Center 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.