A new class of cholesterol drugs is coming to market, and these novel therapies carry with them mind-boggling price tags. CVS Health (NYSE:CVS) is in the middle of the action, recently releasing a statement that its pharmacy benefit management segment will wait for the second of these drugs to be approved before making coverage decisions.
Meanwhile, speaking of ballooning costs, the Affordable Care Act is about to increase the fee slapped on Americans without health insurance. But is this fee still less than the cost of buying in to a health insurance plan? Motley Fool analysts discuss these issues and more on this week's episode of Industry Focus: Healthcare.
A full transcript follows the video.
Michael Douglass: One way you don't want to keep up with the Kardashians -- this is Industry Focus.
Hi, Fools! Healthcare analyst Michael Douglass here today. It's Wednesday and we're talking about healthcare. Lots of interesting news and headlines. I'm joined, as always, by long time contributor Todd Campbell and by my fellow healthcare analyst Kristine Harjes. Welcome, everyone.
Let's jump right in. The first and probably least important one of the bunch but one that was just far too interesting to not bring up and lead off with. The FDA has sent a warning letter to Kim Kardashian. On her Twitter, she promoted this morning sickness drug called Diclegis. In doing so she didn't mention the drug to drug interactions and safety issues. She only spoke about its effectiveness and how useful it's been for her.
The company Duchesnay Inc. got a warning letter from the FDA about this Kim Kardashian tweet proving that the FDA is definitely monitoring this social media world. Quick takes; Todd, what do you think?
Todd Campbell: I think it just goes to show that you need to follow the tweets of all the Kardashians until you get all the news that you possibly can on various drugs that are on the market.
Kristine Harjes: We're not just talking Twitter. We're talking Instagram, Facebook -- they're all over it. To be fair, she did point out that they have a website, that there is safety info, but apparently that isn't sufficient. My takeaway on this is I hope that Kanye is ready to go to bat for her and tell the FDA if the pill isn't killing anyone, it's only making them stronger.
Douglass: She just quoted a Kanye song. Folks, that's a wrap! I'm just kidding. Let's head into some of our other news. Interestingly, CVS has decided to delay negotiating with Regeneron (NASDAQ:REGN) and Sanofi about their PCSK9 inhibitor, Praluent, until there's an FDA decision about the competitor drug Repatha. Todd, give us a little background on PCSK9 drugs and set the stage for these conversations?
Campbell: Sure. This is a lot like what we saw a year and a half ago when Sovaldi first came to market. It was a hepatitis C drug with a very high price, $1000 pill, lots of media attention; it kicked off that whole debate on how much drug companies can charge for drugs and how much they should be charging for drugs, and if we should be paying for that.
PCSK9 inhibitors are cholesterol-busting drugs. For two decades, we've been using statins to help control cholesterol and prevent heart attack and stroke. Statins don't do a good job for everybody. Of the 36 million people who take statins, roughly one-third of those people aren't controlling their cholesterol to the level that their doctors would like to see.
Companies like Regeneron and Amgen -- who has another drug coming up with the FDA on August 27th -- develop this new class of drugs that can be used alongside statins to reduce cholesterol even further. Once they receive approval form the FDA to begin marketing this new drug Praluent, they set a price tag of $14,600. That's an eye-popping sum for a drug that could be used by millions of people.
Douglass: Especially when you consider the fact that this drug is not curing cholesterol. This isn't a one and done kind of drug. This is a drug that will likely be taken for years. You think about that from the profitability side of the company and that obviously looks very nice for them, but for a pharmacy benefit manager like CVS, or anyone concerned about drug spending, it becomes a bigger problem.
Let's face it, CVS had previously guided that PCSK9 drugs could be the highest-selling class of medicine in history, just in terms of the amount of money that will have to be spent.
Harjes: I'll add that CVS released something in February that projected this class could end up bringing costs of $150 billion annually to the U.S. healthcare system. That's an exorbitant number. That was based on an estimate of selling these drugs for $12,000 a year, which is actually less than they're going to be sold for now.
Douglass: Right. That's certainly a big bunch of numbers and that just rehighlights the debate we continue to have in the country about drug pricing and what an appropriate price, or the "juice for the squeeze" for payers. Todd, what's your take? Was this a good move by CVS?
Campbell: Yes and no. This is a move they have to make. They operate a pharmacy benefit management company that helps insurers and employers control drug costs. They serve 70 million patients through that pharmacy benefit manager. It's their responsibility to the insurance company clients, to the employer's customers, to negotiate the cheapest price they possibly can. You could argue that their attempts to control pricing may not trump the need for someone to get access to this drug.
I could see where doctors would say, "Don't tell me how to prescribe. If I feel like my patient needs to have this drug to lower cholesterol, don't tell me it's too expensive. Cover it." There could be pushback from patients and doctors to CVS, just as CVS is pushing back against Regeneron on the cost of these drugs.
We did see some of that play out last year. Gilead (NASDAQ: GILD) was pretty effective in being able to communicate the advantages of taking hepatitis C medications, as far as delivering functional care. Through negotiations and everything else that's fallen out, those drugs are getting more and more widely used. I would assume the same thing will play out here in this class of drugs.
Without a doubt, though, the sales that could come from these drugs trumps anything else that we've seen up to this date.
Douglass: Kristine, what's your take?
