Survey shows doctors ready for PCSK9s
Although the two PCSK9 inhibitors still need the FDA's approval to hit the market, a poll by marketing analytics firm InCrowd indicates that physicians are ready to prescribe the experimental cholesterol-lowering drugs.
The poll also showed that enthusiasm for these injectable treatments varied by professional specialty. The new medications represent the newest cholesterol treatment since statins, which became a blockbuster market that included drugs like Pfizer's Lipitor.
The survey of 113 physicians showed that 76% of the 50 surveyed cardiologists planned to prescribe PCSK9 inhibitors for 10% of their patients as a monotherapy and would use them as add-on treatments for 16% of their patients. Further, 44% of cardiologists told InCrowd they would prescribe the drugs as soon as they could and 80% said the clinical-trial data was impressive.
In contrast, only 32% of primary-care physicians were won over by the clinical-trial data and 8% said they were ready to prescribe the new medications once they become available. InCrowd explained PCPs were included in its poll because they write more than half of the prescriptions that help patients manage high cholesterol.
Diane Hayes, an epidemiologist and InCrowd co-founder, told MM&M that the split between cardiologists and PCPs makes sense because generally healthy patients with high cholesterol may choose to work with a PCP to manage their cholesterol, whereas harder-to-treat patients, who may also be juggling additional health issues such as high-blood pressure, may be more likely to end up being treated by a cardiologist.
An FDA advisory committee endorsed Sanofi and Regeneron's PCSK9-inhibitor Praluent on June 9 and Amgen's Repatha on June 10. The FDA is not bound by committee decisions, but it is common for the FDA to agree with panel recommendations.
The poll also showed that doctors are less reserved about the drugs' potential than the FDA advisory committees are.
The committees recommended that the drugs be prescribed for hard-to-treat patients with heterozygous and homozygous familial hypercholesterolemia, genetic conditions associated with high cholesterol and heart attacks at a young age, but 34% of surveyed physicians said they thought these experimental medications should be limited to this small pool of patients. The expectation that the drugs could be valuable for a wider swath of patients has had pharmacy benefits managers on edge for some time. CVS Health said in February that PCSK9-inhibitor prescriptions for hypercholesterolemia patients would be a $16.4 billion market, and prescriptions for a broader range of conditions would increase that value by between $50 billion and $100 billion.
Price is another issue. Jefferies analyst Eun Yang said in a research note last week that she expects Amgen's Repatha to cost $10,000 a year. About 79% of polled physicians told InCrowd that they expect the anticipated high prices of the therapies may prevent patients from filling prescriptions.
Hayes said she was not surprised that doctors said they were concerned about price and said there was a similar reaction when statins were first approved in the late 1980s, when the FDA approved Merck's lovastatin in 1987. However, she said an effective treatment sometimes needs time to capture market share as patients and physicians discover whether the drug will in fact lower bad cholesterol and potentially lower the risk of cardiovascular events. “I think the market absorbs it over time and I think it is hard to push back if it in fact is working,” she said.
The FDA committee's recommendations last week were based on data that the pharmaceutical companies are compiling about these drugs. Sanofi and Regeneron and Amgen continue to run trials about their respective drugs that assess the impact the experimental medications have on measurements such as cardiovascular outcomes or how they may affect patients with diabetes.