Journal of clinical pathways : the foundation of value-based care

Cancer treatment decisions should be made by patients and their oncology care teams, informed uniquely by tumor biology, disease stage, prior therapy, comorbidities, and patient preferences—not constrained by coverage rules. Utilization-management approaches, traditionally associated with other therapeutic areas, are increasingly applied to medical-benefit oncology, leading to treatment delays, added administrative burden, and barriers to evidence-based care. This report describes how payer management in oncology is evolving, why the current environment is worsening, the impact to patients and practices, and the policy changes needed to protect timely access and physician-led decision making in cancer care.

Teclistamab and talquetamab are bispecific antibody (BsAb) therapies approved for relapsed/refractory multiple myeloma (RRMM). It is important to understand how practices evolve BsAb step-up dosing (SUD) in outpatient care models that improve patient access while ensuring safety. A qualitative interview was conducted with hematologists at Atrium Health Wake Forest Baptist Comprehensive Cancer Center to understand their processes and experiences with administering teclistamab/talquetamab SUD in an outpatient setting. Atrium Health hematologists used Hospital-at-Home (HAH) programs to administer outpatient SUD, thereby reducing health care burden and increasing access to these therapies. Patient eligibility for outpatient SUD was determined by presence of caregiver support, proximity to Atrium Health’s main campus, and clinical characteristics. Hematologists and HAH staff jointly work to monitor vitals, and HAH paramedics conduct home visits between step-up doses. Atrium Health hematologists developed adverse event management processes, including guidance for at-home medications, nurse triage, and emergency department protocols. These findings showed that outpatient SUD for teclistamab/talquetamab is feasible and can be safely implemented for selected patients with RRMM. This care model may serve as an example to inform the development of outpatient SUD programs at other centers.

Racial disparities in uterine cancer stem from biological, clinical, and socioeconomic factors, yet the impact of clinical pathways in mitigating these factors remains largely unexamined. Using Surveillance, Epidemiology, and End Results (SEER) data and propensity score matching, we analyzed uterine cancer cases to assess disparities between non-Hispanic (NH) Black and White patients in hysterectomy rates and overall survival (OS). In Cohort 1 (N = 133 839), 10 952 NH Black patients were matched 1:1 with 10 952 NH White patients; NH Black patients had lower hysterectomy rates and shorter median OS (114 vs 170 months, P < .001). In Cohort 2 (N = 59 516), 9314 NH Black patients were matched 1:1 with 9314 NH White patients. Similar disparities persisted, with NH Black patients showing lower hysterectomy rates, higher mortality (30.67% vs 23.15%, P < .001), and higher risk of death (HR, 1.41; 95% CI, 1.34-1.49). Moreover, NH White patients lived a median of 4.5 years longer than NH Black patients, who also had higher mortality risk. These findings suggest that equity-focused clinical pathways that standardize hysterectomy recommendations and address social determinants, along with real-time monitoring, may help reduce racial disparities in uterine cancer and improve care of NH Black patients.

Oncology clinical pathways emerged in the mid-2000s to reduce unwarranted variation, standardize evidence-based treatment, and control costs. Two decades later, roughly 75% of integrated delivery systems and most major payers have adopted pathway programs, yet variation in cancer care persists and oncologist frustration has intensified. Evidence supporting pathways is limited. Provider-led programs at well-resourced institutions have demonstrated modest clinical and financial benefits, while payer-led programs have shown low compliance, with one large cohort study finding 64% on-pathway prescribing despite substantial financial incentives. Oncologists increasingly navigate multiple conflicting pathway systems that lag behind a rapidly evolving therapeutic landscape, including 54 new US Food and Drug Administration oncology approvals in 2025, growing use of combination regimens, and biomarker-driven prescribing. Payer-led pathways may lack adequate clinical granularity, which is especially problematic given their often mandatory enforcement through prior authorization. A more sustainable approach anchors clinical review to continuously updated National Comprehensive Cancer Network Guidelines and high-quality evidence, deploys targeted prior authorization for complex or expensive therapies, and rewards demonstrated adherence to evidence-based standards with prior authorization relief.

