Hepatology Expert Opines On Alleged Discrimination in Hepatitis C Treatment

This case involves an individual who had been living with hepatitis C for several years before seeking a cure produced by a major pharmaceutical company. The patient’s insurance company, however, refused to cover the treatment due to the patient’s condition. An expert in hepatology that regularly treats hepatitis C was sought to discuss the drug in question and opine on whether medication should be started based on an individual’s status or whether the medication should be started regardless of the individual’s condition.

Question(s) For Expert Witness

1. Please describe your experience treating patients with Hepatitis C.

2. In your opinion, what determines whether a patient should be started on medication: the individual's status or their condition?

Expert Witness Response E-038357

I am a board-certified gastroenterologist and transplant hepatologist. I currently serve as the director of hepatology at a large east coast medical center, where I oversee the care of a large cohort of HCV patients. I am an assistant professor of medicine at an Ivy League university where I co-direct a viral hepatitis grand rounds CME program. I am also the director of a liver cancer tumor board and multidisciplinary liver cancer clinic. I have extensive experience treating HCV. I have overseen the treatment of roughly 300 patients, and I have extensive experience treating HCV with Harvoni and Viekira Pak. I authored a Phase IV study for SOF/RBV in genotype. My publications are mainly in translational immunology related to HCV and related complications. I authored a paper looking at longterm outcomes of IFN treated patients. My legal consultation work has mainly revolved around malpractice cases in gastroenterology. I also have reviewed cases for attorneys deciding whether or not to pursue litigation.

The astronomical cost of the medications at present makes it impossible for payors to treat every patient in any one fiscal year. This is a problem 40+ years in the making and it is going to take more than a year or two to resolve. Initial AASLD guidelines (in my opinion correctly) included language regarding prioritization. More recently they have removed this language, but I am in the minority opinion that this was a huge mistake. I also believe there is a strong conflict of interest among the AASLD/IDSA committee because most of the members are beholden to the largest pharmaceutical companies for their ongoing research studies. Others have voiced this criticism.

Most cost-effectiveness analyses indicate that presently, willingness-to-pay thresholds treatment is cost-effective only for G1 patients with cirrhosis. Most analyses in resource-constrained systems indicate that prioritization of F3-F4 patients produces the most societal gain (of course these are from 2nd-3rd world settings but do justify a sickest first approach). I don't think that anyone argues that early stage patients shouldn't eventually be treated, but that these patients can wait until sicker patients are cured and drug costs come down with competition in the marketplace. Most supporters of "treat all" strategies use data on PROs to justify the argument. These data are fraught with ascertainment bias. The vast majority of F0-3 patients are completely asymptomatic from the virus, and almost all symptoms can be attributable to stigmatization or somatization. An F0-1 patient with a 30-40 year history of infection at age 60 has nearly a zero risk of developing HCV-related complications during his/her lifetime if they have not already had one (e.g. MPGN, lymphoma) and are going to die with and not of HCV infection. Data that HCV increases cardiovascular risk is highly flawed and contradicted by some well-done studies. HCV and DM are causally related in a small subset of patients but it is unlikely that treating HCV this year versus 5 years from now in a patient with longterm chronic infection will alter that outcome. The drugs cost $150 to make. If they were priced concordant with manufacturing and R&D costs, there would be no obstacle. However, such is not the reality.