Editor's note: Adds comments from Horizon Pharma.
For the third year in a row, Express Scripts unveiled a new national formulary excluding dozens of drugs. And for the third year in a row, a short list of winners and losers comprises some of Big Pharma’s biggest launches.
The list of excluded meds--85 for 2017--covers many of the same brand names as before. For instance, Novo Nordisk’s blockbuster GLP-1 diabetes drug Victoza and two of its top-selling insulins remain barred, as Express Scripts favors Eli Lilly’s diabetes range--and most likely, Lilly’s discounts. AbbVie’s hepatitis C cocktails Viekira Pak and Technivie remain the chosen therapies in that field, with Gilead Sciences' first-to-market meds Harvoni and Sovaldi out in the cold.
But there were surprises, too. Merck & Co., which launched its hep C entrant Zepatier earlier this year, didn’t make the cut for 2017. When Zepatier rolled out at a much lower price point, Express Scripts CMO Steve Miller predicted that the drugmaker’s 2017 formulary negotiations could boost the new combo regimen’s sales significantly. Apparently, those negotiations didn’t go Merck’s way, at least not at Express Scripts.
Express Scripts and its biggest pharmacy benefits rival, CVS Health, started the exclusionary formulary trend a few years ago by kicking off a handful of meds that they saw as too costly and easily replaced. Those lists of exclusions grew year by year as the PBMs grew more aggressive about pitting drugmakers against one another for discounts. Drug classes with many rivals, such as diabetes and hep C, have been particularly vulnerable to exclusions.
Eli Lilly’s new anti-inflammatory drug Taltz is one example. As the second-to-market IL-7 inhibitor for psoriasis, Taltz is trying to challenge Novartis’ Cosentyx, which has a commanding lead. Express Scripts awarded Cosentyx preferred status on its 2017 coverage list--and excluded Taltz completely.
Lilly did score a win in another hotly competitive market, however. In addition to keeping its preferred placement on the insulin side, Lilly won a formulary spot for its new weekly GLP-1 drug Trulicity, which is duking it out with Novo’s Victoza. Trulicity’s score was GlaxoSmithKline’s loss, too; the U.K. drugmaker’s weekly GLP-1 Tanzeum joined the PBM’s excluded list.
Other Big Pharma meds won their way back onto the Express Scripts list after being excluded for 2016. Pfizer’s Xeljanz, for one, which is approved for rheumatoid arthritis and is working its way toward a new use in ulcerative colitis. And GSK’s Arnuity Ellipta, part of the company’s new suite of respiratory meds, captured a slot as well.
Meanwhile, Express Scripts continued its tradition of punishing drugmakers that have pushed through big price hikes, used co-pay discount cards to hawk me-too meds, and employed other strategies the PBM considers no-nos.
For instance, Valeant Pharmaceuticals, which has run afoul of more than one payer because of price hikes, found its dermatology med Zyclara excluded from coverage. That cream, used to treat actinic keratosis, has taken several price leaps in recent years and now costs more than $1,100 per tube, according to pharmacy price comparison tools. Valeant offers a co-pay assistance plan limited patients’ out-of-pocket costs to $35 per script.
Horizon Pharmaceuticals, whose new combo-drug launches Vimovo and Duexis first took a hit from Express Scripts’ 2015 formulary, still wasn’t able to persuade the pharmacy benefits manager to change its mind. When the two combo meds were first excluded, the company estimated that sales could suffer by 20% to 30%. Both products marry drugs that are available separately at cheap generic prices.
CVS Health's brand-new formulary, unveiled Tuesday, does include both drugs, however, spokesman Geoff Curtis told FiercePharma in an emailed statement. The company "continues to have discussions with Express Scripts" and sees a possibility of "a potential partnership" with the PBM beginning in 2017, the company said. Horizon also is in talks with other payers about increasing access to the meds.
The PBM also kicked off a couple of gout drugs that are modern versions of an ancient generic, colchicine. Takeda’s Colcrys--a brand lambasted by critics when its previous owner, URL Pharma, rolled it out after limited testing at a premium price of $5 per pill, or up to $650 per month--and Hikma Pharmaceuticals’ more recently approved rival Mitigare both got the boot.
Newer erectile dysfunction meds left off the coverage list last year--Bayer’s Levitra and Vivus’ Stendra--are still excluded.
Express Scripts’ 2017 formulary covers 25 million people in the U.S., the pharmacy benefits manager said in a Monday blog post.
- see the Express Scripts blog post
Merck's new hep C contender Zepatier faces a long runway, but 2017 could bring takeoff
Lilly's new psoriasis med faces off against Novartis’ quick-launching Cosentyx
Takeda wins temporary reprieve for controversial gout drug Colcrys
Doom for combo meds? Express Scripts, CVS dump Horizon Pharma two-in-one drugs