The pivotal NAPOLI 3 trial reported superior overall survival (OS) for NALIRIFOX (liposomal irinotecan+oxaliplatin + 5-fluorouracil/leucovorin) vs gemcitabine + nab-paclitaxel (GnP) in patients with treatment-naive metastatic pancreatic ductal adenocarcinoma (mPDAC) (P = .036). No prospective studies have compared first-line NALIRIFOX vs FOLFIRINOX (irinotecan + oxaliplatin + 5-fluorouracil/leucovorin) for mPDAC. Using patient-level data from NAPOLI 3 and the Flatiron Health electronic health record database, we compared OS for first-line NALIRIFOX in NAPOLI 3 to external control arms treated with FOLFIRINOX or modified FOLFIRINOX (mFOLFIRINOX). The mFOLFIRINOX cohorts were aligned to NAPOLI 3 eligibility criteria and statistically matched (inverse probability of treatment weighting [IPTW]) on key baseline characteristics. The NALIRIFOX cohort included 383 patients; the FOLFIRINOX and mFOLFIRINOX cohorts included 219 and 154 patients, respectively. Measurable baseline characteristics for the comparator cohorts were generally well balanced following IPTW adjustments. IPTW-adjusted OS (HR; 95% CI) favored NALIRIFOX vs FOLFIRINOX (0.79; 0.64-0.96; P = .02) and mFOLFIRINOX (0.80; 0.64-0.99; P = .04). Pending evidence from clinical trials or real-world prospective studies, this analysis provides preliminary insights into the comparative survival benefit of NALIRIFOX vs mFOLFIRINOX in patients with untreated mPDAC.

The high cost of cancer care is partly driven by the high price of key oncologic drugs, such as pembrolizumab, which are often administered as flat doses rather than the weight-based doses for which they were originally ap­proved by the US Food and Drug Administration. Pharmacoeconomic experts have advocated for a return to weight-based dosing as a drug waste-minimiza­tion strategy and to reduce the cost of cancer care. However, this recommend­ed shift may present significant workflow challenges. At the American Oncology Network (AON), a large multisite community oncology practice participating in the Enhancing Oncology Model (EOM) with Thyme Care, we implemented various strategies to influence weight-based dosing of pembrolizumab. Approximate­ly 8% of EOM episodes involve pembrolizumab administration, of which 70% in­volve patients whose weight would allow for reduced vial usage with weight-based dosing. Following several technological and process improvements, about 45% all pembrolizumab administrations at AON are now dosed by weight. Key takeaways from this effort include optimizing uses for technology, streamlining workflow, educating physicians, and using live-tracking modeling to measure performance and calibrate ongoing effort against results.

Radioactive iodine (RAI) refractory papillary and follicular thyroid can­cer have poor prognoses. These tumors often harbor BRAF V600E and NRAS Q61R mutations, which can be targeted with BRAF and MEK inhibitors to pro­mote redifferentiation. In this study, patients underwent next-generation se­quencing (NGS) testing and a 6-week protocol of trametinib and dabrafenib (pa­tients with BRAF V600E mutation) or trametinib alone (patients with NRAS Q61R mutation), followed by dosimetry and therapeutic RAI. Imaging and biochemi­cal analysis were performed at regular intervals. Of 26 patients, 24 showed RAI uptake post-redifferentiation. The correlation between RAI dose and time to re­sponse was negligible (0.033), while higher RAI doses showed a moderate neg­ative correlation with progression-free survival (PFS) (−.438), though not statis­tically significant (P = .278). Telomerase reverse transcriptase (TERT) positivity significantly reduced PFS by 4.5 months (P = .016). Larger studies are needed to refine patient selection for redifferentiation therapy.

Clinical guidelines recommend tumor testing for patients with metastatic prostate cancer (mPC), but testing rates remain inconsistent across patient populations. To address this, we developed a care pathway and investigated opportunities to leverage the electronic health record (EHR) to standardize testing workflows and support practices in the United States. Using a modified Delphi methodology approach with a hybrid offline and live format, we conducted an online survey and panel discussion with live polling to identify opportunities for improvement and real-world implementation considerations. Based on the identified barriers, clinical guidelines, and real-world practices, we developed a care pathway and three clinical resources covering EHR applications. These tools guide the use of EHR automation to improve patient identification, enhance clinical decision-making, and optimize the integration of tumor and germline testing into clinical workflows across care settings. The results of this study may support practices in standardizing molecular testing and may reduce care inequities for patients with mPC.

