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Four new drugs and a biosimilar should be on your radar.
Rheumatoid arthritis (RA) affects about 1.5 million people nationwide and is a chronic condition requiring treatment over the long term for impacted patients, according to the Centers for Disease Control and Prevention. For this reason, managing RA can be a cost challenge.
“There are some remarkable therapies to treat RA that have been on the market for the last roughly 15 years that have dramatically improved patients’ conditions,” says Mark Ginestro, a principal who focuses on life sciences companies at KPMG Strategy. “Because of the chronic nature and the benefit patients experience, some of the medications for this condition, as well as Crohn’s disease, psoriasis, and ankylosing spondylitis, are some of the biggest selling drugs worldwide.”
As Ginestro notes, key specialty drugs-etanercept (Enbrel, Amgen), infliximab (Remicade, Janssen) and adalimumab (Humira, AbbVie)-started hitting the market for this condition about 15 years ago, moving the standard of care beyond methotrexate, gold salts and anti-inflammatory drugs, such as corticosteroids.
“These specialty drugs, however, can cost tens of thousands of dollars annually,” Ginestro says. “On the plus side, these drugs have improved the quality of life for most patients, since they slow disease progression, which can lead to disability and joint replacement surgeries.”
Disease-modifying anti-rheumatic drugs (DMARDS), anti-tumor necrosis factors (anti-TNFs), Janus kinase 3 (JAK3) inhibitors, interleukins (ILs) and biosimilars comprise the RA treatment universe, according to Todd Evans, director, strategy, sales and marketing, pharma/life sciences, health advisory industries at PwC.
“The first JAK3s initially came to market with great expectations, however there is the hope that the next generation of JAK3s provide an even greater improvement over today’s TNF efficacy range with a more discernible margin of superiority,” says Evans. “ILs hold promise as well, but will take longer to reach the market and impact the current standard of care. Lastly, expectations around biosimilars remain high with respect to their ability to drive erosion of the current TNF pricing premiums. However, the possibility of switching a substantive portion of the market to biosimilars may prove difficult until rheumatologists are convinced there is enough benefit to justify the risks.”
RA drugs, such as Enbrel and Humira, are likely in everyone’s top two specialty drugs list under the pharmacy benefit and most notably, may be the top one or two drugs overall, ranked by spend, according to Nadina Rosier, North America Practice Leader, Pharmacy, Towers Watson.
“Through the medical benefit, Remicade, an infused product also used for RA and other inflammatory conditions, is likely to be the highest spend, non-oncology specialty drug for most plan sponsors,” Rosier says.
Four new drugs are expected to receive FDA approval for RA and will compete with existing drugs such as the TNF inhibitors Enbrel, Humira, tofacitinib (Xeljanz, Pfizer), and tocilizumab (Actemra, Genentech), says Rosier. Three of them-clazakizumab (Alder BioPharmaceuticals), sarilumab (Sanofi and Regeneron), and sirukumab (GlaxoSmithKline) are novel monoclonal antibodies that inhibit the pro-inflammatory cytokine interleukin-6, or IL-6, and similar to existing products, are also given by subcutaneous injection.
“Thus, these will likely be primarily covered under the pharmacy benefit,” Rosier says.
The fourth drug, baricitinib (Eli Lilly and Company and Incyte Corp.), is an oral JAK inhibitor which will compete with Xeljanz and other agents in the market, Rosier says, adding that in clinical trials “it has performed better than methotrexate and was deemed comparable to Enbrel and Humira.”
From a patient perspective, an oral drug is likely preferable and might result in faster adoption of this product relative to injectables, according to Rosier. “Some physicians would be reluctant to make any changes in therapy, even to oral medications, if the current regimen is working effectively. However, having another oral option that works well clinically relative to anti-TNFs could be a game changer for the Pharmaceutical Research and Manufacturers of America.”
All four of these drugs are expected to cost approximately $40,000 per patient per year, “which is consistent with the pricing for current treatments,” Rosier says.
Also notable, the biosimilar for Humira, Amgen's ABP 501, may soon be available, which is top of mind for many plan sponsors, according to Rosier. In November, Amgen announced that in a study on more than 500 patients with RA, ABP 501 met its primary and secondary end points of improving symptoms at a rate similar to Humira with a comparable safety profile. Following the release of this data, Amgen submitted its biosimilar to FDA on November 25, 2015 for approval.
“This biosimilar could potentially offset some of the costs expected in this drug class; however, the exact cost reduction relative to their brand parent drugs is still largely unknown,” Rosier says.
Biosimilars will face a crowded category for TNF inhibitors and could exert some pressure on pricing for these drugs, since there will be there will be new supply on the market, says Ginestro.
“The questions remain about how the manufacturers will respond. If the original product makers are confident that doctors won’t switch their patients to the biosimilar, they may not feel pressure to respond with lower prices,” he says. “On the other hand, most of the development costs of these drugs have been recouped. The brand-name manufacturers have the prerogative to cut price and box out a biosimilar launch. This will be a very interesting scenario, since this category is competitive but no biosimilar has emerged here yet.”
Payers may want to control spend by including any prospective biosimilar for treating RA in a lower cost tier to encourage the patients to ask the doctor to switch, Ginestro says. “Specialty drugs are usually in a separate, higher-cost tier for pharmacy coverage, affecting the coverage of many standard RA treatments,” he says. “If a patient switches to a biosimilar product, the change can save a benefit plan thousands of dollars. The incentives to steer patients that route are there.”