Oncology Pathways Drive Adoption of High-Quality Treatment Regimens and Deliver Drug Cost Savings

 J Clin Pathways. 2023;9(4):8-12. doi:10.25270/jcp.2023.07.02

Medical knowledge is growing at unprecedented rates and picking up speed every year. In 1950, it took 50 years to double medical knowledge. In 2010, it took 3.5 years. In 2020, it was estimated to be 73 days.¹

In oncology, the National Comprehensive Cancer Network (NCCN) made over 150 updates to their published cancer guidelines and compendia in 2018 alone.² The number of evidence-based medical journals and resources is increas­ing to a point where, one oncologist wrote, it would take more than 627 hours a month—about 21 hours a day—of reading to keep pace.³

While positive for medical innovation, this information explosion creates chal­lenges for providers. A recent survey found that 95% of physicians want to learn more about new trials, treatments, or procedures that could help improve out­comes for their patients, but more than two-thirds of them, and 80% of oncolo­gists, report feeling overwhelmed by the amount of information they must keep up with.⁴

As a result of these knowledge gaps, patients do not always receive evidence-based care. Research shows that as many as half of all cancer treatments (47%) do not follow the latest scientific recommendations.⁵

At the same time, oncology costs are rapidly increasing. Spending for cancer drugs was $185 billion in 2021, which is a 50% increase from 2017, and costs are forecasted to reach $307 billion by 2026. The pipeline for new drugs is also strong, with oncology trials reaching historic highs in 2021, up 56% from 2016.⁶

Adherence to guidelines, such as those from NCCN, has shown the potential to reduce the oncology costs. However, additional measures are needed to drive high-value cancer care. Clinical pathways are a solution that can help bridge knowledge gaps for providers and ensure pa­tients get quality, affordable cancer care. According to the American Society of Clinical Oncology (ASCO), “High-qual­ity oncology clinical pathways are detailed, evidence-based treatment protocols for delivering cancer care to patients with specific disease types and stages. When properly designed and implemented, oncology pathways can serve as an important tool in improving care quality and reducing costs.”⁷

ASCO has developed criteria that should be met when creating oncology clinical pathways. They include transpar­ent pathway development with a clear, consistent process and methodology. The pathways should be clinically driven, with established methodology for prioritizing efficacy, safety, and cost. The pathways should also be patient-focused, including alternative evidence-based options to account for differences in patient characteristics or preferences.

Several leading oncology organizations, such as ASCO, NCCN, and the European Society for Medical Oncology (ESMO), have also developed value-based oncology frame­works. For example, the ASCO Value Framework Net Health Benefit score and ESMO Magnitude of Clinical Benefit scale are both intended to be objective measures of the clinical ben­efits of oncology drug treatments.⁸ Though these frameworks are similar, some key differences between ASCO and ESMO frameworks include weighting of toxicities and of absolute and relative gains in survival, as well as distinct approaches for re­warding long-term survival benefits. However, a study showed a high correlation between the frameworks in determining the relative value of treatments in the noncurative setting.⁹

NCCN has also added value-based components to its guidelines, including evidence blocks, which measure five components of value for treatment regimens, as well as devel­opment of categories of preference, which consider efficacy, toxicity, and, when appropriate, cost.

eviCore Healthcare (eviCore), an Evernorth Health Ser­vices company that manages medical benefits, uses an inno­vative clinical decision support model to assist providers in selecting the most clinically appropriate, highest-value cancer regimens. eviCore’s standard medical oncology prior autho­rization program approves any NCCN-approved regimen. To expand on this approach, eviCore’s and Cigna’s clinical teams developed an Oncology Value-based Pathways (VP) program.

In building the VP program, the clinical teams sought to create an objective and reproducible methodology, including the ASCO Value Framework Net Health Benefit score, ESMO Magnitude of Clinical Benefit scale, and NCCN guidelines value-based components. Through a proprietary weighted scoring methodology using these frameworks, the clinical teams are able to assign a value-based score for each regimen. That score is based on efficacy, safety, and other outcome com­ponents, such as quality of life improvements. Cost is consid­ered only when two or more regimens had a value-based score within 10% of each other. The clinical teams also identified appropriate clinical exceptions for preferred on-pathway regi­mens, recognizing that patient-specific characteristics impact the value of various treatment options. All on-pathway regi­mens are a subset of NCCN-recommended regimens.

In settings where the available NCCN-recommended regi­mens had evidence only from single-arm, nonrandomized tri­als, the clinical teams were unable to apply a multiframework methodology. Instead, the available literature was reviewed, and a clinical consensus approach was applied to identify on-pathway regimens.

Each pathway underwent extensive clinical validation. In­ternally, it was evaluated by medical oncologists, pharmacists with extensive oncology experience, and a dedicated enter­prise Pharmacy and Therapeutics Committee. External vali­dators included medical oncologists from community-based practices, as well as disease-specific experts from National Cancer Institute–designated centers and NCCN member institutions. All feedback on the pathways were considered prior to finalization.

