Cost Comparison of Fulvestrant Regimens

New Orleans—A study comparing the cost of fulvestrant 250 mg and 500 mg found that 250 mg appears to be a cost-effective option in treating postmenopausal women with breast cancer, considering an incremental cost-effectiveness ratio (ICER) of $10,972 for the 500-mg regimen. As a result, third-party payers may prefer the 250-mg regimen over the 500-mg regimen. Overall, the cost of either drug is dependent on willingness to pay by third-party payers.

The results were presented at the ASHP meeting during a poster presentation titled Cost-Effectiveness of Fulvestrant 250 mg vs 500 mg in Postmenopausal Women with Estrogen Receptor-Positive Metastatic Breast Cancer and Disease Progression after Antiestrogen Therapy.
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Fulvestrant is an estrogen receptor (ER) antagonist indicated for the treatment of ER-positive metastatic breast cancer in postmenopausal women following treatment with an antiestrogen. Prior to 2004, the US Food and Drug Administration–approved dosing was 250 mg injected intramuscularly once every 28 days. After the CONFIRM (Comparison of Faslodex in Recurrent or Metastatic Breast Cancer) trial, which increased progression-free survival (PFS) in women receiving 500 mg versus 250 mg, the approved dosing was changed in September 2010 to 500 mg on days 0, 14, 28, and every 28 days thereafter. The labeling change for fulvestrant warranted investigation into the cost-effectiveness of the new regimen. Therefore, the researchers sought to determine whether 250 mg of fulvestrant was cost-effective compared with the 500-mg dose. The analysis was conducted from a third-party payer perspective. Clinical efficacy data, including probability of PFS, was obtained from the CONFIRM trial. Cost data were based on 2011 Medicare outpatient prospective payment system/ambulatory payment classification rates.

A Markov model was constructed allowing patients to receive fulvestrant 250 mg or 500 mg monthly over a period of 24 months. Cost-effectiveness was determined by ICER of US dollars per month PFS. The results showed that the cost per month for 500-mg and 250-mg regimens were $11,899 and $4258, respectively. The duration of PFS was similar between the treatment arms (16.78 months for the 500-mg regimen vs 16.08 months for the 250-mg regimen). The ICER as determined by the Markov model was $10,972 per month PFS for 500 mg fulvestrant. Along with limitations inherent in the CONFIRM trial, the researchers recognized that their analysis was restricted to Medicare payment and may not be generalizable to all payers.

Considering the incremental gain of about 21 days, the value of the additional costs in the 500-mg arm depends on the amount the payer is willing to spend on treatment. The researchers outlined possible cost scenarios. If the payer is willing to spend $5000 a month ($60,000 a year), then the 250-mg dosage is a more cost-effective option. If the payer is willing to spend $15,000 a month ($180,000 a year), then the 500-mg regimen may be more financially beneficial. At a cost of $10,000 a month ($120,000 a year), the 250-mg regimen would be cost-effective 75% of the time. The researchers noted that while a single correct value cannot be assigned to a year of life, various sources have described an acceptable cost of $50,000 to $200,000.