By my watch, I am somewhere over Lincoln, Nebraska, flying back from the ASCO Provider-Payer Initiative (PPI) Meeting. It’s the third annual PPI meeting and the fact that it exists is significant evidence of ASCO's ability to adapt in response to circumstances and of the increasing resources that ASCO is investing in support of clinical practice. Aetna, United Healthcare, Cigna, WellPoint, and other private payers were invited. Ten years ago, the suggestion to expand the scope of payer discussion beyond CMS by hosting meetings with private payers was considered unfeasible. The First Amendment would be solemnly evoked as the Constitutional basis permitting discussions with a federal agency under freedom of speech that did not apply to private payers. To be sure, anti-trust concerns are real whenever payers and providers meet together, and ASCO arranges for a health law professor to be present throughout the PPI meeting to monitor the discussions for this reason.
The focus of this year’s PPI was the role of pathways in oncology practice. Pathways are commercial products that provide guidance on chemotherapy selection, although they can be used for distilling clinical guidelines in other aspects of cancer care such as use of radiation, molecular testing, or palliative care. Five pathway products were presented, and all follow a similar development process. The starting point is a review of the evidentiary base, which includes published literature, compendium, and guidelines from sources such as NCCN and ASCO. Expert panels are then brought to bear to evaluate the evidentiary base, often a mixture of academic and community oncologists. Considerations of efficacy, toxicity, and sometimes cost are applied to rank order chemotherapy regimens. Integration of these pathway products into electronic medical records would provide useful clinical decision support, and efforts to do this are underway. Developers of pathways do not intend that their pathway products be rigidly used, although some products require that a provider deviating from the pathway provide a reason for so doing. They understand that clinical judgment and patient realities need to be respected.
On the payer side, pathways were viewed favorably and some payers are starting to waive pre-authorization of chemotherapy if a proposed treatment is on a pathway. Some of the private payers were outspoken on their view that universal compliance with pathway recommendations should be expected and demanded to know why oncologists would feel otherwise.
ASCO members, in turn, vigorously argued that a patient-centric approach would at times require clinically legitimate deviation off of a pathway. Thoughtful integration of the pathways into the workflow of oncologists so as to not detract from provider-patient face time is a necessary condition for user acceptance. Of note, one of the pathway developers presented evidence to refute the idea commonly held in some quarters that economic gain drives physician choice of chemotherapy and suggested that physician behavior is far more complex and subject to multiple factors.
The question I posed to the pathway developers was this. How do they know that they have gotten it right? In the end, the pathway product is the result of expert opinion attempting to supplement an incomplete evidence base with a best guess. There is absolutely nothing wrong with that as a starting point; one needs to drive a stake in the ground somewhere, but it should be a point of departure and not a destination. We need a way to validate that the pathway construction was correct and adjust if not. Without the reassurance that the system design has an inherent ability to correct the course it is plotting, physicians will hesitate to walk down that path. Dr. Larry Norton, speaking about another investigator, once remarked to me that the investigator in question believes his own data. It is a human trait to believe most what we see with our own eyes and touch through our own experiences. And that instinct is not without some merit.
This is precisely what a rapid learning health system can provide us, the reassurance that our own experiences count and contribute to collective wisdom. Rapid learning health systems value the experiences of all providers and draws learning from the aggregated data of our electronic medical records. If going off pathways still leads to good patient outcomes, we have learned something important and in the end have an improved pathway that others can follow. To get there though we will need to agree upon a new set of outcomes that add to those that journal editors and the FDA value. It is certainly critical to have survival data for drug approval, but this figure has lesser meaning to an individual patient who may be more concerned about control of symptoms and that elusive quality of life assessment. For CancerLinQ to succeed the entire oncology ecosystem will need to contribute data, including in this case pathway developers and payers. We will need to re-think and accept new concepts such as patient-centered outcomes. There is no point in building CancerLinQ to ossify what we are already doing. More than a registry, CancerLinQ is an opportunity to challenge ourselves to apply ingenuity to innovation and illumination to invention.