Physician Views: Are new data for Praluent practice changing?

Sanofi and Regeneron Pharmaceuticals presented long awaited data from the ODYSSEY OUTCOMES trial at the annual meeting of the American College of Cardiology (ACC) this weekend for the PCSK9 inhibitor Praluent. Results initially look similar to those presented for Amgen's Repatha, though ODYSSEY showed a sub-group of high-risk patients derived the greatest benefit from Praluent treatment.

Analysis - KOL Views Results: Leading cardiologist pleased with both ODYSSEY data and Praluent price cut and ViewPoints: ODYSSEY data, Regeneron/Sanofi strategic shift offer something for everyone.

Sanofi and Regeneron plan to target this subgroup and are ready to negotiate net price with payers to facilitate access.

To gauge potential impact, we are snap-polling US cardiologists with the following questions…

The ODYSSEY OUTCOMES trial met its primary endpoint, demonstrating that high-risk patients who added Praluent (alirocumab) to maximally-tolerated statins experienced significantly fewer major adverse cardiovascular events (MACE) compared to those on maximally-tolerated statins alone (a reduction in risk of MACE of 15%).

A more pronounced effect was observed in patients with baseline LDL-C levels at or above 100 mg/dL despite maximally-tolerated statins, who are at high risk of suffering a future event; in this group, Praluent reduced risk of MACE by 24% and was associated with a 29% lower risk of death overall.

In patients with LDL-C levels at or above 100mg/dL are these results practice changing?



Will data from the ODYSSEY OUTCOMES trial make you prescribe Praluent more frequently in patients with baseline LDL-C levels at or above 100 mg/dL despite maximally-tolerated statins?


Yes - Slightly

Yes - moderately

Yes - significantly

Will data from the ODYSSEY OUTCOMES trial make you prescribe Praluent more frequently in other patients you consider a candidate for PCSK9 inhibitor therapy?


Yes - Slightly

Yes - moderately

Yes - significantly

Taking into account your experience with the two PCSK9 inhibitor agents (Praluent and Repatha [evolocumab]) and these new data for Praluent, do you consider one of the products superior to the other?

No - they are interchangeable

Yes - Praluent (alirocumab) is superior

Yes - Repatha (evolocumab) is superior

Sanofi and Regeneron have also said they are willing to reduce to price of Praluent to between $4460 and $7975 a year for payers "to help ensure more affordable and timely access to patients most in need."

The reduced price - in alignment with a new value assessment for high-risk patients from the US Institute for Clinical and Economic Review (ICER) - will be offered to payers "that agree to reduce burdensome access barriers to high-risk patients," and will take a precision medicine approach, "focusing efforts on high-risk patients most vulnerable for future CV events, such as those who have suffered a previous coronary event and are unable to reduce their LDL-C below 100mg/dL despite maximally-tolerated statin therapy."

Which will have the biggest impact on any increase in utilisation of Praluent? - New CV outcomes data or new lower pricing?

New CV outcomes data

New lower pricing

Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

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