Dr. Fleck presents at Michigan State Medical Society Conference on Bioethics

Len Fleck photoCenter Professor Dr. Len Fleck presented at the 20th Annual Michigan State Medical Society Conference on Bioethics, held on November 12, 2016 in Ann Arbor. The theme of the conference was “Ethical Issues in the Pharmaceutical Industry: Current Controversies and Challenges.” Dr. Fleck’s presentation was titled “Curing Hepatitis C: Whose Cost? Whose Responsibility?” Dr. Fleck discussed several ethical and policy issues around the drug Sofosbuvir, otherwise known as the $1000 pill. This is a drug that requires 12 weeks of treatment at a cost of about $100,000.

There are about 3.2 million Americans who are Hepatitis C (HCV) -positive. About 30% of those individuals do not know they are HCV-positive. Unlike most drugs on the market today, this drug is actually curative for up to 95% of patients treated. But the cost of treating all Americans who are HCV-positive at current prices would be $300 billion.

About 800,000 HCV-positive individuals are covered by Medicaid. No Medicaid program can afford to provide this drug to all HCV patients without a massive shifting of resources that would be neither just nor justified. The relevant medical facts are that HCV could result in life-threatening liver problems for as many as 70% of these patients, but these outcomes would typically be ten to thirty years after infection (if ever). Many of these individuals will die of something else, which is one reason why Medicaid wants to avoid paying to treat these individuals. Also, the Medicaid population “churns” a lot from year to year, primarily because many individuals are successful in getting jobs and getting out of poverty. Consequently, someone else would become responsible for paying for the drug (if they have a job with employer-sponsored insurance). To limit costs most Medicaid programs require recipients of the drug to have advanced liver fibrosis, Stage F3 or F4. This is ethically problematic because Sofosbuvir will cure their HCV but not stop disease progression. Consequently, 7% of F3 patients will die of complications of liver disease and 22% of F4 patients will suffer that fate. This is not at all ethically or medically congruent with the way heart disease or cancer or other chronic degenerative conditions would be treated in these patients.

Dr. Fleck concluded three things: (1) The price of Sofosbuvir is unconscionable; there is no ethical or economic justification for that price. (2) Medicaid programs would be on sounder ethical ground if treatment were initiated no later than F2 where 3% of patients would still die of liver complications. (3) The deeper source of the ethical issues in this case is the fragmentation of the American system for financing access to needed and effective health care. That fragmentation encourages the diffusion and disavowal of responsibility for meeting the health care needs of these patients.

The Ethical Challenges Raised by Hepatitis C Drugs

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series. For more information, click here.

By Leonard Fleck, PhD

Here is the key question I will address in response to a recent Forbes article: Does everyone infected with hepatitis C (HCV) have a just claim to a drug that costs $100,000 for a course of treatment but that yields a cure rate greater than 95% (but that costs less than $1000 to produce)? I would not blame the reader who instantly reacts with the thought “profit margins like that are unconscionable; THERE is the ethical problem.” But the purpose of this essay is not to engage in Big Pharma bashing (though a few good whacks would certainly be ethically justified). Instead, I want to examine the downstream ethics issues that have been generated by these drugs and their pricing.

Let us start with a few medical and demographic facts. The CDC estimates that about 3.2 million Americans are infected with HCV, roughly half of whom are unaware of the fact that they may be infected. I remind the reader that HCV was not identified until 1989. This means that some form of broad population testing would be necessary to identify all who are infected with HCV. The medical consequences of untreated HCV are often severe: liver fibrosis, liver cirrhosis and liver cancer. However, this is not the fate of everyone with untreated hepatitis C. Roughly 10% of these patients will suffer cirrhosis within 20 years of infection, while 30% will suffer this fate somewhere beyond 20 years. (Bastian, 2014) This fact alone will create a major ethical problem (see below). HCV is transmitted through bodily fluids, much like HIV. The point here is that HCV represents a public health threat.

There have been relatively less expensive HCV treatments that have achieved cures in some range of cases, but these treatment regimens required 48 weeks of treatment with peginterferon, which more than half the patients found intolerable, which resulted in their quitting treatment. Sofosbuvir (Sovaldi) shortened treatment time to 12 weeks, though the whole regimen still required interferon. However, adding ledipasvir to sofosbuvir (Harvoni) eliminated the need for interferon. The cost of Sovaldi is $84,000 for those twelve weeks, or $1000 per pill. Harvoni is priced at $1125 per pill or $94,500 for a 12-week course of treatment. If all 3.2 million Americans infected with HCV were to receive either treatment, that would represent $300 billion in sales. If we ask how individuals might become infected with HCV, the answer is that a large majority became infected through IV drug abuse. Roughly 500,000 individuals infected with HCV are in prison (Liu et al., 2014); another 750,000 or so are eligible for Medicaid coverage; roughly that same number is now covered by Medicare (or will be by the year 2020).

