies.

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Sample of KOLS interviewed for this report

We interviewed 6 US payers and 6 from the EU. All interviewees have expertise in formulary development and drug reimbursement. All respondents requested that their details remain confidential.

US Payers

  • Medical Director, Medical Policy, Managed Care Organisation, US
  • 2 Pharmacy Directors, Pharmacy Benefit Management, US
  • Senior Director, Pharmacy Drug Policy and Formulary Management, US
  • Medical Director, National Health Plan, US
  • Head of Manufacturer Relations/RX Director, National Health Plan, US

EU Payers

  • Senior G-BA Member and Advisor, Germany
  • NICE Managing Director, Medicines and Prescribing Associate, UK
  • Health Economics Expert, previous member of HAS, France
  • Pharmacy Director and P&R Expert, Germany
  • Health Economics Expert, Healthcare Committee and HTA Advisor, UK
  • Health Economics Expert, Advisor to National P&R Committees, France

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