In a New England Journal of Medicine article called The Effect of Incentive-Based Formularies on Prescription-Drug Utilization and Spending a team from Harvard found that three-tier formularies work. Three tier formularies are what PBMs and health plans introduced in response to rising drug uilization and prices in the late 1990s. In essence the PBM puts generics, and the branded drugs for which it has negotiated the best rebates, into the cheap first and second tiers ($5 or $10 co-pays) and charges huge co-pays for the others. Amazingly enough this means that people switch. In this study:
Among the enrollees who were initially taking tier-3 statins, more enrollees in the intervention group than in the comparison group switched to tier-1 or tier-2 medications (49 percent vs. 17 percent, P<0.001) or stopped taking statins entirely (21 percent vs. 11 percent, P=0.04).
While the only press article I could find on this in the Boston Globe, plays up the fear that patients will stop taking their drugs, my guess is that some of those people would have given up anyway. The key stat is that half the people switched. Presumably switching to another statin doesn’t make much difference on health. Medpundit has some interesting things to say about the clinical impacts of this switching (and, Sydney, we agree in this case!)
This is what Ian Morrison calls "the Ross Perot effect"–you can move people around for $10. (Apparently in 1992 Ross Perot spent $10 for each vote he got). Actually it’s a little more than $10 in this case, but it shows that therapeutic substitution based on money is very powerful.
My sense is that this shows that the power of the PBM has been underused. The PBMs have been mostly the handmaiden of the pharmas. For their health plans and employer clients they have in general been unwilling to really move people away from branded drugs, unable to get too many of their clients to move to very aggressive formularies, and unable to get doctors to prescribe according to the formulary. However, this study shows that the opportunity to move people between products is very real, and with Medicare formularies on the way (in the new PBM-managed formularies) they may become even more important.
Well I told you last week that I’d had a small bet on the PBMs losing value this week as investors realized that the Medicare legislation wasn’t guaranteed to pass. It happened for random reasons that I bought put options last week on AdvancePCS, which trades in lockstep with Caremark, which is acquiring it. (In case you don’t know, put options go up if the underlying stock goes down). Did it go down because of the delay in passing the Medicare bill? Heck no, so I was wondering what to do as the options expire tomorrow. Then midday today the news comes out that Caremark is being sued by whistleblowers who:
allege that Caremark resold returned drugs, failed to credit the state employees’ health plan for copayments on returned drugs and falsified and destroyed documents to make it appear as if the company had complied with contractual time limits for processing and delivering prescriptions.
Interestingly enough, the state of Florida which was the client and who supposedly was defrauded, did not join the suit. So it probably has no legs.
Nonetheless the news was enough to push AdvancePCS stock down $2 and to make my options to be worth 3 times what I paid for them. As the traders say, "it’s good to be good and it’s good to be lucky, but it’s better to be lucky than good!" Pity that it was only a small bet.
Cox-2 Inhibitors have been a major therapeutic class since their introduction in the late 1990s. Led by Pfizer’s Celebrex and Merck’s Vioxx, the pain-relievers are roughly a $6bn market–not as large as the statin market but nothing to sneeze at. These drugs have been aimed primarily at arthritis’ sufferers, in particular at the substantial minority who have had stomach problems from regimes using traditional painkillers like ibuprofen or NSAIDs. But in recent years the growth of the market has slowed due to several setbacks, including a 2001 JAMA report of cardiovascular side-effects, and suggestions that COX-2 inhibitors might impede blood vessel creation (for wound repair), and also suggestions that Celebrex wasn’t as good for gastro-irritation as was promised. Additionally two new Cox-2 inhibitors have had their approval delayed. These are Prexige from Novartis that won’t appear in the US until 2005 although it is already approved in the UK, and Arcoxia, Merck’s new COX-2 inhibitor.
But looked at another way, COX-2 inhibitors have been an example of big pharma’s ability to change patient and physician behavior. Don’t forget that this class of drugs doesn’t offer any superior pain relief than ibuprofen or NSAIDs, and costs seven to ten times as much. The reason for their success is that they reduce associated stomach irritation. Of course that means that people who don’t have that kind of irritation from long-term ibuprofen use shouldn’t need to go on COX-2 inhibitors, at least until they have some other symptom or reach a certain age (often 60 is used). So the PBMs, health plans and other formulary enforcers have a tricky job. They have to battle the weight of the pharma DTC advertising and physician promotion in order to get patients to stay with the OTC or generics.
