Formulary Advantages in Immune Biologics: Brand Maneuvering in a Market Increasingly Constrained by Limited Payer Reimbursement

Immune diseases such as rheumatoid arthritis, psoriasis, inflammatory bowel disease, psoriatic arthritis and ankylosing spondylitis produce a substantial amount of human suffering and disability. Biologic therapies used for the treatment of these conditions (i.e., immune biologics) represent a significant stride in the development of therapies aimed at inhibiting disease progression and limiting disability. However, the costs of these agents constrain their widespread use compared with conventional small molecule therapies. Using tiering and restrictions data from Fingertip Formulary, as well as insight from 50 pharmacy directors, this report determines the key trends in reimbursement of immune biologics, drivers of these trends, and how stakeholders can capitalize on future shifts in coverage to steal share from the competition.

Questions Answered in This Report:

  • While HealthLeaders-InterStudy and Decision Resources forecasts continued market growth for immune biologics, payers’ reluctance to reimburse these agents will serve as the single, most-pressing market constraint. What strategies do payers currently employ to limit the costs of reimbursing immune biologics, and what strategies will be adopted within the next five years? Which agents will benefit from current and future trends in reimbursement and which will suffer? How do strategies used by health plans to limit costs of immune biologics vary by health plan size? Where are there opportunities for marketers to better position their immune biologic brands among payers? How have previously-implemented strategies already affected the immune biologics market in the U.S.?

  • If conventional disease modifying therapies fail to limit disease progression, physicians typically prescribe one of three Tumor Necrosis Factor-alpha (TNF-alpha) inhibitors, Amgen/Pfizer’s Enbrel (etanercept), Abbott Laboratories’ Humira (adalimumab), or Centocor Ortho’s Remicade (infliximab), as a first-line biologic therapy, and these agents frequently receive preferential reimbursement by payers over other immune biologics. Of these three agents, which will emerge as the top preferred agent among U.S. payers? What attributes of immune biologics dictate preference among payers now and in the future? How can marketers better position their brands to increase patient access? Which newer-to-market agents pose the largest threat to established TNF-alpha inhibitors?

  • A substantial portion of patients with an immune condition will fail therapy with a first-line biologic. Competition among next-line agents will be fierce, especially in light of the growing number of marketed agents and the lengthening list of indications for which immune biologics may be prescribed. What agents are in direct competition as next-line immune biologics? How does competition break down by immune indication? For which immune indications are there opportunities to capture early-line market share? What can marketers of next-line immune biologics do to better position their brand, given market constraints and limited payer reimbursement?


  • Current reimbursement: Nationwide coverage of tier placement, prior authorization and step therapy restriction rates for both commercial and Medicare plans from Fingertip Formulary’s database of over 1,600 plans. Longitudinal analysis of data over five quarters by both percentage of plans and percentage of covered lives.
  • Primary research:
    Surveys with 50 U.S. pharmacy directors, each with at least 3 years experience on their plan’s Pricing and Therapeutic Committees and each responsible for at least 100,000 covered lives.