Clinical value translates into commercial success, finds Trinity Partners study

Pfizer’s Ibrance was the star performer from the class of 2015 FDA approvals


It is common-sensical to find that a new drug with true clinical value is also one that is more successful commercially, but in these days of intense pressure on drug pricing, stern formulary decisions and the looming introduction of biosimilars, it’s nice to see the pharmaceutical innovation gets rewarded. For three years running now, the consulting firm Trinity Partners has conducted a fairly complex evaluation of industry portfolio decisions, looking at where companies placed their bets on new drug introductions.
For the class of drugs approved in 2015 (with Trinity allowing two years since approval for the commercial trajectory to be established), this year’s study finds the top drug to be Pfizer’s Imbrance oncolytic, followed by Janssen’s Darzalex (for multiple myeloma), Gilead’s Genvoya (HIV antiviral), Novartis’ Cosentyx (psioriasis) and AstraZeneca’s Tagrisso (oncolytic). (These are the top five; 23 other drugs were also evaluated.)

Trinity’s ranking of 2015 drug introductions (R&D investment not shown). Credit: Trinity Partners

Trinity Partners has developed a measure of strategic success that goes beyond merely toting up annual sales. The analysis combines cumulative (and projected future) sales; therapeutic value as measured by a comparison of existing standard of care for a condition (plus a poll of prescribers); and R&D investment (based on analyses of the scale and duration of clinical trials). The three together then calculate a cumulative 1-5 score (with 5 being top performance). Imbrance scored a 4.5; the lowest-performing drug, of those studied, was Amgen’s Imlygic oncolytic, at 1.5.

However, clinical value alone doesn’t get a drug across the finish line. 2015 was also the year that Sanofi’s Praluent and Amgen’s Repatha (both so-called PCSK9 anti-cholesterol drugs) were introduced, to limited commercial success. Trinity rated them 3.0 (Praluent) and 3.1 (Repatha). Although their clinical value seemed clearly demonstrated, payers balked at the relatively high prices of the drugs, in part because high cholesterol is such a widespread health condition. Price reductions and value-based contracts have followed; Trinity says “We will be watching these developments over the next few years” to see their effects.

“Based on this third annual index, we found commercial success to be dependent on a drug’s true clinical differentiation relative to the standard of care, or alternatively, indication expansions to widen the patient base,” said Leslie Sandberg Orne, senior partner at Trinity Partners. “This is the case even when introducing new products into already crowded markets: being able to adapt to the growing complications of the drug market proves greater success.” Ibrance, a kinase inhibitor indicated for breast cancer, did well as a first-of-its kind for its mechanism of action; Darzalex has four indications (only one of which is a monotherapy); and Genvoya combines medications to create a once-daily dosing schedule.