Sanofi and Regeneron Pharmaceuticals said results from the ODYSSEY OUTCOMES trial presented at the American College of Cardiology's annual scientific session (ACC) showed that Praluent (alirocumab) significantly lowered the risk of major adverse cardiovascular events (MACE) in high-risk patients, and was associated with a lower death rate. The companies also indicated that, based on input from the Institute for Clinical and Economic Review (ICER), they plan to offer discounts of up to 69 percent in exchange for insurers and pharmacy benefit managers expanding their coverage of the PCSK9 inhibitor.
"Today, we have made the opening move and we challenge payers to respond by making Praluent readily accessible to high-risk patients," stated Regeneron CEO Leonard Schleifer. Specifically, the companies indicated that they will seek to renegotiate their contracts with insurers by offering rebates and discounts for Praluent that would bring the US net price per patient between $4500 and $8000 annually, down from its list price of $14 600.
The ODYSSEY OUTCOMES trial evaluated the effect of Praluent on the occurrence of MACE in 18 924 patients who had experienced an acute coronary syndrome a median of 2.6 months before enrolling, and who were already on maximally-tolerated statins. Participants, randomised to receive either Praluent or placebo, were treated for an average 2.8 years, with some being treated for up to five years. The drugmakers said the study was designed to maintain patients' LDL cholesterol (LDL-C) levels between 25 mg/dL and 50 mg/dL, using two different doses of Praluent.
Results demonstrated that the MACE composite endpoint, which includes myocardial infarction, ischaemic stroke, death from coronary heart disease (CHD) or unstable angina requiring hospitalisation, was reduced by 15 percent in Praluent-treated patients, compared to those on maximally-tolerated statins alone. Further, Praluent was associated with a lower risk of all-cause mortality and there were also numerically fewer CHD deaths.
In addition, Sanofi and Regeneron noted that there was a "more pronounced effect observed" among patients whose baseline LDL-C levels were at least 100 mg/dL, with Praluent reducing the risk of MACE by 24 percent, while a post-hoc analysis of this group showed that the drug was associated with a 29-percent lower risk of death overall. Meanwhile, the companies reported there were no new safety signals in the trial, as well as no differences in neurocognitive events or new-onset diabetes between the groups.
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Elias Zerhouni, president of Sanofi's global R&D unit, remarked that "not all patients with heart disease are the same. Through this trial, we have been able to identify high-risk patients treated with optimal statins who still have an urgent need for additional treatment options." He added that "with nearly 90 percent of the patients in this trial on high-intensity statins, the data demonstrate that a precision-medicine approach in the field of cardiovascular disease may further advance how we better treat high-risk patients."
Analysts had expected that PCSK9 inhibitors such as Praluent, which was approved in the US and EU in 2015, as well as Amgen's Repatha (evolocumab), also cleared in 2015 in both the US and European markets, to quickly generate $1 billion or more in annual sales. However, Praluent garnered $194 million in worldwide revenue last year, while Repatha recorded sales of $319 million.
Amgen, which last year presented late-stage results from the FOURIER outcomes study showing that Repatha also significantly cut the risk for cardiovascular events, unveiled data at this year's ACC conference suggesting that an estimated 65 percent of patients requesting PCSK9 inhibitors were denied access. Schleifer echoed the sentiment, saying a majority of those prescribed Praluent do not actually fill their prescription. "Enough is enough," he said, ICER's analysis "represents a good faith assessment of [Praluent's] value to patients… We're willing to work in their [price] range, providing that payers agree to reduce their burdensome barriers for patients." However, Schleifer indicated that the exact discount that insurers receive will hinge on how much they loosen restrictions on who gets the drug.
ICER president Steven Pearson remarked that the move to adopt the institute's recommended price range for Praluent reflects the growing scrutiny on drug costs. "This never would have happened three, four years ago," he said, adding that "the conversation that needs to happen is, can value-based pricing be successful in the marketplace. They have to show this is a successful business model." Meanwhile, Express Scripts' chief medical officer Steve Miller said the pharmacy benefit manager is "anxious to see the new [ODYSSEY OUTCOMES] data and re-examine our criteria to see if they're still relevant."
For related analysis, see KOL Views Results: Leading cardiologist pleased with both ODYSSEY data and Praluent price cut.
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