WASHINGTON ─ Hepatitis C virus is moving from chronic disease to curable; however, there are obstacles to eradication and “the hope of ending the hepatitis C epidemic kindled by the new regimens will be extinguished,” Brian R. Edlin, MD, of Weill Medical College of Cornell University, said here.
“This is a watershed moment…in the history of medicine,” Edlin said of HCV treatment. “We are now crossing the threshold where for the first-time, chronic, lifelong, life threatening viral disease has finally now been transformed from being incurable to being readily curable.”
However, there are barriers to a cure and the eradication of HCV through a “highly effective, potent treatment that is safe, easy [and] durable,” he said. “Has this new era of scientific and medical and public health progress been met with the jubilation that it really warrants?”
“Well, actually…we have a mixed picture as a consequence of the price of the drugs,” he continued.
Edlin said there has been “rationing of treatment” by payers based on fibrosis stage, substance abuse and the specialty of the provider and this has created conflict.
He has seen justification for overt discriminatory practices in which the health care system mandates that a patient have a negative urine toxicology screen to receive medical care.
“We are dealing with a very vulnerable population in many cases who already suffer from the stigma of hepatitis C and now we are telling them that the treatment is available but very expensive and reinforcing the message that the patients might not be ‘worth’ the expense of treatment,” he said.
Edlin said many payers in both the public and private sectors are now required to have: advanced fibrosis (F3 or F4); cirrhosis (F4); abstinence from alcohol, marijuana and illicit drug use; mandatory drug and alcohol testing; active participation in treatment for substance use; no substance use treatment in the past 12 months; no substance use diagnosis in the past 12 months; no malignancy of any organ; and “extensive experience” treating HCV by the prescriber. He also said there are arduous prior authorization processes.
“These provisions lack any medical justification; there is no evidence base for them and no scientific foundation,” he said. “There is no argument that the restrictions have been implemented for financial reasons.”
These restrictions contradict medical society guidance; specifically, that “evidence clearly supports treatment in virtually all HCV infected patients,” he said.
The American Association for the Study of Liver Diseases’ and the Infectious Diseases Society of America’s prioritization guidance have been “construed as reason for rationing,” Edlin said.
“These restrictions are discriminatory. There is no other condition for which curative, medically indicated therapy is being withheld by insurance companies purely because they don’t want to pay the cost,” he said. “Payer restrictions are most likely illegal in most jurisdictions.”
Cost and price are different things, according to Edlin. Cost requires “sacrifice by society” and has the characteristic of intervention. Price is made by corporate executives and requires the “transfer of money from one sector of society to another sector of society,” Edlin said. Therefore, HCV treatment is pricey, not costly.
HCV treatment policy is being determined by the consequences of drug makers and insurers each pursuing their respective financial goals, he said, and the patients’ interests are not being represented. It is the physicians’ responsibility to represent the interests of their patients with HCV.
Edlin said prices are dropping, so there may be a light at the end of the tunnel and active litigation may affect these restrictions.
While new regimens offer the promise of eradicating HCV, a national consensus is needed to make this happen, he said.
“We have loss of our vision of how transformative these new curative drugs can be,” Edlin said. – by Joan-Marie Stiglich, ELS
Edlin BR. Sp473. Eradication of hepatitis C in persons with limited access to health care. Presented at: Digestive Disease Week; May 15-19, 2015; Washington, D.C.
Disclosure: Edlin reports no relevant financial disclosures.