Attempts to repeal and replace the Affordable Care Act dominated healthcare headlines in the first half of 2017, but there was plenty of other healthcare news that moved stocks higher and lower this year. For instance, advances in gene therapy pushed us closer toward personalized and precision medicine, the FDA's Scott Gottlieb orchestrated a restructuring that's accelerating drug development, and the nation's biggest e-commerce company flirted with getting into the drug business.
In today's episode of The Motley Fool's Industry Focus: Healthcare, analyst Kristine Harjes and healthcare stock-picker Todd Campbell highlight the biggest healthcare stories of 2017, including the launch of game-changing drugs from Biogen (BIIB) and Gilead Sciences(GILD), how we're trying to solve the opioid crisis, why Amazon.com (AMZN) has Walgreens Boots Alliance (WBA) and CVS Health (CVS) scurrying, and more.
A full transcript follows the video.
This video was recorded on Dec. 20, 2017.
Kristine Harjes: Welcome to Industry Focus, the podcast that dives into a different sector of the stock market every day. As it is Wednesday, we'll be diving into healthcare. Today's date is Dec. 20. I'm Kristine Harjes, and I'm joined via Skype by longtime fool.com contributor Todd Campbell. Todd, how's it going?
Todd Campbell: Hi, Kristine! Happy Wednesday!
Harjes: Happy Wednesday! As our listeners are probably aware if they've been listening already this week, we're doing a year in review here on Industry Focus, where each sector is recapping the major stories and headlines from their respective coverage areas from 2017. Most of the stories that, Todd, you and I are about to highlight happened over the course of the year. So we won't be going chronologically. In fact, we're actually going alphabetically, according to how we labeled the different stories in our show notes. I just want to make sure no listener wastes brainpower trying to figure out why we chose this order. Todd, do you want to kick things off?
Campbell: I tell you, Kristine, I have to admit to you and all the listeners, I struggled with this show a little bit only because when you're knee-deep in the trenches of an industry or a sector, sometimes it's hard to pull yourself up and get into a tree and get the bird's-eye view of the landscape and see, this is where we've been, and maybe this is where we're going.
Harjes: It's also hard to determine what actually happened in 2017. There are a couple of stories where I was like, "Oh, that was a huge deal," and no, it happened in 2016. It's such an arbitrary cutoff date, but we thought it was important to pull stories from all the way back in January, and also the ones that have been recently making news.
Campbell: Exactly. I would say if 2016 was the year of drug price scandals, maybe 2017 we can label as the year of repeal and replace of Obamacare. In the first six months, especially, you couldn't turn on a computer or a TV and not be hit by a story about the latest that's going on in Congress about trying to change or reform healthcare.
To give people a little bit of background, I'm sure most of our listeners are very familiar with this topic, and we covered it in the past. The Affordable Care Act was passed in 2010; it opened for business in 2013. And what it did is to establish state-by-state marketplaces where insurers could compete for your business in the individual market. It also expanded Medicaid in states that opted in to do that. As a result, more than 20 million Americans since the passage of the ACA are now insured by it.
However, there's been a lot of push-back on it, because obviously, insuring this many people can be a little bit pricey from a government standpoint. There's also been a lot of concerns about mandating insurance in a country that's based on freedom. We don't want to necessarily be told that we have to go get it. We should want to go get it. So that's been an issue, too.
So, of course, Republicans won in 2016 on a platform that included the repeal and replacement of the ACA. And through the first six months of the year, they had decided, this is going to be the policy that we try to get done first. They stumbled in March. The House tried to get a repeal and replacement plan done, and they weren't able to get enough votes, so they shelved that vote. Then, in the summer, the Senate's attempts also came up shy of the votes that were necessary. As a result, repeal-and-replace was basically considered DOA for the rest of 2017 until tax reform.
Then it all became front and center again, because in order to allow for tax reform to pass with a simple majority vote, they needed to come in with a bill that would increase the deficit by less than $1.5 trillion over 10 years. To do that, they included repealing the mandate, because the mandate will save the government some money because they won't have to pay for subsidies. They won't subsidize insurance if fewer people end up signing up.
