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.
The RA therapeutic class consists of multiple therapies, including oral, subcutaneous and intravenous agents. Payers with more than four-fifths of lives have rebate-based contracts in place for these drugs. The most popular type of agreement is portfolio-based deals, held by payers with almost half of lives. AbbVie Inc.’s Humira (adalimumab) and Rinvoq (upadacitinib) are the most common drugs for these arrangements (see chart).
In addition, payers with one-third of lives have indication-based deals, and Humira was again the most popular, followed by Amgen Inc.’s Enbrel (etanercept) and Bristol Myers Squibb’s Orencia (abatacept). Payers covering almost one-fifth of lives have a market share-based contract in place, with Humira the top therapy, followed by Pfizer Inc.’s Inflectra (infliximab-dyyb) and Rinvoq.
The FDA has approved four biosimilars of Remicade (infliximab) from Janssen Biotech, Inc., a Johnson & Johnson company: Pfizer’s Inflectra and Ixifi (infliximab-qbtx), Merck & Co., Inc.’s Renflexis (infliximab-abda) and Amgen Inc.’s Avsola (infliximab-axxq). All are available except Ixifi, which Pfizer has no plans to launch in the U.S. Avsola was the most recent approval, in December 2019, and it launched in July 2020. Payers with about half of covered lives are unlikely to prefer Avsola over other infliximab agents, but rheumatologists show more interest in prescribing it (see chart). Payers with more than half of lives will cover it more restrictively than its label or not cover it at all.
Mechanism of Action
The RA class consists of drugs with different mechanisms of action, including tumor necrosis factor (TNF) inhibitors, Janus kinase (JAK) inhibitors, interleukin-6 (IL-6) inhibitors and CD20/80 treatments. Among payers managing by mechanism of action, the top drugs they plan to pursue first-line contracts for are Humira in the TNFs, Rinvoq in the JAK inhibitors, Sanofi Genzyme and Regeneron Pharmaceuticals, Inc.’s Kevzara (sarilumab) in the IL-6s and Roche Group member Genentech USA, Inc. and Biogen’s Rituxan (rituximab) in the CD20/80 market basket.
Rheumatologists’ most ideal first-line RA therapy is Humira, favored by more than half of respondents, followed by Enbrel, cited by almost one-third of respondents. Rheumatologists cited both drugs’ efficacy, safety and side-effect profiles, as well as their experience with the agents and health insurers’ requirements. The same two therapies were the top drugs rheumatologists selected as their most ideal second-line treatments, followed by Rinvoq and Orencia.
Message: “Rinvoq was studied in five different clinical trials in RA patients totaling over 4,300 patients, with varying patient populations including biologic-experienced patients. Rinvoq was superior head to head vs. Humira and placebo for ACR20 response. The product met all primary and secondary endpoints across all five trials, which has not happened before with other agents in this disease. Safety profile was similar to placebo, no new safety signals were seen, and respiratory infection was the highest adverse event.”
Payer Thoughts: “The clinical data for the product is impressive, and the product appears to be very effective.”
Biosimilars Market Is Heating Up
As of early 2021, the FDA had approved 29 biosimilars. For various reasons, mostly patent litigation by reference drug companies, only 20 of those products actually have launched onto the U.S. market. But as the biosimilars market has yet to demonstrate its full potential, it certainly seems to be picking up steam.
PBMs Deploy Indication-Based Pricing
PBMs are implementing indication-based pricing, in which medications are priced differently depending on their effectiveness in different indications, for the anti-inflammatory class — particularly for rheumatoid arthritis — due to its high cost and growing availability of biosimilars. Autoimmune drugs are some of the most expensive therapeutic treatments, reaching several thousands of dollars per month.