The entrenched positioning of biologics (in particular, tumor necrosis factor-alpha [TNF-alpha] inhibitors) to treat moderate to severe rheumatoid arthritis (RA) has generated a multibillion-dollar market. Bristol-Myers Squibb’s selective costimulation modulator Orencia (abatacept), Biogen Idec/Roche/Chugai/Zenyaku Kogyo’s B-cell inhibitor Rituxan (rituximab), and Roche/Chugai’s interleukin-6 (IL-6) inhibitor Actemra (tocilizumab) largely compete for TNF-refractory patients. Since the launch of an SC formulation of Orencia in 2011, several biologics (Orencia, Janssen/Merck/Mitsubishi Tanabe’s Simponi, and Actemra) have become available in both IV and the SC formulations. In November 2012, Pfizer/Takeda’s oral janus-activated kinase (Jak) inhibitor, Xeljanz (tofacitinib), was approved. Xeljanz’s convenience (twice-daily oral administration) and efficacy profile, which is similar on several key outcome criteria to that of biologics, make it a compelling option for RA patients, although it does possess a black-box warning, as do many biologics, for its risk of serious infection and malignancy. An additional Jak inhibitor, Eli Lilly/Incyte’s baricitinib, and additional biologics (Novartis’s IL-17 inhibitor secukinumab, Sanofi/Regeneron’s IL-6 inhibitor sarilumab, and Janssen/GlaxoSmithKline’s IL-6 inhibitor sirukumab) have the potential to launch over the next few years. Biosimilar versions of AbbVie/Eisai’s Humira (adalimumab) and Rituxan are expected to launch in 2017. Thus, competition in this market will become increasingly fierce.

Questions Answered in This Report:

  • Assess the cost-control measures physicians and RA patients most frequently encounter for each biologic agent. What percentage of candidates for treatment with biologics does not receive biologic treatment for cost-, safety-, and coverage-related reasons? What step therapy requirements are most commonly employed for each RA biologic, according to surveyed physicians and payers?

  • Explore how treatment rates with biologics and prescribing by line differ in Medicare versus non-Medicare populations. What percentage of Medicare versus non-Medicare beneficiaries moves to biologic therapy? How do physicians typically prescribe biologics, by line of therapy, in Medicare and non-Medicare patients?

  • Evaluate physician and payer perceptions of the new oral Jak inhibitor, Xeljanz. To what extent are physicians willing to prescribe a novel oral kinase inhibitor and non-TNF-alpha-inhibitor biologics in place of commonly used first- and second-line biologics? What step therapy requirements are payers demanding for Xeljanz? In which lines of therapy are physicians most likely to prescribe a kinase inhibitor?

  • Explore the most likely changes to the treatment algorithm after the launch of biosimilar adalimumab and rituximab. How soon do rheumatologists expect to incorporate biosimilars into the RA treatment algorithm? Will biosimilars cannibalize the majority of patient share of the Humira and Rituxan brands due to the lower cost? Will payers impose step therapy requirements and favor biosimilars over branded agents?

  • Understand the perceived unmet need for additional RA biologics. Are physicians and payers enthusiastic about additional RA biologics? Which currently marketed biologics do surveyed physicians foresee as potentially being direct competitors with Eli Lilly/Incyte’s once-daily oral kinase inhibitor baricitinib, Sanofi/Regeneron’s IL-6 inhibitor sarilumab, Novartis’s IL-17 inhibitor secukinumab, and Janssen/GlaxoSmithKline’s IL-6 inhibitor sirukumab if further data for these agents are positive? What reimbursement hurdles could they face, according to surveyed payers?

Scope:

Markets covered: United States.

Primary research: We surveyed 105 rheumatologists, 20 managed care organization (MCO) pharmacy directors (PDs), and 10 MCO medical directors (MDs).

Author(s): Ronnie Yoo, Ph.D.

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