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.

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“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.

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  • I was put on repatha and it was a disaster….not enough trials, I was not put on a statin along with drug….after 4 months, I was so sick with side effects that I stopped the drug . I also had withdrawal problems and I have never seen any conclusion that withdrawal can also have continued side effect problems…The co-pay cost was ridiculous for a drug that has not been studied long enough and the incubation really put me off…..incubated in the genetically engineered ovary cells of Chinese hamsters…..that’s not a conducive marketing ploy….I could not get any help from amgen or repatha ready financially for the cost of my copay….their restrictions are ridiculous…I am so disgusted with big pharma and their lack of empathy for seniors especially…keep us alive with all of these drugs but make them unfordable…..

  • I have had a wonderful response to my use over the last 2 years with Repatha 140mg injectable. My LDL has stabilized between 64 and 68 and I have had no bad reactions with these injections twice a month. It’s a shame that my health has been comprised by my failure to afford the price monthly for this much needed medication.

  • My new prescription for Repatha has at this time been denied. I have taken every statin on the market and found I am allergic to them. I have a serious case of high cholesterol and have had surgery to clear my right Carodid artery. I need this medicine.

  • I suffer from familial B hyperlipidemia. My uncle passed at a young age from a heart attack due to the effects of the genetic disorder. My cholesterol was over 400 at age 4 and has not had any improvement on stations which I have been taking for the last 27 years.

    I have developed neurological issues thought to be linked to extended statin use. I was finally prescribed praluent and within 3 months of use my total cholesterol dropped from 427 to 234. It works wonderfully but it is expensive and requires constant appointments with a specialist which I cannot afford. Because of the high cost I fell off this medication and my cholesterol has shot back to over 400 and I have been experiencing several heart related issues.

    Please, save my life and make this drug affordable. Insurance only covers so much, I cannot imagine what is in this injection that creates a cost of $1,000 per month or $500 per shot.

  • I have had Two heart attacks tryed 5 or 6 different Staten I have severe foot and leg pain do you know of anything that might help . I am now on Repatha which has lowered my I D L by about 60%

  • I used staten drugs for several years it has caused severe foot and leg pain will either one of these drugs help my condition

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