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| Jan 30, 2012
The announcement by Aveo Pharmaceuticals and Astellas on January 3, 2012 that tivozanib improved progression-free survival over Nexavar® (sorafenib, Onyx) in a Phase III trial for renal cell carcinoma (RCC) got me thinking about the knock-on effects of the explosion of activity in this disease. The number of active agents available for treatment jumped from two types of cytokines (interleukin and interferon) in 2005 to eight in 2011 including Sutent® (sunitinib, Pfizer), Votrient® (pazopanib, GlaxoSmithKline), Torisel® (temsirolimus, Pfizer), Afinitor® (everolimus, Novartis), Avastin® (bevacizumab, Genentech) and Nexavar®. Two additional agents that met primary endpoints in Phase III trials could reach the market in 2012 or 2013 – namely Inlyta™ (axitinib, Pfizer) and tivozanib. The immediate question is how many agents a market of approximately 11,000 drug-treated patients can sustain. Sutent® is firmly entrenched as the first-line standard of care in the United States with Torisel®, Nexavar®, Avastin® and Votrient® splitting much smaller portions of this market. Patients who receive later lines of therapy essentially receive any agent they were not exposed to in first-line, although Afinitor® might have an advantage with the best clinical data supporting its use in later lines.
The next question is whether hospitals or payers will begin to restrict utilization in some fashion. With subtle differentiation among some of these agents, not all necessarily will be added to a hospital’s formulary, especially if physicians are not requesting them. Hospitals will recognize any newly launched drug that does not provide an important advance on the current standard of care and will treat it accordingly.
Hospitals generally have not targeted oncology drugs for potential savings, in part due to the limited availability of therapeutic equivalents or alternate treatment options. Products with therapeutic equivalents that are used frequently in the inpatient setting may be restricted to a specific treatment pathway. The only reprieve for the set of agents approved for RCC might be that the intravenous drugs in the above set (Avastin® and Torisel®) tend to be utilized in the outpatient setting and the others are orally available. The fact that these expensive drugs are typically used in the outpatient setting means they have little impact on inpatient diagnosis-related group (DRG) profitability.
However, payers may opt to become more restrictive on which agents are on-formulary or authorized. Step therapy could be implemented as it is commonly done in cardiovascular disease or diabetes. As more payers are experimenting with pathways to manage utilization more strictly than current guidelines, RCC might represent an area at-risk for this type of management. A temporary reprieve for this market might be that most pathway programs are focusing on larger disease states such as colorectal, non-small lung, and breast cancers. With physicians and payers playing a role in developing pathways, manufacturers of products in the RCC market need to evaluate product differentiation and price as key aspects in value determinations.