Revving up for price war with Amgen, Sanofi plots low-cost starter dose of PCSK9 med

Payers have promised a fight over the price of PCSK9 drugs, a new class of cholesterol fighters. Drugmakers in the field--including frontrunners Amgen ($AMGN) and Sanofi ($SNY)--prepared for that fight. And now, analysts think they've defined the battle lines.

It's about dosage and convenience--and price.

Sanofi and partner Regeneron ($REGN) plan to launch their entrant, Praluent, with a low-dose injection at 75 mg along with a 150-mg dose, both given every other week. Amgen is looking at a 140-mg injection of Repatha on the same schedule, plus a 420-mg dose to be given once a month.

University of Iowa epidemiologist Jennifer Robinson

Sanofi's lower dose will give patients, physicians--and importantly, payers--the option of starting with a less expensive option, or so the story goes. "Sanofi will say you can start off at this cheaper, lower dose," said University of Iowa epidemiologist Jennifer Robinson, who conducted research on Praluent (as quoted by Reuters). "If you don't reach the LDL goal, you can move up" to the 150-mg dose, at a higher price.

How much cheaper? Sanofi's not talking now, but Bernstein analyst Geoffrey Porges figures on a $5,000 annual price for the 75-mg version and twice that much for the 150-mg dose.

Porges sees Amgen putting that same $10,000-per-year price tag on Repatha, whether given biweekly or once a month. That pricing parity would give patients an incentive to go for the higher, once-monthly dose--and payers less reason to reject it.

Offering a lower dose isn't an option for Amgen, a company exec told Reuters, because the higher dose works better. "It goes back to the patients we are trying to serve--patients with elevated, very high LDL cholesterol," Scott Wasserman, Amgen's head of cardiovascular and metabolic therapies, told the news service. "We didn't feel that a low dose option would serve those patients."

Whatever the dosing strategy, Sanofi/Regeneron and Amgen will have to be willing to cut some deals. Right now, there's not much to differentiate the PCSK9 drugs from one another; though early data from outcomes trials suggest that Repatha and Praluent might cut CV-related events in half compared with regular statin therapy, but full data won't be available till 2017.

That means payers will treat them as interchangable--and use that fact to twist some arms, just as they did with the hepatitis C drugs some months ago. Pharmacy benefits manager Express Scripts ($ESRX) traded exclusive coverage on AbbVie's ($ABBV) Viekira Pak for a hefty discount, while rival PBM CVS Health ($CVS) inked an exclusive with Gilead Sciences ($GILD), also in return for a deal.

Earlier this year, CVS Health made headlines with a study concluding that the PCSK9 class could cost the U.S. as much as $150 billion per year. That puts the cost of hep C to shame. CVS used a top-end price of $12,000 per year and a broad definition of eligible patients to come up with that figure; other, more conservative estimates put the annual cost at $20 billion or so. In any case, $10,000 per year remains a lot of money for a cholesterol drug, presumably to be taken for years on end, compared with up to 12 weeks of hep C treatment or a year of cancer therapy.

- read the Reuters news

Special Report: Top 15 pharma companies by 2014 revenue - Sanofi - Amgen

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