The 2016 ASCO Policy Statement on Clinical Pathways in Oncology delineated attributes of oncology clinical pathways (OCPs) that support transparency, timeliness, evidence-based recommendations, and the best practices of academic and community oncologists.¹ In particular, the design of OCPs should support the choice of a clinical trial when available, and oncologists should not be subjected to compliance with multiple OCPs when one would meet the criteria for high quality. The focus is on the governance and process by which OCPs are constructed and not on the specifics of each OCP.

In this issue of Journal of Oncology Practice, Daly et al² report on OCP products currently available in the United States. Only four such products were identified by the authors, and fears regarding the proliferation of OCPs that would result in variability and confusion have not yet materialized. Two OCPs can trace their origins to academic medical centers. The first is Via Oncology, which originated at the University of Pittsburgh Medical Center, and its disease committees had a strong commitment to input from community oncology. The second is Value Pathways, which is powered by the National Comprehensive Cancer Network (NCCN), and it combines the NCCN academic medical center network with the community oncology–based US Oncology Network of McKesson Specialty Health, which provides oncology drug distribution among its business lines. Third is the Anthem/AIM Cancer Care Quality Program, which is owned by a payer, and fourth is New Century Health, which is owned by Water Street, a health management company.

Two state legislatures have bills under consideration that regulate the use of OCPs by health plans and insurers. Both California state oncology societies, Association of Northern California Oncologists and Medical Oncology Association of Southern California, cosponsored AB 1107.³ This bill provides an opportunity for input on OCPs from oncologists and oncology societies, requires timely updates as new evidence develops, transparency regarding the evidence base and rationale used and identification of the individuals or institutions involved in designing the pathways.

Importantly, an OCP is broadly defined as a cancer treatment plan used by physicians and surgeons that includes procedures, tasks, interventions, and treatment regimens, and it is not limited to chemotherapy. The California Health Benefits Review Program (CHBRP), created by the University of California under statutory authority, is required to assess the medical, economic, and public health impact of legislation that involves essential health benefits and health insurance benefit design. CHBRP review of AB 1107 identified two studies that reported a reduction in the use of emergency departments and hospital admissions and seven studies that reported on the medical effectiveness of OCPs. However, the quality of these studies was judged to be insufficient, often because of the lack of a comparison group and in the report to the legislature “CHBRP concludes that there is limited evidence that provider use of OCPs improves some health outcomes, such as hospital length of stay, and does not decrease overall survival rates relative to usual care.” In terms of potential cost savings resulting from the use of OCPs, the report states that “CHBRP concludes that there is insufficient evidence to assess the extent to which plan/insurer use of OCPs impacts costs.” Opposition to the bill was raised to the California Assembly Committee on Health by Anthem, which objected to disclosing the identity of third-party evaluators of pathway regimens and argued that doing so would subject evaluators to outside pressure and because the bill would prohibit step therapy and prior authorization cost containment strategies. Also in opposition was Kaiser Permanente which argued that it should be excluded because, as a health care system that includes providers, hospitals, and a health plan in one entity, internally developed OCPs are consensus driven and approved by all stakeholders. The California Assembly Committee on Health passed the bill, but it is in suspension by the Appropriations Committee because of the budget impact of enforcing this law.

Connecticut Bill 435 proposes regulation over the processes by which OCPs are formulated, requires public input, and restricts the use of financial incentives with OCPs.⁴ The Connecticut General Assembly desired further study on the use of OCPs by health carriers and required the state insurance commissioner to conduct such a study and report back to the General Assembly.