Long story short, and to be continued into 2018, ACA remains, but the mandate will disappear over time. From an investing standpoint, of course, then it becomes, how do we figure out how this is going to affect insurers? Should I own insurers in 2018 or not?
Harjes: Yeah, absolutely. I think, going back to one year ago, if I had looked at the future of Obamacare and said, is this going to survive giving the current political climate, I would not have anticipated that the Republicans in control right now wouldn't have been able to get the job done on repealing and replacing it. The individual mandate has always been the least popular part of Obamacare, so it's not surprising that that's looking to be definitively on the chopping block. But as you mentioned, it does remain to be seen how this will actually impact insurers and the broader healthcare market.
Campbell: I think the big takeaway from this news story of 2017 is simply that investors are probably going to want to focus more on insurers that are less exposed to the individual marketplace and more exposed to Medicare, so, for example, a company like Humana, or to the employer-sponsored market, because job growth may offset some of the declining enrollment associated with repealing the mandate on that side of the world. Maybe a UnitedHealthcare does well on that side.
Harjes: Next step, turning from policy to science, a hugely important headline in medicine. In May, cancer drug Keytruda was approved for a certain biomarker-positive type of cancer of any type. Prior to this moment, cancer treatment was determined by the original location of a patient's tumor. However, as the field of precision medicine advances, scientists are finding that it might make more sense to tailor treatment based on the genetic makeup of the tumor itself rather than just its origin. Keytruda, which is a PD-1 drug, had been on the market for several years approved specifically for a handful of different cancers. But it's the unique nature of the approval that came in May that makes it worth celebrating.
Campbell: Yeah, pretty crazy story here. Now, regardless of where the cancer originates, patients would have access to Keytruda. It doesn't have to be "I have lung cancer; I have this other kind of cancer." It can be just "I have this type of tumor, and as a result, regardless of the origination, where the cancer started, I can now take this drug."
Harjes: Which is super cool. I bet we're going to end up saying this about every single topic that we hit today, but there will be a continuation of this story going into 2018. For example, one of the companies that we covered on the show, Loxo Oncology, has their drug, Laro, which is seeking approval for any tumor that expresses the Trk protein that the drug targets. They're expecting that they will complete their new drug application submission to the FDA in 2018. This one would also be a landmark, because this drug is not already approved, whereas Keytruda had been on the market for a few years, so you had real-life data about its efficacy and, very importantly, its safety. Laro is seeking approval for its first approval for this pan-location-based tumor type of approval, which will be very interesting to watch.
Campbell: Yeah, it will be. Going into 2018, investors also want to keep an eye on the companies that are going to help identify which patients will benefit most from this movement toward biomarkers. We talked previously on the show this past year about Foundation Medicine, a company that I happen to like a lot. They recently won approval for a screening test that allows them to basically take a patient's sample and look at it and figure out, because of what we've determined from the sample, these drugs may work best in the patient, these clinical trials are going on that could be a good fit for the patient, and here's some grant money that may be available to that patient as well.
Harjes: Yeah, which is very exciting. I know our next topic also is on the lines of oncology. Todd, do you want to share that one?
Campbell: I think it's hard to talk about 2017 and not talk about CARs. And I'm not talking about Elon Musk and Tesla here. I'm talking about chimeric antigen receptor therapies, specifically CAR-Ts, chimeric antigen receptor T-cell therapy. This is a game-changing, a very new approach to tackling cancer.
Essentially, what you're talking about with CAR-Ts is, you have a patient who has a specific type of cancer, you take the T-cells out of that patient, you re-engineer them so they can spot and bind to and kill a protein tumor or cancer cell that expresses a certain protein, and then you infuse those back into the patient.
The response rates that we saw in 2017 to these therapies was downright remarkable. You had heavily treated patients in non-Hodgkin lymphoma, and you saw a data from Kite Pharmaceutical showing incredibly high response rates to its Yescarta. You had pediatric ALL patients who responded incredibly well to Novartis' CAR-T, called Kymriah. And those response rates were so good that the FDA rushed through with approvals for them.
