June 2013 Edition Vol.7, Issue 6

Advances in Metastatic Melanoma Bring Price Competition, Redefinition of Value, and Likely Increased Payer Utilization Management

Advances in Metastatic Melanoma Bring Price Competition, Redefinition of Value, and Likely Increased Payer Utilization Management

By Gordon Gochenauer

Traditionally, payers have been increasingly more proactive in their management of drug expenditures in cancers with the highest prevalence and with the more costly therapeutics—for example, non-small cell lung cancer (NSCLC), breast cancer, and colorectal cancer (CRC) according to Kantar Health’s survey of managed care directors.  In a follow-up question to these payers, respondents cited the number of available treatment options as the top reason for targeting a specific cancer.  This would account for the presence of kidney and prostate cancers on the list of targeted disease states since there has been an increase in the number of available treatments, where previously, few options had been available (Figure 1).

Source: Kantar Health; Managed Care Organization Survey, August 2012—Which of the following cancer types are specifically targeted for utilization management in your organization? Select all that apply.  What are the reasons specific cancer(s) are management priority?  Select all that apply

Perhaps adding to this list of increased payer management to a disease state, where up to a few years ago limited treatment options were available, may be the emerging competition to the established standards of care in melanoma. As more treatment opportunities for metastatic melanoma become available, it increases opportunities for payers to manage utilization; and it may also provide manufacturers with opportunities to define the value of their respective drugs through clinical and price differentiation.

Melanoma Presentations at ASCO

Melanoma has been a hot topic at the annual American Society of Clinical Oncology (ASCO) meetings since 2010, when the pivotal data for the novel immunotherapy Yervoy [ipilimumab; Bristol-Myers Squibb], a CTLA-4 antibody, was presented; and subsequently, led to its U.S. FDA approval in 2011. This approval was followed shortly after with another FDA approval for metastatic melanoma in 2011: the BRAF inhibitor, Zelboraf [vemurafenib; Plexxikon/Genentech-Roche/Daiichi-Sankyo].

Remarkably, only three days before this year’s ASCO, GlaxoSmithKline made headlines with the tandem FDA approval of its two drugs to treat metastatic melanoma: Tafinlar (dabrafenib), a BRAF inhibitor, and Mekinist (trametinib), a MEK inhibitor.

Furthermore, this year’s ASCO also presented further progress in the metastatic melanoma immunotherapy space with intriguing Phase 1 data from a series of antibodies targeting PD-1.  Bristol-Myers Squibb presented Phase 1 data on its investigational drug nivolumab, and Merck presented Phase 1 data on its PD-1 antibody, lambrolizumab. Not to be left out of the mix, Roche presented Phase 1 data on its PD-L1 antibody, MPDL3208A; and Amgen presented Phase 3 data on its intratumoral immunotherapy, talimogene laherparepvec (T-VEC).

Near-Term Management of Oral Therapies in BRAF-Mutated Melanoma

With the imminent entrance of Tafinlar and Mekinist, GSK is redefining value. Both drugs were approved with a companion diagnostic called the THxID BRAF test (bioMerieux). The diagnostic will detect V600E and V600K mutations in the BRAF gene. Tafinlar labeling indicates that, like Zelboraf, it is only approved for use in patients with the V600E mutation (approximately 80% of all BRAF mutations). On the other hand, Mekinist is approved for use in patients with both of the BRAF mutations. This difference in labels between the two drugs represents an opportunity for sophisticated payers to differentially manage utilization.

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