Value. It’s one of the most frequently used buzzwords on both Wall Street and in healthcare. Virtually every press release from a publicly traded company assures us that its latest acquisition/layoff/tax inversion/sale of assets was designed “to increase shareholder value.” But what exactly is “value” and how is it measured? Here are some definitions from the online Merriam-Webster dictionary:
1: a fair return or equivalent in goods, services, or money for something exchanged
2: the monetary worth of something: market price
3: relative worth, utility, or importance
4: something (as a principle or quality) intrinsically valuable or desirable
These definitions remind me of Supreme Court Justice Potter Stewart’s famous characterization of pornography, “I know it when I see it.” Wikipedia’s description of Potter’s phrase as “a colloquial expression by which a speaker attempts to categorize an observable fact or event, although the category is subjective or lacks clearly defined parameters” could just as easily be applied to the word “value.”
What’s got me pondering the meaning of the word “value”? Drug pricing. I’m trying to figure out when a drug’s price crosses over the invisible and undefined threshold from value into greed. How much should a drug really cost, and how are drug prices actually calculated? This mysterious process takes place behind closed corporate doors with a secrecy that would make the National Security Agency proud. It’s a process that, to the public at least, is as transparent as mud. It’s understandable why companies want to keep secret the details of how they set a drug’s price, but this lack of transparency leaves them open to charges of price gouging. Numerous questions must be answered. What price will the market bear? How likely is it that insurers will reimburse the cost? Can patients afford the co-pays? How much is likely to be sold at any particular price point?
I don’t think many people would argue with the concept that a drug’s price must cover manufacturing costs as well as reimburse the company for money expended on getting the drug to market. Beyond covering expenses, of course, is profit. That translates into money that companies claim will be reinvested back into R&D to enable future drug discovery. The fact that most Big Pharma companies actually spend more money on marketing than they do on R&D makes this argument a bit dicey. Cash can also be used to pay for upcoming mergers and acquisitions and to fund stock buybacks. Big profits will drive up the stock price, benefiting shareholders as well as employees with stock options, especially senior management.
The current poster children in the debate on drug pricing are Gilead Sciences’s (NASDAQ: [[ticker:GILD]]) hepatitis C drug sofosbuvir (Sovaldi) and it’s follow-on sibling Harvoni (which contains a mixture of sofosbuvir and a second drug, ledipasvir). Sovaldi recently set the record for the fastest drug launch ever. The cost for a standard course of treatment with it is $84,000, while Harvoni costs $94,500. The FDA recently approved Johnson & Johnson’s (NYSE: [[ticker:JNJ]]) hepatitis C drug simeprevir (Olysio); it’s meant to be taken in combination with sofosbuvir. Since simeprevir costs $66,000, the combination will cost a whopping $150,000. If these prices seem high to you, keep in mind that sofosbuvir actually ranked only 19th on the 2013 list of most expensive drugs.
These hepatitis C drugs, if you’re not familiar with them, are truly groundbreaking medicines. Researchers who work in drug discovery strive to create and bring to market exactly these kinds of medicines. Not only are they much more effective than previous treatments, they have fewer side effects . They are curative for the vast majority of patients taking them. These medicines are not home runs; they are knock-it-out-of-the-ballpark grand slams. New drugs that actually cure people are extremely rare. And because these drugs only need to be used for a limited amount of time (unlike drugs for chronic diseases such as rheumatoid arthritis and diabetes), a company has only a relatively brief period to recoup its investment on a per-patient basis.
The price, however, has been very controversial. Several members of Congress sent a letter to Gilead asking company executives to come before them to explain how the price of the drug was arrived at and how it would be made available to low-income patients, among others. Many feel the cost is simply too high, a feeling I share. Steve Miller, the chief medical officer of Express Scripts (NASDAQ: [[ticker:ESRX]]), a pharmacy benefit management company, argues that the price of sofosbuvir is indefensible. He wrote, “What we’re seeing today in hepatitis C is orphan-drug pricing for non-orphan drugs,” and remarked, “The cost of [sofosbuvir] is unsustainable for many of our plans.” There are about 3.2 million patients in the U.S. who are chronically infected with hepatitis C and would be eligible to take these drugs. Medicines receiving orphan disease indications are generally limited to populations with fewer than 200,000 people in the U.S. Paying for sofosbuvir and similar drugs will have a huge impact on state Medicaid programs in particular, because they cover large number of hepatitis C patients.