Well it appears that they are not succeeding. A new report in The American Journal of Managed Care from PBM, Express Scripts, looked at new users of COX-2 in 2000 at a PPO. 65% had no indication of being at risk for gastrointestinal events. Furthermore 68% had not tried an NSAID first. In the study only 18% of the population were over 60–one of the minimum required indicators for going straight to COX-2. In other words, in order to be somewhat conservative about costs in a sub-Medicare populations almost everyone should be first trying NSAIDs or ibuprofen. In fact over 60% are going straight to COX-2 inhibitors.
You can look at this two ways. Perhaps there should be a 60% reduction in COX-2 use. Or perhaps PBMs and formularies are ineffective in the face of the pharmas. Either way what’s happening now is presumably not the right answer. Given that there’ll be new COX-2 drugs on the market soon and PBMs are going to be used by Medicare (Maybe!) to restrict Medicare drug costs, the question of how this gets resolved is key for the future of PBMs’ credibility.
Despite my doubts as to whether we’re going to get a Medicare drug bill, the market has decided a) that we will and b) that the PBMs are going to benefit the most from it. The last two days have seen a 10% rise in the PBMs stock price, and in the last 2 months they’ve gone up above their all time highs of 2 years ago. Somewhere a little north of here, I feel a pullback is imminent–perhaps I can just get word to Ted Kennedy and we can split a short position together?
I noticed that the PBM stocks took off like a rocket at the end of the trading day yesterday. The news was that a tentative deal Medicare has been reached by the committee negotiating a compromise Medicare bill. PBMs are likely to add millions of members under the version of the bill that may be passed. However, of course this slight optimism is tempered by the fact that neither the hard-core Democrats like Ted Kennedy nor the fiscally-conservative Republicans are likely to sign on to this compromised version of the bill, because it either will lead to the death of Medicare as we know it, or the bankrupting of the Federal government–depending on your point of view.
In any event, I’m not sure that adding a large number of members via a government-funded program which may make them low-margin contractors is the best solution for fast future growth for PBM bottom lines.
The newly independent PBM Medco Health Services’ stock has been doing very well since its independence from Merck just a few months ago. In fact if you received Medco stock at the time of the disbursement you’ll find that it’s up about 30% while Merck’s is down about 15%. There are some grumbles on the Medco message board about the management, but that’s being ignored by the market which has bid the stock up more than $5 since Medco increased its projected earnings for next year (from 44 cents a share to between 44c and 47c).
Meanwhile competitor CaremarkRx has also seen a decent rise in its stock. It’s now back up to roughly where it was before it fell on the news that it was "overpaying" for rival AdvancePCS on September 3. On Tuesday it announced results that beat the market’s expectations by a penny. More interestingly Caremark seems to be shrugging off a recent lawsuit that claimed it misled shareholders over a settlement concerning its failed purchase of Phycor back when it was called Medpartners. Neither its stock price nor that of AdvancePCS showed any concerns that the FTC’s has made a ‘Second Request’ regarding the merger deal. While the lawsuit claiming $3.2 billion is probably a long-shot, the FTC does have to look carefully at the merger.
Between them Caremark and Medco control a big chunk of the mail-order drug market. If the merger goes through, Caremark’s main job is increasing AdvancePCS’ use of mail-order. Currently about 10% of Advance’s drugs go out via mail order, whereas for Caremark it’s about 40%. (Medco’s is around 33%) Of course supplying a drug via mail-order is much more profitable than just processing the claim and having another pharmacy fill the script. If Caremark manages to increase mail-order use, it becomes a significant lever in its dealings with both pharmacies and perhaps manufacturers, and mail-order overall will become much more significant–something the FTC will be watching. This market concetration also goes for supplying mail-order and other services in the specialty pharmacy market–usually based around drugs for specific relatively rare diseases which use a lot of expensive drugs.. The Drug Cost Management Report (full article well worth reading) notes that:
The existing managed care clients that AdvancePCS brings to the table could theoretically give the new company enough leverage to severely disadvantage other specialty pharmacy players, including CVS ProCare, Accredo Health, Curascript, Chronimed, Option Care and MIM Corporation’s Bioscrip unit.
Added to this concern from the FTC is the accusation from pharmacies that Medco and other PBMs are deliberately routing scripts away from them to their mail-order businesses. Meanwhile others like health plan Highmark are getting into this business.
