Innovation in oncology continues to progress at an astonishing pace, however it places a high cost-burden on the healthcare system. According to a recent report from the IQVIA Institute, over the last five years there were 62 novel cancer therapies launched in the US, which cover 130 indications (Iqvia, 2021). In 2020, US spending on oncology drugs reached $71 billion (Iqvia, 2021). As payers look for ways to control cost while providing high-quality care, they have used both guidelines and pathways as clinical management tools.

Guidelines include all drugs or interventions that are considered by a panel of experts to be within a standard of care for a disease (Chiang, 2018). Guidelines are commonly used by payers to help inform coverage. Guidelines may have many different recommendations, including ones with varying efficacy, toxicity, and cost. Although they assist with making decisions about appropriate care, they do not formally address cost and resource utilization.

With rising healthcare costs and the shift towards value-based healthcare, payers are taking guidelines further and utilizing clinical pathways, which are detailed, evidenced-based protocols. While guidelines may contain all recommended regimens, pathways generally select a subset of those regimens that provide the best available evidence and deliver the most value. Pathways reduce variability in treating conditions, with the goal of improving quality and reducing cost (Chiang, 2018). Payers may choose to build their own pathway programs using expert clinicians to select the on-pathway regimens or utilize a pathway vendor. Pathway programs allow payers to measure provider adherence to pathways, and payers may incentivize providers that follow pathways or potentially even penalize providers that are not.

The American Society of Clinical Oncology estimates 60 individual health insurance plans that cover 170 million individuals are implementing oncology pathways (pathways, n.d.). A recent survey conducted by Xcenda showed the top 5 reasons payers gave for adopting clinical pathways included to improve patient outcomes, to reduce oncology care variations, to improve overall quality of care, decrease total cost of care, and to decrease costs linked with anticancer drugs (Inserro, 2021). While there may be variation in the tumor types included in each payers pathway program, they tend to focus on prevalent cancers with high cost of care that have variability in treatment patterns. Some common tumor types for pathways include breast, colorectal, lung, and multiple myeloma.

CVS Health has integrated NCCN guidelines into their proprietary Novologix clinical decision support prior authorization tool (Singh, 2018). Providers have access to the latest evidence supported NCCN recommended regimens prior to treatment selection to optimize patient’s therapy to regimens with high level of evidence (Singh, 2018). They can select multi-drug regimens and receive automatic approval for guideline-recommended regimens in a single authorization, even for drugs that cross over the pharmacy and medical benefit (Singh, 2018). Regimen level dosing limits are also integrated to ensure cost-effective clinically appropriate utilization (Singh, 2018). Several payers have implemented their own oncology pathway programs, including United Healthcare and Cigna. United Healthcare currently has 14 oncology pathways (Program, n.d.), while Cigna currently has 10 (cigna, n.d.). Both use guidelines as a framework, then their experts select regimens with superior clinical benefit and toxicity profiles to be included in the pathway (development, n.d.) (cigna2, n.d.). Cost is only considered when clinical benefit and toxicity are comparable.

While pathways have traditionally been used in oncology due to wide variation in utilization and cost, there is potential for them to expand into non-oncology specialties. There may be additional challenges in this expansion, including lack of a clear evidence base, lack of independent bodies to determine standards of care, and limited consensus about standards of care (Brillstein, 2020). Pathways have been noted as an approach for managing other specialty drug classes, and their use in other therapeutic areas is likely to grow. Rheumatology, cardiology, diabetes, and multiple sclerosis have been identified as therapeutic areas for pathway expansion (Chawla, 2016).

As payers expand their use of pathways, they will need to monitor adherence to pathways and assess the savings associated with pathway concordance to show value. They will also need to ensure buy-in from providers, as often providers have their own pathway programs that may not always align with the pathway of the payer. It will be important for manufacturers to communicate their product’s value to payers with high-quality evidence to achieve pathway inclusion.


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