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The Three “A’s” of Treatment Options: Approved, Accessible and Affordable. Market Access Implications of Big News from ASCO 2014

Over the course of five days during ASCO 2014, data from hundreds of clinical trials were shared, answering the question of whether there’s a new treatment option for cancer patients. Increasingly, despite approval the FDA doesn’t have the final say on whether the drug in question represents a viable treatment option for potential patients. Payers too are exerting influence over treatment options through prior authorization requirements, as well as patient cost sharing, which can threaten affordability. In an era when the cost of a course of therapy with branded cancer drugs is typically measured in the tens of thousands of dollars and, not infrequently, over $100,000, FDA approval is no longer sufficient for treatment selection. Accessibility and affordability have become essential considerations as well.

CALGB 80405: Fodder for prior authorization and pathways?

The results of this large, Phase III trial were widely anticipated to elucidate conflicting data presented at ASCO in 2013, which demonstrated a survival benefit of Erbitux over Avastin in the first-line treatment of KRAS wild-type colorectal cancer (CRC)1 in the absence of a progression-free survival (PFS) benefit.

Treatment pathways are becoming a more prevalent means of managing cancer treatment, and CRC is one of the three most common cancers to be the subject of pathways. Whether initiated by payers or practices, treatment pathways are designed to drive selection of “preferred” treatment modalities and products. These products generally represent the most cost-efficient, evidence-based means of treating patients at each line of therapy. While demonstrated efficacy is usually paramount, tolerability and cost are also given critical consideration. When clinical outcomes are comparable, cost is usually the most important driver.

The secondary but important factors of cost and administrative burden already favor Avastin over Erbitux, and prescribing patterns clearly show a preference for Avastin over Erbitux in first-line, even in patients with the KRAS mutation. The lack of difference in efficacy between Avastin and Erbitux revealed in CALGB 80405 presumably removes the clinical efficacy rational for selecting Erbitux in the first-line setting. Payers may further leverage prior authorization to not only require biomarker testing for KRAS but also the use of Avastin before the more costly Erbitux will be covered. Such action may prompt practices to avoid the administrative burdens associated with Erbitux use. Pathways will likely be leveraged by both payers and oncology practices to further solidify the dominance of Avastin in first-line CRC.

EORTC 18071: How much of a good thing is too much?

Malignant melanoma is infamous its poor prognosis. When Yervoy launched in 2011, it represented not only improvement in median overall survival but also the chance at long-term survival for some patients. However, this clinical benefit came with an unprecedented (at the time) price among cancer treatments of $100,000 to $120,000 for a four-cycle course of treatment.

The strong positive recurrence-free survival data reported in EORTC 18071 for Stage III melanoma patients receiving adjuvant treatment with Yervoy represents a significant advance. However, the cost per cycle in the adjuvant setting is more than three times greater than for the current indication of metastatic disease, due to higher dosing. Further, treatment continues after the initial four rounds with maintenance infusions every three months for up to three years. At the current WAC price of Yervoy, a first year of adjuvant treatment will likely exceed $300,000, a cost likely to spark renewed scrutiny among payers. Until Yervoy receives an FDA indication or National Comprehensive Cancer Network (NCCN) guideline recommendations (level IIb or higher), oncology practices are likely to experience claims rejections due to a dose in excess of the indication.

Closing Thoughts

We are in an exciting era of clinical development of cancer treatment. Oncologists and hematologists have an unprecedented array of tools at their disposal to extend the lives of cancer patients. Biopharmaceutical companies have invested countless years and billions of dollars to bring these drugs to market. This investment and the unmet needs that these drugs address are reflected in high prices that are driving explosive growth in spending on cancer care. Not only do physicians have more “tools in their toolbox,” but payers have a growing armamentarium of tools that at their disposal to help rein in the cost trend. Be it through pathways, prior authorization, formulary tiers or cost sharing, payers will continue to leverage these tools to exercise influence over drug selection and utilization. Clinical evidence is and will remain the single most important determinant of access in the U.S., but the evidence can no longer be viewed in scientific isolation. Not only payers but also patients and physicians will weigh the evidence within a broader value context that takes price, therapeutic alternatives and outcomes into account.

1Heinemann, Abstract LBA3506, ASCO 2013.

By Debbie Warner, Vice President, Commercial Planning, Kantar Health

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