Zitter Pulse Check: Rheumatoid Arthritis (May 2022)

Coverage

Rheumatoid arthritis (RA) is a high-cost category with an increasing number of therapies that treat the condition. To help stakeholders absorb datapoints and perceptions from all directions and synthesize those insights into a tangible strategy for RA, Zitter Insights surveys a leading panel of pharmacy and therapeutics (P&T) decision makers at payers and integrated delivery networks. The Managed Care Biologics and Injectables Index combines deep payer insights with the industry standard in market access information to produce quarterly reports and insights summaries on leading specialty brands.

Payer Management

Many therapies approved for RA also have FDA approval for other anti-inflammatory conditions. Payers with approximately three-quarters of covered commercial lives said that their management of RA has a strong influence on their management of psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease (see chart). In contrast, those with less than half of lives had the same opinion about their ankylosing spondylitis management. Payers covering Medicare lives reported similar data.

On average, payers reimburse more pharmacy benefit claims for RA agents than medical benefit claims. Payers reported an average of six RA agents that their organization preferred or parity preferred for first-line treatment, followed by four therapies in the second-line setting and three third-line medications.

Key Findings

Humira Biosimilars

As of early May 2022, the FDA had approved seven biosimilars of AbbVie Inc.’s Humira (adalimumab). Due to patent litigation settlements, none of the agents will be able to launch in the U.S. until 2023. First expected is Amgen Inc.’s Amjevita (adalimumab-atto), approved Sept. 23, 2016, which has been cleared to launch on Jan. 31, 2023. Payers with almost two-thirds of covered lives said they anticipate changing their number of preferred or parity preferred RA therapies when Humira biosimilars become available. Of those respondents, payers representing almost three-quarters of lives said they expect to increase the number of preferred or parity preferred RA agents. The competition may help payers with rebates, they said, as well as drive lower costs within the therapeutic class.

Pipeline

A handful of agents are in the late-stage pipeline for RA, including Biogen Inc. and Bio-Thera Solutions, Ltd.’s BAT1806, GlaxoSmithKline plc’s otilimab, R-Pharm-US LLC’s Artlegia (olokizumab) and Sanofi’s ozoralizumab. Of these therapies, payers and rheumatologists are mostly aware of otilimab. Overall, payers exhibited a higher awareness of the pipeline products than did rheumatologists. Commercial payers expressed the most interest in otilimab and ozoralizumab, followed by Artlegia and then BAT1806 (see chart). Payers covering Medicare lives reported similar data. Rheumatologists also were most interested in otilimab.

JAK Inhibitors

In September 2021, the FDA said that it was requiring revisions about increased risk of serious heart-related events such as heart attack, stroke, cancer, blood clots and death to the labels of the Janus kinase (JAK) inhibitors indicated for inflammatory conditions: Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib). The move followed the agency’s review of a large, randomized safety clinical trial of Xeljanz that compared it with TNF inhibitors in people with RA. The FDA also limited the approved uses for all the drugs to certain people who have not responded to or cannot tolerate at least one TNF inhibitor. Payers with 20% of covered lives said that the findings and regulations influenced their management of RA. Among the actions that payers reported taking were moving the JAK inhibitors to second-line use, changing prior authorization to ensure monitoring and assessment of safety risks and adding a therapy with a different mechanism of action to the preferred tier so that JAK inhibitors were not the only drugs there.

Trends

Biosimilars

Message: “We discussed current strategies that have been implemented by health plans when CMS granted approval to use step therapy and preferred biosimilar use when appropriate. Plans can only have patients step through cheaper alternatives. As biosimilar utilization is increasing, it is estimated that over the next five years, the savings potential is >$27 billion.”

Payer Thoughts: “The overview provided regarding the biosimilar space was effectively delivered with supporting data and studies. The MSL [i.e., medical science liaison] provided a nice diagram depicting the estimated increasing spend with biosimilars, noting that spend is expected to increase from $5.2B in 2019 to $27B in 2024.”

FDA Extends Xeljanz Safety Warnings to Other JAK Inhibitors

The FDA is requiring revisions about increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots and death to the labels of the Janus kinase (JAK) inhibitors indicated for inflammatory conditions: Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and AbbVie Inc.’s Rinvoq (upadacitinib). The move follows the agency’s review of a large, randomized safety clinical trial of Xeljanz. The FDA also is limiting the approved uses for all the drugs to certain people who have not responded to or cannot tolerate at least one tumor necrosis factor (TNF) inhibitor. While some payers may already have had TNF inhibitors as a first step, they need to make sure that they have utilization management strategies in place to help ensure these drugs are used in the second-line setting, recommend industry experts.

FDA Grants Interchangeable Status to Humira Biosimilar, but Certain Factors May Hamper Its, Other Adalimumabs’ Uptake

Less than three months after granting interchangeable status to a biosimilar for the first time, the FDA has approved that status for a second biosimilar, Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm). It and multiple other biosimilars of AbbVie Inc.’s Humira (adalimumab) are slated to come onto the U.S. market in 2023, but plans should be preparing now for the drugs’ launches, say industry experts. Still, a handful of factors could pose an issue with the agents’ taking market share from the reference product.

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