If all who were eligible for Medicaid coverage and HCV infected were treated this year, the cost to the states would be $55 billion. (Kardish, 2014) The same would be true in the prison system. These are costs that are impossible for the states to bear both ethically and economically. Consequently, most states are putting in place severe restrictions on access to these drugs. Specifically, individuals must have advanced liver cirrhosis in order to receive the drug at state expense. In addition, individuals must not have engaged in drug or alcohol abuse for a period of three months (alcohol abuse speeds cirrhosis in HCV patients). Further, if individuals re-infect themselves after curative therapy, they will not be eligible for another course of Harvoni at State expense. (Silverman, 2014; Bannow, 2014)

A mix of arguments is given to justify what appear to be these draconian policy choices. First, roughly 70% of HCV infected patients will not develop advanced liver cirrhosis or liver cancer. So, the argument goes, why spend tens of billions of dollars for a drug that will not make much of a practical difference in the lives of these patients? Further, individuals on Medicaid or in prison very often move out of poverty or serve their time. So, the argument goes, why should we (Medicaid or the prison system) have to pay these costs for these asymptomatic patients when they will leave the system and someone else can be the bearer of those costs. This same argument is being invoked by private insurance companies that are mindful of the frequency with which individuals switch insurance plans. Along these same lines, these considerations undermine any motivation for wanting to do population testing to identify individuals who are unaware of the fact that they are HCV infected. Finally, given limited resources (what taxpayers are willing to spend), providing unlimited access to Harvoni or Sovaldi would require substantial re-prioritization of health needs to be met for these populations, which (it is asserted) would be neither just nor justified.

Still, there is something medically and morally perverse about these arguments. Last year we in the US spent $17 billion on statins with the intent of preventing some number of heart attacks and strokes. No one argued that we should wait to see who suffered a heart attack and survived before offering a therapeutic response. Current protocols for treating HIV+ individuals recommend initiation of triple therapy as soon as infection is confirmed (as opposed to waiting several years for compromise of the immune system). The cost per year of those drugs is about $35,000 per person, and the gain in life expectancy may be thirty years or more. That represents more than a million dollars in lifetime costs for those drugs. If we see that as something a just and caring society ought to provide, both for the good of the patient and for public health reasons, then why would not moral consistency require the same for Harvoni or Sovaldi? Again, HCV is infectious. If HCV-infected individuals are untreated for twenty years, then they have the capacity to infect others through unprotected sex or needle-sharing, even if they never go on to advanced cirrhosis. Further, failing to screen for HCV in high-risk populations can only make that situation worse.

It must be remarked that HCV-infected patients are largely of low social status. Further, strong social disapproval is attached to the behavior that results in much HCV infection. So there is the subtle suggestion that these individuals are responsible for their impaired health, and consequently, do not have a just claim to the social resources needed to restore their health. I have argued elsewhere this is a seriously ethically flawed perspective. (Fleck, 2014)

Given constrained state budgets, the argument about unjustly skewed priorities that would result from unlimited funding for Harvoni has some ethical merit. That brings us back to the pricing issue. Gideon, the distributor of Sovaldi and Harvoni, claims that the drug is fairly priced because of all the future cases of liver disease related to HCV that would be prevented. However, the current annual cost of treating those diseases in the US is about $6.5 billion. (Kabiri et al., 2014) That yields a twenty-year cost of about $130 billion, far below the $300 billion in total sales Gideon might expect. So that argument is mathematically and morally specious.

There is the argument about research costs and failed drugs routinely invoked by drug companies. But Gideon spent nothing to develop this drug. Gideon bought the company that developed the drug for $9 billion. That is exactly equal to the first nine months of sales of Sovaldi. If the price of Sovaldi and Harvoni were reduced by 90% to $8000, the ethical issues raised above would all disappear. And since the actual cost of manufacturing the drug is only $1000, that still leaves a $7000 profit margin per prescription. If Senator Proxmire from Wisconsin were still alive, Gideon would deserve a gold-plated Golden Fleece award. Failing that, several severe ethical whacks to their corporate conscience are well deserved.

References:

Fleck smallLeonard Fleck, PhD, is a Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Philosophy at Michigan State University.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, November 6, 2014. With your participation, we hope to create discussions rich with insights from diverse perspectives.

You must provide your name and email address to leave a comment. Your email address will not be made public.