The oncology value pathway for metastatic kidney cancer provides a good example of how the VP program works. For a patient with poor or intermediate risk, NCCN recommends four treatments. When the VP model is applied, the ipilim­umab/nivolumab regimen (Table; Regimen 1) is associated with the greatest clinical benefit and cost effectiveness. In ad­dition to highlighting this regimen in its clinical decision sup­port tool, eviCore provides clinical consultation if a provider selects a lower-value treatment regimen. In the consultation process, the provider is sent a brief synopsis highlighting the higher clinical benefit of the preferred option, and proactive peer-to-peer (P2P) outreach is also initiated by an eviCore medical oncologist to review the information together. In addition to better outcomes for patients, the estimated drug-cost savings is up to $170,000 per year per patient over some of the other NCCN-recommended regimens.

Beginning January 1, 2021, Cigna and eviCore implemented the VP program in a large commercial population. The VP program tiers NCCN-approved regimens into preferred (on-pathway) and nonpreferred (off-pathway) categories for specific clinical cohorts based on patient outcomes, quality of care, and value. Between January 1, 2021, and January 1, 2022, the VP program was developed and implemented in 3 phases, spanning 51 clinical pathways and covering 50% of cancers.

Prior authorization requests made for off-pathway regi­mens in these clinical cohorts result in a P2P discussion be­tween the requesting physician and an eviCore medical oncologist with the intent of redirecting the requesting phy­sician to an on-pathway selection. As it is designed to provide clinical decision support, there are no denials issued for off-pathway selections, and providers are not required to switch to on-pathway regimens. eviCore tracks the outcomes of these P2P conversations. If the requesting provider chooses to stay with the off-pathway regimen after the P2P, eviCore records whether this was due to patient-specific contraindi­cations to the on-pathway regimens, a continuation of care request, or individual physician preference.

Three metrics evaluate the impact of the VP program: the on-pathway regimen improvement rate, the successful P2P rate, and the opportunity impact rate.

Prior authorization data collected from the 12 months prior to implementation of each phase was used to determine the baseline on-pathway regimen rate by cohort (approved authorizations for on-pathway regimens/approved authoriza­tions for total on-pathway and off-pathway regimens). The on-pathway regimen rate in the baseline period was compared to the rate in the post-implementation period to determine on-pathway regimen rate increase. This first metric does not exclude clinical exceptions, which are defined as patient-spe­cific contraindications and continuation of care, as this infor­mation was not being tracked in the baseline data.

The second and third metrics both exclude patients with clinical exceptions from the denominator. The successful P2P rate captures the direct impact of the P2P discussions by tracking how many resulted in an updated request from an off-pathway regimen to an on-pathway regimen.

The opportunity impact rate captures both the direct impact of the P2P discussions and the indirect educational impact of the program. It is calculated by dividing the number of patients impacted by the opportunities for impact. The patients im­pacted are calculated by multiplying the on-pathway regimen improvement rate by the post-implementation authorization volume. This captures both direct and indirect shifts.

Results are provided for the three core metrics from January 1, 2021, through June 30, 2022. Overall, the VP program has delivered an estimated oncology-related drug savings of $24 million or $0.13 per member per month in a commercial managed population. The savings were calculated based on the average sales price (ASP) of the drugs as published by the Centers for Medicare & Medicaid Services (CMS). There were no drug discounts or rebates included in the VP program.

Metric 1: On-Pathway Regimen Improvement Rate

In the 12 months prior to program implementation, there were 6,218 authorization requests with a combined 71.9% on-pathway regimen rate within the applicable cohorts. In the 18 months post-implementation, there were 7,146 authorization requests, and the on-pathway rate increased to 77.1%, which is an overall improvement of 5.2%.

Metric 2: Successful P2P Rate

In the 18-month program history, there have been 972 P2P conversations between requesting physicians and eviCore medical directors. Of those total P2Ps, 475 did not include clinical exceptions, which are patient-specific contraindica­tions or continuation of care requests. These would not be considered opportunities to shift a patient from an off-path­way regimen to an on-pathway regimen. Of the 475 P2P conversations without clinical exceptions, 18.3% (87) directly resulted in an updated request from an off-pathway regimen to an on-pathway regimen.

Metric 3: Opportunity Impact Rate

There were 417 total patients shifted due to the VP program in the first 18 months, and there were 1,473 opportunities for impact (the sum of all patients shifted plus all cases that ended with an off-pathway regimen selection that do not meet the clinical exception criteria). As a result, the opportunity impact rate is 28.3% (417/1,473).

To note an important difference between the second and third metrics, the successful P2P rate captures the direct im­pact of the P2P discussions following a nonpreferred regimen selection. The opportunity impact rate captures the direct and indirect impacts of the program, as it includes patients shifted to an on-pathway regimen whose physician did not have a di­rect P2P conversation. Indirect impacts are likely the result of the clinical decision support system notifying the ordering providers that on-pathway regimens are higher value and have better outcomes. The difference between the opportunity impact rate and the successful P2P rate captures the durable educational impact of the program.

