The Future of Clinical Guidelines in Oncology 

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Whatever the underlying decision processes and methods, information and data on the effectiveness, safety, and cost of treatment will need to be delivered in valid, concise, electronic packages to address the decision-making needs of all involved cancer care constituencies.

—William T. McGivney, PhD

Clinical guidelines, like those of ASCO and the National Comprehensive Cancer Network (NCCN), clearly have represented the standard of care and, to a large extent, the basis for coverage policy, especially in the area of medical oncology. However, guidelines increasingly seem to be in the shadow of an “algorithmic pathway eclipse”—that is, the increasing import of clinical pathways as a tool in decision-making and policy-setting— casting uncertainty with respect to the continuation and extent of guideline influence.

Guidelines have been criticized for providing a multitude of clinical options with insufficient attention paid to the comparative effectiveness or cost of the options that are provided. In response, the cancer care delivery system has witnessed the development and provision of clinical pathways that seek to prioritize and circumscribe available options through comparative evaluation. To their credit, developers of guidelines have taken notice and have initiated steps to specify preferred options.

Targeting Payers

Payers responded positively when altruistic clinicians and commercial entities began to develop clinical pathways or guideline derivatives that sought to be more selective regarding available options for specific patient subpopulations based on comparative effectiveness and cost considerations. A number of commercial pathway products became available, with some targeting a customer market of payers.

These products offered the narrowing of options based on scientific evidence and cost as evaluated by the pathway developers. Payers favor the availability of such pathway products, as such pathways can be asserted to represent the thinking of oncologists about appropriate options.

The development of pathway products has not been limited to commercial enterprises. Community practices (large and small) and large academic and nonacademic hospital centers or networks have developed pathways that proffer the opportunity to deliver treatment of equivalent or improved effectiveness and safety but at a lower cost, or at least in a manner that might diminish the rate of rising costs of cancer care. For larger academic centers, the need to become more efficient and competitive from a cost perspective is a partial driver for pathway development.

Pathway and pathway-like products are being formatted as electronic decision-assist tools marketed by companies such as D3 Solutions, Elekta, Eviti, and McKesson. The McKesson iKnowMed product from US Oncology has had its decision-assist tools successfully integrated into an electronic health record for some time. Other pathway companies are following suit and negotiating with oncology-specific electronic health record companies and larger enterprises to integrate pathways electronically into electronic health record systems.

‘Crosswalked’ Systems

The next necessary step is to compare the elements and results of, or “crosswalk,” the electronic decision-assist tools between providers and payers. This is needed so that both sides are using the same clinical logic and evidence in the same system, to determine the appropriateness of treatment options for specific patient subpopulations. The availability of such a “crosswalked” system would diminish the contention between payer and oncologist, would lessen the wasted efforts of counterproductive haggling on both sides, and would get patients and clinicians answers in a more assured and timely manner.

While pathways represent a partial algorithmic dimming of guidelines, the looming bundled or episode-based payment methods may even more broadly eclipse the more general guidelines. Under such scenarios, actual and detailed measurement of resource consumption and resultant clinical outcomes may diminish the practice need for a guideline product.

Provider-side proponents of bundled payments for oncology are increasing in number. Leaders, both in the community and in academic settings, have indicated that they will pursue such financial arrangements with payers. In this scenario, the financial terms of an agreement may establish the more dominant guideline for practice.

Ultimate Roles of Guidelines

The ultimate roles of guidelines may fall to educating overburdened clinicians and to remaining the basis for overall coverage policies. Both roles are important. Community oncologists who treat six, eight, or more tumor types are being challenged by the rapid advance of scientific knowledge. Payers are being challenged similarly. The availability of recognized, authoritative, freely available, and timely guidelines provides a sound and common basis for the education and decision-making of providers and payers.

The integration of guidelines and pathways in electronic systems will be critical to maintain and enhance improvement of cancer care. The cancer care delivery system manages millions of patients and hundreds of millions of decisions every year. As our scientific and clinical knowledge base expands, treatment decisions may become more complex or biomarker-driven. The cancer care delivery system likely will try episode-based or bundled payment methods.

Whatever the underlying decision processes and methods, information and data on the effectiveness, safety, and cost of treatment will need to be delivered in valid, concise, electronic packages to address the decision-making needs of all involved cancer care constituencies. ■

Dr. McGivney is Principal, McGivney Global Advisors.

Disclosure: Dr. McGivney is a consultant for pharma/biotech companies.