This weekend's annual meeting of the American College of Cardiology (ACC) was dominated by presentation of full data from Amgen's late-stage FOURIER study; while the PCSK9 inhibitor Repatha significantly cut the risk of cardiovascular events when added to statin therapy, results from the outcomes study arguably fell short of expectation – including those of cardiologists polled by FirstWord last month – Physician Views Poll Results: Cardiologists suggest magnitude of benefit seen with PCSK9s will be key to driving broader adoption of drug class.
With results now in hand, we are snap-polling US and EU5 cardiologists once again to assess their reaction to the FOURIER data and how access to the PCSK9 class has evolved over the past six months; results from an analysis presented at ACC also showed that nearly 80 percent of first claims were initially rejected during the first year that Repatha and competing product Praluent (marketed by Sanofi and Regeneron Pharmaceuticals) were available.
Specifically we are asking…
Detailed results from the late-stage FOURIER trial show that Repatha (evolocumab), when added to statin therapy, led to a significant 15-percent reduction on a combined measure consisting of hospitalisation for unstable angina, coronary revascularisation, heart attack, stroke or cardiovascular death. The study also found a significant 20-percent reduction in the hard major adverse cardiovascular event (MACE) composite endpoint of first heart attack, stroke or cardiovascular death. Furthermore, it was noted that "consistent with recent trials of more intensive LDL lowering, there was no observed effect on cardiovascular mortality."
What is your assessment of these data?
Neither impressed or disappointed
Also taking into account the cost of therapy, do you think these data will drive increased utilisation of Repatha?
No – utilisation will stay the same
Yes – slight increase
Yes – moderate increase
Yes – significant increase
Yes – very significant increase
Which specific data from the FOURIER trial do you think will most significantly drive increased utilisation? (single select)
15% reduction (p<0.001) in the risk of the extended MACE composite (primary) endpoint, which included hospitalisation for unstable angina, coronary revascularisation, heart attack, stroke or cardiovascular death
20% reduction (p<0.001) in the risk of the key secondary MACE composite endpoint of first heart attack, stroke or cardiovascular death (benefit started as early as six months and continued to accrue through the median 2.2 years of the study. Magnitude of the risk reduction grew over time, from 16% in the first year to 25% beyond the first year).
27% reduction in the risk of heart attack (nominal p<0.001)
21% reduction in the risk of stroke (nominal p<0.01)
22% reduction in the risk of coronary revascularization (nominal p<0.001)
Relative risk reduction for fatal and non-fatal heart attack or stroke of 19% in the first year (p=0.003) and 33% beyond the first year (p<0.00001).
Do you believe that a 20% reduction (p<0.001) in the risk of the key secondary MACE composite endpoint of first heart attack, stroke or cardiovascular death should broaden the label for Repatha?
Over the past six months prior to the publication of these outcomes data for Repatha, how has your access to the PCSK9 inhibitors changed?
Stayed the same
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.
As always, FirstWord would very much like to receive your feedback and suggestions. Note: FirstWord Polls are powered by MedePolls, a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties and over 100 markets. To conduct this poll with a different audience, or an entirely different poll, contact us at firstname.lastname@example.org
To read more Physician Views articles, click here.