Emerging Regimen for Metastatic Pancreatic Cancer Has Survival Benefit, but Is It Cost-Effective?

August 2011, Vol 2, No 5

Chicago, IL—A cost analysis presented at ASCO 2011 and performed at the University of Toronto, Odette Cancer Center, Ontario, showed that the emerging combination regimen that includes oxaliplatin (Eloxatin), irino tecan (Camptosar), fluorouracil (Adrucil) and leucovorin (FOLFIRINOX) is not cost-effective when considered within the framework of a willingness-to-pay threshold of $100,000 per quality-adjusted life-year (QALY). Nevertheless, treatment with FOLFIRINOX may provide the most clinical benefit for patients with metastatic pancreatic cancer.

The $100,000 per QALY amount is the benchmark generally used in the United States to consider cost-effectiveness of a treatment.

“Right now the standard treatment for metastatic pancreatic cancer is gemcitabine [Gemzar],” said Vincent C. Tam, MD, lead investigator and Gastrointestinal Oncology Fellow at Odette Cancer Center.

In the setting of metastatic pancreatic cancer, “there are also variants on the gemcitabine theme—adding capecitabine [Xeloda] for instance, or the targeted-agent erlotinib [Tarceva]…. But most treatments have been shown to be effective only by way of metaanalysis, because of the small number of patients enrolled in many trials,” Dr Tam said.

Dr Tam and colleagues undertook the current cost analysis, because FOLFIRINOX has recently been shown in another study to have superior survival rates when compared with the standard therapy with gem - citabine. Those results were presented last year at ASCO 2010 and have just been published (Conroy T, et al. N Engl J Med. 2011;364:1817-1825).

“This is going to be the emerging treatment,” said Dr Tam. “We need to now consider the price tag.”

Cost Analysis

To determine cost-effectiveness, a Markov model was constructed for a hypothetical cohort of patients with metastatic pancreatic cancer to assess the costs and outcomes of the 4 treatment options—gemcitabine, gemcitabine plus capecitabine, gemcitabine plus erlotinib, and FOLFIRINOX— over a 2-year period.

The primary outcome was the incremental cost-effectiveness ratio (ICER), measured in dollars per QALY. Efficacy data for all 4 treatments were obtained from the published results of phase 3 clinical trials.

Resource utilization data were derived from reviewing charts of consecutive patients treated at Princess Margaret Hospital between 2008 and 2009, and supplemented with resource utilization data from the medical literature. Unit costs were obtained from the Ontario Ministry of Health and Long-Term Care, Sunnybrook Health Sciences Centre, and the literature. Both cost and effectiveness were discounted at 3%.

The results of this analysis show that the ICERs of gemcitabine plus cape - citabine, gemcitabine plus erlotinib, and FOLFIRINOX compared with gemcitabine were $82,982/QALY, $204,952/QALY, and $154,323/QALY, respectively (Table).

“The model is mostly driven by the acquisition cost of drugs, and it may be sensitive to the relative efficacy of treatments,” reported Dr Tam. He said that in Canada, the unit price of FOLFIRINOX (primarily the oxaliplatin component) would have to be reduced to attain the $100,000 greenlight threshold. As is, the gemcitabine plus capecitabine regimen is more cost-effective.

Significant Survival Advantage

The issue of price and the newly published results showing a 3- to 4-month survival advantage for FOLFIRINOX will certainly become the subject of debate among providers, patients, and payers. “Patients will be pushing for this treatment,” said Dr Tam, while drug manufacturers will be pushing for FOLFIRINOX to be reimbursed. How this will play out in drug formularies in the United States remains to be seen.

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