The use of oncology clinical pathways (OCPs) is rapidly rising as more data suggest that they can reduce cost and improve quality. But amid the advantages to pathways, there are growing concerns about hidden conflicts of interest.

“There is a lot of promise from these pathways in delivering the right care to the right patient at the right time,” said Bobby Daly, MD , an oncologist and health services researcher at Memorial Sloan Kettering Cancer Center in New York. “But oncologists and patients really want to understand how these pathways are being developed. The issue of transparency is one that patients and providers feel strongly about.”

A recent research letter coauthored by Dr. Daly in JAMA Oncology highlights the crossroads of pathways and financial conflicts. For the study, Dr. Daly and his colleagues reviewed the Centers for Medicare & Medicaid Services Open Payments database to abstract 2015 financial conflicts of interest for the 2016 voting members of three OCP vendors: Value Pathways (a collaboration of McKesson Specialty Health, US Oncology, and the National Comprehensive Cancer Network), the medical oncology committee chairs for Via Oncology, and the medical advisory board for eviti. Investigators found that nearly all physicians on the panels received nonresearch payments, including 92% of US Oncology voting members, 86% of NCCN voting members, 84% of Via Oncology chairs, and 69% of the eviti medical advisory board.

While collaboration with industry is the key to innovation, Dr. Daly wrote that “to ensure patient and clinician trust and maintain their momentum in the value space, pathway developers will need to be transparent about [financial conflicts of interest] and how those interests are managed.”

Pathways: What’s the problem?

Clinical pathways are defined as detailed, evidence-based treatment protocols for delivering quality cancer care to patients with specific disease types and stages. Adoption of these protocols has swiftly grown in recent years, with close to 60% of oncologists currently using or planning to use pathways, according to a 2017 report from the American Society of Clinical Oncology (ASCO). Academic medical institutions, health care providers, commercial organizations, and health insurance companies are all using these pathways.

But as pathways have become more prevalent, concerns have emerged among physicians about who is making pathway treatment decisions and, specifically, about instances in which medications are being selected without disclosure of investments or financial relationships that could influence those decisions, said Robin Zon, MD , chair of the ASCO Task Force on Clinical Pathways.

“In addition, there have been concerns about the methodology of how treatments decisions are made with regard to efficacy, toxicity, and cost, as well as the weighting of these factors in making decisions for the pathway program,” Dr. Zon said in an interview.

Taken together, the mounting questions led to an analysis and by the ASCO task force.

“What the task force found was that standards defining high-quality pathways did not exist, so we became concerned that there could be a risk for wide variations with regards to the quality, utility, functionality, and impact of pathway programs,” Dr. Zon said.

The findings were the catalyst behind a March 2016 ASCO policy statement aimed at ensuring that clinical pathways in oncology promote – not hinder – cancer care. The task force called on pathway developers to adopt a process that was consistent and transparent to all stakeholders and to disclose potential conflicts of interest by the companies and individuals involved in pathway development.

“The criteria were developed to address the multiple issues brought to our attention by ASCO members and to be used as possible standards for pathway development, implementation, and evolution,” Dr. Zon said.

The push for more transparency is directed at for-profit companies and health plans that are developing and promoting their pathways, said Matt Kalaycio, MD , chair of hematology and medical oncology at Cleveland Clinic Taussig Cancer Institute. An estimated 60 U.S. health plans are currently implementing oncology pathways, and more than 170 million patients covered by the plans are potentially treated under a plan-sponsored pathway program, according to ASCO.

Meanwhile, the Cleveland Clinic has been utilizing pathways for more than 5 years and has published nearly 50 clinical pathways related to cancer care, Dr. Kalaycio said.

“Our care paths were designed to help physicians make clinical decisions that are in the best interest of their patients and the Cleveland Clinic,” he said in an interview. “These care paths are here for clinical reasons, not for financial reasons – we might ultimately use them to make financial decisions, but that’s not why they were developed. In contrast, the [JAMA Oncology study] is referring to pathways that are being developed by for-profit companies to control cost – big, big difference.”

The problem is that some insurers want to hide the identity of their advisors and how much they are being paid, which creates uncertainty about the validity of their pathways, he said. Dr. Kalaycio noted that the individuals selected for pathway panels and committees are often those who conducted the studies that the pathways are based upon and that those studies are frequently supported by the pharmaceutical industry.

“There is always going to be some degree of conflict of interest and as long as that’s disclosed, that’s fine,” he said. “It’s when you try to hide who’s getting paid for what that you get into trouble because you can’t say with certainty that someone’s not getting paid off.”

To address the transparency void, the California legislature in 2017 introduced the Oncology Clinical Pathways Act. The bill would have required health plans that develop and implement OCPs to provide the names, qualifications, affiliations, and conflicts of anyone involved in the research or analysis for an oncology clinical pathway if it were requested by a physician or surgeon. The bill died in committee.

Health plans push back

The California Association of Health Plans had opposed the bill because the proposal “unnecessarily sought to regulate voluntary clinical guidelines developed by health plans,” said Charles Bacchi , president and CEO for the group. “AB 1107’s so-called push for transparency was a veiled attempt by drug companies and others to gain access to the names of independent providers in order to influence the process,” Mr. Bacchi said in an interview. “In this case, more transparency would have done more harm to patient care than good. The names of participating third-party panelists are purposely not shared in order to protect these panelists from lobbying or other pressure by numerous entities, including drug companies, in their efforts to create bias in the clinical evidence review process.”

America’s Health Insurance Plans (AHIP) spokeswoman Cathryn Donaldson said health plans are being unfairly targeted in the drive toward more transparency. The recent efforts are an attempt to single out clinical care pathways developed by health plans as needing additional oversight standards while ignoring pathways that are developed by drug distributors, hospital systems, academic institutions, and others, Ms. Donaldson said in an interview.

“Hospital systems, medical centers, pharmaceutical distributors, and academic centers all create their own pathways but have not been subject to these transparency efforts,” she said. “Given all the various relationships in the system, we strongly believe that if additional oversight to voluntary clinical care pathways is added, then the oversight should apply to all pathways.”

ASCO’s Dr. Zon stressed that the criteria her task force created for pathways is aimed at all types of developers.

“In other words, we felt that the criteria should apply across all the pathway program developers whether they were provider or payer facing,” Dr. Zon said. “We also did not differentiate between not-for-profit and for-profit entities. Standards for high-quality criteria should apply to any pathway program being developed regardless of the source.”

Dr. Daly added that every entity that develops a pathway should have some policy around conflict of interest and how to address any transparency issues that may arise. Despite the recent debate over transparency, Dr. Daly said he believes the future of pathways is bright.

“I think the future is that pathways hold a lot of promise,” he said. “But I think we really need to ensure that the pathways that are being employed are of high quality because they influence how patients are treated.”

Dr. Daly serves as a director of Quadrant Holdings Corporation and receives compensation from this entity. This news organization is a subsidiary of Quadrant Holdings Corporation.