Cancer drugs: New products and uses and guidelines — oh my! Payers historically have avoided aggressive utilization management of cancer drugs because restrictions are fraught with scientific, political, economic, and public relations challenges. Today, however, with utilization on the rise and unit costs soaring to new heights, employer and government purchasers are on a quest to find palatable ways to bend the cost curve.
In essence, when given a choice, payers can take one of two paths when making thorny market-access decisions. On one path, payers shift the decision-making burden to an external organization, typically the National Comprehensive Cancer Network (NCCN), by basing coverage policies on guidelines. On the other path, payers leverage guidelines, FDA indications, and the literature to inform coverage policies, but they independently develop restrictions that are not necessarily supported by the guidelines. Each of these two approaches has strengths and weakness.
The case for shifting the burden
Syncing oncology formulary decisions to NCCN guidelines, as UnitedHealthcare has done since 2008, confers several benefits. First and foremost, basing coverage policies on NCCN guidelines removes the payer from product-specific decisions and, as Lee Newcomer, senior vice president of Oncology, Genetics, and Women’s Health at UnitedHealthcare has pointed out, transfers judgment about the appropriateness of therapies from the payer to the oncologists who develop the guidelines. Second, NCCN guidelines are evidence-based and developed by representatives of the nation’s leading cancer centers through a rigorous, and transparent process. As a result, coverage policies based on NCCN guidelines are widely accepted. Third, payer policies based on these guidelines can be simple and predictable — if a drug is recommended, it is covered, if it is not recommended, it is not covered. Fourth, NCCN guidelines are readily accessible for all to see. Fifth, shifting responsibility can save time and resources that would have been needed to review products and make recommendations.
If shifting the burden sounds almost too good to be true, it has a couple of significant downsides. One, by shifting the burden, the payer becomes increasingly reliant on external guidance. Two, the payer may not agree with the external guidance upon which it relies. The FDA revoked Avastin’s (bevacizumab’s) breast cancer indication in 2011, but NCCN guidelines support the use of bevacizumab for breast cancer in combination with paclitaxel to this day. Newcomer told the ASCO Post at the time, “As a medical oncologist … I think the toxicity outweighs the gains, and if I were in the clinic, it would not be one of the drugs I would use to treat that disease. But as a payer, I will cover bevacizumab because the NCCN recommends it.” Newcomer’s sentiment suggests that, if left to its own devices, UnitedHealthcare probably would not cover bevacizumab for breast cancer. However, the perceived benefits from following NCCN guidelines apparently exceeds the perceived costs, financial and otherwise.
The case for going it alone
CVS Health removed two CML products, Gleevec and Tasigna, as well as the prostate cancer drug Xtandi, from its 2017 formulary. These bold moves represent a departure from payers not wanting to restrict access to cancer products — let alone excluding them from the formulary. As Troyen Brennan, EVP and CMO at CVS Health, explained, “In situations where the medications are equivalent, from a medical point of view it makes sense to do this in order to reduce cost.” Reducing the spend on cancer drugs is a potential upside of trailblazing exclusions and other restrictions. And maintaining an in-house capability to evaluate and recommend cancer drugs could be another upside of going it alone.
However, the potential downsides of “off-road” restrictions not supported by guidelines are considerable. Such restrictions may be more vulnerable to attack, even if the new restrictions are limited to new prescriptions. Pushback from members and providers could increase the administrative costs associated with additional exception requests, appeals, complaints, and grievances — not to mention lower levels of member and provider satisfaction and “noise” that can negatively impact payer relations with some purchasers. The extent to which these additional administrative costs will erode and perhaps exceed any drug-related savings is unclear.
The jury’s out
For payers, there are costs and benefits associated with every approach to oncology-drug access. Time will tell which road will become more or less traveled. Years from now, payers and observers may even look back and believe (but not likely prove) that the road they took made a difference, positive or negative. But, a difference doing what? Deciding which products to restrict, or defending restriction decisions? An evaluation of the solution depends on how the problem is framed.
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