Targeted therapies have transformed the cancer treatment land­scape, marking a paradigm shift in cancer treatment. Bispecific antibodies (BsAbs), which engage two antigens simultaneously, represent the next ad­vancement in targeted immuno-oncologic treatment. However, as treatment modalities become more sophisticated so do their associated toxicities, necessi­tating more time-intensive and specialized approaches to toxicity management. This results in increased efforts by clinics to monitor patients, particularly in the absence of trainees or specialized staff, further adding to the cost of care associ­ated with such advanced treatments. Remote therapeutic monitoring (RTM) us­ing electronic patient-reported outcomes (ePROs) is a key component to cost-effective toxicity management for promising drugs such as BsAbs. It may enable greater access to BsAbs by reducing the burden of otherwise manual patient monitoring and symptom management. This manuscript reviews the use of BsAbs, barriers to their adoption in communi­ty clinics, and how RTM can streamline and support patient management to im­prove patient outcomes and reduce the cost of adopting these novel treatments.

The purpose of this study was to analyze the clinical outcomes associated with Cigna Healthcare’s site-of-care management strategies that redirect injected and infused specialty medications from high-cost hospital outpatient setting or out-of-network providers to less costly, in-network, and clinically appropriate alternative settings. This large, real-world retrospective study examined Cigna Healthcare’s commercial medical claims data of 122 448 patients receiving 995 333 injection/infusion instances of 72 specialty drugs between January 1, 2021, and October 31, 2023. Descriptive statistics, chi-square statistics, and logistic regression were conducted to evaluate post injection/infusion outcomes (ie, medication-related adverse event, injection/infusion-related infection, emergency department visit, and hospital admission) between hospital outpatient setting and non-hospital outpatient settings (ie, physician’s office, patient’s home, non-hospital affiliated ambulatory infusion suite). The odds of incidence of medication-related adverse events, emergency department visits, and hospital admissions were lower in the non-hospital outpatient settings compared with the hospital outpatient setting. These findings reveal that the site-of-care optimization of specialty drugs is associated with favorable clinical outcomes and quality in the alternate settings compared to that of the hospital outpatient setting and that these medications can be safely administered in these alternate settings when clinically appropriate.

This retrospective study examined the clinical implementation of an oncology-directed model of delivering guideline-concordant germline genetic testing in patients living with and receiving standard-of-care treatment for advanced prostate cancer. Clinical information was obtained per chart review of electronic medical records (EMRs), and biostatistics analysis was performed utilizing SAS. Of the cohort of 132 patients with prostate cancer who received germline genetic testing, most had negative test results (n = 57, 43.2%), with a smaller subset of patients found to have pathogenic or likely pathogenic (P/LP) germline variants (n = 11, 8.3%). The incidence of actionable homologous recombination repair alterations was lower than previously reported in the literature at 4.7% (n = 6). There was a low rate of alterations in autosomal dominant genes, ~6.3% (n = 8). Variants of uncertain significance were more frequent in patients who self-identified as Black compared with White and Hispanic patients. Of the patients with P/LP germline variants, 100% received follow-up care with genetic counselors. Ultimately, this study aimed to promote greater access to genetic testing and counseling for individuals with prostate cancer in an ever-changing field.

Rapid advancements in oncology have led to an exponential rise in treatment costs, making the value proposition of anticancer agents more impor­tant than ever. Adherence and adoption of recommendations to avoid low-val­ue treatments vary across the cancer continuum. Evolent evaluated the impact of active deimplementation strategies to achieve meaningful reductions in low-value oncology care.

