New Study Examines Clinical Pathways: An Overview of Current Practices and Potential Implications for Patients, Payers, and Providers

As health care payers seek to transition to new, value-based payment models, clinical pathways are one strategy payers and providers are using in their efforts to contain costs and promote evidence-based care. New research released this week by Avalere Health examines current practices related to these programs and stakeholder reactions to their growing use.

Clinical pathways are multi-pronged care plans that prescribe specific guidance on the sequencing of care steps.  They can encompass a wide range of activities – from care protocols that help reduce infection or prevent unnecessary visits to the emergency department, to those that seek to promote more efficient treatment decision-making. Much of the recent focus in oncology has been on use of tools that narrow options based on decisions about treatment efficacy, side-effects and cost.  In other words, pathways can take a range of treatment options and narrow a physician’s options to a select few. It’s like taking an eight lane highway and narrowing it to two. Recently, some payers are even linking use of their preferred clinical pathways to financial incentives.  

These trends raise a number of questions:  who decides which treatments will be “on-pathway,” what criteria do they consider and what does the process mean for patients – particularly patients whose needs differ from the average?

Avalere’s research found that practices for developing pathways vary between and among providers, who may develop pathways for their own use, and vendors -- many of whom work with payers to develop pathways for deployment in value-based payment arrangements.  Pathway developers differ in who is involved in committees that design pathways and, importantly, what sources of evidence are used. The testing or validation process is similarly variable. Only in limited cases are patients involved in pathway development.

With so much variation in development processes and more payers using financial incentives to drive pathway compliance, patient advocates and physicians alike are raising concerns that pathway programs could negatively impact patient choice and create barriers to accessing treatments designated as off-pathway.    In payer-driven programs, off-pathway options may be tied to more stringent utilization management criteria, and jumping through extra hoops can mean treatment delays for patients (if they are even made aware of off-pathway options).

Rapid advancements in personalized medicine - particularly oncology, where the majority of clinical pathway programs are currently being deployed – add to these challenges.  A recent paper by the Personalized Medicine Coalition notes: “As personalized medicine provides new insights on the role of genetic variation in what works or does not work for a patient, clinical pathways and other decision support tools will be challenged to keep pace with changes in evidence – and importantly, what works for an individual patient. “

To address these challenges, researchers recommend stakeholders work together to create principles or standards for the development and implementation of clinical pathways that will best serve the needs of patient. Standards that address the composition of the committees that develop pathways, the criteria they use to evaluate evidence and the practices for implementing pathways will go a long way to alleviating stakeholder concerns and creating tools that help to get the right treatment to the right patient, as opposed to tools that are just focused on managing costs.

To learn more about PhRMA’s commitment to new models that reflect the needs and preferences of individual patients, medical advances and increasing personalization in medicine, read our Principles for Payment and Delivery System Reforms.