NEW ORLEANS—With the passage of the Patient Protection and Affordable Care Act, many changes are in store that will affect the field of oncology. Joseph S. Bailes, MD, chairman of the Government Relations Council and past-president of the American Society of Clinical Oncology, described what oncology pharmacists can expect in his keynote address.
“Cancer is viewed in Washington as an area that needs much greater efficiency,” he said, predicting that essentially all aspects of oncology will be affected by healthcare reform. “This horse has left the barn, and they tied an awful lot to it,” he said of the act. “We will all be engaged in this, whether we like it or not.”
But this “engagement” does not have to be negative, he indicated. The healthcare reform act illustrates “the critical role that oncology pharmacy plays” in areas that include drug development and usage, literature evaluation, development of pathways and guidelines, and comparative effectiveness research (CER), he told attendees.
It is estimated that at least half the compounds now in clinical development are oncolytics, and many are oral agents that will require strict monitoring. “You are critical to this area,” he said.
Pharmacists will also be central players in the merging of major medical and pharmacy benefits. This has many implications; for example, it could affect how institutions will issue formularies, he said. Risk evaluation and mitigation strategies, which the US Food and Drug Administration is increasingly putting in place for drug safety and monitoring, will fall under the auspices of pharmacy. Finally, “step therapy,” which is commonly used in other diseases, may enter oncology, although Bailes said he does not see this “fitting in with how oncologists practice.”
Evaluation of the medical literature is becoming important in the development of compendia and in justifying or denying the off-label use of drugs. “You will see the Centers for Medicare & Medicaid Services doing a more critical read of the clinical trial literature, especially with regard to the study populations. You will see this evolving fairly rapidly as a way for Medicare to deal with compendia problems,” he predicted.
Pathways and guidelines are being increasingly promoted by payers, institutions, and practices. It is unclear what this means for choice of treatments, but evidence-based development is critical, as is monitoring of compliance.
“You, the oncology pharmacists, will be at the center of these discussions in your institutions because your work revolves around pharmaceuticals,” he said.
CER will change practice
CER aims to assess how various drugs, devices, therapies, or procedures compare in treating a disorder. It is a major focus of the movement to obtain valuebased cancer care.
In oncology, the major focus is on drugs and their cost implications. The Institute of Medicine has articulated 100 priority topics for CER. How this research is conducted will be very important, and there is a need for methodology to compare studies.
In 2009-2010, CER received significant short-term funding ($1.1 billion) from the American Recovery and Reinvestment Act. Current healthcare reform proposals would restructure this initiative and enhance long-term funding. “This has become very politicized,” Bailes noted. “In restructuring, more stakeholders have been brought in and they have an enormous say.”
The Congressional Budget Office has estimated “trillions of dollars” in savings if CER findings are tied to provider incentives, he added.
The fiscal year 2011 budget is likely to include additional funding for CER. The Agency for Healthcare Research and Quality will be budgeted approximately $286 million, which is an increase of $261 million over fiscal year 2010.
The Senate Finance Committee proposal recommends that CER be governed by a nonprofit entity with a public/private board. It proposes long-term funding from private insurers and a Medicare trust fund on a per-member basis. Language was added to ensure that CER not be used as the sole basis for Medicare coverage decisions. Coverage determinations must give weight to all relevant studies and evidence, and to evidence suggestive of benefits to specific subpopulations, “even if, on average, no such benefit is seen,” he said.
“I think this will change over time, however, as experience widens with CER and more become involved,” he predicted. “Our view is that oncology needs to be part of the decision-making process in CER.”