As the pharmaceutical pipeline begins to churn out specialty products at a higher rate than traditional therapies, the nation’s healthcare payers are experiencing double-digit growth in their costs for biologics and other high-cost specialties, with specialty drugs expected to consume half of the drug spend by 2018. Perhaps the concern is nowhere more magnified than in the autoimmune disease category (especially rheumatoid arthritis[RA]), given that it represents the highest-cost disease category in the U.S. (according to the pharmacy benefit management industry) and one for which cost trend is expected to accelerate the most, next to oncology.

U.S. managed care organizations (MCOs) have responded by enacting a series of cost-control strategies to tame the trend toward high-cost biologics—from prior authorization and step therapy protocols and increased member cost-sharing to the use of lower-cost sites of care for provider-administered therapies and the use of specialty and mail order pharmacies to better control tracking, reporting, and utilization of drugs.

A variety of therapy options exist for the treatment of the autoimmune conditions RA, psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Typically, conventional disease-modifying antirheumatic drugs (DMARDs) are prescribed first, and the wide availability of generic products in the class helps hold down costs for payers and patients. For patients who do not respond to those treatments, the highly effective newer biologic versions of DMARDs, including the frequently prescribed tumor necrosis factor-alpha (TNF-α) inhibitors (i.e., Enbrel [etanercept, Amgen/Pfizer], Humira [adalimumab, AbbVie], and Remicade [infliximab, Janssen/Biotech]), offer patients a chance to get relief and resume life’s activities. These and other later-line and emerging therapies—including some of the first biosimilars to come to the U.S. marketplace—will create more cost pressures for managed care companies, but also set the stage for competitive contracting and preferred drug tiering, a key strategy in holding down costs.

Questions Answered in This Report:

  • Prescribing and tiering of autoimmune therapies. What percentage of patients treated for RA, PsA, and AS are prescribed a biologic agent, and what percentage of patients receive a DMARD? Which of the biologic treatments and the oral Janus-activated kinase (JAK) inhibitor Xeljanz (tofacitinib, Pfizer) are more often prescribed as a first-line versus a second-line therapy for RA and other conditions? How are the various approved treatments and off-label products positioned in MCOs’ drug benefits in terms of coverage tiers, and which are more likely to be excluded from coverage now and in the next 12 months? Do Enbrel, Humira, and Remicade face any real competition when it comes to MCO coverage and physician prescribing?

  • Cost-control strategies employed for high-cost biologics. What level of control from payers do rheumatologists encounter when prescribing biologic therapies and Xeljanz? Which of the cost-control measures are most likely to be encountered by specialists for each of the three conditions? How much of a concern for MCOs is the increased administration of biologic therapies at hospital-based sites of care, and what percentage of MCOs has enacted restrictions on the sites of care? What is the most common reimbursement method for infused and self-administered autoimmune products? To what extent is rebating used for autoimmune therapies? How are MCOs’ specialty pharmacy provider networks structured for autoimmune biologic therapies?

  • Impact of payer controls on prescribing. To what extent have payer tiering decisions and restrictions impacted rheumatologists’ prescribing of biologic therapies as well as Xeljanz for RA, PsA, and AS? For which products do specialists report that they have decreased their prescribing rate because of payer controls? What is the result of payer controls on rheumatologists’ tendency to follow preferred drug lists? What is the extent of specialists’ use of specialty pharmacies? How do specialists react to site-of-care restrictions?


This U.S. Physician and Payer Forum report contains insights from a survey of 103 rheumatologists and 40 MCO pharmacy and medical directors (27 pharmacy directors and 13 medical directors) regarding the impact of high-cost biologics on the tiering and prescribing of autoimmune therapies for RA, PsA, and AS. We explore the impacts on specific therapies treating these three conditions and implications for the pharmaceutical industry.

Markets covered: United States.

Primary research: Online survey of 103 rheumatologists and 40 MCO directors.

Author(s): Chris Lewis