Vemurafenib for BRAF V600+ Metastatic Melanoma

San Francisco—Metastatic melanoma is a rare but rapidly progressing form of cancer that develops in the melanocytes of the skin. The BRAF protein kinase plays an important role in the progression of the disease.

Vemurafenib is a BRAF inhibitor designed to target and inhibit the V600E mutated form of the BRAF protein, and was approved in August 2011 by the FDA for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (as detected by an FDA-approved test).

In a poster session at the AMCP meeting, researchers presented a budget-impact model designed as a tool to be used by healthcare plans to assess the budgetary impact of covering vemurafenib for treatment-naïve and previously treated V600 mutation-positive unresectable or metastatic melanoma. The poster was titled Budget Impact of Vemurafenib for BRAF V600+ Metastatic Melanoma.

The model considered 2 scenarios: (1) vemurafenib was not a treatment option; and (2) vemurafenib was a treatment option and was used until disease progression or unacceptable toxicity for a proportion of eligible patients.

The baseline values for the model were obtained from peer-reviewed literature and where not available from market research conducted by Genentech. The parameters were ±25%.

The results of the model showed that there were 6.6 cases of metastatic melanoma expected in a 500,000-member plan per year. That figure was broken down into the expected number of new cases (4.9) and the expected number of recurrent cases (1.7).

The overall budget impact was a savings of $0.04 per member per month (PMPM) compared with other therapies currently on the market. The total costs and PMPM for the 500,000 health plan enrollees with no vemurafenib were $1,215,838, while the costs with vemurafenib were $978,129. With a total change in costs of −$237,709, it was determined that the change in costs PMPM was −$0.0396.

Additionally, sensitivity analyses indicated that there was a cost saving under a variety of scenarios. It was shown that the results were relatively sensitive to the proportion of patients receiving ipilumimab, the cost of ipilumimab, the proportion of patients receiving vemurafenib, the percent of patients positive for the V600E mutation, and the percent of patients receiving first-line treatment.

Although the model was limited to FDA-approved therapies and those recommended by the National Cancer Care Network guidelines, the effect of excluding some therapies is likely to be minor since the proportion of patients receiving the excluded treatments is small, the researchers noted.

In conclusion, the researchers summarized that a hypothetical health plan of 500,000 enrollees including vemurafenib for treatment of patients with BRAF V600E+ metastatic melanoma will see a cost savings of $0.0396 PMPM. The sensitivity analyses show that PMPM cost savings is at least $0.03. They said, “Overall, the findings imply that providing vemurafenib therapy will have a relatively minimal budget impact and may possibly be cost saving.”

This study was supported by Genentech, Inc.