You now have two CAR-Ts on the market, which is quite remarkable, considering the time that these went into clinical trials only a few years ago. Now they're available to patients. I think it's a major advance, and a story that's going to continue into 2018, because you have all sorts of other studies that are going right now in other types of cancers, where these drugs are being evaluated. You're going to get data readouts from companies like Juno Therapeutics. You're obviously going to get sales numbers start to come in for companies like Gilead Sciences, who bought Kite Pharma --
Harjes: And that's crazy, that that's just a sub-point of this broader point. That was a huge headline on its own. But that just goes to show how big this entire CAR-T story has been this year.
Campbell: Right. There's been so much research going on in CAR-T that it wouldn't shock me if there's more consolidation next year within the CAR-T players by some of these bigger companies like Gilead Sciences. I doubt Gilead will do another, but I think it's something to keep an eye on in 2018, that CAR-Ts are going to continue to advance, and it's pretty remarkable science. They could get used earlier and earlier in patient treatment. Keep an eye on it. This is going to be a story of 2018 as well.
Harjes: Did I just hear a dog in the background agreeing with you?
Campbell: Yes, that was my dog. My dog is a huge fan of CAR-Ts, apparently.
Harjes: He's a Gilead bull. [laughs]
Campbell: [laughs] Absolutely!
Harjes: Our next story goes back to policy, government at the very least, which is the turning tide in the FDA. The FDA has always had to balance two competing interests -- getting drugs to market as soon as possible for the sake of patients who need them, and also pressure from the drugmakers who are eager to profit; and on the other hand, keeping people safe by really scrutinizing data and demanding that drugs show they're both effective and safe. The FDA has traditionally been very cautious in approving new drugs, particularly following everything that happened with thalidomide in the mid-1900s. If you're not familiar with the story, we did an entire episode on thalidomide on May 24, so go check that out.
With Trump's appointment of Dr. Scott Gottlieb as the FDA commissioner, who was sworn in on May 11, it appears that some of these strict regulations will be relaxed. One particular story that I want to highlight is the approval of Bevyxxa from Portola Pharmaceuticals. This blood thinner technically failed its phase 3 trials, which you would think would be a non-starter. You can't be approved if you failed your trials. But after some post-hoc massaging of the numbers -- and I say this as a Portola bull; don't think I'm criticizing them here -- the drug ended up being approved. And I think this turned a lot of heads. That's why you saw such a pop in the stock on the day of its approval. I think it signals more broadly that 2017 has been a year that the FDA has actively committed to changing the balance between caution and expediency, and leaning a little bit more toward the end of getting drugs to market quickly.
Campbell: What's interesting, Kristine, I started thinking about the fact that you were going to be talking about this one on the show, and I started thinking, where did that really start? And for me, it started with Sarepta Therapeutics in 2016, and it's really accelerated here in 2017. If you remember what happened with Sarepta, they had this muscular dystrophy drug that the advisory committee for the FDA actually voted against recommending approval of, and the FDA said, "No, we are going to recommend it after all. We're going to approve it and it's going to go to the market. We don't care what you said about it, Mr. Ad-Com."
I think that basically cracked open the door for what we saw in 2017, which is a major push to work very closely with drugmakers to help them design and accelerate the development of new and novel drugs. We just saw, this past week, I think, Christine, a new guidance letter from Gottlieb talking about gene therapies and the steps that they're going to be taking to try to get these gene therapies to market more quickly.
So yeah, it's fascinating, and I think what it means for investors is, you're going to see more and more drugs win approval more quickly than you would have normally seen. If you normally expected a decision in 10 months, maybe you're going to see a lot more of them come early.
Harjes: You mentioned gene therapy. This wasn't on our list, but it's something that I meant to highlight back when we were talking about CAR-T. Technically, those were the first -- "those" meaning the two CAR-T therapies that you mentioned, Yescarta and Kymriah -- those were the first two gene therapies approved in the United States. But I would say that the first true gene therapy that actually fixes the genes of people who have an inherited disease was just approved yesterday, Tuesday, and it is Luxturna, the drug from Spark Therapeutics that we were just talking about last week. So I wanted to wedge that into this episode just as a follow-up from something that we opened up at the topic for discussion last week.