Meanwhile the big health plans are likely to be looking at the PBM market. Given that merger-mania and the underwriting cycle will eventually reduce the possibilities for revenue growth in that market, reintegrating health plan and PBM services must be tempting to the folks in Indianapolis and Minneapolis. After all, it’s not as if PBMs have actually helped health plans or employers actually do what they were supposed to do over the past decade–reduce the cost of the drug benefit!
You may remember my post somewhat facetiously titled The End of Managed Care. The concept was that managed care plans had stopped trying to manage physician behavior and had given up in the face of aggressive class action lawsuits from doctors who wanted to get paid more quickly and objected to being "down-coded".
Well the lawyer behind that suit is turning his sights on the PBMs on behalf of some smaller pharmacies. The new suit filed today alleges that the PBMs are forcing patients to use their mail-order services instead of the local pharmacies (which seems likely but probably not illegal to me) and are forcing unfair contracts upon small pharmacies (which if your definition of "unfair" means "using your buying power to extract lower prices" also seems likely but not illegal). Still, worth watching this space and seeing if yet more legal antics for the PBMs actually has any effect on their business. As someone who completely underestimated the impact of the backlash against managed care, I’m loathe to say that this seemingly hopeless suit will have no impact on PBMs.
Here’s what Medco said in its IPO offering document last April:
In February 2000, two qui tam, or whistleblower, complaints under the Federal False Claims Act and similar state laws were filed under seal in the United States District Court for the Eastern District of Pennsylvania. These
complaints allege improper pharmacy practices, violations of state pharmacy laws and inappropriate therapeutic interchanges. We have not been served with the complaints and have not been required to defend against the allegations.
Well now that the US Attorney is joining the suit, it appears that the "practices" included
"Inappropriately filled prescriptions includ(ing) instances where a Medco pharmacist said he consulted a doctor but didn’t, or when a prescription was canceled suspiciously". The stock market doesn’t seem to care, based on the fact that the existence of the suit was disclosed in the S1. However, the US Attorney is being very aggressive claiming that the government can charge $5000 for each script that was affected, and that there are thousands and thousands. It’s worth keeping an eye on this one as PBMs may find their future in whatever comes out of the Medicare Drug Coverage bill is affected by this publicity–whether or not Medco is found guilty and fined a huge sum.
The Feds have backed two whistleblower suits against Medco. The allegations claim that Medco used a variety of techniques to favor Merck (which owned Medco at the time) and was paid $430m in 2001 to switch scripts from Merck’s competitors. Back in March 2003, Milt Freudenheim in the New York Times highlighted Medco’s income from rebates (some $1 billion a year) and its ability to move share towards Merck’s drugs.
PBMs have for a long time made money from rebates, and have also been very economical with the truth to their health plan customers about how much they got from pharma companies for those rebates and how much was passed through to their customers. However, during the late 1990s their performance seemed very ineffective in keeping down the cost of drugs for their plan and employer clients, either in reducing their usage or by holding down their unit price. For more of my take on PBMs see this post.
Interestingly enough, Medco’s stock price went up over a dollar in the latter part of the afternoon after 2pm when the confirmation (of somewhat old news) came out that the US Attorney’s office was joining the suit.
Today’s New York Times confirms what I said yesterday. Caremark is paying a bit too much for AdvancePCS, but is doing so to get into the Medicare scrum as in the NYT’s words "large drug benefit managers jockey for position in hopes of handling the potentially huge Medicare drug program that a House-Senate conference in Congress is drafting for 40 million elderly and disabled Americans." Meanwhile, Express Scripts shares have headed down to meet the percentage loss in Caremark’s since yesterday (Sept 3) morning’s deal, although there’s no clear reason why and ESRX already has a lower PE ratio than the other two. Caremark has gone down because a) they are paying too much (especially as they are debt-free and Advance still has $400m debt left over from its purchase of PCS a while ago) and b) they were growing revenues at 30% per year (and profits more so) and won’t be able to do that if they merge with as big a player as AdvancePCS — unless of course:
a) they convert many of Advance’s customers onto their mail-order pharmacy sooner than you’d expect, and/or
b) all PBMs get an amazing deal out of the Medicare Rx coverage negotiations. I’d say that’s unlikely unless the entire bill is held up and we get an even more Republican-leaning Senate in 2005 and they don’t notice that we have a eensy teensy problem with a thing called a deficit.