Tag Archives: healthcare

Profit maximization in pharmaceuticals

From a microeconomics exam recently. The source article is “How a Drug Maker Tries to Outwit Generics” from the WSJ. (If that link doesn’t work, here is a PDF of the fulltext.)

Describe the nature of demand for Provigil. How much market power is there and why? If Cephalon raised the price of Provigil by 74%, with no apparent increase in production costs, does that mean that Cephalon was not initially pricing to maximize profits from Provigil? By raising the price, are they now profit-maximizing? Discuss. How would you expect the introduction of generics to affect the demand for Provigil? The price of Provigil has been raised before Nuvigil is launched. Discuss how the demand for Nuvigil would have been affected if the price of Provigil was not increased. Evaluate Cephalon’s strategy as a means of achieving its goal of corporate profit maximization.

Provigil is in extremely high demand; the trouble is that it is expensive, and it is almost never covered by people’s insurance. Right now, the average wholesale price (AWP) for 30 count of Provigil 200mg is $361. Provigil is also in an interesting place in terms of patent protection. It’s not a new drug, and through manipulating pharmaceutical patent law, Cephalon (who acquired the IP for the drug when they bought out Lafon) has been able to extend the life of the patent two or three times.

In healthcare, supply and demand do not function freely. In Provigil’s case, there is a distortion: one needs a prescription to buy it. In terms of price, there is another distortion: third party insurers will not pay for it. (9 out of 10 times it requires a prior authorization, which is almost always denied.) There are substitutes for Provigil. While it is the only drug of its kind, the stimulant ADHD medications promote wakefulness as well, though they often have other undesirable side effects, and are contraindicated in patients with anxiety and panic disorders and in patients with cardiac arrhythmias, hypertension, etc. Provigil, with its different mechanism of action, does not have these limitations because it does not function like drinking a cup of coffee. It simply removes fatigue and promotes wakefulness in the same way that it’s opposite, Benadryl, makes you sleepy and dopey. (Indeed, Benadryl is a messy antihistamine that works in the body and in the brain, and Provigil is a pro-histamine that works only in the brain.)

Because of the lack of competition within the pro-histamine drug class, Cephalon does have some market power. In my view, Cephalon was not profit maximizing for the long-term until these recent price hikes (more on that in a bit), because Provigil has always been expensive relative to its other patent-protected, cross-class competition (ADHD meds). Had they priced their medications right along at $100-150/month, they might have made up in volume what they would have lost in price. It’s not possible for me to know that, but I know that there is quite a bit of off-label demand from prescribers who would like to use Provigil, but cannot because it’s too expensive to buy out of pocket for most patients, and the majority of insurers will not cover it. The only way to know this for sure is to wait until the generic is released, and then see if there is a generic modafinil boom. I expect that there will be because it’s an excellent drug for many conditions that it’s not technically indicated for. (When I did graduate psychopharmacology, the one of the answers for many of our case studies was often modafinil, with the inside joke being “Just kidding, it won’t be covered so let’s not waste our time.”)

Now that Cephalon has raised the price by 74%, they are potentially sacrificing profits for the short-term, but maximizing them for the long-term. In the short-term, they are only potentially sacrificing profits because Provigil is never covered without a prior authorization to begin with. As patients not buying the drug out of pocket all have PAs in effect, that authorization does not expire just because there’s a price bump. Those prescribers who are successful in getting Provigil approved for their patients are unlikely to have a harder time getting it approved now that the price has gone up, because that’s not how the PA process works (even though I know that’s probably counter-intuitive).

What Cephalon will do is bump Provigil’s price while there’s still a brief amount of time left on its patent. Then they will release Nuvigil, while Provigil still has some patent life left. (Usually it’s a 6 to 9 month window on the patent for the old drug.) Nuvigil, priced in a more friendly fashion will almost immediately replace Provigil as the drug of choice. Cephalon will fund lots of studies that show that Nuvigil works great for those off-label things that prescribers have been using Provigil right along for, they will win FDA approval to use Nuvigil for these now-approved indications, and they’ll market the hell out of Nuvigil for these new uses.

In the meantime, the patent protection on Provigil will come to an end, just as Cephalon’s marketing campaign for Nuvigil is winding down, and most patients that were on Provigil will have been switched to Nuvigil (because it’s cheaper and ostensibly “better”), and then generic Provigil will hit.

For about two months, the prescription benefit managers (PBMs) will do nothing. People will fill their monthly Nuvigil scripts, and then the clinical pharmacists working for the PBM will have finished their research, made their recommendations, and the formularies will change. Nuvigil will suddenly require a prior authorization, and pharmacies will begin faxing doctors’ offices to change from Nuvigil to the newly-generic Provigil. And doctors will sign off on this switch back to the old drug because doing prior authorizations is a giant pain in the rear, and the opportunity costs associated with taking 15 extra minutes to fill out paperwork for each Nuvigil Rx is enormous.

