Cost-Effectiveness of Olaratumab in Combination with Doxorubicin for Patients with Soft Tissue Sarcoma in the United States

Abstract

Background Standard first-line treatments for advanced soft tissue sarcoma (STS) have changed little for 40 years, and outcomes have been poor. Recently, the United States (US) Food and Drug Administration conditionally approved olaratumab in combination with doxorubicin (Olara + Dox) based on a randomized phase II trial that reported a significant 11.8-month improvement in median survival versus single-agent doxorubicin (Dox). The present study investigated the cost-effectiveness of Olara + Dox compared with Dox and five other standard-of-care regimens from the US payer perspective. Methods An economic model was constructed to estimate costs and outcomes over patients' lifetimes from start of therapy. Progression-free and overall survival were based on survival analysis of patient-level data and a meta-analysis. Adverse-event rates were based on trials. Costs were from published sources. Results Olara + Dox resulted in an estimated additional 1.27 life-years (LYs) compared with Dox, with an increase in total expected lifetime costs of $133,653. The incremental cost-effectiveness ratio (ICER) was estimated at $105,408 per LY gained; in a fully incremental analysis, all other regimens were dominated (higher costs and lower LYs or a higher ICER). Conclusion Olara + Dox is cost-effective for STS treatment compared with Dox and other standard-of-care regimens at willingness-to-pay thresholds of $150,000 per LY and above.

Value of clinical trial narrative data to estimate the costs of adverse event management: a feasibility study

“…Of the publications that included costs of AEs mentioned previously [3][4][5][6][7][8][9] , only Hess et al 8 provided costs for managing nausea and thrombocytopenia, which were used in a modeled cost-effectiveness analysis. Hess et al 8 assumed that grade 3-4 AEs required hospitalization and assumed a cost per nausea event of $6,225 and for thrombocytopenia of $18,354 (inflated to 2017 US dollars 15 ) based on hospitalization cost data from HCUP.net 17 .…”

“…imputed data (n ¼ 22), the average LOS per hospitalization was 6.9 days (range, 2-22). The average LOS per hospitalization for grade 3-4 thrombocytopenia including imputed data (n ¼ 13) was 7.6 days (range, [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]; excluding imputed data (n ¼ 8), the average LOS per hospitalization was 7.4 days (range, [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]. For nausea, the expected cost of hospitalization including imputed data was $15,057 and excluding imputed data was $16,680 (Table 8).…”

“…The National Institute for Health and Care Excellence (NICE) notes that technology appraisals should identify health outcomes that are important to patients, such as health benefits and adverse effects 2 , although NICE does not specifically mention the costs of adverse effects. Using lung cancer as an example, many economic evaluations of treatments incorporated the costs of AEs [3][4][5][6][7][8][9] . In some economic analyses, AEs are a cost driver 8,9 ; in others, AEs are not a substantial component of costs [3][4][5][6][7] .…”

“…Using lung cancer as an example, many economic evaluations of treatments incorporated the costs of AEs [3][4][5][6][7][8][9] . In some economic analyses, AEs are a cost driver 8,9 ; in others, AEs are not a substantial component of costs [3][4][5][6][7] . This may reflect the actual distribution of costs, but it also may reflect the methods and data sources used to estimate AE costs.…”

Olaratumab in the management of advanced soft tissue sarcoma

“…The incremental cost-effectiveness ratio (ICER) for olaratumab plus doxorubicin versus single-agent doxorubicin was estimated to be $105,408 per life-year (LY) saved. 33 Thus, at willingness-to-pay thresholds of ≥$150,000 per LY in the US payer context, olaratumab–doxorubicin combination is considered cost effective in comparison with doxorubicin for the treatment of advanced STS. However, caution should be exercised when interpreting the above cost-effectiveness analysis since it was based on extrapolation of immature OS data from the randomized phase 2 study by Tap et al.…”