Oncology pathways have the potential to support clinical deci­sion making by highlighting the treatment regimens associated with the best efficacy or safety profile. If those factors are equal, pathways also allow consideration of the relative cost-effective­ness of available treatment options. This research offers prom­ising evidence that effective pathways based on high-quality evidence and applied accurately to individual patient regimen decisions can lead to better adoption of on-pathway regimens and lower costs.

Limitations and Opportunities

To date, objective studies demonstrating that oncology path­ways positively impact costs and patient outcomes have been limited. The VP program shows that an educational steerage model can be effective at increasing pathway adoption with substantial demonstrable savings. However, eviCore’s ability to currently document improved patient outcomes is limited due to insufficient access to longitudinal clinical record data in this cohort to identify statistically significant differences. As these data become more mature, eviCore is planning to share information such as overall disease-free survival rates, as well as other important quality of life measures. Further analysis is also possible to evaluate progression and toxicity data.

Another consideration is that these data do not incorporate the total cost of care. The focus is solely on drug costs because those costs are easily obtainable through claims. However, if oncology pathways are developed, maintained, and applied correctly, they should not only reduce drug costs but also im­prove patient disease outcomes, which should lower the total cost of care.

For example, a study compared quality-of-care outcomes for patients with breast cancer who received an on-pathway regimen versus those who did not. It found that the average post–6-month cost of care was $16,176 lower in the on-path­way cohort.¹⁰ Future research that considers pathways’ effects on total cost of care would contribute to understanding the extent to which they can be impactful beyond drug costs.

VP Model Benefits and Possible Applications

The VP program represents a significant improvement over traditional models for medical oncology decision support. By incorporating several value frameworks in its pathway develop­ment process, the clinical teams were able to consider the per­spectives of multiple stakeholders, including patients, provid­ers, and payers. It is also important to note that the pathway development methodology was supported by extensive clinical review and encompasses analytic validity, clinical validity, and clinical utility. Due to its unique approach, eviCore was ap­proved for a patent for the VP model.¹¹

Provider-friendly approaches like the VP model, which account for clinical efficacy, safety, quality of evidence, and affordability, are likely to have increasing applications, par­ticularly in alternative payment models. For example, CMS recently announced its Enhancing Oncology Model (EOM), which went live in July 2023.¹² Unlike its predecessor, the On­cology Care Model, the EOM will require participants to ac­cept downside risk.¹³ As providers consider joining these types of models, they are likely to seek highly effective tools like the VP program that can help them lower drug costs relative to the baseline while maintaining positive patient outcomes.

Additionally, the results of this study suggest the viability of an educational P2P approach for pathways programs. The VP program was able to achieve a rate of on-pathway regimen adoption to similar studies without the use of financial incen­tives or prior authorization denials.¹⁴

Future Role for Pathways

Innovation in oncology is growing at unprecedented rates, which are expected to continue to increase. These advance­ments are good for patients if they can be accurately incorpo­rated into care regimens. The challenge is that medical knowl­edge is advancing at a pace that is difficult for providers to keep up with. At the same time, rising oncology costs are putting significant strain on patients, payers, and the health care system. This study demonstrates the role innovative new approaches like the VP model can play in ensuring the adoption of quality treatment regimens for patients and lowering oncology drug costs.

At the same time, an opportunity exists for expanding oncology clinical pathways to become more comprehensive in scope, which may help close gaps in patient care. Winston Wong, PharmD, recently suggested transforming current clini­cal pathways into broader “care pathways.” He wrote, “In a care pathway, the clinical pathway becomes a component, along with pathways for diagnostics, social determinants of health and patient preference, patient engagement/navigation, and payer/employer interfaces. These pathways would be support­ed by the backbone of real-world data from existing discon­nected data elements integrated into a single data set.”¹⁵

Moving toward more comprehensive, patient-centric care pathways may further support quality care amid the rapid pace of innovation in oncology care.

Authors: Kathryn Christensen, MS; Timothy Dollear, MS; Rama Al Ghannam, PharmD; Eric Gratias, MD; Robinson Ortiz, MD; and Stephen Hamilton, MD

Affiliations:  Cigna Healthcare, Bloomfield, CT; eviCore, Bluffton Healthcare, SC.

Address correspondence to: 

Stephen Hamilton, MD

400 Buckwalter Place Blvd.

Bluffton, SC 29910

Email: stephen.hamilton@eviCore.com

Disclosures: K.C., T.D., and R.A.G. reported employment and stock ownership with Cigna. E.G. reported employment with eviCore; stock ownership with Cigna; and holding a related patent through Cigna. S.H. reported employment and stock ownership with Cigna; and holding a related patent. R.O. reported employment with Cigna.