Express Scripts stiff-arms AZ's Onglyza, Vivus' Qsymia with new 2016 formulary

Express Scripts ($ESRX) has passed judgment for 2016. Almost 20 new meds, including some closely watched products like Vivus' ($VVUS) weight-loss med Qsymia, won't be covered on the pharmacy benefits manager's 2016 preferred formulary.

The additions--and a few subtractions--bring Express Scripts' list of excluded meds to 80. All together, those exclusions will save $1.3 billion for the insurance-plan customers that use its National Preferred Formulary, the PBM says. That formulary is Express Scripts' most widely used, covering up to 25 million Americans.

Among the victims are two AstraZeneca ($AZN) diabetes remedies, Onglyza and Kombiglyze, which came under FDA scrutiny earlier this year after study data flagged a potential increase in heart failure risks. Also joining the list of rejected meds is Johnson & Johnson's ($JNJ) Olysio, a hepatitis C treatment that's often used alongside the already-excluded Sovaldi from Gilead Sciences ($GILD). GlaxoSmithKline's ($GSK) new respiratory med Arnuity didn't make the cut, either.

But GSK won a turnabout for another in its stable of new respiratory meds: Breo, which lost out on a formulary spot for 2015, won its way into Express Scripts' good graces. Eli Lilly ($LLY) and Boehringer Ingelheim's diabetes remedy Trajenta also got a spot after being excluded from the 2015 list. The controversial pain med Zohydro, rejected for 2015, made the approved list for next year.

In announcing the new exclusions on its company blog, Express Scripts said it's excluding "a handful of 'me-too' products that have no clinical benefit beyond what's provided by more affordable alternatives." The PBM taps an "independent group of physicians" to review clinical data and determine which newer meds actually work better for patients than older alternatives, and then weighs the drugs' costs to decide which will be covered--and which won't.

As expected, the 2016 formulary continues to put the kibosh on Gilead Sciences' ($GILD) hepatitis C drug combo Harvoni and its single-drug pill Sovaldi, in favor of AbbVie's ($ABBV) Viekira Pak. The Express Scripts-AbbVie pact on that drug cocktail touched off a hepatitis C pricing war at the end of 2014.

Though Express Scripts and its biggest rival, CVS Health ($CVS), had issued exclusionary formularies before, the big hepatitis C deal touched off an unprecedented pricing war and set the stage for more aggressive negotiations between payers and pharma. Express Scripts isn't shy about taking credit for changing the pricing climate, either. "[A]s the plan sponsors we represent have demonstrated that they are willing to exclude medications that are priced above clinically equivalent alternatives, manufacturers are now approaching us earlier to ensure the affordability and accessibility of their products," the company's blog post says.

And the PBM is still promising changes ahead for cancer, saying that its plans for reimbursing products based on their performance in individual indications will be unveiled later this year. And the company called out PCSK9 inhibitors as one group of meds due for formulary decisions as the year progresses. Sanofi ($SNY) and Regeneron's ($REGN) entry, Praluent, was approved last month, and Express Scripts President Tim Wentworth last week said the new class is poised to "wreak havoc" on pharmacy costs.

- read the Express Scripts blog post
- check out the list of exclusions