This descriptive study aimed to evaluate the total cost of care and components of health care resource use and costs in androgen receptor path­way inhibitor (ARPI)-naïve Medicare-insured patients with metastatic castra­tion-sensitive prostate cancer (mCSPC) who initiated their first ARPI. Clinical data from US community urology practices (Precision Point Specialty Analytics) were linked with administrative claims (Komodo Research Database; January 1, 2016, to September 30, 2022) to selected Medicare-insured patients with mCSPC who newly initiated apalutamide, enzalutamide, or abiraterone acetate. Patients with ≥ 12 months of continuous insurance eligibility were followed from the date of first use of apalutamide, enzalutamide, or abiraterone acetate (index date) until the earliest of castration-resistance progression, treatment discontinua­tion, initiation of a new therapy, end of continuous insurance eligibility, or end of data availability. All-cause and prostate cancer (PC)–related health care costs per patient per year (PPPY; 2022 US dollars) were summarized using descrip­tive statistics. A total of 152 patients receiving apalutamide (mean on treatment duration of 7.3 months), 189 patients receiving enzalutamide (mean on treat­ment duration of 7.7 months), and 387 patients receiving abiraterone acetate (mean on treatment duration of 9.4 months) were included. Mean all-cause total costs PPPY were $128 187 (apalutamide), $145 382 (enzalutamide), and $114 959 (abiraterone acetate). Mean PC-related total costs PPPY were $116 416 (apalu­tamide), $132 236 (enzalutamide), and $100 338 (abiraterone acetate). Mean all-cause medical costs PPPY were $22 902 in the apalutamide cohort, $30 933 in the enzalutamide cohort, and $35 625 in the abiraterone acetate cohort. Similar trends were observed for mean PC-related medical costs PPPY: $15 067 (apalu­tamide), $20 968 (enzalutamide), and $24 760 (abiraterone acetate). Mean all-cause pharmacy costs PPPY were $105 285 (apalutamide), $114 450 (enzalu­tamide), and $79 334 (abiraterone acetate). Observed variations in medical costs between ARPIs may provide an early indicator of their ability to manage PC.

Medications in the US are approved because of safety and efficacy, not price. Often, new biologic therapies are exceedingly expensive. The object of this study was to determine potential prices if an indication-specific pricing existed for bevacizumab in cervical and colon cancer using a willingness-to-pay (WTP) threshold of $100 000 per quality adjusted life-year (QALY). Data from two phase 3 studies were examined with pharmacoeconomic techniques, specifical­ly Markov analysis, Monte Carlo simulation, and deterministic sensitivity analy­sis. The per-cycle cost of bevacizumab for use in a patient with advanced cer­vical or advanced colon cancer is currently $11 637 for a patient who weighs 100 kg ($77.58/10 mg, Medicare average sales price plus 6%). If a WTP of $100 000/QALY is the target, the cost would be increased to $79.92/10 mg for cervical cancer and $61.60/10 mg for colon cancer. This would be a 3% increase in cost per dose for a cervical cancer indication and a 20.6% decrease in cost per dose for the indication of advanced colon cancer. Indication-specific pricing would change prices for bevacizumab when used for cervical cancer and colon cancer depending on the WTP target.

The importance of rapid access to high-quality health care is a well-established principle in the fields of trauma, neurology, and cardiovascular med­icine. Given what we now understand about the frequency of cancer treatment delay and its ability to significantly diminish cancer survival, there is a strong ra­tionale for expanding the “golden hour” metaphor to include cancer care, with the goal of developing diagnosis-specific policies, procedures, benchmarks, regula­tions, and enforcement mechanisms that promote timely initiation of cancer care. As we have seen in trauma and other specialties, clinical pathways are a perfect medium for not only facilitating evidence-based cancer care but also setting re­quired, short-term, interval, time-driven goals that must first be met to achieve overall time to treatment initiation goals. Implementation of “golden hour”–fo­cused clinical pathways can be facilitated by digital health care management so­lutions that expand value-based health care by simultaneously improving health care quality (eg, fewer deaths, less morbidity, and more guideline-compliant care); lowering direct and indirect health care costs; reducing patient financial toxicity; and achieving greater patient, provider, and payer satisfaction.

This study investigates the challenges leading to a substantial de­cline in participation among academic oncology practices within the Enhancing Oncology Model (EOM), introduced as a successor to the Oncology Care Mod­el (OCM) by the CMS Innovation Center. Analyzing the withdrawal of 14 practic­es from the EOM, previously part of the OCM Collaborative, three primary factors are identified: immediate downside risk in a context of narrow provider margins, inadequate risk adjustment failing to appropriately account for drug costs, and onerous reporting burdens for extensive clinical data. Under the EOM, immedi­ate downside risk for seven specified cancers diverged significantly from the OCM’s upside-only risk structure, posing financial challenges for practices. Inad­equate risk adjustment, particularly the omission of crucial clinical data, raised concerns about the model’s focus on drug costs without considering essen­tial patient-specific variables. The study also highlights the burden of reporting requirements, exacerbated by reduced enhanced services payments, impacting practices financially. To address these challenges and encourage EOM participa­tion, policy options are proposed. These include reconsidering financial risk lev­els, refining target price methodology to incorporate clinical data, and reducing reporting burdens by aligning data requirements with EOM financial and quality methodologies. These adjustments aim to strengthen the EOM, fostering more accurate performance measurement and incentivizing high-quality patient care delivery in oncology practices.

