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A new survey completed within hours after the US Food & 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% 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.
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.
If drugs such as Praluent™ (Sanofi-Regeneron) and Repatha™ (Amgen), which use injected monoclonal antibodies that inhibit the PCSK9 gene, achieve FDA clearance and became available on the market, the cardiologists and primary care physicians (PCPs) surveyed would immediately prescribe them to 7% of their patients as a replacement for their present medications, and to 11% 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% saying they were very excited about the promise of PCSK9 inhibitors and on average planned to prescribe them for 10% of their patient base as a solo treatment and to 16% 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%), Zocor® (24%) and Crestor® (23%). In a further sign of receptivity, 44% of cardiologists agreed that that would begin prescribing PCSK9 inhibitors as soon as they were approved, compared with 8% of PCPs. In addition, 80% of cardiologists agreed that the clinical data to date has been shown to be impressively efficacious, compared with 32% 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% 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%) than PCPs (68%). Interestingly the side effects and safety profile of the new drug category was not a significant issue for most doctors – in fact 20% 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 – results largely reiterated survey results on the types of conditions for which the physicians would prescribe PCSK9 inhibitors -only 34% of all doctors surveyed believe PCSK9 inhibitors should be restricted to high-risk patients. Some 47% 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 execs, and related life sciences experts.
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