bad news/good news

[Lani]

bad news-- the bean-counters strike again and declare addition of lapatinib to capecitabine for Stage IV is not cost-effective on a "societal basis":

ABSTRACT: Cost-effectiveness analysis of lapatinib in HER-2-positive advanced breast cancer
[Cancer]
Background: A recent clinical trial demonstrated that the addition of lapatinib to capecitabine in the treatment of HER-2-positive advanced breast cancer (ABC) significantly increases median time to progression. The objective of the current analysis was to assess the cost-effectiveness of this therapy from the US societal perspective.
Methods: A Markov model comprising 4 health states (stable disease, respond-to-therapy, disease progression, and death) was developed to estimate the projected-lifetime clinical and economic implications of this therapy. The model used Monte Carlo simulation to imitate the clinical course of a typical patient with ABC and updated with response rates and major adverse effects. Transition probabilities were estimated based on the results from the EGF100151 and EGF20002 clinical trials of lapatinib. Health state utilities, direct and indirect costs of the therapy, major adverse events, laboratory tests, and costs of disease progression were obtained from published sources. The model used a 3% discount rate and reported in 2007 US dollars.
Results: Over a lifetime, the addition of lapatinib to capecitabine as combination therapy was estimated to cost an additional $19,630, with an expected gain of 0.12 quality-adjusted life years (QALY) or an incremental cost-effectiveness ratio (ICER) of $166,113 per QALY gained. The 95% confidence limits of the ICER ranged from $158,000 to $215,000/QALY. A cost-effectiveness acceptability curve indicated less than 1% probability that the ICER would be lower than $100,000/QALY.
Conclusions: Compared with commonly accepted willingness-to-pay thresholds in oncology treatment, the addition of lapatinib to capecitabine is not clearly cost-effective; and most likely to result in an ICER somewhat higher than the societal willingness-to-pay threshold limits.

Good news?-- maybe this will get GlaxoSmith Kline to lower the price!(no evidence this is the case, just trying to be an optimist!)

Now THIS truly IS good news!:
1: Breast Cancer Res Treat. 2009 Jan 20. [Epub ahead of print]

Lapatinib plus capecitabine versus capecitabine alone for HER2+ (ErbB2+) metastatic breast cancer: quality-of-life assessment.

Zhou X, Cella D, Cameron D, Amonkar MM, Segreti A, Stein S, Walker M, Geyer CE.
RTI Health Solutions, 200 Park Offices Drive, Research Triangle Park, NC, 27709, USA, xzhou@rti.org.
The randomized phase III trial EGF100151 demonstrated that the combination of lapatinib plus capecitabine (L + C) significantly improved time to progression (TTP) compared with capecitabine alone (C) in heavily pretreated patients with HER2+ (ErbB2+) advanced or metastatic breast cancer. This analysis assessed the effects of study treatments on quality of life (QOL) among patients in EGF100151. Quality of life was assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) and EuroQoL (EQ-5D) questionnaires. Patients completed questionnaires during efficacy and safety assessment visits (i.e., at screening visit, every 6 weeks for the first 24 weeks, every 12 weeks thereafter, and at discontinuation of study treatment). Primary analyses compared the treatment groups based on change from baseline QOL. Exploratory analyses compared proportion of patients achieving minimum important differences (MID) in QOL scores and the relationship between QOL and tumor status. Quality of life for patients in both treatment groups was maintained during 24 weeks of follow-up. Adjusted mean changes from baseline in all QOL scores for the L + C arm were comparable to those for the C arm. The between-group differences ranged from 0.7 to 2.2 (FACT-B total) and 0.3 to 1.8 (EQ-5D visual analog scale) and were consistently in favor of the L + C arm, although not statistically significant. Patients with an objective tumor response or stable disease showed clinically meaningful differences in QOL scores compared to patients with progressive disease. A greater proportion of patients receiving L + C versus C achieved the MID for all five QOL scores, although differences were not statistically significant. The addition of lapatinib to capecitabine significantly increases TTP without any evidence of a deleterious effect on patients' QOL, confirming its clinical benefit in this heavily pretreated patient population with advanced HER2+ breast cancer that has progressed on trastuzumab therapy.
PMID: 19153829