Harjes: I think one thing that needs to enter the conversation is the long-term cost savings that we could be seeing here where, even if you're spending this tremendous amount of money on managing cholesterol, the trade-off there is that you're avoiding the much more expensive complications that could come down the road.
That's the same thing you see in the argument from Gilead Sciences, and companies that make these very expensive hepatitis C drugs. They're pointing out that, if they're saving people from needing a $500,000 liver transplant down the road; the cost is somewhat justified.
Douglass: It's a complicated and difficult set of issues. I think this really highlights in healthcare that so much of what's going on in healthcare depends on what's going on with government regulations. In a lot of ways, that's kind of a black box. There are a lot of things that could come down the pike and not come down the pike.
When you think about the Medicaid expansion and the Affordable Care Act -- which we'll be talking about next, so stay tuned -- but it's difficult to plan for a lot of these things. That's one of the things that makes healthcare so difficult to model for and understand long term. It's also one of the reasons why investments over the long term in healthcare is so important.
More on that as we know more. Let's hop over to one of the other big healthcare stories of the past six years now; the Affordable Care Act. Obamacare. The biggest thing you need to know about Obamacare in 2016. Open enrollment is less than three months from now and penalties are going to jump again. Todd?
Campbell: If you haven't signed up for insurance through healthcare.gov, or the state exchanges, you might want to consider doing it because the stick is going to get a lot thicker and more painful in 2016 than it was last year. Last year, the IRS says that 7.5 million people worked over a combined $1.5 billion in penalties for not having health insurance that allows them to avoid the Obamacare penalty.
That was based on a fine of $95 per adult, or 1% of income. In 2016, it's going to be way higher than that. It's going up to $695 per adult, or 2.5% of income, whichever is greater.
Douglass: That's definitely a much bigger number. There are other factors in this, too. Kristine?
Harjes: One of the things to think about is, when an individual is faced with this decision of "Do I bother to get healthcare?" If you're someone that doesn't like this mandate, you don't feel like you need to get your own health insurance, you think it's too expensive -- that's actually not a bad point. When you compare the amount that people are paying for these health plans to what the penalty is, you actually end up having an odd comparison there.
If this penalty is going up to $325 per adult, or 2% of income, even if it jumps in 2016 to $695 per adult or 2.5% of income, that doesn't compare to the costs of even the cheapest plan that you could get. The average premium of a plan purchased on the marketplace during Obamacare's first open enrolment period was $82. This was after a bunch of cost assistance.
If you multiply that by 12, you end up with $984 per year. That's $984, compared to $695.
Douglass: Of course, on the flip side, if someone gets sick, if someone needs to visit the doctor; there is that trade-off where you're suddenly paying the uninsured rate, rather than the insured rate. Instead of a $20 copay, it would be a couple hundred dollars for some things. It very much depends on the person and their circumstances.
Me, personally, I have always tended toward thinking that it's better to be safe than sorry when it comes to insurance. Of course, everyone has to make their own decisions. Here at The Motley Fool, we'll be covering what's going on with Obamacare. It's certainly been a big win in terms of driving down the uninsured rate, and in terms of benefiting insurers and hospitals.
I think one of the big long-term questions is going to be: What does it actually do for quality of care? There are a lot of ways that the law is working, including the Accountable Care Organizations -- which we've talked about from time to time here on the podcast. There are a lot of different opportunities to see what we're doing in terms of helping people get healthier. That's going to be a big thing for us to watch in the ACA moving forward. Todd, Kristine, thanks for your take. Todd as always, Kristine, not as often. That's going to be changing.
Folks, a little bit of housekeeping for you here. Following up an announcement that was made on Monday's financials Industry Focus podcast -- which is an excellent podcast with John Maxfield, our senior banking specialist -- if you haven't listened to it, be sure to listen.
We are shifting our Industry Focus personnel around a bit. Gaby Lapera is going to be working with John in the financials Industry Focus on Mondays, and Kristine Harjes is going to be taking over my position and working with Todd in healthcare. It has been a real honor and pleasure to be in this podcast since its inception of Industry Focus late last year, and to work with you, Todd, throughout the time.
I know, dear listeners, that I am leaving you with someone who has a lot fewer vocalized pauses than I do and cares about healthcare just as much and just as deeply. Kristine has really done a great deal to make sure that we're answering and focusing on listener questions, so please send those along. She loves getting them. IndustryFocus@Fool.com.
Todd, thanks for the memories. It's been a fantastic run. I still intend to be here regularly as a special guest. Kristine has very kindly allowed me to drop in. So I will still be here regularly, but perhaps not quite as regularly. With that, I think we're done today. Stay tuned for Industry Focus tomorrow; it's energy. I will be filling in with Tyler Crowe.
If you fear missing my voice, you'll certainly hear it again tomorrow, for better or for worse. Kristine's rolling her eyes in the studio. Thanks much, all. Fool on! As always, remember that folks on the show may have positions in stocks that we discuss and The Motley Fool may have formal recommendations for or against stocks that are discussed on the show, or may own stocks mentioned on the show.
So, as always, please don't' do anything based just on what you hear. Do your own research, do your own due diligence. It's the Foolish way and it's the best way to invest. Thanks.
Kristine Harjes and Todd Campbell own shares of Gilead Sciences. Todd also owns shares of Twitter. The Motley Fool recommends CVS Health. It recommends and owns shares of Facebook, Gilead Sciences, and Twitter. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.