Conference Coverage

Best HCV value? Screen all baby boomers, treat all infections

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Treatment is worth the price

Chronic HCV infection is a common worldwide problem afflicting approximately 170 million people. HCV has significant morbidity and mortality, and it is currently the leading indication for liver transplantation in the Western world. Yet, the natural history is long, and most patients are asymptomatic and will not develop advanced liver disease.

The recent year has been marked by the stunning approval in the U.S. of all-oral, interferon-free treatments for chronic HCV, including genotypes 1, 2, and 3. Approved regimens are characterized by excellent tolerability and cure (sustained virologic response, SVR) rates for most patient subgroups above 90%. For genotype 1, the most common in the U.S., SVR rates in excess of 95% were observed in clinical trials.

Since the regimens are so well tolerated and effective, the number of patients seeking therapy has increased dramatically. Because the medical regimens are expensive, there have been draconian restrictions by many third-party payers for provision of antiviral therapy for HCV patients. This has led to analyses on cost-effectiveness of contemporary therapy.

The article describing a study presented at AASLD 2014 by Younossi et al. is an important contribution to this discussion. Younossi assessed a computer simulation analysis comparing four strategies for screening and treatment of HCV plus an option of no screening or treatment. He found that birth cohort screening and treatment of all HCV patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY); well below the accepted threshold used to define cost-effectiveness in health care. The assumptions regarding cost of the regimens, the rates of cirrhosis, hepatocellular carcinoma, liver transplantation and liver-related death were appropriate. The conclusion that all baby boomers should be screened and treated is not surprising.

The savings did not include an estimated $3 billion dollars annually in savings from work productivity. The analysis also did not account for the costs associated with many extrahepatic manifestations of HCV including diabetes mellitus, lymphoma, cryoglublinemia, chronic renal disease, and others that are not associated with the stage of liver disease and have significant morbidity and mortality. All-cause mortality, not only liver-related mortality, has been shown to decline in patients treated successfully compared with unsuccessful therapeutic attempts.

Never before has there been a serious medical illness for which a well-tolerated and highly effective therapy is available that has been subject to denial of therapy based upon cost by third-party payers. This is an unfortunate precedent.

All patients do not require therapy on an urgent basis. However, the decision to initiate therapy should be between a patient and his or her health care provider. Although it would be best if the cost of the medications could be reduced, even at the current costs, Younossi’s study provides clear data to support identification and treatment of HCV patients sooner rather than later.

Dr. Steven L. Flamm is chief of transplantation hepatology and professor of medicine and surgery at Northwestern University Feinberg School of Medicine, Chicago. He is a speaker for AbbVie, Janssen, and Gilead; and consults for AbbVie, Gilead, Janssen, BMS, and Merck.


 

AT THE LIVER MEETING 2014

References

BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.

A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.

That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.

Dr. Zobair Younossi

Dr. Zobair Younossi

In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”

Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.

Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.

Higher costs, lower risks

Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.

The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.

Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.

To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.

The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.

Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.

The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.

The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.

A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.

HCV costlier than other conditions?

When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.

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