Abstract: How does the health system simultaneously manage cost, maintain quality care, and determine the value of cancer treatment for patients, their health care providers, and payers? This question was a driving factor for the development of clinical pathways. The adoption of clinical pathways is helping to standardize the cancer care process, with adherence to established protocols impacting efficacy, safety, and overall cost of care. The author’s strategic health care consulting firm has been tracking and assessing pathways since 2011 through secondary market research as well as quantitative surveys and in-depth qualitative interviews with payers, oncology providers, and pathway vendors to capture the evolving clinical pathways market and identify major trends. The findings demonstrate that clinical pathways have undergone significant evolution over the past 5 years. In this article, the author provides a snapshot of the current landscape and insights into where pathways may be heading.
Citation: Journal of Clinical Pathways. 2017;3(2):33-40.
Received January 10, 2017; accepted February 14, 2017
In 2015, for all payer types, the total per member per year specialty oncology drug spend continued to climb (Figure 1).1-4 This upward trend was driven by substantial increases in utilization and unit costs. With continuing Food and Drug Administration approvals for targeted therapies, oncology medications continue to rank among the most expensive therapies. Spending growth may be tempered by the fact that many new drugs and biologicals are indicated for rare cancers rather than larger volume cancers. However, this may be countered by challenges with patient adherence—an estimated 38.4% of patients are nonadherent with oral oncology medication prescription instructions4—that contribute to cost concerns.
Forecasts through 2018 predict that the oncology drug class growth trend will continue to increase at an approximate rate of 20% annually. As more patients survive their initial course of cancer treatment, these patients will move to being treated under a chronic disease model, receiving either maintenance therapy or treatment for recurring disease, and utilization will increase. At the same time, payer management of oncology drugs is being shifted from the medical benefit to the pharmacy benefit with the rise of oral and self-administered oncology medications. This also increases utilization and cost on the pharmacy side.4 Current market dynamics also indicate that generics and biosimilars will not offset high prices for branded oncology drugs in the same way that they did in the small molecule drug environment.
Resources that rate various treatment options for a particular cancer based on accumulated clinical data, including clinical drug compendia and clinical practice guidelines such as the National Comprehensive Cancer Network’s NCCN Guidelines, are often used by health care providers and payers to support evidence-based clinical and reimbursement decisions, respectively. Much of this was driven by the significant variation in patient care, drawing attention to the need for evidence-based care. In 2013, eviti, Inc, estimated that 32% of oncology treatment plans deviated from evidence-based standards and were not medically justified.5 In 2010 and 2013, Dartmouth Atlas Reports6,7 showed that care received by patients with cancer varied depending on geographic area. The percentage of patients admitted to an intensive care unit during the last month of life has increased from 23.7% to 28.8%, and the percentage of patients for whom hospice was initiated during the last 3 days of life increased from 8.3% to 10.9%.7 Use of hospice care varied markedly across regions and hospitals, with less than 50% of patients with poor prognosis cancers receiving hospice services.
Clinical guidelines and drug compendia often evaluate treatment options based on their own merit but not in comparison to each other. These resources do not always handle subset populations or provide information on what to do in cases where preferred treatments are contraindicated. In cases where a health care provider does not have a set protocol for how to treat, the research to develop a treatment plan can be tedious. As a result, there is a need for more meaningful regimen selection for distinct patient treatment scenarios. This need has been a driving factor for the development of clinical pathways.
The adoption of clinical pathways is helping to standardize the cancer care process, with clinician adherence to established care protocols improving the efficacy, safety, and overall cost of care. Since 2011, DK Pierce & Associates (DKP) has been conducting research on the evolving management of oncology drugs and biologicals by eliciting information directly from the key stakeholders making decisions on cancer care. DKP has integrated qualitative interviews and online surveys with three main stakeholder populations—clinical pathway vendor organizations, health care providers, and payers—to obtain perspectives on the successes, as well as the gaps still existing, in the provision of high quality cancer care.Preliminary research for this article did not uncover any publications providing a comprehensive review of the clinical pathways market today. In 2012, DKP published an article in Oncology Issues to share top line insights on early research,8 and, in 2015, provided a benchmark of the oncology clinical pathway landscape to the American Society of Clinical Oncology (ASCO), informing their long-term strategy and position statement on clinical pathways.9 In this report, we provide a summary of changes in the clinical pathways market as well as trends and insight into their role in the future of cancer care.
