June 2014 Edition Vol.11, Issue 6

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

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

By Debbie Warner
 

Over the course of five days during ASCO 2014, data from hundreds of clinical trials were shared.  Arguably, Phase III data garner the most attention as it usually answers the question: “Is there a new treatment option for cancer patients?” However, Phase III trial results provide only part of the answer until the FDA determines whether or not to approve the drug for the studied indication. Increasingly, 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 that must be met for coverage to be approved, as well as patient cost sharing, which can threaten affordability of the treatment. 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.

In the May 2014 edition of OBR Green,1 Arnold DuBell, PhD, MBA, a consultant in Oncology Clinical and Scientific Assessment for Kantar Health, highlighted 10 abstracts anticipated to draw high interest at the conference. Among these were abstracts reporting of data on the currently marketed drugs Avastin®, Erbitux®, Yervoy®, and Imbruvica®. The range of outcomes represented by these trials, from the impressively positive data for Imbruvica in relapsed/refractory chronic lymphocytic leukemia (CLL), to the draw between Avastin and Erbitux, represent a range of market access implications as well as clinical ones.

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)2 in the absence of a progression-free survival (PFS) benefit. Although the frequency of KRAS mutation in the U.S. population of CRC patients is 34%-38%,3 only 8% of metastatic patients receive Erbitux in the first-line setting.4 Three-quarters of the oncologists surveyed by Kantar Health in April 2014 indicated that payers require KRAS testing for prior authorization of Erbitux. Further, while oncologists experienced more reimbursement challenges for Avastin than for Erbitux (likely driven by greater volume of Avastin use), they were more likely to change Erbitux to a different treatment choice.5 Less than 50% of oncologists test for the KRAS mutation in first-line.3 While KRAS testing is critical for identifying patients likely to benefit from Erbitux, it adds cost, time and administrative burden to oncology practices selecting Erbitux, especially for first-line treatment.

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. While the definition of “preferred” is highly individualized, 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. For pathways developed within practices, commonplace especially in large oncology practices, administrative burden and patient affordability are also important factors.

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, already targeting Avastin and Erbitux for utilization management, 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 for 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 about $100,000 to $120,000 for a four-cycle course of treatment. In the 2012 Kantar Health Oncology Market Access oncologist survey, Yervoy along with Provenge® were the drugs most frequently cited by oncologists as being targeted by payers. By 2014, fewer oncologists cited Yervoy as one of the most payer challenged IV cancer drugs, though it remains among the top five. Payers, however, are not the only stakeholders sensitive to the cost of Yervoy. Nearly a third of practice managers identified Yervoy as the treatment most likely to have patients referred to the hospital for treatment for strictly financial reasons. Among them, carrying cost to the practice and out-of-pocket cost to the patient were the most frequent financial reasons for referral.

 

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