W

hen 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.

advertisement

“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, has a list price of $14,100 a year, while Praluent, which is marketed by Sanofi 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.

Newsletters

Sign up for our Morning Rounds newsletter

Please enter a valid email address.

Leave a Comment

Please enter your name.
Please enter a comment.

  • It breaks my heart.
    Non profit NC insurer spends thousands on sports team sponsorships.
    My love and wife of 25 years can’t take Statins. The new injection drug makes a great difference in her life.

    Not rich enough to pay for it, not poor and dead enough to qualify.

  • These two phama companies are beginning tv advertising to try and generate significantly higher sales as yearly sales for both companies together were only $60M last year which is way to low for them to even begin to recoup their investments. As we all know, the main reason for poor sales is too high of a price and both companies know this. Basic business sense dictates a price to demand relationship. So, hopefully demand does not go up appreciably so that the price drops soon. I need this drug! I can possibly afford $200 per month but not $1200!

  • Why does the medicine have to cost so much? I need but the prices are exhorbitent. Pharmas just want to get rich of of people’s illness’s

  • Why produce a medicine that works for thousands of people, but make it so expensive that the normal American can’t afford it even with insurance??? I wonder if these drug manufactors even care that thousands die each year and all it would take is an affordable medication to prevent it. GREED, GREED, GREED, is all these Companies care about, not about healthy Americans.

  • The new drug Repatha, ok have heredity high cholesterol and CAD have had open heart surgery. Cannot see why if this would help why price is so high what are these people doing like hey we can help but if u arent a milionare just go ahead and die.

  • Maybe the manufacturers should look at spreading the R&D costs worldwide. Then MAYBE Americans will be able to afford these meds without having to get special approval from their insurance companies and MAYBE low income people who don’t have prescription coverage could afford to get these medicines from their local pharmacies.

  • I have been receiving Repatha free of charge the last few years. It has worked great with no side effects. In years past I have tried many statin drugs but had severe side effects. Now we are trying to get my Medicare Part D insurance to cover it and it won’t. They denied the prior authorization. I know there is the opportunity for appeal, but it appears that is pointless. I cannot afford $1200+ a month and we are slightly over the income limit to get financial assistance. I hope someone will come up with a better option to this dilemma.

  • My cardiologist just recommended me for Praluent. When I asked the cost of the injections, why did he not just tell me to have a heart attack! First insurance companies cannot bear the cost of such prices. Why would a pharmacy even make a drug that costs more than anyone in their right mind be able to afford over a long term course of treatment. I will have to put up with sores in my mouth and aching muscles on statins before I will make anyone pay for such crazy prices. Common pharmacies, get with the program!

  • I was on repatha and a low Staten. I have been on ever staten, never has My cholesterol in under 230. This time my cholesterol was 100 and I’m 56 years old. My shots for free through repatha however it did stop and expectedly now getting Insurance to pay for it keeps getting denied. there’s gotta be a better way to get this going for people like me

  • My husband has been dealing with hereditary heart-related issues for many years, is unable to tolerate statins, and is the owner of 20 cardiac stents, which are keeping his heart operational. It has taken over 6 months for our insurance company to finally approve his use of Repatha. We tried to get on a program for Praluent where they would cover his meds for a year while we waited for approval, but the program was suddenly cancelled one month into it. Really? These meds really do work and bring his cholesterol down to normal limits. Seems the insurance companies would rather shell out over $100K every year or so for stents and heart surgery for each patient rather than pay a measly $14K for a medication that works and will (hopefully) save a life and create a better standard of life for a person.

Sign up for our Morning Rounds newsletter

Your daily dose of news in health and medicine.

X