In light of the scarcity of evidence regarding the impact of OCPs on oncology clinical practice, this issue of JOP provides useful insight into the current OCP offerings and how well they meet ASCO criteria for high-quality clinical pathways.² Each is unique. The Anthem/AIM Cancer Care Quality Program adds administrative claims data that are helpful for measuring resource use and outcomes, which might allow better documentation on the cost savings of using OCPs. However, as seen in the opposition to the California bill, insurers have proprietary interests to protect, and it seems unlikely that a pathway produced by one payer would be acceptable to another, especially in an environment in which insurers and drug distributors are merging. Value Pathways (powered by NCCN) combines the credibility of NCCN guidelines with a broad clinical subject matter expert base in the US Oncology Network. In addition, integration with McKesson iKnowMed electronic health records (EHRs) can be accomplished more easily, although integration with other EHR vendors will take more time. Both New Century Health and Via Oncology seem to be positioned more neutrally in the market with regard to payers, providers, EHRs, and drug distributors.

It is surprising that both the number of OCP products available and documentation of their impact remain limited. This may be similar to oncology treatment summary documents, which is a good concept but one that is challenging to develop and implement well enough to improve outcomes and drive wider adoption. In light of this, we should pause to consider the intended consequences of pathways.

A principal goal of chemotherapy pathways is to reduce unwarranted variation in the use of regimens by specifying acceptable treatment options and by ranking regimens by efficacy, toxicities, and cost, while simultaneously allowing warranted variation resulting from emerging new standards of care and patient factors. Current OCPs address the former as described in the article by Daly et al.² However, patient factors such as comorbidities, persistent toxicities resulting from prior treatments such as neuropathy, and patterns of drug resistance or response are not well developed in pathway products. Products in development such as IBM Watson Oncology are exploring these functionalities, but a higher degree of interoperability with source EHRs than presently exists will be needed, which is a nontrivial task. The current state of OCP integration into provider EHR workflows is not transparent but is almost certainly insufficient in most cases. As the degree of data inputs into OCP tools and the demand for bidirectional interoperability between the EHRs and OCP software increase, OCP vendors will need to accept more responsibility for working with EHR vendors, and oncologists should hold OCP vendors accountable on this. Patient preferences also need to be considered, such as the number of treatment visits or risks of adverse events, including hospitalization. Advanced machine logic, algorithms, and heuristics that prompt such considerations would help overcome objections that OCPs are arbitrary or are not patient-centric decision support tools.

Another goal is facilitating cost containment efforts by adopting the analysis performed by the OCP vendor. There are other mechanisms to achieve this while retaining a greater degree of internal control. At the level of individual drugs, pharmacy and therapeutics committees found in larger health care systems frequently restrict therapeutics on the basis of redundancy or value considerations. Oversight at the regimen level can be achieved through governance by multidisciplinary teams of physicians, pharmacists, and information services staff who objectively evaluate the evidence supporting chemotherapy regimens, ensure correct dosing, and select supportive care medications such as antiemetics appropriate to the regimen built into the EHRs. Provider deviation from standard regimens and requests for special regimen builds can be monitored.

There continues to be a concern that OCPs, if inappropriately implemented, would have a significant impact on oncology providers’ workflow, especially if different payers require a specific OCP for patients covered by their insurance product. That only four OCPs were identified in the article by Daly et al² and the limited evidence base cited by the California and Connecticut legislatures suggest that the fear that medical oncologists will be overwhelmed by a plethora of OCPs that result in poorer patient outcomes has not yet materialized in a substantial or widespread manner. However, evolving health care industry trends, such as bundled payments models and consolidation among payers, drug distributors, pharmacy benefit managers, and health care systems may accelerate the adoption of OCPs and underscore the need for continued vigilance by ASCO and oncologists.

Finally, as the California bill proposes, pathway designs are not limited to chemotherapy, but they could be extended to cover diagnostics such as imaging and genomic tests, interventions such as surgery, radiation, and interventional radiology, and end-of-life care. Arguably, costs related to the use of these modalities have greater global potential to impact the overall cost of care. In a world increasingly driven toward efficient, effective, and outcomes-based care, practices must improve their governance over quality and cost. To the extent that pathways contribute to this as a tool by which practices achieve higher-quality value-based care, they will be judged successful. They are not, however, a substitute for internal accountability and governance.