Black box warning? No worries, Valeant bills Siliq as the ‘low-cost’ psoriasis alternative to rivals from Novartis, Eli Lilly

Joe Papa, Valeant

Valeant knew it wasn’t getting the best new injectable biologic for psoriasis when it went bottom-fishing at AstraZeneca and picked up brodalumab for $270 million in pre-launch cash and milestones. And now that it has the FDA’s approval to sell the drug as Siliq, Valeant is aiming at a pair of major league rivals by pricing at a slightly lower list price.

Valeant’s Patient Access and Pricing Committee — a recent creation of their crisis mediation efforts in the wake of a lingering price gouging scandal — set the public price of Siliq at $3,500 a month ($42,000/year).

That, boasted Valeant, is “the lowest injectable biologic psoriasis treatment currently on the market.”

The wholesale acquisition price is somewhat meaningless, in the sense that the real work now starts on coming up with a private discount price with payers. And Valeant will need to undercut Novartis’ Cosentyx, which was the first out, and Eli Lilly’s blockbuster contender Taltz, where it’s been charging hard at the market.

What’s holding the company back on price is the drug’s black box warning on suicidal thinking, a side effect that caused Amgen to simply wash their hands of their partnership and walk away. AstraZeneca did what it always does with a disappointing asset and sold it to the highest bidder in 2015.

Valeant has good reason to believe that physicians won’t be averse to using it. Their panel review came with a number of endorsements for this drug, which FDA experts saw as a viable addition to the arsenal of therapies for use against psoriasis.

“It seems to me the benefit for this drug has tremendous potential for these patients who are absolutely miserable,” said Harvard’s Lynn Drake, who sits on the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee, last summer. “I think we have a drug here that is at some levels a bit of a game changer.” As for the six suicides: “It’s a suggestion, not a signal.”

That’s exactly what Valeant wanted to hear last summer as the company picked up a unanimous vote in favor of approval.

“The Patient Access and Pricing Committee was constructed to help our company ensure patients have the best possible access to our products. Our goal with SILIQ is to provide outstanding efficacy while being the most affordable injectable biologic for patients with moderate-to-severe plaque psoriasis,” said Joseph Papa, chairman and CEO of Valeant.

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