Campbell: Yeah, and it was an early approval.
Harjes: Yeah, it was almost a month early.
Campbell: Again, you have the FDA moving extremely quickly. There was a flurry of activity this past week. You also saw Exelixis win early approval for their supplemental application for their kidney cancer drug. I think that wasn't expected until February. So yeah, you're seeing these decisions come faster and more quickly. And hopefully not at the detriment of patient safety.
Harjes: Todd, I believe it's your turn for our next highlight.
Campbell: And obviously, our sponsor is perfect for today, because that next highlight is genetic sequencing.
Harjes: That's a good segue.
Campbell: It became mainstream this year. It's much more common. It's not just first movers who are going out and using these services to learn more about their DNA profile. And I think one of the reasons, but this has been able to become so much more mainstream is because you have companies like Illumina who are at the forefront of gene sequencing, and they're developing faster and better systems that allow you to sequence genes for a lot less money. It used to be incredibly expensive and time-consuming to sequence genes. Now it can be done relatively quickly, with a level of sensitivity that would have been hard to imagine three years ago. And you have this quest now to drive the cost of gene sequencing from $1,000, which was crazy cheap to begin with, to as low as $100 over time because of Illumina's latest machines, the NovaSeq.
I think in 2017, that's been a very big story -- the mainstreaming of genetic sequencing. I think we're going to see that increasingly, increasingly, increasingly over the coming years. More and more people are going to have to know about their particular genetic makeup, and they're going to share that with others, including caregivers, to get more insights about their body and how their body works and how their body may respond to medicine.
Harjes: Yeah, and this fits right in with several other of the stories that we've told here today. If you have a wider-spread adoption of gene sequencing, particularly low-cost gene sequencing, then the research can be furthered; new drugs can potentially be brought to market that do target specific genetic makeup. I think overall, this is an industry that had a huge advancement in 2017 with the introduction of the NovaSeq in January and will still continue to be a huge story in 2018 and beyond.
Campbell: Yeah. I think a lot of that is going to be tied to deep sequencing. If you're not familiar with deep sequencing when it comes to the sequencing story, spend a little time on Google checking it out, because it's really intriguing, listeners. Basically, the way sequencing works now is, it doesn't go very deep into, say, into the tumor tissue. So the amount of insight this provides is kind of limited. As we get better and better at being able to sequence, you can go deeper and deeper and come up with greater and greater understanding. That's very important in figuring out exactly what's the cause of different tumors, for example, within patients. It's a fascinating subject, and it's going to be, I guess, the backbone of drug discovery and patient treatment over the course of the next generation.
Harjes: For sure. This next story has been living in the shadows for years. Just this year, it really broke into the spotlight of national attention. It is the opioid crisis. First, some numbers. Every day, 650,000 opioid prescriptions are dispensed. Deaths in the U.S. due to opioids has quadrupled since 1999, which means that 78 people die from an opioid-related overdose every single day, which roughly equates to the number of people that are killed in car crashes. The deaths from heroin alone outnumbered gun homicides in 2015. This is a hugely impactful crisis facing our nation.
So I wanted to highlight a few dates that stand out from the past year. On March 29, Trump established the President's Commission on Combating Drug Addiction and the Opioid Crisis. Chris Christie, the governor of New Jersey, was made the chairman. On May 23, previously mentioned FDA Commissioner Scott Gottlieb asked for more forceful steps to stem the crisis. On July 31, a White House panel asked Trump to declare a national public health emergency, and Trump made several statements throughout the summer suggesting that a strong response is needed, which culminated in Oct. 26, when he actually did declare it a public health emergency and directed federal agencies to provide more grant money to combat this epidemic. Which, if you look at the details, it doesn't actually unlock new funding, but it shuffled it around, and it certainly give some legitimacy to the efforts directed on combating this. It's so abundantly clear that something needs to be done.
So while it's heartbreaking that this story exists at all, I'm really glad that it's caught the attention of policymakers. Estimates are that the opioid epidemic costs $55 billion in health and social costs each year, not to mention the absolutely immeasurable pain and suffering of addicts and their family and friends, which is something that affects us all.
