The head-to-head fight for PCSK9 reimbursement ended in a tie. At Express Scripts, both Sanofi ($SNY) and Regeneron's ($REGN) Praluent and Amgen's ($AMGN) Repatha scored a spot on the preferred formulary, which gives both products a chance to snare the pharmacy benefits manager's patients.
Discounts on both meds, together with strict limits on patient eligibility, mean Express Scripts ($ESRX) can cover Praluent and Repatha without breaking the bank, the PBM said Tuesday.
That's not what analysts had expected--or what PBMs had promised ahead of the next-gen cholesterol fighters' approval. Worried about their enormous cost compared with standard statin therapy, Express Scripts and its archrival, CVS Health ($CVS), had raised red flags about billions in additional costs for the meds and promised a tough fight for discounts in exchange for formulary placement.
But the FDA did payers a favor: In approving both drugs, the agency stopped short of designating them for patients who can't tolerate statins. Instead, they're approved for patients with a hereditary form of high cholesterol, and those at high risk of heart problems who haven't responded to aggressive statin therapy.
|Express Scripts' Steve Miller|
Those guidelines opened the way for Praluent and Repatha to win spots on the Express Scripts formulary, CMO Steve Miller wrote in a blog post Tuesday. Before the first of the two hit the market, the PBM rolled out a system to strictly limit use, using "rigorous clinical documentation to ensure access to the right patients" and minimize "wasteful spending," the post states.
In fact, Express Scripts expects to spend about $750 million on PCSK9 drugs next year, "far lower than industry forecasts," Miller reports. He's not kidding; CVS executives published an analysis in JAMA projecting costs of up to $20 billion a year--or far more, if all patients with cholesterol problems were put in line for therapy.
Formulary placement can change in time, of course, as Miller reminds his readers. Praluent and Repatha may end up in a hand-to-hand fight in a few years, when cardiovascular outcomes data on both meds become available. If their cholesterol-lowering prowess does translate into actual reductions in heart attacks and strokes, the FDA says it might be willing to broaden their approvals to statin-intolerant patients, a much bigger market. More patients, higher costs--and probably, more pressure for discounts.
In the meantime, it will be a standard market-share contest between drugs with similar benefits and almost identical FDA indications. For their part, Sanofi and Regeneron say they're pleased with the decision.
The two companies are "confident in the value that Praluent … provides to appropriate patients and the overall healthcare system, and are pleased that patients in the U.S. now have increased access to [it]," they said in a statement. "We are committed to ensuring appropriate patients can access medicines that improve their health, and we are dedicated to establishing agreements with insurers to help achieve that goal."
- see the post from Express Scripts
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