Specialty Pharmacy Pipeline Suggests New Drug Approvals Will Bounce Back in 2017

During a presentation at the AMCP 2017 Annual Meeting, Aimee Tharaldson, PharmD, senior clinical consultant in the Emerging Therapeutics department at Express Scripts, updated managed care professionals on the upcoming specialty pharmacy approvals—and showed that the new drug approval rate is expected to bounce back after a slowdown in 2016. 

Dr Tharaldson started by highlighting some of the market trends in specialty pharmacy. These trends included an increase in competition; with between 7 to 12 drugs in the pipeline for most of the major specialty drug treatment areas. She also highlighted the fact that there will be 64 patent expirations through 2021, allowing for up to $23.7 billion in revenue opportunity. 

The Impact of Biosimilars on the Marketplace

As part of her discussion on increased marketplace competition, Dr Tharaldson explained that biosimilars represent a unique opportunity for new drugs to come to the market. She noted that through 2021 there will be 73 patent expirations relevant to biosimilar development, representing $46.2 billion in potential opportunity. 

She highlighted the four currently approved biosimilars, Zarxio (filgrastim‐sndz; Sandoz), Inflectra (infliximab‐dyyb; Celltrion/Pfizer), Erelzi (etanercept‐szzs; Sandoz), and Amjevita (adalimumab‐atto; Amgen). While these four are all currently approved, due to patent litigation, only Zarxio and Inflectra are currently available on the marketplace. Dr Tharaldson pointed out that while Amjevita would have significant impact on the marketplace as a biosimilar to Humira (adalimumab; AbbVie), she does not expect that the biosimilar will hit the market until at least 2022.

Furthermore, she outlined the seven biosimilar products currently slated for approval between April and October of 2017. Most notably, Dr Tharaldson explained that trastuzumab (Mylan/Biocon), a biosimilar to Herceptin (Genentech), which treats breast cancer, will be the first biosimilar product approved for cancer in September 2017.

She added that there is a lot more litigation expected surrounding all of these products, with each company claiming multiple patents for each drug. According to her presentation, there will likely be at least two Supreme Court cases this summer regarding biosimilars. 

Litigation aside, the average projected savings associated with launch of these products will be a price reduction of about 15%. 

Cancer Drugs in Development

The second market trend that Dr Tharaldson addressed was the development of new cancer drugs. She noted that 17% of the specialty drug market is made up of cancer drugs, with 1.7 million new cases diagnosed each year. She also pointed out that cancer survival is increasing, with a 23% decrease in cancer mortality since the early 1990s. This has led to the development of more drugs that will help to treat cancer as a chronic condition as survival rates increase even more.

While the cancer drug pipeline also took a dip in 2016, there are currently 12 to 14 new cancer drugs slated for approval in 2017—returning to the same level as 2015, when 15 new cancer drugs were approved. 

Among the 14 drugs expected to receive FDA approval in 2017, Dr Tharaldson highlighted brigatinib (Ariad), an oral treatment for non-small cell lung cancer; midostaurin (Novartis), an oral treatment for acute myeloid leukemia and systemic mastocytosis; avelumab (Merck/Pfizer); an infusion therapy for merkel cell carcinoma and advanced urothelial carcinoma; durvalumab (AstraZeneca), an infusion therapy for advanced urothelial carcinoma; and niraparib (Tesaro), an oral therapy for epithelial ovarian, fallopian tube, and primary peritoneal cancer.

“All of this competition is not really bringing down the price of these medications yet,” Dr Tharaldson said. “Each new cancer drug usually launches at about $100,000 per year to $150,000 per year—so they are still very expensive.”

The Orphan Drug Pipeline

According to Dr Tharaldson, the third market trend affecting specialty pharmacy is the approval of drugs with new orphan drug designations. 

She noted that orphan drugs only treat conditions with less than 200,000 patients in the United States and there are 7000 orphan diseases affecting 30 million patients, yet they make up 35% of total specialty drug spending. Dr Tharaldson also pointed out that these drugs are very expensive, with around 30% of them considered blockbuster drugs. 

She further explained that today specialty drug spending—which consists of half cancer and orphan drug treatments combined—makes up 37% of all pharmacy spending. Furthermore, she anticipates that specialty drugs will make up more than 50% of total drug spending by 2020—but these drugs will only be used by less than 2% of patients. 

She noted that 2016 was the worst year for specialty drug approvals since 2010, but that she expects this dip to reverse in 2017.

“In 2017 we are going to rebound,” she said. “There are 30 specialty drugs pending approval right now at the FDA—so we are going to see this come back.”—David Costill