Healthcare providers and payers are increasingly turning to clinical pathways as tools to manage the cost of care and promote evidence-based treatment.  Clinical pathways, when appropriately developed and applied, can help to guide clinical decision-making.  However, as innovative medical advances drive towards increasing personalization in healthcare and patient-centeredness becomes a more prominent focus of healthcare quality improvement efforts, these tools must remain flexible to allow providers to tailor care to individual patient needs and avoid a “one-size-fits all” approach to healthcare decision-making.

Currently there is significant variability in how clinical pathway programs are developed, the evidence used, and the flexibility that physicians have to treat patients.  This variability has prompted concern from patient advocates and physicians that poorly designed pathways could pose barriers to patient access to individualized, high-quality care, particularly in light of advancements in personalized medicine.[i]

For pathway programs and similar decision support tools to meet stakeholder goals for quality improvement, more consistency and accountability is needed in the processes by which they are developed, maintained, and used in the course of patient care.  Well-designed, patient-centered pathway programs will support informed choices by healthcare providers and their patients from the full range of treatment options and allow physicians to consider the evidence through the lens of an individual patient’s characteristics, treatment goals, and preferences. 

PhRMA supports the following principles for the development and use of clinical pathways:

Pathway Development:

• Pathways should be developed by practicing physicians and clinical experts through an open, transparent process that includes input from patients, providers and other stakeholders into their content.
• Pathways should consider relevant, scientifically rigorous health outcomes evidence from many types of studies. Pathways should incorporate relevant evidence on the range of outcomes that matter to patients and caregivers, including quality of life, patient preference and satisfaction, survival, and productivity.
• Pathways should be objectively, systematically, and regularly reviewed and updated (e.g., at least annually) to keep pace with medical innovation and changes in scientific evidence over time. There should be a continuous open and transparent process for stakeholders to request a timely review of pathways to account for new technology and other advances or other changes in the evidence-base.
• Economic considerations should always be secondary to clinical considerations in determining which treatment regimens will be included in a pathway and in selecting from different care pathways.

Pathway Use:

• Consistent with PhRMA’s principles for payment and delivery reform, value-based payment models (e.g., those that provide financial incentives for use of clinical pathways) should be grounded in evidence and developed through an open and transparent process with opportunities for public and stakeholder input.  Patients should be aware of their participation in these programs, the nature of the payment arrangement, and its implications for their care.
• Pathways should be flexible to allow for choice from the range of available treatment options without penalty and should not limit patients’ access to treatments that they and their healthcare providers determine to be the best option for their care.  In the event that access to treatment options are limited based on a clinical pathway, patients should have access to a timely appeals process.
• Pathways should support the tailoring of care to individual patient needs based on the practice of shared decision-making, to include conversations that inform patients and caregivers of all options available, as well as the risks and benefits associated with each.
• Clinical pathway programs should present clinical trials as an option and encourage participation in clinical trials as appropriate.
• Pathways should account for variability in treatment guided by companion diagnostics where applicable, allow for customization based on diagnostic information, and avoid barriers to the adoption of personalized medicine. 
• Clinical pathway programs should include a mechanism to continuously assess health outcomes for patients treated both on and off pathway in order evaluate the impact of the pathway program on quality of care and patient outcomes.

[i] Avalere Health, LLC., Clinical Pathways: Overview of Current Practices and Potential Implications for Patients, Payers, and Providers, July 2015.  http://avalere-health-production.s3.amazonaws.com/uploads/pdfs/1438002728_AH_Pathways_final.pdf