Physicians Are Already Excited and Willing to Prescribe PCSK9s

Doctors are already considering switching their patients from statins to PCSK9 inhibitors—and no such treatment has even been approved by the FDA yet.

Earlier this month, two separate FDA panels recommended the approvals of two PCSK9 inhibitors: Sanofi and Regeneron’s Praluent (alirocumab) and Amgen’s Repatha (evolocumab). If approved—and the FDA does not have to agree with the panels’ recommendations—this would represent the first new class of drugs to treat high cholesterol in decades. It also has the potential to disrupt the high cholesterol market, which has been dominated by statins since the late 1980s.

Following the announcements from the panels, market intelligence firm InCrowd conducted a survey of 113 physicians—50 cardiologists and 63 primary care physicians (PCPs)—and found that 47% of respondents are enthused, very excited or consider this to be a very promising class.  In fact, 18% said they would already consider prescribing a PCSK9 inhibitor as a replacement for a current therapy or in addition to a current medication.

Cardiologists More in Favor of PCSK9 Inhibitors

However, cardiologists seem much more excited about the potential new treatment compared to PCPs. While 76% of cardiologists highly agree with the statement, “Overall, I am very excited about the promise of PCSK9 inhibitors,” only 38% of PCPs felt the same. In terms of the clinical data presented to the FDA, 80% of cardiologists said that it showed PCSK9 inhibitors are impressively efficacious but only 32% of PCPs found the results to be equally impressive.

And while both groups of physicians are worried about the potential high cost of the drugs—some are predicting a price tag of $10,000 a year—PCPs are far more concerned than cardiologists regarding the increased administrative burden of prescribing this treatment (63% vs. 30%), the fact that PCSK9 inhibitors are only available as injectable medications (68% vs. 24%) and the side effects/safety profile (41% vs. 12%).

“The fact that the cardiologists are more excited makes sense,” explains Diane Hayes, Co-founder and President of InCrowd. “Typically, new drugs come to market for harder-to-treat patients first, and then once they get approved for that very particular population, you’ll see over time—if they really work and are effective and safe—the patient selection criteria begin to broaden. This will be a really interesting class to watch over time to see how much of the market picks up in the coming months and years.”

Physicians’ Take on the New Treatment

The doctors seem to agree with that assessment. Respondents indicated they are more likely to consider PCSK9 inhibitors for patients who are statin intolerant with type II diabetes (63%), statin intolerant with the need for secondary prevention (62%) or have familial hypercholesterolemia (61%).

“I am excited to start using this new class of drugs for high risk patients not to goal or statin intolerant patients,” explains Robert Kirk, MD, a cardiologist practicing in Syracuse and Pulaski, NY. “Everything I have read indicated dramatic drops in LDL.”

One respondent likes the potential of the treatment for another reason. “I have so many patients on statins that suffer serious side effects that I would welcome any new drug. The myositis, myalgia and rhabdomyolysis are just too frequent.”

Another predicts a bright future for this new class of treatment, “If outcomes data are favorable I think this is a blockbuster class. Provided the long-term safety is established, I see it becoming a major player.”

However, not all physicians are so positive. One respondent said, “Given the fact that they are expensive and administered by injection, I think that they will find minimal use. I am also not aware of any prognostic data. Just because they lower cholesterol, one cannot assume that they will decrease cardiovascular disease or improve survival.”

One physician believes that the drugs will likely prove to be more dangerous than studies show once they are used in huge numbers. Another said prescribing these drugs would be out of the question. “I cannot get the patients to take a pill let alone an injectable for a condition that does not hurt them, gives them no symptoms and has potential costs and side effects.”

However, even those who are interested in prescribing it don’t believe this would spell the end for statins. “I would not stop statin therapy in favor of PCSK9. There is a lot of evidence that statins do more than just lower cholesterol, stabilizing plaque. With some of my statin-intolerant patients, I may change them to PCSK9, but the majority of them would see it added to their current regimen.”

Meanwhile, others are already anticipating issues with trying to prescribe these drugs. One respondent said, “Given their cost, I expect major hassles in prescribing this class, including step-therapy requirements. Even with that, I expect patients will be left with a high co-pay to discourage use. I hope the drug manufacturers find a way to price this reasonably.”

And one physician thinks that pharma companies have to hold back on advertising these drugs directly to patients—at least in the beginning. “I think that this treatment should not be advertised to patients as they will come in seeking it in lieu of any other treatment. This should remain a physician decision until we develop familiarity with the drugs.”

But it is not all doom and gloom, as many physicians believe PCSK9 inhibitors can be a real game changer. One even said that this will “revolutionize lipid management.” The cardiologist added, “I have many patients at high risk who are intolerant of statins and cannot get anywhere near their goal. I also have many who are at maximum dose of statins and two other drugs and still are not at goal. This class of drugs will fill a large unmet need.”

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