Questions remain about the cost of homologous recombination de­ficiency (HRD) testing to guide the prescribing of poly (ADP-ribose) polymerase (PARP) inhibitors as first-line maintenance for advanced ovarian cancer (AOC). This model evaluates the cost of an HRD biomarker-guided (BMG) approach (olaparib for BRCA-mutated; olaparib and bevacizumab for HRD-positive BRCA wildtype; bevacizumab for HRD-negative) vs a non-BMG approach (niraparib for all patients) for 100 patients with newly diagnosed AOC. The model uses a Mar­kov structure with a US payer perspective and assumes comparisons between therapies based on extrapolated clinical trial results, real-world evidence, and published costs. Despite the upfront cost of HRD testing, a BMG approach is pro­jected to reduce total cost of care by $10 521 642 over 5 years ($51 633 928 vs $62 144 570) and increase progression-free survival in the AOC population (1699 vs 1523 months). This produces $26 in savings for every dollar spent on testing. These data suggest using a BMG approach based on HRD test results to pre­scribe first-line AOC maintenance therapy may reduce overall cost of care and improve clinical and economic outcomes.

Improving timeliness represents a critical opportunity to maximize patient experience, quality of care, and overall health of a co-located multidis­ciplinary cancer (MDC) program. The primary objective was to develop a timeli­ness dashboard using a primary nursing care coordination model to track met­rics selected for care efficiency. The secondary objective was to identify whether timeliness improved with implementation of an MDC clinic with expanded visi­bility to care coordination. A nursing care coordination model was developed to perform data collection alongside frontline patient care to track patients’ jour­ney with cancer. A spreadsheet was first used but then transitioned to a web-based database based on nursing feedback. Timeliness metrics were collected from May 2019 through April 2023 with descriptive analysis performed to iden­tify trends. Results signify implementation of a co-located MDC with primary nursing care coordination has improved timeliness. The project showcases the importance of nursing care coordination in a high-volume clinic with increased visibility to patients’ journeys with cancer. It also demonstrates establishing and updating standardized work procedures for data collection, cleaning, and analy­sis for quality of care monitoring.

Use of artificial intelligence (AI) in health care quality measurement can enhance the precision and efficiency of performance assessment. However, the use of AI in measurement also raises concerns about biases that could perpetuate disparities and affect vulnerable individuals. There have been recent national discussions that emphasize the need for ethical, transparent, and equi­table AI applications in health care quality measurement, such as the US Centers for Medicare & Medicaid Services’ (CMS) information session titled “AI in Quality Measurement” and the Biden-Harris Administration’s Executive Order on AI. Addressing bias is crucial to ensuring that AI tools do not exacerbate existing inequalities, but instead contribute to fair quality assessment and high-quality outcomes. This article explores the use of AI in health care quality measurement and tactics to mitigate bias in AI-enhanced measurement.

As value-based oncology care gains traction, health practices and providers on the frontlines of care delivery increasingly rely on technological so­lutions that enable and support favorable performance across a dynamic array of alternative payment models. Successful participation requires a values-based transformation, a key component of which includes practice alignment with ev­idence-based pathways, which prioritizes the highest-quality treatment options over lower-value, clinically equivalent regimens. In this retrospective, observa­tional, real-world study of treatment selection patterns across American On­cology Network medical oncologists, we analyze pathway adherence rates be­fore and after a pilot project where Evolent level 1 pathways were integrated into Flatiron Assist, an electronic health record-embedded clinical decision sup­port tool in OncoEMR. Results suggest that integrating evidence-based path­ways into ordering workflows may improve adherence by providing clinicians with just-in-time clinical and financial insights for optimal treatment decisions.