Campbell: Yeah, we could probably do an entire show -- actually, we did, earlier this year. Back in March, I think, we covered the opioid crisis in a lot of depth. There's so many things to unpack in this story. One of the advantages of the fact that it's now become front and center in people's minds is, it's uncovered a lot of bad actors and bad actions by people employed at different companies that are involved in the production of opioid medicine.
We obviously talked about Insys Therapeutics in the past, and some of the marketing of its breakthrough cancer pain drug, Subsys, and how there were arrests and there could be potential fines with off-label marketing of that drug. You had McKesson, which agreed to a $150 million settlement for not vetting the pharmacies more carefully that it was distributing drugs to. And you have, like you mentioned, the FDA taking a lead role in providing guidance, saying, "Listen, we're going to do what we can to facilitate new abuse-deterrent drugs reaching the market quickly." They approved Zilretta from Flexion earlier this year. That drug could theoretically reduce the use of opioids in patients with osteoarthritis of the knee. You have a drug by Nektar, NKTR-181, that could get filed for approval in back pain next year, which crosses the blood-brain barrier more slowly and theoretically could displace opioid use in back pain patients if it's approved.
So I think that's going to be a story as well that continues. And maybe the next chapter in that story is going to be how do these next-generation solutions for pain end up replacing or displacing the use of drugs like Oxycontin?
Harjes: The next highlight that we wanted to share is a little bit lighter in nature. Todd, do you want to explain that one?
Campbell: Retail pharmacies, wow. What a year. It's been remarkable, the ups and downs that we've seen in the retail pharmacy stocks. In particular, the activity and the action we saw between Walgreens and its planned tie-up with Rite Aid (RAD). Right, Kristine?
Harjes: Absolutely. This was a saga.
Campbell: Saga is a great way to frame it. Originally, Walgreens had planned to buy Rite Aid lock, stock, and barrel. They announced it in 2015. It was a $17 billion deal if you include debt. But regulators were very nervous about consolidating that much market power in those two pharmacy retail chains. As a result, they had to restructure the deal. And that wasn't good enough. Then they came back with another restructuring, and that wasn't good enough. Finally, in June of this year, Walgreens said, "You know what? Forget it. We're not going to try to buy Rite-Aid anymore lock, stock, and barrel. We're just going to buy a bunch of stores, hand them a pile of cash, and move on with our lives."
Harjes: Yeah, I was editing an article talking about Fred's, which was a chain that was rumored to be picking up a bunch of these Rite Aid stores that would mean to be divested. And I feel like they really suffered throughout this entire thing, because when it fell apart, it's like, that's not going to happen anymore.
Campbell: Yeah, they were going to get a thousand stores.
Harjes: Yeah, they got the short end of that.
Campbell: And all of a sudden, it's like no, you're not.
Harjes: Yep. Something that's also very intricately tied to the story is the recent news that CVS is going to attempt to acquire Aetna, the insurer, for $69 billion, which is absolutely enormous and is very much a vertical integration. Remains to be seen whether or not it will pass. But what I really want to get at here is, why do this retail pharmacies feel the need to go through all this M&A activity?
Campbell: I know, right? And that's probably the biggest backstory to this whole situation with the retail pharmacies. You're looking at it and saying, why is it that these already really large companies feel the need that they have to either vertically integrate or horizontally integrate or whatever? And it really comes down to potential threats. Potential threats from none other than Amazon, for example, which is a distribution and purchasing powerhouse. If they decide to enter the same market as CVS and Rite Aid, it could dramatically reshape how people go about purchasing and getting their hands on their medicines. And that rumor has been around, that Amazon is going to get involved in pharmacy retail, for a big chunk of this year.
Harjes: Yeah. Amazon completely underpins all of this. It remains to be seen how Amazon is going to affect this market. There's the obvious point of foot traffic to retail stores, brick-and-mortar, has gone down now that people shop online. So you can see how the retail pharmacies are afraid of what that might do. If people aren't coming into the store anymore to pick up their prescriptions and buy whatever, they have less cross-sell opportunities. Mail-order drugs might become even more widely used than they currently are, and that's also something that Amazon is looking to get into. This is really an industry that's going to have to pull some dramatic levers in order to not be disrupted by Amazon.
