Monday, May 15, 2023

Eliminating Hepatitis C, now that there's a cure (even though it's expensive)

 There's growing discussion about eliminating Hep C in the U.S., doing appropriate deals with the two drug companies whose patents still run for another six years.

Fleurence RL, Collins FS. A National Hepatitis C Elimination Program in the United States: A Historic Opportunity. JAMA. 2023;329(15):1251–1252. doi:10.1001/jama.2023.3692

"One of the most dramatic scientific achievements of the last few decades has been the development of direct-acting antivirals (DAAs) that can cure hepatitis C in more than 95% of people infected. But 9 years after the first such treatment was approved in the United States, the simple 8- to 12-week oral cure is not reaching a significant fraction of the more than 2.4 million US residents chronically infected with hepatitis C.1 More than 15 000 US residents die of hepatitis C every year unnecessarily. In its fiscal year 2024 budget proposal, the Biden-Harris administration has put forward a bold 5-year program to put the nation on course to eliminate hepatitis C in the United States.

"The consequences of untreated hepatitis C can be severe: cirrhosis, liver failure, hepatocellular cancer, and death. Curative treatment stops transmission, prevents liver cancer and liver failure, and saves lives. It is even likely to be cost-saving, by avoiding expensive medical treatments for liver failure and liver cancer. So why is this not a public health success story? One major reason is that many people with hepatitis C have poor access to health care and experience other chronic health and social inequities. Hepatitis C disproportionately affects individuals without insurance, American Indian and Alaska Native persons, non-Hispanic Black persons, justice-involved populations, and people who use illicit drugs.2


"Among those diagnosed, hepatitis C treatment coverage is far below what is needed to achieve elimination goals. Only about one-third of people diagnosed with hepatitis C who have private insurance, Medicare, or Medicaid get treated, and the proportion is probably even lower for those without insurance.4 This is in part due to current restrictions, such as requirements for patient sobriety, requirements to document evidence of liver fibrosis, and the restriction of access to treatment only to those seen by specialists, that have been put in place by public and private insurers in reaction to the high cost of DAAs ($90 000 per patient initially, still around $20 000). Low rates of treatment may also reflect the complexity of traversing the full cascade of care in our health care delivery system.

"Addressing this missed opportunity can save both lives and money. A national effort can build on lessons from programs launched by jurisdictions such as the states of Louisiana and Washington, the Cherokee Nation, the Veterans Health Administration, and the Federal Bureau of Prisons. For example, the Veterans Health Administration has treated more than 92 000 veterans with hepatitis C virus since 2014, with cure rates exceeding 90%.5 A key lesson from these initiatives is that success requires both managing the cost of the medications and developing a comprehensive public health effort to identify persons with hepatitis C and link them to care.


"the program aims to provide broad access to curative hepatitis C medications. A key element will be a national subscription model to purchase DAAs for those who are particularly underserved today: Medicaid beneficiaries, justice-involved populations, people without insurance, and American Indian and Alaska Native individuals who are treated through the Indian Health Service. With this approach to drug purchasing pioneered in Louisiana,7 the federal government will negotiate with manufacturers to purchase as much treatment as needed for all individuals in the designated groups. The pharmaceutical industry can expect more revenue for DAAs for these populations than it is receiving today, but at a much lower per-patient cost. That’s a win-win. Beyond the subscription model, the program will seek to provide additional co-pay assistance to Medicare beneficiaries. Private insurers will also be strongly encouraged to increase coverage for hepatitis C testing and treatment and limit out-of-pocket costs where possible."

No comments: