Treatment Navigation in Breast Cancer Management: Process Cost Analysis Based on German Case Studies.

Introduction
The high incidence of breast cancer, in combination with a growing shortage of healthcare professionals, presents considerable challenges for the German healthcare system [1]. Furthermore, the adoption of innovative therapies, particularly oral tumor treatments, is gaining prominence, leading to a significant shift of oncological care into the outpatient sector [2]. Consequently, this development leads to a growing patient load in the outpatient sector, further intensifying existing capacity constraints [3].
In the outpatient sector, limited time and personnel resources can hinder effective communication and coordination of care. The anticipated rise in patient volume necessitates a forward-looking adaptation of existing care structures [3].
A promising approach to improve these processes is the delegation1 of specific medical tasks to qualified nonphysician healthcare professionals, including medical assistants, nonphysician with advanced training, physician assistants, and advanced practice nurses, hereinafter referred to as “treatment navigators.” Their responsibilities encompass patient coordination, therapy monitoring, and administrative support, ultimately relieving the workload of physician and nursing staff while improving treatment quality and patient satisfaction [4]. The implementation of treatment navigators thus offers an opportunity to optimize care processes, reduce waiting times, and allocate resources more effectively.
The objective of this study was to assess the economic effects and efficiency gains associated with the use of treatment navigators in breast cancer care, with a specific focus on how delegation options are currently or could potentially be implemented in outpatient practice settings. By contextualizing economic and process-related impacts within real-world scenarios, the study aimed to generate nuanced evidence on the actual and potential benefits of Treatment Navigators as a care model in outpatient oncology.

Methods
The present analysis followed the methodology for assessing resource use and efficiency of the Institute for Quality and Efficiency in Health Care (IQWiG). A three-step approach was applied: (1) identification, (2) quantification, and (3) evaluation of relevant resources in the context of task delegation in the outpatient care for breast cancer patients [5].

Identification
In the first step, all relevant medical services typically provided as part of the outpatient care of patients with breast cancer were systematically identified. This was based on the following resources:I.The agreement regarding the delegation of medical services to nonphysician staff in outpatient statutory healthcare, in accordance with § 28 paragraph 1 sentence 3 SGB V [6].

II.The disease management program (DMP) for breast cancer, using the example of the Association of Statutory Health Insurance Physicians of North Rhine [7].

III.The S3 guideline for the early detection, diagnosis, treatment, and follow-up of breast cancer [8].

IV.The catalog of the Uniform Evaluation Standard (EBM) [9].

The aim was to capture typical services along the patient journey of individuals with breast cancer that are both embedded in standard care and potentially suitable for delegation to qualified nonphysician healthcare professionals (“treatment navigators”).

Quantification
To quantify the individual services, remote structured interviews were conducted with purposively selected office-based specialists in hematology and oncology as well as gynecologists specializing in gynecologic oncology.

a) Duration
For each service, the required time for the physician, if the task was not delegated (0% delegation), was recorded. In cases where a time range was indicated, both the minimum and maximum values were considered to estimate the potential time savings.

b) Reported Delegate Rate
For each service, the percentage to which the task is considered delegable was documented. The interviews focused on the assessment of the delegation potential, representing a best case scenario for an average patient.
Interview partners were asked for additional services that they considered delegable but were not included in the survey yet. Potential additions were included in the survey of the next interview partner. Data collection was conducted on a case-based level to reflect practical differences in care processes and interprofessional task distribution.

Evaluation
In the third step, an economic evaluation of the potential effects of delegation on resource use was performed. For this purpose, imputed personnel costs were calculated for both medical and nonmedical professional staff (i.e., treatment navigators).
To estimate physician wages, the currently valid annual gross salary of EUR 117,060 was assumed, based on a 51-h workweek and 229 working days per year (including 20 vacation days and 12 additional days off). This corresponds to an annual working time of 140,148 min. Assuming a productivity rate of 87.5% (i.e., excluding general tasks such as practice management), the imputed wage per productive minute is [10, 11]:
For treatment navigators, the currently applicable collective wage agreement for medical assistants was used [12]. The calculation was based on salary level 3 (years of experience 9–12) of activity group IV with an annual salary of EUR 41,174.40. Assuming a 40-h workweek and 219 working days (including 30 vacation days and 12 additional days off), this corresponds to 105,120 min per year. Assuming the same productivity rate (87.5%) [10], the result is:
To assess the potential time and cost savings resulting from the delegation of medical services to nonphysician personnel, a scenario-based comparison was conducted. Two scenarios were considered: full-service provision by physicians (scenario without delegation) and the scenario with delegation to treatment navigators (shown in Fig. 1). The calculation was based on the total duration of each service without delegation (scenario 1), as reported during expert interviews. This duration was proportionally allocated to physician and treatment navigators according to the reported degree of delegation. The respective time shares were then multiplied by the imputed wage rates to determine the total costs of service provision under the delegation scenario (scenario 2).
The monetary savings potential per individual service was derived from the difference between the costs of physician-only provision (scenario 1) and those of the partially delegated provision (scenario 2). In addition, physician time savings were calculated based on the share of tasks that could be delegated. For each defined service group, time and cost savings were cumulatively aggregated to provide a differentiated overview of the overall economic benefit associated with delegation.

Results

Identification
As part of the literature review, 11 service categories were identified. These include medical history, patient counseling and education, diagnostic procedures, monitoring, pharmacological therapy, supportive measures, administrative tasks, DMP enrollment, DMP consultations, tumor board coordination, and other delegable services. In total, the 11 service categories comprise 40 individual service descriptions (see Table 1). Four of the services were identified during the interviews and assigned to the category “other delegable services.”

Quantification
Four experts were recruited for interviews, including office-based specialists in hematology, oncology, and gynecology with a focus on gynecologic oncology. The characteristics of the interviewees and their practices are summarized in Table 2. The practices varied considerably in size, staffing structures, and patient volumes, reflecting a heterogeneous setting. The identified services and the results of the four expert interviews are summarized in Table 1.a.The reported durations of physician involvement varied significantly between cases. Particularly large ranges were reported for outpatient care 4 h (4–30 min), outpatient care 6 h (6–45 min), and final counseling and explanation (15–60 min). In contrast, reported durations were more consistent for the overarching service categories administration of pharmacological therapies and for the enrollment and consultations for the DMPs, such as enrollment and structured consultations.

b.Regarding delegation, a high level of consistency was observed for certain diagnostic tasks. All interviewees reported a full delegation (100%) of the performance of an electrocardiogram and laboratory diagnostics. Similarly, the administration of medications (e.g., intravenous, subcutaneous, or oral premedication) was consistently considered fully delegable. Reported delegation rated for standardized communication and the explanation of informational material ranged from 75% to 100%. In contrast, delegation rates were highly heterogeneous for other tasks. For example, monitoring over several hours was assessed very differently across cases (delegation range: 0–100%). Likewise, substantial variation was found for services such as detailed medical history (0–90%), final counseling and explanation of therapy options, side effects and follow-up (0–75%), DMP consultations (0–87%), and preparation of individual physician letters and medical reports (0–87%).

Evaluation

Table 3 presents the cumulative savings potential across service categories as observed in the different case examples. The highest savings potential was identified in the categories patient counseling and education (2.5 EUR [min], 22.5 EUR [max] or 5 min [min], 45 min [max]), monitoring (0.5 EUR [min], 51.75 EUR [max] or 1 min [min], 95.5 min [max]), supportive measures (3.13 EUR [min], 39 EUR [max] or 6.25 min [min], 78 min [max]), and DMP consultations (4.95 EUR [min], 46.82 EUR [max] or 9.9 min [min], 93.6 min [max]). These categories also exhibit the greatest variation in savings potential between the individual case studies, indicating substantial heterogeneity in delegation practices and perceived efficiency gains across settings. All results of the qualitative survey and the detailed calculations of the potential time and cost savings are provided in supplementary Table 1 (for all online suppl. material, see https://doi.org/10.1159/000548889).

Discussion
To our knowledge, this is the first process analysis to provide insight into the assessment of delegable services and the associated potential for time and cost savings in Germany. The present findings highlight substantial heterogeneity but also considerable potential (particularly in the following categories: patient counseling and education, monitoring, supportive measures, and DMP consultations) regarding the delegation of medical tasks across outpatient gynecological and medical oncology settings. These differences reflect the structural diversity of practices in the German healthcare system, particularly with respect to practice size, organizational form, and the availability of qualified nonphysician personnel [13].
An additional qualitative insight from the interviews was that the extent of delegation is strongly influenced by internal practice structures and the level of training of nonphysician staff. Interviewees suggested that, in practices with clearly defined responsibilities and access to treatment navigators possessing advanced qualifications, a higher degree of task delegation would be feasible. This could contribute to a more efficient allocation of clinical resources.
At the same time, it becomes clear that there is no uniform understanding among healthcare providers regarding which medical tasks can be delegated and which must remain the responsibility of the physician. Although national professional bodies – such as the German Medical Association (Bundesärztekammer [BÄK]) and the National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung [KBV]) – have published a guidance document outlining the possibilities and boundaries of task delegation, delegation practices remain inconsistent. This includes, for example, the option to delegate preparatory tasks for medical history taking and informed consent, as long as the physician remains responsible, reviews and completes the conversation afterward [6, 14].
Legally, medical services may also be billed by physicians through the German Uniform Evaluation Standard even if they are performed by nonphysician staff under specialist supervision (§§ 28 (1) sentence 2 and 15 (1) sentence 2 SGB V2; § 15 (1) sentence 5 BMV-Ä3). This regulation creates a financial incentive to delegate eligible services in a structured way to qualified staff without compromising the economic viability of medical practice [15]. In an outpatient practice participating in the oncology agreement, the ambulatory specialized care and the DMP for breast cancer, reimbursable revenues range from approximately EUR 230 to EUR 970 per patient per quarter, depending on the federal state and the specific patient case [7, 16–18]. The structured delegation of tasks enables an efficient response to the increasing patient volume associated with innovative adjuvant therapy options [3]. By reducing the time burden on physicians in times of personnel shortages, the approach facilitates a more efficient allocation of available resources, thereby enabling the treatment of a greater number of patients within existing structural constraints.
Our findings are in line with available evidence demonstrating that, in communication-intensive areas such as gynecological and medical oncology counseling, task delegation holds particularly strong potential. Previous studies have shown that structured delegation – e.g., to treatment navigators or specialized nursing staff – not only alleviates physician workload but also results in significant cost savings and improved patient-centered care. This includes higher therapy adherence, better clinical outcomes, and increased patient satisfaction [4, 19–21].
The PACOCT study provides a notable example: delegating routine consultations in oral cancer therapy to structured nursing appointments enabled physicians to treat up to 40% more patients in the same amount of time while simultaneously improving adherence and reducing side effects [20]. Moreover, the systematic review by Chen et al. [22] provides an international perspective on the impact of patient navigation in oncology. The review of 59 studies highlights the important contribution of patient navigation, showing consistent benefits such as improved access to care, shorter time to treatment initiation (reported in 70% of 23 studies), better treatment adherence (71% of 17 studies), higher patient satisfaction (87% of 15 studies), and enhanced quality-of-care indicators (81% of 11 studies). These findings underscore the importance of systematically training nonphysician personnel and integrating their roles more firmly into routine care – particularly for counseling-related tasks. The scope of delegable tasks depends, among other factors, on the qualifications and level of training of treatment navigators. With higher qualifications and advanced competencies, they may also assume selected counseling responsibilities in addition to routine and standardized activities [23]. According to the current requirements of the German Medical Association (Bundesärztekammer), however, the delegation of counseling and monitoring must always be assessed individually, taking into account patient needs, staff qualifications, and the care environment. Physicians retain overall responsibility for supervision and documentation, while complex or high-risk tasks must be performed personally [24].
Oral tumor therapies, which now account for more than 25% of antiproliferative treatments, are gaining increasing importance. This development is leading to a growing number of patients being treated in outpatient settings who require close monitoring to ensure therapy adherence and manage potential side effects. Delegation represents a significant opportunity for time and cost savings, enabling continuous patient support without overburdening physicians [21].

