How can new launches mimic Keytruda, Harvoni and Opdivo? A new report has some ideas

Trinity Partner's new drug index features a ranking of 2014's top drug launches, a "banner year" for FDA greenlights, led by Merck's immuno-oncology star Keytruda.

In just a few years, pharma's top launches of 2014 have not only amassed huge sales but reshaped treatment, too—and they're now among the biggest launches ever. The names? No surprise: Gilead's hepatitis C treatment Harvoni, Merck's immuno-oncology therapy Keytruda and its head-to-head rival, Bristol-Myers' Opdivo.

Together, the meds represent the most successful launches in Trinity Partners' second annual drug index, with Keytruda topping the field and Harvoni and Opdivo following in order. The annual report looks back at launches from previous years to asses why certain rollouts were hugely successful and others sputtered.

This time around, Trinity's focus is on 2014, a year that featured 41 new drug approvals and some significant heft at the top of the rankings. Speaking with FiercePharma, Trinity managing partner David Fitzhenry said it was "one of the biggest years at the top of the index that we will see in a long time." 

To rank the meds, Trinity compiled details about R&D costs, commercial success, therapeutic value and more. In last year's index, Gilead's single-agent hepatitis C pill Sovaldi topped the 2013 approval class, followed by Johnson & Johnson and AbbVie's Imbruvica, and Biogen's Tecfidera. 

The report is designed to help biopharma companies prioritize their R&D projects and recoup expenses. Behind the top three meds this year were Biogen's hemophilia drug Eloctate; Takeda's colitis and Crohn's treatment Entyvio; Biogen's Alprolix, also a hemophilia therapy; Roche's idiopathic pulmonary fibrosis drug Esbriet; Celgene's immunology agent Otezla; and two other cancer treatments, Eli Lilly's Cyramza and AstraZeneca's Lynparza.  

With specialty drugs on the ascendance, it's new treatments on either end of the continuum at risk of struggling, Fitzhenry said. New products can suffer commercially if they're aimed at a mass market and offer little therapeutic advance, or if they target ultra-orphan indications where the market is small, despite their high price tags.

Another risk? Payer clampdown. Big rebates that hit Gilead's ultra-successful hep C launches have contributed to their slowdown, for instance. If payers believe a new drug has the potential to disrupt their budget for the upcoming year, Fitzhenry said, they put up barriers to restrict uptake. He pointed to new PCSK9 cholesterol meds from Sanofi and Regeneron and Amgen, plus heart failure drug Entresto from Novartis, as examples of launches suffering from that trend.

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Those meds, he said, "generated data that should've been good enough for pretty good launches, but the concern by payers was serious," and so they put up prior authorization and other obstacles to slow adoption. It's a dynamic Novartis CEO Joe Jimenez has highlighted in explaining why Entresto didn't meet early expectations. 

"We think that is going to be the case going forward," Fitzhenry said. 

Lastly, the report highlights a serious issue for drugmakers and public health alike: The lack of commercial incentives for new infectious disease meds and anti-infectives. Under the current reimbursement system for hospital-based pharmaceuticals in the U.S., it's "not advantageous to use a branded drug until you have no other option," Fitzhenry said, so the drugs struggle commercially.  

"We believe something has to happen because anti-infectives are important," Fitzhenry said. "Right now, there aren't the commercial rewards that we would hope for."