Individualized Care Through Treatment Pathways: Isn’t This an Oxymoron?

 J Clin Pathways. 2024;10(4):29-31. doi:10.25270/jcp.2024.06.02

The original development of oncology clinical pathways was based on methods of public health initiatives, which often follow a population-based approach where treatments can be successful for most patients but not others. On the other hand, precision medicine considers individual differences in people’s genes, environments, and lifestyles, thus, giving professionals the resources they need to target an illness with specific treatments during individual encounters.

Public health initiatives have fostered a focus in value-based care and are patterned after the well-known health care value equation: value = quality/cost. The Triple Aim objective can also be crafted into a similar patient-centric equation: patient satisfaction = population health/cost. From these concepts, oncology clinical pathways were formed with the following original aspirations:

1. Improve quality of care and patient experience.
2. Reduce unwarranted variation in care.
3. Support pathway validation through disease committees for efficacy, toxicity, and cost.
4. Optimize appropriate drug utilization (ie, right patient, right drug, right time).
5. Encourage pathway adherence to drive more cost-effective, value-based care.
6. Decrease administrative burden and prior authorizations.
7. Enhance clinical trial enrollment.

President Obama introduced one such public health initiative, the Precision Medicine Initiative, at the 2015 State of the Union Address, which is managed by the National Institutes of Health (NIH) with an initial budget of $130 million.¹ Hundreds of thousands of citizens have volunteered their health information and biological samples for the initiative to accelerate health and medical breakthroughs, enabling individualized prevention, treatment, and care. This initiative advocated the concepts of precision medicine and individualized care going forward.

About 15-20 years ago, oncology clinical pathways were less complicated. Fewer potential pathway “decision branches” allowed for population-based approaches because patients could fit into large groups. The rapid expansion of molecular diagnostics and precision medicine has made treatment choices more complex. Now, there is a proliferation of disease states and treatment pathways. For example, with lung cancer, there are at least 13 molecular targets depending on the mutation status, programmed death-ligand 1 (PDL-1) status, and whether immunotherapy or targeted therapy will be provided at certain periods. As a result, this creates more decision branches that interact, which makes the development and maintenance of pathways much more of a challenge.

Physicians, patients, payers, pathways vendors, and molecular diagnostics companies “collide” to combine pathways and precision medicine.

For example, a study by Schleicher et al discussed how to rethink the role of clinical pathways in the era of precision medicine.² The researchers looked at lung cancer as a model to evaluate the interplay between appropriate drug utilization and rising drug costs. Pathways were used during the pre-immunotherapy and targeted therapy eras. During the study, there was rapidly evolving standard of care with marked expansion of actionable molecular targets. They concluded that:

Pathways importantly may still drive value by ensuring that patients get the correct treatment, their ability to reduce costs through utilization management is less evident in the era of precision medicine when treatment choice is more narrowly tied to distinct disease phenotypes, and treatment costs depend more heavily on drug prices than on appropriate utilization… These types of investigations will be of paramount importance in informing the extent to which future payment policy solutions that target treatment utilization, as opposed to treatment price, will be effective in incentivizing high-value care.”²

In addition, a study by Mason et al used clinical pathways to investigate biomarker testing patterns for patients with non–small cell lung cancer (NSCLC) among providers using clinical pathways.3 The researchers found that these providers had high biomarker testing rates (94%), and 96.8% of patients had been prescribed the appropriate treatment. The remaining 3.2% of patients were enrolled in a clinical trial, and those with PDL-1 expression greater than 50% received immunotherapy (87.1%). Overall, the study showed that providers can use clinical pathways as a tool to promote testing of key biomarkers and assist with the selection of precision therapy for patients.

From these and similar studies, we can begin to formulate solutions for integrating precision medicine-based pathways into value-based care (Table 1). Facilitating the shared alignment of precision medicine data and treatment pathways requires the essential contribution of multiple stakeholders in optimizing the delivery of health care to our patients. These include electronic health record (EHR) vendors, molecular diagnostics companies, pharmacies, payer formularies, pathways vendors, and cancer care networks. Pharmaceutical research to improve therapeutics is also necessary.

As a vision for the future, the points in Table 1 serve as a call to action for EHR vendors, molecular diagnostics companies, pharmacies, payer formularies, pathways vendors, and cancer care networks—through their areas of expertise—to contribute innovative solutions to further enhance the Triple Aim objectives and improve patient outcomes. These are complex solutions driven by our expanding knowledge and our capacity to collaborate. Such deliverables include better reporting of marker and genomic data in structured formats; direct EHR integration of structured pathways data; expansion from simply addressing drug treatments to comprehensive cancer care management; and integrating means of better communicating with patients and bolstering patient shared decision-making to optimize the patient’s perception of value.

We can develop a far more robust treatment pathways system/decision support tool that is fully integrated and fluid with precision medicine information. This will provide more precise and individualized recommendations that will strengthen the Triple Aim’s aspirational goals. Such decision support systems/pathways are needed to assist oncologists and patients in navigating the increasingly complex cancer care environment.

Developing these tools will require intricate involvement from various stakeholders. Their algorithms will also need to define specific recommendations based on the patient’s molecular profile and the most efficacious treatment options, toxicities, and even patient values and preferences. Further, treatment pathways need to move beyond purely systemic therapy selections to address the entire continuum of cancer care delivery.

Pathways cannot be designed to be entirely population-based to align our objectives. When increasing individualized care through precision medicine, we all must be good stewards of the protean choices we have available to patients. That means there must be far more decision branches in the pathways—ideally out to each individual leaf. However, outside of clinical trials, we should not exploit unvalidated treatments and prescribe “orphan drugs” without prudence.

Pathways shall continue to be a great decision support tool, even when we are out on the thin branches of individualized care.

Affiliation:

The Center for Cancer and Blood Disorders, Fort Worth, Texas

Correspondence:

Ray Page, DO, PhD, FACOI, FASCO

The Center for Cancer and Blood Disorders

800 W. Magnolia Street, Fort Worth, Texas 76104

Email: rpage@txcc.com

Disclosures: The author reports clinical use of the Elsevier CliniPath pathways, and has uncompensated contribution to their pathways committees.