Nonetheless, Cephalon is profit-maximizing in the long-run by doing this because despite the delayed shift from Nuvigil back to the generic Provigil, there will be some folks that remain on the Nuvigil. How many will depend on pricing. So long as Cephalon isn’t price-gouging on the new drug the way they are on the old one, PBMs may be more lax about requiring PAs or trials of other drugs before approving the Nuvigil. (Instituting a PA, after all, creates inefficiency and requires the hiring of more personnel to process the PAs, etc.) Gouging is, of course, a relative thing.

This kind of behavior happens all the time in the prescription drug industry. AstraZeneca did it with Prilosec. They jacked the price of 40mg Prilosec way up (AWP is currently $247, though it was over $300 just a few months ago), released 40mg Nexium at a lower price (AWP currently at $181), and then generic Prilosec hit the market, and took back a bunch of marketshare, but not all. Nexium remains a very profitable drug, despite there being the evidence that suggests that it is only marginally better than Prilosec, if that. (Most AstraZeneca-funded studies compared 20mg of Prilosec to 40mg of Nexium, and only published this detail in the fine print. I actually had a talk with an AstraZeneca sales manager about it a few years back after he moved to Forrest, and he admitted that Nexium was only created to perpetuate the revenue stream.) In the industry, we call this game of patent-extension “evergreening” and there are a huge number of drugs that bear this label: Lexapro (based on Celexa), Nexium (Prilosec), Nuvigil (Provigil), Clarinex (Claritin), Xyzal (Zyrtec), Pristiq (Effexor), Trexima (Imitrex+Naprosyn); the list goes on and on and costs the healthcare system billions every year.

An example of a company that didn’t do this, and is NOT profit-maximizing is Sanofi-Aventis with Xyzal, which I mentioned above, and they ended up with a drug that was dead in the water on arrival. Xyzal was supposed to replace Zyrtec which was losing its patent protection, but because SA didn’t take the necessary steps the way Cephalon is and AstraZeneca did, their drug went nowhere. It was released about a year ago, and I can count on one hand the number of prescriptions I have filled for it. Zyrtec, on the other hand, was one of our fastest movers. (And is now available over the counter which killed script volume for it.) On the other hand, Sanofi-Aventis is still making money from the over-the-counter sale of the old Zyrtec, so they are maximizing profits in the second best way. (Having a patent monopoly for an Rx-only drug is more lucrative because you can charge prices that you’d never make up for even with the oceans of relatively undistorted free-market OTC volume.)

In my 8 years in the pharmaceutical industry, Cephalon is a company that I simultaneously loathe and admire. I dislike them because their drugs are very expensive when common sense suggests that they probably shouldn’t be (Provigil was invented in the 1970s). On the other hand, I find myself admiring them because they are incredibly legally savvy. If this savvy is present in their pricing discussions — and I have no reason to think that it is not — there is a good possibility that they are indeed profit-maximizing within their legal constraints. I know that earlier I suggested earlier that they might make more money in volume if they lowered their prices, but most PAs will not be approved unless the indication is on-label or you are a specialist, and since Provigil only has one indication, they might indeed be profit maximizing inasmuch as they can realistically be in a heavily distorted market. The information asymmetry here means I can do no more than speculate.

Massachusetts: a less than perfect healthcare model

I will have a large writeup on real, honest-to-God ways we can reform healthcare in this country without resorting to re-distributionist tactics in the next couple of days. No hand-waving. No pie-in-the-sky. I promise. But until then…

By Frank Micciche from the New America Foundation/Providence Journal:

439,000 people have acquired health insurance since the reform became law — an astonishing 9 percent increase in coverage at a time when the national rate increased by one-half of 1 percent.

Nearly 200,000 of the newly insured acquired private, unsubsidized coverage, mostly through their employers.

Written another way: “More than half of the individuals are subsidized with taxpayer money.”

Libertarians will have a field day with the other piece of puzzle: many individuals would rather pay the fine associated with forgoing the mandatory medical insurance than pay the premiums. Why? The fine costs less. Many healthy people simply don’t want to buy health insurance. The original projections for the number of unsubsidized signups ended up being wildly optimistic:

Massachusetts’ financing challenge emerges from its success in covering the state’s neediest residents. Enrollment in the fully subsidized Commonwealth Care program has been higher than expected, while enrollment in the unsubsidized Commonwealth Choice plans has been lower than anticipated. Therefore, costs to the state have risen dramatically.

