When the first injectable medicines for lowering cholesterol were launched last year, Wall Street was looking for blockbuster sales. Instead, the products have, so far, been a disappointment. The price tags are high and some patients still resist injections.
So what will it take for these drugs, which are known as PCSK9 inhibitors, to ring registers?
The manufacturers are running clinical trials to measure the extent to which their medicines lower the risk of heart attacks and strokes. But cardiologists are more likely to prescribe the drugs if the trials show cardiovascular risks drop by at least 20 percent, according to a survey conducted last month by the Leerink brokerage firm.
“Positive data are likely to generate a significant increase in prescription volumes and reduce reimbursement barriers,” Leerink analysts wrote.
Their survey canvassed 59 cardiologists, half of whom reported that anything less than a 20 percent risk reduction would mean the drugs are not clinically relevant. The Leerink analysts believe the trials will succeed, but that risk reduction lower than 15 percent is “unlikely to be sufficient for commercial success.”
The drugs are approved for patients with a hereditary condition called familial hypercholesterolemia, or with heart disease but are not helped by statins, widely used pills that cost a few dollars a month. By comparison, Repatha, which is sold by Amgen (AMGN), has a list price of $14,100 a year, while Praluent, which is marketed by Sanofi (SNY) and Regeneron, costs $14,600.
The drugs must be taken indefinitely, which explains why payers have pushed back.
Within a few weeks after the product launched, the Institute for Clinical and Economic Review, a nonprofit organization that is influential in analyzing the cost effectiveness of medicines, declared that both PCSK9 inhibitors represented a “low” long-term value for patients at those prices. The group suggested the list prices should have been roughly half of what the manufacturers set.
In the pharmaceutical world, however, list prices are not what is actually paid. There are typically rebates and other forms of givebacks. So the drug makers began striking deals with pharmacy benefits managers, which maintain lists of drugs for preferred insurance reimbursement. The discounts, however, were not revealed.
In any event, sales have remained anemic.
Sales for Praluent were about $12 million between last July, when the treatment first became available, and this past February. And physicians wrote about 9,500 prescriptions, according to IMS Health, the market research firm. For Repatha, sales totaled roughly $16 million and nearly 11,800 prescriptions were written between last August and this past February.
The Leerink survey underscores the issue. Cardiologists do not view the drugs very differently from each other in terms of safety or efficacy. But insurance barriers are among the top reasons for not prescribing the PCSK9 inhibitors. Either some insurers do not cover one or both drugs, or insurers require patients to first try other medicines, a common tactic for lowering costs known as prior authorization.
Besides payer resistance, the companies have also faced marketing challenges. They are promoting expensive drugs to specialists, who are accustomed to prescribing low-cost pills — not pricey injectables — to needle-shy patients. As the Leerink analysts noted, “these barriers were anticipated prior to the PCSK9 launches but were not sufficiently considered in Wall Street or company expectations.”
Of the 59 cardiologists surveyed, 21 have no patients on Repatha and 19 have no patients on Praluent. The survey, however, found that could change if the risk reduction is met. By three years after the trial data is released, the physicians estimate that about half of their patients who do not benefit from a statin would be prescribed a PCSK9 inhibitor.
The trial data, by the way, will be released at different times. The results from the Amgen study are expected later this year, while the results from the study run by Sanofi and Regeneron are due next year, but a widely anticipated interim analysis is also due later this year.
An Amgen spokeswoman wrote us to say that its own survey of doctors found that patient reluctance to injections was not a “primary barrier to prescribing.” She added that internal company data showed that about 75 percent of patients – whose diagnosis was consistent with the FDA approved indication – were prescribed Repatha, but were denied insurance coverage “after numerous, lengthy appeals, sometimes taking up to several months.”
We asked Sanofi and Regeneron for comment and will update you accordingly.
This post was updated to include a response from Amgen.