Radar on Specialty Pharmacy

More and more of the pharma pipeline consists of specialty drugs. Going forward in 2020, areas that may see a lot of activity include biosimilars, orphan drugs and gene therapies, as well as potentially the first FDA-approved drug for Alzheimer’s and the first for nonalcoholic steatohepatitis (NASH).

More orphan drugs are expected to launch this year, continuing a trend examined in an issue brief by America’s Health Insurance Plans (AHIP) released in August 2019. Researchers found that 10% of all drug approvals in 1998 were orphan products, but by 2017, that percentage had risen to 44%.

As far as overall industry themes expected in 2020, drug pricing will remain a hot topic. Following a year in which FDA approvals of biosimilars hit double digits for the first time with 10, it’s not much of a surprise that many sources foresee a continued focus on these products in 2020. Last year also saw the launches of the first oncology biosimilars, and multiple competitors to three top-selling drugs — Herceptin (trastuzumab), Avastin (bevacizumab) and Rituxan (rituximab) — could see aggressive payer contracting efforts to try to bring down prices in multiple oncology indications (RSP 1/20, p. 1). And the approval and subsequent launch of Zolgensma (onasemnogene abeparvovec-xioi), the first product in the United States to top $1 million, has put the spotlight on other gene therapies coming down the pike.

“Pricing will remain a key focal point for 2020, but one thing to keep an eye on specifically within this realm will be pricing of biosimilars,” says Andrew Cournoyer, R.Ph., vice president, director, access experience team at Precision for Value. “A number of key biosimilar launches are expected in 2020.…There are expectations that biosimilars will help to lower specialty drug costs. The extent of potential savings will be interesting to watch but could be realized from a couple of avenues.

While arguably the biggest news within the specialty pharmacy arena in 2019 was the U.S. approval and launch of the $2.1 million gene therapy Zolgensma (onasemnogene abeparvovec-xioi) (RSP 6/19, p. 1), plenty of other happenings stood out in the industry. Among them were FDA approvals for promising treatments for cancer, sickle cell disease (SCD) and cystic fibrosis (CF), as well as double-digit approvals for biosimilars. Independent specialty pharmacies continued to be squeezed by a variety of factors (see story, p. 1), as larger combined entities took up more and more market share. AIS Health asked various industry experts to weigh in on the biggest specialty pharmacy events in 2019.

Looking back over the past year, what do you think were the most noteworthy occurrences within the specialty pharmacy industry, and why?

✦ Express Scripts and Prime Therapeutics LLC unveiled a partnership by which the former will offer the latter services related to retail pharmacy network and drug manufacturer contracts. Through the three-year deal, Express Scripts, a Cigna Corp. subsidiary, will provide pharmacy network development and negotiate with drugmakers for pharmacy benefit drugs on behalf of Prime’s 28 million members, as well as its own 75 million customers. Each company will work independently on managing medical benefit therapies and value-based contracting. In a Jan. 7 Drug Channels blog, Adam Fein, Ph.D., CEO of Drug Channels Institute, a subsidiary of Pembroke Consulting, Inc., maintains that the transaction “has potentially major implications,” as “manufacturers and pharmacies will face the biggest PBM ever.” Contact Prime’s Karen Lyons at klyons@primetherapeutics.com and Cigna’s Will McDowell at William.mcdowell2@cigna.com. Read Fein’s blog at https://bit.ly/36xvnJb.

✦ Prime Therapeutics has entered into an oncology value-based arrangement with Pfizer Inc. “Prime will utilize real-world patient pharmacy data to support a value-based agreement related to patients’ adherence to their cancer treatment,” says that company in a press release. Prime declined to respond to AIS Health questions about the partnership. Contact Prime’s Jenine Anderson at jenine.anderson@primetherapeutics.com.