Cancer and diabetes remain top therapeutic areas for healthcare executives to watch in 2017, but other conditions, such as autoimmune diseases, fatty liver disease and the rarer Duchenne muscular dystrophy are sparking interest in the upcoming year.
With an explosion of new and combination specialty and other drugs, these areas are ripe for grabbing the attention of managed healthcare. The projected specialty/biotech trend rate for 2017 is 18.7%, according to Segal Consulting.
“Specialty drugs are the largest driver for all areas,” says Carmelina Rivera, practice leader, West Division Pharmacy, Willis Towers Watson. “It’s where we will feel the most pain, and they will continue to be a problem.”
Here are some of the latest developments in top therapeutic areas for 2017.
Heather Morel, chief operating officer, The US Oncology Network, says oncology is a key therapeutic area no matter which way you slice it. She attributes the focus to an aging population—a cohort that cancer is most likely to affect—advances in treatment, early detection, patients living longer and more multi-modal therapies, including surgery, radiation and medication therapies. She says, however, that the biggest cost contributor is hospital care.
Immunotherapy, a treatment designed to help the body naturally fight cancer, is the big thing in oncology right now—a trend continuing from last year, says Julie Rubin, director of clinical services, CompleteRx, a pharmacy management company. Biologic therapies like nivolumab (Opdivo) and pembrolizumab (Keytruda), commonly referred to in practice as “checkpoint inhibitors” are recent examples of drugs designed specifically for this purpose.
Immunotherapy is an expensive, incredibly novel set of treatments that have a great impact on survival, Morel adds, pointing out its six indications: non-small cell lung cancer, renal cell carcinoma, melanoma, Hodgkin’s lymphoma, head and neck cancer and urethral cancer (bladder cancer).
“Historically, if you had breast cancer, we treated you for breast cancer, but now we’re going way beyond that looking at how all of the immune pathways work and how drugs can be used to manipulate those pathways to therapeutic advantage. We’re developing biomarkers that allow us to identify patients who will be most likely to respond well to immunotherapies,” Rubin says. “Not all cancers look alike so there are going to be more granular options.”
Next, she says, it’s expected that the FDA will approve immune checkpoint inhibitors as a first-line therapy for more cancer types, which should have a huge impact on disease spread and growth. These inhibitors have been approved only as a second-line therapy for advanced lung and kidney cancers that have not responded to other therapies and as a first-line therapy for advanced, unresectable melanoma, she adds.
David Lassen, chief clinical officer for Prime Therapeutics, a pharmacy benefits manager, says there is a “rich pipeline” for oncology drugs with unique mechanisms of action and an organic expansion of new indications for existing drugs. He says oral cancer drugs consume 5% of the PBM’s drug costs.
Up until recently, treatment for bladder cancer has remained the same for decades. Nivolumab received a breakthrough therapy designation in June 2016 and is expected to be approved in March of 2017 for the condition. It already received the designation for previously treated non-small cell lung cancer, advanced melanoma and metastatic cell carcinoma.
Rivera at Willis Towers Watson says oncology is growing because many new and existing drugs are targeting specific cancers. “Many manufacturers seek one indication to get a drug on the market but once in use, provide evidence of value for other indications,” she says.
She warns payers and PBMs that they should evaluate pathways to ensure drugs are being used for the right indications. “Pathways drive evidence-based ways to treat patients,” she says.
Tecentriq (atezolizumab) is another recently approved drug for bladder cancer and is due to hit the marketplace in late 2017 or early 2018. Its price tag will be about $12,500 a month, or about the same as Opdivo.
Two generics for Gleevec (imatinib mesylate) that treats myelogenous leukemia joined the market in 2016. The cost of brand Gleevec since its approval in 2001 has quadrupled. In anticipation of patent expiry, the average wholesale price (AWP) of Gleevec jumped 45% from January of 2014 ($102,000 per year) to $148,000 per year today, per Medi-Span database figures.
And in October 2016, the FDA approved Keytruda as a first-line therapy for non-small cell lung cancer, making this the first-time immunotherapy has been designated as an initial treatment for lung cancer.
Another important drug is Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test. “The approval constitutes the first of a new class of drugs for treating ovarian cancer,” Morel says.
In addition, Mylan N.V, and Biocon Ltd. submitted a biologics license application for a proposed trastuzumab biosimilar to Roche’s Herceptin treating certain HER2-positive breast and gastric cancers.