With as many as 80 autoimmune diseases potentially attacking all parts of the human body, it should be no surprise that spending on treatment for these conditions rose 28%, to $30.2 billion, between 2014 and 2015, according to an IMS Institute for Healthcare Informatics report released last May.
Among the top 15 therapy classes ranked by per member per year spend, inflammatory conditions top the list at $118.21, followed by diabetes at $108.80, according to Express Scripts’ 2016 Drug Trend Report, released in February. Among the top 10 specialty drugs, four products are for inflammatory conditions. The top two are Humira (adalimumab) and Enbrel (etanercept). Total trend for this class was 26.4%. Employers paid an average of $3,587.83 per prescription for inflammatory drugs.
Autoimmune diseases run the gamut from more well-known conditions such as rheumatoid arthritis, inflammatory bowel diseases and psoriasis to other conditions such as Graves’ disease and Myasthenia gravis, affecting the thyroid gland and nerves, respectively.
New drugs for RA, psoriasis, type 1 diabetes and Crohn’s disease—some recently approved and others coming down the pipeline—could have an impact on the industry in both their anticipated clinical results and price tags.
“The biggest thing we are waiting for are biosimilars for Humira and Enbrel, the market leaders, but patent litigation is delaying bringing Amjevita [adalimumab-atto], a Humira biosimilar, and Erelzi [etanercept-szzs], an Enbrel biosimilar, to market,” says John Nicolosi, senior vice president and chief clinical officer, healthcare, Highways Rx, a pharmacy benefits manager. Enbrel and Humira, the market leaders, are priced at about $3,500 and $2,400 a month, respectively, setting the trend for other new drugs in the class.
Inflectra (infliximab-dyyb), a biosimilar for the well-known drug for RA, Remicade (infliximab), was approved in April 2016. It also faces patent litigation before it hits the marketplace.
“Once it is made available, it is only projected to initially provide a 15% discount compared to Remicade,” says Nicolosi. “Although expected, this is much lower than the discounts seen for the Remicade biosimilar in Europe—about a 45% discount.”
The impact on this drug will be largely dependent on its availability, cost and adoption within clinical practice.
Nicolosi expects that biosimilars in general will lower costs by 15% because market leaders dictate costs. However, he holds out optimism for a growing number of new products with similar outcomes coming down the pipeline for RA—more than 10—as a means of stirring up competition and lowering costs.
Although Enbrel exploded the biologic therapeutic marketplace with its introduction in 1998, followed by other medications with different mechanisms of action that proved to be effective in inducing remission, Nathan Wei, MD, clinical director of the Arthritis Treatment Center and a rheumatologist in Frederick, Maryland, says this is an era of me-too drugs and those with different mechanisms of action are slow to follow the first to market in a category.
Pat Gleason, PharmD, senior director of health outcomes, Prime Therapeutics, agrees with Wei that there is little differentiation among new autoimmune drugs and that they only add to expenses due to inflation and more utilization. He acknowledges that these drugs have been driving drug spend from 2012 to 2015 even though 25% of use falls under the medical benefit.
Three other drugs in the category could potentially pose threats for established drugs for treating RA: baricitinib, a JAK1 inhibitor, and sarilumab and sirukumab, both interleukin-6 receptors.
Baricitinib, administered orally once daily, is currently in development. Nicolosi says it will likely compete with Xeljanz and Xeljanz XR (tofacitinib citrate), which are existing products on the market with similar administration and mechanism of action. Baricitinib’s Prescription Drug User Fee Act (PDUFA) date that spells out deadlines by which the FDA must review new drug applications was slated for April at press time.
However, there have been serious safety concerns with baricitinib, which include major cardiovascular events and malignancies that have added some significant hesitation with this product, says Nicolosi. “This could be another option for individuals who had an inadequate response to other treatment options, but I don’t anticipate it having any significant impact on the treatment algorithm for RA,” he says. “Despite the safety concerns, I have read the projected U.S. annual sales for baricitinib could range from $1 billion by 2020 to $2.9 billion by 2025.”
The arrival of sarilumab also has been detained on its journey to the marketplace but in this case, for manufacturing concerns. Its original PDUFA date has come and gone and is now set for mid-2017.
Sirukumab is currently in phase 3 trials and has shown mixed results.
Wei adds that people on JAK inhibitors can also have an increased risk of certain cancers, high cholesterol and triglycerides, liver function abnormalities, kidney dysfunction and a drop in white and red blood cell counts. He expects the newer drugs in the pipeline to be safer.
He says some of his patients who are controlling their RA have chosen to go the non-traditional route of trying herbal remedies to avoid toxicity. “But if they are not in remission or even close, I try to steer them to the conventional route.”