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Doctors would opt for new PCSK9 inhibitor drugs today if FDA approves their use
BOSTON—A new survey completed within hours after the U.S. Food and Drug Administration (FDA) hearings this week on two new PCSK9 inhibitors for reducing LDL cholesterol—the first new class of cholesterol-reducing drugs in decades—shows that doctors already are considering prescribing the drug to 18 percent of their patients, with many regarding the drug class as a "triumph of modern genetic engineering," while also mindful of the drugs' cost, injectable-only delivery and lack of outcomes studies until 2017.
“Overall they [PCSKs] provide a useful option for patients who are statin intolerant or who have HoFH [homozygous familial hypercholesterolemia]," says Dr. David Kong, a cardiologist at Duke Medical Center in Durham, N.C.
Data compiled by InCrowd, provider of real-time market intelligence to life sciences firms, represent the first analysis to quantify the expected shift in prescribing patterns represented by the new drug class.
On its website, InCrowd promises that healthcare professionals can “In less than two minutes … provide your expert opinion on important issues facing the healthcare community. Your valuable contributions will influence the future of medicine, you’ll earn rewards and gain access to expert opinions from your colleagues.”
If drugs such as Praluent (Sanofi-Regeneron) and Repatha (Amgen), which use injected monoclonal antibodies that inhibit the PCSK9 gene, achieve FDA clearance and become available on the market, the cardiologists and primary care physicians (PCPs) surveyed say they would immediately prescribe them to 7 percent of their patients as a replacement for their present medications, and to 11 percent of their patients as an addition to their therapeutic regimen. PCP sentiment was tallied because they represent the front line of cholesterol reduction and prescribe over half of drugs for treating high cholesterol. Survey respondents treated an average of 155 patients per month with high cholesterol in their practices.
Cardiologists were especially enthusiastic, with 76 percent saying they were very excited about the promise of PCSK9 inhibitors and on average planned to prescribe them for 10 percent of their patient base as a solo treatment and to 16 percent of their patients in addition to patients’ existing drug therapy. Most patients that the doctors would move to the new PCSK9 inhibitors are presently on statins such as Lipitor (40 percent), Zocor (24 percent) and Crestor (23 percent). In a further sign of receptivity, 44 percent of cardiologists agreed that that would begin prescribing PCSK9 inhibitors as soon as they were approved, compared with 8 percent of PCPs. In addition, 80 percent of cardiologists agreed that the clinical data to date has shown impressive efficacy, compared with 32 percent of PCPs.
"This is groundbreaking therapy—a real game-changer," said one doctor, while others said it would "revolutionize treatment for familial hypercholesterolemia" and give options to the statin-intolerant.
Patient cost was the #1 expected barrier to prescribing the drugs and was cited by 79 percent of respondents, with numerous comments on its "extreme pricing" similar to the early days of statins. Injection dosing was also a concern—"I cannot get the patients to take a pill, let alone an injectable for a condition that does not hurt them," one respondent said—although markedly less to cardiologists (24 percent) than PCPs (68 percent). Interestingly, the side effects and safety profile of the new drug category was not a significant issue for most doctors—in fact 20 percent of cardiologists cited side effects and safety as either a very low concern or no concern at all.
Regardless of FDA recommendations that Praluent and Repatha be used for harder to treat hetereozygous and homozygous familial hypercholesterolemia, only 34 percent of all doctors surveyed believe PCSK9 inhibitors should be restricted to high-risk patients. Some 47 percent agreed that the PCSK9 inhibitors will satisfy previously unmet major needs in treating high cholesterol.
The survey included 113 physicians—50 cardiologists and 63 PCPs—who are part of InCrowd's 1.8 million member "Crowd" of verified health care professionals. Respondents answered the microsurvey during a several-hour time window Wednesday June 10, the majority of which were completed on physicians' mobile devices. InCrowd's "Crowd" includes a host of other physician clinical specialties groups, nurses, hospital executivess, and related life sciences experts.
Although InCrowd assists 18 of the top 20 pharmas in the world plus other life science firms, InCrowd performed the survey as an independent assessment of prescriber sentiment and not at the request of any interested party.
"We're delighted to help quantify what the medical community thinks about this exciting new class of drugs, and the changes it may bring to the pharmaceutical industry," said Diane Hayes, co- founder and president of InCrowd.
InCrowd provides real-time market intelligence from validated experts, connecting life-sciences companies directly with prescribers, patients, and other screened and validated healthcare professionals around the globe. Our easy-to-use proprietary web-based application allows clients to ask questions of specific respondent groups—"Crowds"—in the form of two- to five-minute online microsurveys. Responses are available in real time through a password-protected account, with the needed answers delivered within hours or days, not weeks and months.
Today, InCrowd has 18 of the top 20 pharmaceutical firms as customers and has just finished its most successful quarter in company history with a record number of answers delivered to clients. Through its powerful mobile microsurvey methodology and analytics engine, InCrowd enables clients to reach 1.8 million healthcare professionals on-demand throughout the United States and around the globe in 20 languages.