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Anna Forsythe and Scott Shortenhaus give their view on the growing role of clinical pathways in oncology.

By Danielle Barron on May 5, 2016

Earlier this year, the American Society of Clinical Oncology (ASCO) released a new policy statement, outlining its concerns that the use of clinical pathways in oncology may be posing significant barriers to providing high-quality, evidence-based cancer care.

The Organization’s statement, which was published in the Journal of Oncology Practice, contained recommendations to ensure that clinical pathways in oncology promote - and not hinder - the care of patients with cancer.

The statement also asserts that the way in which these treatment management tools have proliferated in oncology raises significant concerns about patient access, care quality, and transparency in pathway development and implementation.

“It’s time to seriously examine the way clinical pathways are designed and implemented to ensure they consistently enhance, rather than diminish, patient care,” said ASCO President Julie M. Vose. “In too many cases, clinical pathways are undermining physicians’ ability to optimally care for their patients with cancer and limiting patient choice.”

The popularity of pathways cannot be disputed – according to DKP Critical Insights “Clinical Pathways Overview and Provider Perspectives, 2015”, an estimated 60 individual health insurance plans in the US are currently implementing oncology pathways. Pathways differ from clinical guidelines; they are structured, multidisciplinary plans of care designed to support the implementation of clinical guidelines and protocols.

Concerns that efforts to address the rising cost of oncology therapies are having an ever-increasing impact on the autonomy of clinical decision-making are not without foundation. The balance between cost-effectiveness and evidence-based medicine is not always achieved with clinical pathways, and their benefits are often matched by their limitations.

Tipping point

Anna Forsythe, Senior Director and Global Head, Global Value and Access Strategy, at Eisai, says there is a “tipping point”.  Forsythe is speaking at Oncology Market Access & Pricing 2016 in Philadelphia, June 16 &17.

She believes that clinical pathways and guidance documents from the relevant oncology physician groups are rapidly moving from being solely clinical-based documents and introducing the concept of value.

“There is more pushback than ever before to justify the cost of care in oncology. For example, Memorial Sloan Kettering guidance appears to be shifting from a strictly clinical approach to one including cost/value considerations. They produce it for not just physicians, but managed-care organizations, health economists, and anyone who has budget considerations in mind.”

According to Forsythe, the world of oncology will be more challenging in years to come as the need to prove value will be inherent; “every drug will not necessarily be reimbursed and will face favorable formulary position and prior authorization and pricing per indication”.

eyeforpharma's whitepaper “The Future of the U.S. Oncology Market: Preparing for Healthcare 2.0”, published last year, highlighted how variation in cost and standards of care in oncology is being addressed by the adoption of clinical pathways. The adoption of these pathways is not only growing, but will be a vital mechanism by which escalating cancer care costs can be contained.

Pathways can vary significantly, however, with no agreed standard for what constitutes a clinical pathway. And while they are meant to support an interdisciplinary approach to care, they are also employed to maximize the efficient use of resources.

Guidelines and pathways cannot be confused – a simple differentiator is that guidelines include all available treatment options, whereas pathways may be framed around a treatment or treatments that have been deemed superior in terms of efficacy, side effect profile, or cost-effectiveness.

Anchored to guidelines

Scott Shortenhaus, Director of Lilly Oncology, says that evidence-based guidelines have been directing clinical decisions for years, and he stresses that they continue to do so.

In oncology, the guidelines produced by the National Comprehensive Cancer Network (NCCN), an alliance of the world's leading cancer centers, are deemed by man to be the “gold standard”, with most oncologists using these as a basis for their decisions, explains Shortenhaus, who will also be speaking at Oncology Market Access & Pricing 2016.

“Pathway providers and payers are anchored to them. They evaluate the safety and efficacy, data quality and data consistency of each drug. They do it well and they have done it well for a long time.”

The NCCN guidelines are based on a clinical exercise; its pathways primarily evaluate clinical considerations, although there is some evaluation of cost. The majority of oncologists use the NCCN Guidelines as a basis. Yet the choice they offer is dramatically reduced once the guidelines are viewed through the prism of value, says Shortenhaus; “If you view the NCCN Guidelines as a 10-lane highway, clinical pathways take it to a two-lane highway and take cost into consideration.”

Lack of transparency

There is a distinct lack of transparency when it comes to exactly how these pathways are devised, he adds.

“If you talk to patient advocacy groups, the methodology behind developing clinical pathways and the transparency at the point of care are completely blind to patients, and that needs to be reconciled,” he explains. Patient advocacy groups are unsurprisingly not happy with pathways that are disproportionately fixated on costs, because they fear new treatment options may be excluded.

Yet, escalating costs, particularly in oncology, are begging to be addressed. Clinical pathways is just one of the various value frameworks that are being employed as payers attempt to provide the best possible care at the best possible price. Shortenhaus says physicians are already exercising prudent clinical decision-making in the oncology field.

“You’ll see a lot of community doctors who create their own pathways, with more organic, locally grown pathways based on their practice experience.”

Confounding pathways

The sheer volume of clinical pathways is also becoming an issue as medics are forced to wade through what can often be conflicting advice. ASCO’s policy document expressed concern that pathways may be developed or applied consistently by insurers and other pathways creators, resulting in wide variations in quality and utility, and stated that they may be “too rigid”, with many placing too much emphasis on cost control.

The Society also notes that oncology pathways can be focused only on the selection of anticancer agents, ignoring other critical aspects of cancer care, including diagnostic evaluation, laboratory testing, and palliative care services, all central to quality patient care.

“These relatively simplistic pathways may restrict patient choices and may conflict with physicians’ clinical judgment,” said the ASCO committee.

Shortenhaus references the ASCO list: “ASCO just came out with their clinical pathways priorities list – it’s confounding how many competing pathways that oncology practices have to deal with. It’s a real issue for doctors’ offices.”

The bottom line is that insurers do not wish to pay top dollar for innovative therapies, but he notes that devising pathways is typically carried out externally, often at a hefty price.

“Pathway development is a commercial endeavor, and pathways companies are selling their products to oncology providers and payers.”

Up-to-date?

What about the drug developers? For pharmaceutical companies, no formal process exists for making a submission to the makers of the clinical pathways. Those decision-makers do not wish to interact with drug companies; rather, they base their decisions on clinical trial evidence and other forms of published, peer-reviewed data.

Shortenhaus explains that a given drug can be “on” or “off” any number of competing clinical pathways, and says innovator pharma companies must determine which data and criteria each of the competing pathways are using to decide which therapy options are included.

According to Forsythe, the pace of development in oncology means pathways can be outdated within months, with decision-makers not privy to the very latest evidence. A regular literature review may omit the latest clinical data available from the manufacturer, which may not have been formally published. This may be “significant”, she cautions.

“There are cases where a drug is approved even before Phase 3 data is published, so there are limits on how much published data can be found. Similarly, there is a lot of data available out there and presented at medical congresses but not all published so may not be discoverable.”

Shortenhaus feels that when it comes to value, current assessment models are short-sighted and incomplete.

“In the overall cost to the system, pharmaceuticals in oncology represents only about 20 percent of all costs, but because of how insurance is designed, today’s oncology drugs create more OOP costs for patients. When assessing value, you need to look across the entire spectrum of care. And while that’s hard to do, it is far more comprehensive than a piecemeal approach which assesses value within silos."