A Cost-Effectiveness Analysis of Treatment Alternatives for Hepatitis B Cirrhosis

Hepatitis B virus (HBV) patients with cirrhosis are at high risk for developing costly, morbid, or mortal events, and therefore require effective therapies. Lamivudine (LAM) [Epivir-HBV] is effective in HBV cirrhosis but is associated with a high rate of viral resistance.

In contrast, newer agents like adefovir dipivoxil (ADV) [Hepsera] and entecavir (ETV) [Baraclude] have less viral resistance, but are more expensive. Because patients with cirrhosis can ill-afford the emergence of viral resistance and potentially life-threatening viral [HBV] flares, there is a delicate balance between avoiding resistance and minimizing cost in the treatment of HBV cirrhosis.

The most cost-effective approach is uncertain.

Researchers at the Greater Los Angeles Healthcare System and Mount Sinai Medical School in New York City performed an economic analysis to estimate the cost-effectiveness of four treatment strategies in a hypothetical cohort of 50-year old patients with chronic HBV cirrhosis and active viral replication:

(1) No HBV treatment (“do nothing”);

(2) LAM monotherapy,

(3) ADV monotherapy, or

(4) LAM with cross-over to ADV upon resistance (“ADV salvage”).

In order to emulate the case-mix in clinical practice, [the investigators] included patients with compensated and decompensated cirrhosis. Because there are currently limited data regarding ETV, [they] did not include this agent in the primary analysis. [They] instead performed a hypothesis generating sensitivity analysis incorporating current drug prices to estimate the potential cost-effectiveness of ETV.

[The researchers] incorporated probability estimates derived from a systematic review, and adopted cost estimates from a third party payer perspective. Monthly prices for LAM, ADV, and ETV were $158, $528, and $720, respectively. The primary outcome was the incremental cost per quality adjusted life-year (QALY) gained.

Results

• The “do  nothing” strategy was least effective yet least expensive.
• Compared with “do nothing,” using ADV cost an incremental $20,011 per QALY-gained.
• LAM monotherapy was more expensive yet less effective than ADV.
• Compared with ADV, in turn, “ADV salvage” cost an incremental $107,165.
• ADV monotherapy was the most cost-effective strategy in HBV patients with both compensated and decompensated cirrhosis.
• ETV revealed “diminishing returns” compared to ADV on the basis of the current 22% higher cost of ETV.

These data indicate that ADV may be the most cost-effective strategy in patients with HBV cirrhosis, regardless of the stage of liver disease. Among the new generation of antiviral agents for HBV, the least expensive agent is likely to remain the most cost-effective.

[The authors conclude,] “These findings should be confirmed in prospective clinical trials that measure the accrued costs and effectiveness of competing agents in HBV cirrhosis.”

11/16/05

Reference
F Kanwal and others. Treatment Alternatives for Hepatitis B Cirrhosis: A Cost-Effectiveness Analysis. Abstract 393. Program and Abstracts of the 56^th annual meeting of the American Association for the Study of Liver Diseases. November 11-15, 2005. San Francisco, CA.