Limitations
The present findings are based on a limited number of interviewees recruited through purposive sampling and therefore do not allow for generalizable conclusions in the sense of a representative cohort. Rather, they serve to illustrate different care realities and delegation practices in selected gynecological and oncological outpatient settings.
In addition, many of the findings are based on subjective estimates provided by interview participants, which may be prone to estimation bias. These subjective assessments reflect a best case scenario for an average patient and may vary depending on the interviewees’ individual experience. Interviewees who have already had positive experiences with delegating tasks to treatment navigators tend to perceive a higher potential for successful delegation. Consequently, average values and qualitative statements must be interpreted with appropriate caution.
Furthermore, the study does not capture the full spectrum of outpatient care in Germany. Regional differences, varying practice models, and specific structural conditions could only be considered selectively. Further research with a broader empirical base is needed to systematically validate these findings and enable generalization to larger populations. Finally, it is important to acknowledge that differences in remuneration and scope of responsibilities exist between the respective professional roles. Physician assistants, for example, are typically granted a broader mandate to perform medical duties than an oncology nurse [25, 26].
This study provides an initial basis for discussion and serves as a starting point for further research. Future research could, for instance, investigate (1) how delegation is actually implemented in practice, (2) how the different qualifications of treatment navigators influence their role in delegation, and (3) the drivers and barriers of delegation, employing approaches such as group concept mapping to systematically capture and organize physicians’ perspectives [27].

Conclusion
In summary, the targeted delegation of medical services – within established legal and quality frameworks – not only has the potential to increase efficiency but also offers substantial added value for patients. However, realizing this potential requires a strategic reorganization of practice structures and sustained investment in the training and professionalization of nonphysician staff.

Acknowledgments
Artificial intelligence-based writing assistance was used to support the formulation and structuring of this text.

Statement of Ethics
Ethical approval is not required for this study in accordance with local or national guidelines. Patient consent was not required for this study in accordance with local or national guidelines.

Conflict of Interest Statement
Jasmin Nachtigall, Ann-Cathrine Froitzheim, Melina Sophie Kurte, and Florian Kron are the employees of VITIS Healthcare Group. Robert Dengler has received consultancy fees and honoraria from Bristol Myers Squibb GmbH & Co. KGaA, Stemline Therapeutics B.V, Novartis Pharma GmbH, Takeda Pharm, GmbH & Co. KG, Omnicare Pharma GmbH. Manfred Welslau has received consultancy fees and honoraria from Amgen GmbH, Bristol Myers Squibb GmbH & Co. KGaA, Celgene GmbH, Gilead Sciences GmbH, Hexal AG, Janssen-Cilag GmbH, Eli Lilly and Company GmbH, medac GmbH, Novartis Pharma GmbH, Roche Pharma AG, Sanofi-Aventis Deutschland GmbH. Steffi Busch has received lecture fees, study support, and support for congress participation from Amgen GmbH, Roche Pharma AG, Novartis Pharma GmbH, Pfizer Pharma GmbH, Esteve Pharmaceuticals GmbH, Lilly Deutschland GmbH, GlaxoSmithKline GmbH & Co. KG, Gilead Sciences GmbH, AstraZeneca GmbH, MSD Sharp & Dohme GmbH, Celltrion Healthcare Deutschland GmbH, Exact Sciences Deutschland GmbH, Stemline Therapeutics B.V. Heidi Schumacher has no conflicts of interest to declare.

Funding Sources
VITIS Healthcare Group has a funding agreement with Novartis Pharma GmbH. The funder of the study had no role in study design, data collection, data analysis, or data interpretation. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Author Contributions
All authors fulfill the ICMJE criteria for authorship and contributed substantially to the work. Jasmin Nachtigall: conceptualization, methodology, investigation, formal analysis, writing – original draft, and project administration. Ann-Cathrine Froitzheim and Melina Sophie Kurte: conceptualization, investigation, writing – review and editing, and project administration. Robert Dengler, Manfred Welslau, Steffi Busch, and Heidi Schumacher: writing – review and editing. Florian Kron: supervision, project administration, and funding acquisition.