On the flip side, defenders of sofosbuvir’s pricing have suggested that folks who think the drug is too expensive, unjustifiable, and unsustainable “are philosophically opposed to a market system in medicine or those who are willing to sacrifice the long-term cost savings of the drug for the short-term savings on immediate costs (government) and profits (health insurance companies).” Supporters of the free market argue that the government has no business deciding what prices are “just and reasonable. ”
We don’t know how Gilead came up with the $84,000 price tag for sofosbuvir. Let’s assume for the sake of argument that the price is reasonable. After all, Gilead sold some $2.8 billion of it in the last quarter, so many insurers were willing to pay the cost. But suppose it had been priced at $104,000, or $124,000, or $204,000. Which of these costs would have still provided “value,” and which would have been price gouging? Overcharging, like beauty, is in the eye of the beholder. Would the drug be a “value” at $64,000?
Specious arguments pop up in the midst of discussions of drug pricing. In the case of sofosbuvir, it’s often pointed out that the drug is significantly cheaper than a liver transplant. This isn’t really relevant. We don’t live in the world depicted in Kazuo Ishiguro’s dystopian novel Never Let Me Go, where wealthy people have clones that they can turn to whenever they need a replacement body part. Even without effective drugs, only a small percentage of hepatitis C patients are likely to develop the advanced cirrhosis or liver cancer that necessitates a transplant. There are only about 6,000 liver transplants done in the U.S. every year, with about 16,000 Americans on the waiting list (and for a variety of diseases, not just hepatitis B and C). So it’s highly misleading to say that we will be collectively saving billions of dollars by avoiding expensive transplants for a large number of infected individuals.
Some insurers are balking at paying for this medication. Even if yours will pay, you may be stuck with a 20 percent co-pay on your drug prescriptions, which in this case could cost you $16,800 (those covered under the Affordable Care Act are in better shape: their out of pocket costs are capped at $12,700). Interestingly, Gilead is selling sofosbuvir in India for a 99 percent discount from its cost in America. To me, this seems like an invitation for U.S. hepatitis C patients to schedule a vacation in India in the near future. See the Taj Mahal, stay at the Lake Palace, and pick up a prescription for sofosbuvir for only $900. For many, the entire trip would cost significantly less than the U.S. co-pay.
Prescription drug prices cover an extraordinary range. At the low end are a large number of generic drugs, many of which are widely available for about $4 per month. At the high end would be Alexion Pharmaceuticals’s (NASDAQ: [[ticker:ALXN]]) drug eculizumab (Soliris), which is used to treat several rare diseases. It costs about $500,000 per year, or $40,000 each month. This price range covers some four orders of magnitude. I tried to think of other items that consumers can buy that might cover a 10,000 fold range of prices, and all I could come up with is jewelry, real estate, fine art, businesses, and stocks. If I restrict the list to tangible goods, then it only leaves the first three categories.
A graph plotting the number of drug prescriptions against their prices would resemble a long tail, with generic drugs (which make up about 85 percent of all prescriptions written in the U.S.) on the left and specialty/orphan drugs on the right. Predictions are that this latter category of drugs will make up 19 percent of the drug market by 2020 (and account for up to 50 percent of total pharmacy spend by 2018), despite the fact that they are only used by relatively small numbers of patients. By contrast, plotting the price distribution of these other items (e.g. jewelry, home prices) more closely resembles the bell shaped curve that many of us are familiar with. Most of us would say that items that occupy the far right portion of a bell shaped curve in these categories are
