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luxury items. Think of a $2 million diamond ring, a $75 million house, or a $40 million painting. In the pharmaceutical category, however, items on any portion of the curve are not luxuries, but necessities. People who take drugs for orphan indications, which are often among the most expensive medicines, would likely die much sooner without them.
So how are the drugmakers doing financially? An analysis of drugmakers’ profit margins in 2013 revealed some pretty impressive numbers: Jazz Pharmaceuticals (NASDAQ: JAZZ): 54 percent; Celgene (NASDAQ: CELG): 47 percent; Regeneron Pharmaceuticals (NASDAQ: REGN): 44 percent; and Alexion: 43 percent. Not too shabby. Big pharma companies had profit margins that ranged from 10 to 43 percent. Most industries can only dream of earning these types of profits, but this is what monopoly pricing of necessary items can do for the bottom line.
Unfortunately, it’s not difficult to find plenty of examples of greed in drug pricing.
Look at the rise of drug prices during our nation’s worst financial crisis since the Great Depression. Since 2007, at the start of the Great Recession, the consumer price index has risen 12 percent. During a time that most Americans could least afford to pay more for their medicines, however, the price of 73 branded drugs increased by about 75 percent, and dozens of established drugs doubled their prices during this time frame. A few examples: Sodium oxybate (Xyrem), which is used to treat narcolepsy, went from $2.30 to $20 per ml; EpiPens that treat allergic reactions went from $90 to $200; Sildenafil (Viagra) went from $22 per pill to $35; and imatinib (Gleevec), used to treat chronic myelogenous leukemia, went from $221 to $350 per pill. Prices have also been soaring for a number of generic drugs, which has pushed lawmakers to look for ways to assist patients that are struggling to pay for even these “bargain” medicines.
As bad as these numbers are, there are a few companies that make these price increases look cheap. Retrophin (NASDAQ: RTRX) jacked up the price of its cystinuria drug tiopronin (Thiola) from $1.50 per pill to $30; Catalyst Pharmaceutical Partners (NASDAQ: CPRX) is planning on increasing the price of 3,4-diaminopyradine (Firdapse, used to treat a rare muscle disorder) to a level that has been described as “unconscionable”; and K-V Pharmaceuticals (now known as Lumara Health) raised the price of its drug hydroxyprogesterone caproate (Makena, used to prevent premature births) from $20 to $1500 per dose until protests forced it to drop the price to $690 and institute a patient assistance program.
Drug makers tell us that they price their drugs to reflect the value that they bring to patients. Much has been written about the refusal of doctors at Memorial Sloan Kettering Cancer Center to initially prescribe ziv-aflibercept (Zaltrap), a new cancer drug from Sanofi/Regeneron. This action was based on their feeling that the drug offered no advantage over existing medicines, and that it was priced far too high. Faced with bad publicity, the companies wound up slashing the price of their drug by about 50 percent. The doctors’ refusal to prescribe the drug illuminated a clear difference of opinion as to the value of this medicine. The price cut, in turn, reflected the companies’ concession that this medicine was indeed priced too high. This public relations fiasco may have contributed in part to the recent ouster of Sanofi CEO Chris Viehbacher.
In the U.K., the government’s Cancer Drug Fund, which pays for expensive drugs not approved by the National Institute for Health and Care Excellence for cost reasons, has overspent its budget. As a result, it will be is reassessing whether it can really afford to provide a number of medicines due to their high prices. Whether such a move will convince drug manufacturers to reduce their prices remains to be seen.
Much of the current excitement in cancer treatments is tied to uncovering the genetic mutations responsible for the uncontrolled growth of each tumor. Next generation DNA sequencing has now been used on tens of thousands of different tumor samples. The data indicate that, in most cases, each tumor contains a fairly large number of mutations, with 50 to 100 not being an uncommon number. While defining the number of mutations is fairly straightforward, the interpretation of these data is much less clear. Some of these mutations are likely to be the key “driver” mutations that are primarily responsible for the transformation of the normal cell into a cancerous one. Picking out which of the many mutations have this “driver” status is still largely guesswork at this point. In general, it is the concerted action of these “driver” mutations that results in the transformation of the cells.
There are actually some drugs available now that can inhibit the action of a small number of these “driver” mutations. Most of the observed alterations, however, are not actionable: there are no available drugs that can modify the deleterious biological effects of the mutation. Let’s assume that in the near future 1) we can accurately identify which are the important “driver” mutations in any given tumor, and 2) there actually are drugs that interfere with the action of most of the common ones. If this were true, then a future strategy for treating cancer would be to simply give patients a combination of drugs that hit each of these mutations. Drug combinations have shown recent success in mouse models of lung cancer and Ewing sarcoma, and are likely to be needed to treat cancers with intra-clonal heterogeneity such as multiple myeloma.
Unfortunately, there are two issues that might prevent such a strategy from reaching fruition. One is biological, the other financial. Most cancer drugs have side effects; some of these are minor, while others can be serious. A combination of five or more drugs to treat the most important driver mutations might be very difficult for an already weakened cancer patient to tolerate. Many of the current generation of targeted cancer drugs are among the most expensive medicines on the planet. The cost of treating a patient with a five drug cocktail from different manufacturers is highly likely to run in the neighborhood of $500,000,based on the current prices of similar cancer drugs. Given the number of cancer patients in the U.S. (according to the American Cancer Society, there will be about 1.66 million people diagnosed this year), this cost would be simply unaffordable. Treating these new cancer patients at a cost of $0.5 million each would add up to a total of $830 billion. If this number seems large, consider that the U.S. government spent about $2.8 trillion on healthcare in 2013. Not all of these newly diagnosed individuals would require this much treatment, but I haven’t included in this calculation patients who have previously been diagnosed and are now in need of treatment. Medical breakthroughs such as these cannot happen in the absence of rational pricing. Some are wondering not if we will have the medical ability to beat cancer in the clinic, but whether we can afford (both individually and as a nation) to financially pull this off.
I recently came across the following passage, which describes the challenge in changing an industrial mindset, “The deep problem with the system was a kind of moral inertia. So long as it served the narrow self-interests of everyone inside it, no one on the inside would ever seek to change it, no matter how corrupt or sinister it became – though even to use words like “corrupt” and “sinister” made serious people uncomfortable…” Michael Lewis wrote this blistering description of Wall Street behavior in his latest exposé, Flash Boys, but he could just as easily been describing our healthcare system. It’s clear that something has to give in the way that drugs are priced and paid for, as we are heading into an unaffordable future. New models are being tested in drug development with collaborations, partnerships, and virtual companies. A similar effort needs to be made by pharma and insurance companies to develop breakthrough medicines and treatments that are affordable not just for the rich, but for all of us. One such idea being looked at, called V-BID (for value-based insurance design), ties expenses to efficacy and cost. The issues here are complex, but wise thinking and novel solutions are clearly needed. Greed cannot be allowed to triumph over value. As Mahatma Gandhi once put it, “There is sufficiency in the world for man’s need, but not for man’s greed.”
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