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PCSK9 Inhibitors after FOURIER Survey

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May 19, 2017
We conducted an eight-question survey of 33 US cardiologists to gauge their views of Repatha's (AMGN, Astellas) FOURIER cardiovascular outcomes trial (CVOT) results, presented at the recent American College of Cardiology conference, as well as how it will impact their long-term prescribing of PCSK9 inhibitors under various scenarios for insurer prior authorization (PA). While the main endpoints of FOURIER showed a modest benefit, investigators attributed this to the relatively short length of the trial and provided landmark data indicating that results may in fact be consistent with what would be expected from the LDL-C lowering. The respondents included 23 cardiologists who were already familiar with current PA, and given current low usage of the class, an additional 11 cardiologist low prescribers. In a separate survey of 13 US cardiologists, we assessed views on pipeline drugs inclisiran (MDCO, ALNY) and oral ETC-1002 (ESPR).

Survey questions and additional resources are listed further below.

If you are a KOL Insight Subscriber, please access the survey from our KOL Insight portal (Subscribers only).

Biomedtracker will be offering KOL Reports and Physician Pulse Surveys for purchase a la carte, or access to all reports and surveys can be purchased as a subscription to KOL Insight. For more information on KOL Insight subscription, please email Biomedtracker or call Biomedtracker Client Services at (858) 200-2357.

For our disclosures, please read the Biomedtracker Research Standards.

Survey Questions:

  • What percent of your patients with atherosclerotic cardiovascular disease (ASCVD) do not meet your LDL-cholesterol (LDL-C) goals with oral anti-dyslipidemia drugs (that is, prior to any patients receiving a PCSK9 inhibitor)?

  • Of your patients with ASCVD who are not meeting your LDL-C goals on oral drugs (that is, prior to any patients receiving a PCSK9 inhibitor), to what percent do you prescribe a PCSK9 inhibitor (including both those approved and denied by insurance). Please use this definition of "prescribe" in future questions.

  • Of the patients to whom you prescribe a PCSK9 inhibitor, what percent are approved by insurance?

  • In the FOURIER cardiovascular outcomes trial (CVOT), the PCSK9 inhibitor Repatha reduced LDL-C by 56 mg/dl compared to placebo from a baseline of 92 mg/dl, and improved cardiovascular outcomes as per the table below. The figure below that compares data from FOURIER with expectations from the CTT statin meta-analysis per 1 mmol/L LDL-C change. Please select which statement best reflects your views on whether the reduction in CV events in FOURIER is consistent with the degree of LDL-C reduction.

  • Referring to the Repatha data in the previous question, please describe how you view the CV outcomes benefit, selecting a response from below that comes closest to your view. Assume a CV indication is added to Repatha's label, and no safety issues are found in practice.

  • Assume Praluent's CVOT results are similar to Repatha's, both receive a label indication for reducing CV events and guidelines recommendations, and both are safe. Assume insurance prior authorization does not change much and cost stays the same. In the long term, to what percent of your ASCVD patients not meeting your LDL-C goals on oral drugs will you prescribe the PCSK9 inhibitors?

  • Now assume that NO chart documentation is required for prior authorization. You still need to submit a form, but you only need to check boxes about conditions. In the long term, to what percent of your ASCVD patients not meeting your LDL-C goals on oral drugs will you prescribe the PCSK9 inhibitors?

  • Now assume that NO prior authorization is needed at all. In the long term, to what percent of your ASCVD patients not meeting your LDL-C goals on oral drugs will you prescribe the PCSK9 inhibitors?

    • Follow up question for those with low projections if PA is no longer needed: In a prior Quick Poll, you were asked about projections for PCSK9 inhibitor use with different insurance scenarios given Repatha's FOURIER CVOT results, assuming Repatha and Praluent had CV indications in their labels and guidelines recommendations. In the scenario where prior authorization was no longer needed, you had projected prescribing PCSK9 inhibitors in <10% of your ASCVD patients not meeting LDL-C goals. Please select the reasons why you would not prescribe the drugs more in that case?

  • Inclisiran inhibits production of PCSK9 long term using RNAi. Assume it is given subQ with a pen injector only 2 times/year yet has the same LDL-C lowering, safety, and tolerability as Repatha/Praluent, and that its CVOT shows a CV benefit consistent with its LDL-C lowering. Assume all are labeled for reducing CV events and recommended in guidelines. In the long term, of your patients who you intend to prescribe a PCSK9 inhibitor for the first time, what share will each of the following receive?

  • Now assume that the LDL-C lowering for inclisiran is 40-50% rather than being similar to Repatha/Praluent, which can lower LDL-C by 50-60%, and that inclisiran's CVOT results correlate with the degree of LDL-C lowering. Given this difference from the prior question, in the long term, of your patients who you intend to prescribe a PCSK9 inhibitor for the first time, what share will each of the following receive?

  • Assume again that inclisiran's LDL-C lowering is similar to Reptha/Praluent. Inclisiran's CVOT could have features (higher baseline LDL- C, longer treatment) so the primary endpoint may show a larger benefit than Repatha's FOURIER or Praluent's CVOT, even though the actual CV benefit for degree of LDL-C lowering could be similar. If this happens, how will the numerically larger CV benefit impact your prescribing of inclisiran and other PCSK9 inhibitors?

  • ETC1002, an oral drug, inhibits ATP citrate lyase a couple steps upstream from the enzyme inhibited by statins. It lowers LDL-C by 20- 22% added to statins, up to 30% as monotherapy, and 48% in combination with ezetimibe. Assume there are no safety issues. In the long term, of your ASCVD patients not meeting your LDL-C goals, what % do you expect to treat with ETC-1002 in each of the below separate scenarios? RESPONSES ARE INDEPENDENT OF EACH OTHER AND DO NOT NEED TO SUM TO ANY PARTICULAR VALUE

Indications Covered: Dyslipidemia / Hypercholesterolemia
 Additional Resources: