Managed Care Restrictions: Barriers to Product Use in Cancer Care

Across specialties, prior authorization (PA) is the bane of physicians and their office staff. Once employed as a utilization management tactic primarily for more benign therapeutic classes, it is now a ubiquitous force in oncology management—one that is expected to become even more targeted beyond US Food and Drug Administration (FDA) indication alone.

Prior Authorization

Figure 1

Recent research conducted by HRA (Healthcare Research & Analytics, a market research consultancy based in Parsippany, New Jersey) reveals that 93% of the 47 major health plans included in its recent study routinely employ PA to manage utilization of oncology agents. Over three-fourths of these payers, which cover over 100 million lives in total, place at least some reliance on rigid PA that links approval with product efficacy at specific milestones, or rely on PA to ensure that the appropriate biomarker tests are conducted prior to approval of specific agents. In the future, the use of more stringent PA criteria is expected to increase significantly—with nearly 90% of the plans intending to link PA to specific treatment milestones and even more planning to link PA with genetic testing ().

“Any specialty other than oncology, this is the way you’d do it—fairly rigid according to what the evidence has shown,” states one key opinion leader participating in the research who is employed by a major US payer organization. “Oncologists want a separate set of guidelines for how they manage patients. The problem is you’re dealing with expensive drugs, and we have a fiduciary responsibility to make sure what the employer is paying for is appropriate, and to keep the physicians honest.…When you have a third party paying for it, they have a right to a say on how it’s being spent.”

As demonstrated in HRA’s study, Changing Paradigms in Managed Care— Oncology Management, surveyed oncologists and oncology nurse navigators clearly are not pleased with the trends toward increased PA use.

“Who’s going to be calling for all these approval[s]?…I’ve got somebody that’s got metastatic cancer. They need to be treated now—not a month from now, not 3 months from now,” stated an oncologist participating in HRA’s study.

“We spend a lot of time in trying to do the best…for our patients [to get treatments] approved and it basically delays care.”

More Stringent Guidelines

Figure 2

In fact, the use of more stringent prior authorization guidelines will lead about half of the 100 medical oncologists participating in the research to reconsider their first-choice oncolytic agent due to the hassle factor that PA presents (). PA based on product efficacy at select milestones or on the number of treatment cycles, as well as step therapy requirements enforced via PA, serve as the primary deterrents, whereas oncologists are less fazed by the idea of payers requiring specific biomarker/genetic tests before approving the associated agents. Fortunately, for the oncologists and the patients they treat, widespread use of PA beyond FDA indication alone is not occurring—yet.

Although managed care is including general PA as a requirement for over two-thirds of oncology agents, on average, more stringent PA is just emerging. PA based on patient response to specific treatments, on biomarker/ genetic testing, and as a means to enforce step therapy is currently in place for one-fifth or less of agents, though significant increases in prevalence are expected over the next few years (Table).

Figure 3

The growing presence of step therapy poses a disadvantage for new oncology agents—logistically as well as conceptually— as oncologists maintain strong perceptions that new oncolytic agents are very likely to be subject to PA. Agreement with this concept is noted among over 80% of oncologists in the research. Further, nearly 2 out of 3 oncologist participants point to PA as a deterrent to prescribing new agents ().

“[There will be] a lot more prior authorization, a lot more attempt to engage oncologists around pathway adherence, and end-of-life discussions earlier in the course of therapy,” said a key opinion leader participating in the research, “because these are felt to be the biggest variables that contribute the most to cost.”

Heavily Managed

Figure 4A

Figure 4B

Increased PA, the development of clinical pathways programs, and high copays/ co-insurance levels are leading oncologists toward perceptions of oncology as now being a “heavily managed” category. While over half of oncologists currently perceive payers as providing hands-on management of oncology, 8 in 10 oncologists predict that active management will be the norm 2 or 3 years from now (). Further, those oncologists who have more negative perceptions of payers and their involvement in oncology are more inclined to suggest that payers will be more stringent in both the short and long term ().

“There is a new intensity of scrutiny from the payer side, a significant increase in protocols and other management constraints on oncology,” said one of the key opinion leaders participating in the research. “Across all lines of business, saying ‘We’re not going to pay for everything, and if we are, we need to have some understanding of medical necessity, and the rationale around morbidity, mortality, and patient improvement.’”

By 2015, oncolytic agents are predicted to be the second- or third-greatest driver of total drug spend, an increase from seventh place in 2011.¹ By 2020, total cancer costs are projected to reach $158 billion.² To ensure their own fiscal survival, payers may be left with little choice but to increase controls in oncology, despite the potential backlash.

So the question remains—which direction will payers take in exerting greater control over the oncology category? Will novel approaches such as clinical pathways programs provide enough specific direction and incentive to control spend, or will payers need to resort to the more traditional mainstay of prior authorization to manage utilization? If prior authorization in oncology continues to evolve, just how far will payers be willing to go in the stringency of their requirements, without risking major repercussions among oncologists? And, will oncologist and payer affiliations in integrated delivery networks help enforce these approaches?

As one payer respondent participating in the research states, “We have a number of prior auth requirements on most of these agents, but are limited in our effectiveness by the strong public pressure and some special legal protections they enjoy.”

Balancing the need for fiscal soundness with public policy considerations as well as—most importantly—the need to provide patients with the most effective treatments is a fine line for payers, one that continues to fray with each new expensive oncology treatment that comes to market.

Author Affiliation: From Healthcare Research & Analytics, Parsippany, NJ.

Funding Source: None.

Author Disclosure: Ms Fox reports employment with HRA—Healthcare Research & Analytics, the company that produced this research. HRA is owned by MJH & Associates, which also owns The American Journal of Managed Care.

Authorship Information: Concept and design; acquisition of data; analysis and interpretation of data; drafting of the manuscript; and critical revision of the manuscript for important intellectual content.

Author correspondence: Lisa A. Fox, Vice President, Research Strategy, Healthcare Research & Analytics, 400 Lanidex Plaza, Parsippany, NJ 07054. E-mail: lfox@hra research.com.1. Study by Express Scripts, via Real Endpoints Advisory Services. www.valueandinnovation.com/research/cancer-pathways-provide-leverage-for-payers-hurting-biopharma/. Accessed December 10, 2012.

2. Cancer’s growing burden—the high cost of care. USA Today website. www.usatoday.com/news/health/story/health/story/2012-02-27/Cancers-growing-burden-the-high-cost-ofcare/53271430/1. Published February 27, 2012. Accessed December 10, 2012.

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