Micciche spins it another way:

The state’s success enrolling lower-income households in the subsidized “Commonwealth Care” program has driven overall costs above original projections, but the actual cost per person covered is lower than expected, as is the average premium.

From an economic standpoint, enrolling lots of lower-income households is not success unless it is offset by sufficient numbers of unsubsidized enrollees.

Obviously it follows that the average premium is lower than anticipated because the majority of enrollees are subsidized and therefore pay lower premiums.

This isn’t rocket science econometrics, folks.

In the fiscal year before passage of health-care reform, Massachusetts spent $710 million to reimburse hospitals and community health centers for unpaid bills. 81 percent of these costs were incurred by individuals without insurance.

Now we spend that money getting these people the insurance they need so when they go to the ED, they aren’t “uninsured”. Instead we buy these people insurance with taxpayer money so we don’t have to spend taxpayer money reimbursing hospitals directly.

What’s not mentioned is that this is good for the hospitals. A lot of “free care” ends up not being reimbursed at all, meaning hospitals have to eat the costs of treating those who cannot afford to pay. The upside for hospitals is that now that these folks have insurance — subsidized though it may be — hospitals can get reimbursed for services they provide that wouldn’t have been reimbursed in the past. It will be interesting to see if there’s an effect on the number of hospital closures and bankruptcies going forward from here.

Costs aside, all agree that sporadic treatment of the uninsured through emergency rooms and clinics is much less effective medically. The commonwealth took on the problem by diverting much of its uncompensated care pool dollars into subsidies to buy private insurance by lower-income individuals and families. Quarterly costs for free care have subsequently dropped 40 percent.

From one money hole to the next. Yes, that has “sustainability” written all over it. Payments to hospitals have dropped by 40%, and that’s a good thing. Except that that money went to the Commonwealth Care program instead. Instead of being red ink in one set of books, it’s red ink in another.

Clearly there’s a difference between red ink and politically-acceptable red ink. At the end of the day, though, the same people end up paying the piper:

The subsidized insurance program at the heart of the state’s healthcare initiative is expected to roughly double in size and expense over the next three years – an unexpected level of growth that could cost state taxpayers hundreds of millions of dollars or force the state to scale back its ambitions.

State projections obtained by the Globe show the program reaching 342,000 people and $1.35 billion in annual expenses by June 2011. Those figures would far outstrip the original plans for the Commonwealth Care program, largely because state officials underestimated the number of uninsured residents.

Back to Micciche:

And the individuals who acquired private insurance now receive coordinated, cost-effective care that will improve overall health outcomes and reduce the need for more expensive late-stage intervention.

An oversimplification. Many of the patients that are now insured — both subsidized and unsubsidized — cannot find primary care physicians because the program didn’t even attempt to solve one of the major problems with healthcare today: there aren’t enough practicing primary care physicians to handle the influx of new patients. Why? Because being a PCP isn’t a financially attractive proposition. Attempts to alter the landscape of our medical system are continually undercut by talk of reducing Medicare reimbursements to primary care physicians — the very people who will bear the brunt of that manufactured demand. This, in turn, sends the wrong signals to medical students weighing a career in primary care as opposed to a more lucrative specialty.

This dearth of PCPs isn’t unique to Massachusetts, either.

Look, I’m all for increased access to healthcare when it makes sense, and I don’t think ED overusage and overcrowding is sustainable or desirable. I know that health outcomes are worse when non-emergent cases are seen in the ED. ED care is also inherently more expensive. In short, you get less bang for more bucks — and it potentially endangers those who are at the ED for real emergencies by diverting the limited resources to non-urgent cases.

I would like to think that everyone in this country can have their own primary care doctor, but I know that our infrastructure cannot support it. I am not a Darwinian capitalist. I don’t hate poor people. But I do know what is sustainable and what isn’t.

It worries me that if the nation looks to Massachusetts as some kind of prototypical model to be copied, we’re going to be manufacturing big problems, because coverage is only a superficial issue.

Healthcare coverage is not the same thing as healthcare access, even though it is politically expedient to conflate the two concepts.

Universal health coverage will manufacture healthcare demand in dramatic fashion, and the existing healthcare infrastructure isn’t equipped to deal with the kind of patient influx that that kind of universal program would create. We don’t have the human capital to meet that demand. We need to work on our healthcare infrastructure before we dump millions of new patients into the system overnight.

The most interesting thing that strikes me when you look at these numbers is what they say about real demand. Demand for universal health coverage by those that can afford to pay for it is less than our models predict. Even by making health insurance mandatory and enforcing it with a fine, many people are still opting out; they find that their money is better spent in other ways.

Maybe we need to revisit our models and (certainly) our cost projections.