The Porcine Prerogative: A Perilous Precedent

While not falling within the CNS arena per se, the consequences of Gilead Pharma‘s decision to platinum-price Sovaldi for Hepatitis C, to the tune of $84,000 per three month treatment cycle in the US, eventually will permeate health care in general. The  pricing seems born of Orphan Disorder modeling, for which tolerance in the US has been expansive, given the small sizes of these populations and the easily-discernible outlines of the scenario for sympathy; pediatric patients otherwise doomed before they ever really get to begin. But Sovaldi is applicable to far larger populations, given that 2% of the US population is estimated to have a Hepatitis C infection. Some estimates of the potential US market, were all HCV-infected patients to be treated, are over $200 billion. That is not going to happen, but where one draws the line in terms of eligibility–e.g. cirrhosis?–invokes an inevitable debate between reactive and proactive intervention models. The most extreme framework for reactive treatment would require that later-stage damage has been done and symptomatically apparent, where transplants might otherwise be part of the conversation. But that would be treatment that arrives too late: True pharmacoeconomic benefit would come from preventing large segments of the HCV population from progressing to serious–and very expensive–stages of hepatic dysfunction. But proactive therapy, intervening before that level of damage has been done, could be expanded to a scale of utilization and cost that would temporarily delight Gilead management and shareholders, and would–and should–horrify all other onlookers.

In fact, there won’t be any true onlookers here; this is the kind of gluttony for which everyone will pay, and which could present the tipping point on the other side of which awaits governmentally-governed pricing constraints, the kind of price-controls that the US has avoided, even as the rest of the developed and semi-developed world has embraced them. The topic of why the EU, for example, has been allowed to shift the true costs of drug development onto the United States by sharply limiting its reimbursement for drugs is a topic unto itself, but sets the context: At some point the cultural antipathy to top-down regulation of drug pricing will shift as the US realizes that it can no longer afford to be the World’s Deepest Pockets for Pharma.

The situation is also one where it will be relatively easy to manipulate the finite empathy of the American public, because rather than serving a population of innocent children, it is a simple public relations maneuver to paint the Hepatitis C population–even if unfairly–as being largely characterized by intravenous drug users whose illness can be traced to their own conduct, and a group more often covered by governmental insurance (e.g. Medicaid).

Once the precedent has been established, it cannot be undone. And it will eventually bring us to the biggest quandary of them all–Who will receive, and who will pay for–the first drugs to slow disease progression in Alzheimer’s? With over five million Alzheimer’s patients in the US, and many more who are on the cusp with MCI or ARCD, the potential scale of that market dwarfs even Hepatitis C. There, the additional socioeconomic argument will come into play regarding the costs of care for those approaching the end of their lives, and the degree to which younger generations should and can go into hock for them.

Any precedents set regarding access and price-controls will reverberate well beyond HepC and Sovaldi, yielding seismic changes in attitudes in the United States, as economic necessity begins to erode the American resistance to governmentally imposed restrictions–particularly when it comes to federally-funded insurance programs. The eventual advent of competing drugs might–at least in theory–set up price-competition that might attenuate the impact, but we would not count on it. By setting this bar so high, Gilead is hoping that the pricing game will be played at this stratospheric level, like MS, with all relevant entrants pushing the cost envelope to some degree. This may not be a crime, but it is also not victimless.  The old saying ends with, ‘Pigs get slaughtered,’ and in their greed, Gilead not only did not consider the damage that they could bring upon themselves, they almost certainly did not envision the likelihood that they could bring plenty of company with them down the kill-chute.



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