Campbell: Right. There could be a lot of disruption. If you look back a decade ago, when you have Wal-Mart and Target and some of these others move into the retail pharmacy space, there was a lot of disruption there. You had a lot of independent pharmacies that either sold to these bigger pharmacies or went out of business. You had, generally speaking, more players now competing for those dollars spent on medicine. If you get a company now, Amazon and other online retailers which come out and start selling access to medicine online, then again, like you said, you could get less foot traffic. You have to come up with new ways to connect with your consumers and make sure they're still coming to your stores. I think that's really what's behind Rite Aid's decision, Walgreens' actions, and CVS's decision to try to integrate with Aetna.
Harjes: Yeah, absolutely. Turning to our last story of the day, this one firmly has its roots in 2016. There were big headlines regarding an antisense RNA drug called Spinraza, which was the first ever treatment for spinal muscular atrophy that won approval in December 2016. I will still count it as a 2017 story because it launched early this year. It's a drug on which Biogen and Ionis Pharmaceuticals were collaborators.
For some background, SMA is a chronic disease. It's life threatening. It's caused by inadequate levels of a protein called SMN, which is very important for the survival of motor neurons. Spinraza, the drug in question, tinkers with the gene responsible for creating this protein, SMN, in order to bump up the production of it, and then hopefully improving the motor activity of patients. So it's not necessarily a cure, but it does help.
One of the major reasons why this caused so much attention is due to the price. SMA affects roughly 9,000 people in the U.S., and around 10,000 people in the EU. It's a very rare disease. As regular listeners of the show will know, rare-disease drugs are often the most expensive, and Spinraza was no exception. One of the many drugs that were indicative of the larger theme that, Todd, you alluded to earlier, which was drug pricing, the annual cost of Spinraza is $750,000 for your first year of treatment, and $375,000 for maintenance therapy, which is ongoing thereafter. I would say, even though 2016 was very much a year of scrutiny over drug pricing, that definitely continued be as theme a of 2017, and I would anticipate it would continue to make headlines in 2018 as well.
Campbell: What I think is really interesting about this story, too, is the fact that it's basically the coming of age of RNA, the research, basically, into the messengers that are responsible for having the genes encode to make certain proteins that often times can get mutated, overexpressed, underexpressed, in patients who suffer from disease. And you have this approval, obviously, of Spinraza, that's game-changing for this patient population.
In 2017, you also saw Ionis and its competitor Alnylam file for FDA approvals of their TTR amyloidosis drugs. Those drugs could win FDA approval in 2018, but it was 2017 here when they filed for approvals. If those get approved, then you have another two RNA drugs that are reaching the market and helping a relatively small patient population.
You also have Akcea Therapeutics, which was spun out of Ionis earlier this past year. They've had their applications accepted for their RNA drug for a type of high-triglycerides condition that's relatively rare. RNA and its use in rare disease definitely took a step forward in 2017, which is important because research has been going on in this area for the better part of 15 or 20 years. So it's good to see finally getting some of these across the finish line.
Harjes: Yeah. It's somewhat reminiscent of the story that we told with CAR-T, where this year, 2017, was really the pivotal one for this research that's been going on forever and ever, and of course will continue to become important as we see how these drugs actually play out in the market and as the science develops. But I would say, 2017, definitely a year to remember for both CAR-T and RNA therapies.
As we wrap up, I wanted to offer a list of Fool.com's Recommended Reading for 2017. We compiled the best of the best of the many thousands of articles published by writers like Todd Campbell on fool.com this past year. We have it all ready to go, ready to send out. Just let us know if you'd like to receive a copy. Our email address is firstname.lastname@example.org. If you haven't picked up on it already, we love hearing from our listeners.
As always, people on the program may have interests in the stocks they talk about, and The Motley Fool may have formal recommendations for or against, so don't buy or sell stocks based solely on what you hear. For Todd Campbell, I'm Kristine Harjes. Thanks for listening, and Fool on!