DKP has conducted qualitative research with key stakeholders in the development and use of clinical pathways since 2011. This research methodology includes quarterly interviews and surveys with clinical pathway vendors, community and oncology practices of various sizes across the United States, and national and regional payers implementing clinical pathways in various books of business (eg, commercial, administrative services only, fully-funded, Medicare Advantage, Managed Medicaid, and exchanges).
Interviews and surveys include questions regarding three areas of interest:
Program operation. Questions address whether an internal or vendor program is used, the age of the program, the purpose of the program, and the design of the program (diseases, modalities, electronic medical record [EMR] integration).
Program development. Questions address the parties responsible for clinical content, the review process for the content, inclusion criteria (including cost), update frequency, references used, and processes for “off-pathway” reviews.
Program function. Questions address performance and/or compliance reports, incentives, incorporation into other value models, and how the program is leveraged with business partners.
Ongoing research has been done to capture pathway activity news reported in the public domain; to identify at least 10 new pathway activities (pending or active), or updates to existing pathway activities, each quarter; and to determine the potential covered lives impacted by clinical pathways. This report provides an analysis of our research to date (2011–2016).
From our research, we have documented 507 known active or pending cancer management models being used in the United States (Table 1). Of these, 255 programs are actively running; 222 of these include clinical pathways. Between 2011 to 2016, there were multiple ways in which health care providers encounter clinical pathway programs (Figure 2). Pathways developed internally by payers and providers have gained popularity, but the top five independent pathway vendors still control 61% of the active market share (Figure 3), with their pathways programs being sold “as is” or tailored to the needs of payer and provider customers.
Based on our payer research through 2016, an estimated 56.5% of covered lives10 are potentially impacted by payer clinical pathway programs, through commercial, Medicare Advantage Prescription Drug Contracting, and managed Medicaid books of business.11 (This estimate is not specific to enrolled members or patients with a diagnosis of cancer.) This estimate of payer covered lives impacted by clinical pathways is based on data from payers and their books of business, where we have found clinical pathways utilized, as well as associated enrollment data.
Clinical pathway programs generally follow similar criteria to one another for determining preferred treatment regimens, ranking these regimens first by efficacy, then safety, and then cost, and taking into account other factors such as comparative effectiveness, manufacturer patient assistance program support, and logistics/paperwork for pathway acceptance. These include extra documentation requirements, such as prior authorization forms, separate clinical pathway portals, and the manuel entry of information not linked to electronic health records.
Despite the general trend of decision-making being based on these same criteria, there continues to be variance between providers in preferred regimens. Pathway vendors have reported that cost is applied differently (eg, based on average sales price or based on Medicare allowable price), and the way in which efficacy is assessed may vary. Vendors use different clinical resources for determining the most efficacious and safe regimens for preference, and vendors have access to different literature libraries, clinical trial databases, clinical guidelines, and clinical drug compendia ratings thresholds. Additionally, their processes for reviewing and updating drug regimens may vary. As a result, consistency in payer coverage and provider treatment decision-making continues to elude stakeholders.
Internal Pathways Programs
Clinical pathways developed by a payer or provider (“internal”) have grown in popularity (Figure 4), as many opt to develop their own pathways programs rather than subscribing to a pathway vendor’s program. A primary goal of internal clinical pathways development is to build on existing processes or resources for selecting appropriate cancer care (eg, clinical guidelines, compendia, and literature), while minimizing the costs associated with implementing a pathways program. As of early Q4 2016, internally developed clinical pathway programs have grown in number compared with the previous 3 years, while the number of pathway vendor-partnered programs has overall remained constant (Figure 5). DKP is monitoring pending provider–pathway vendor and payer–pathway vendor collaborations that may increase these numbers, should those programs become active in 2017.
Clinical Pathway Vendors
When it comes to clinical pathways, pathway vendors still play a significant role. In recent conversations with vendors, DKP learned that vendor offerings are developed in such a way as to allow tailoring by the user, afford integration with EMRs, provide technology to reduce duplicative work, and generate performance reports.
Evolution over the past few years has seen pathway vendors who primarily focused on payers as a customer base now working to improve the relationship with providers, either through feedback loops during the use of clinical pathways or indirectly through provider risk-bearing groups (eg, independent practice associations [IPAs]).
VIA Oncology, LLC, reports that their Via pathways are capable of providing pathway recommendations for over 95% of clinical patient presentations to identify the best treatment option based on a patient’s information. Via has also expanded into developing surgical, advance care planning, and symptom management pathways (prevent, triage, treat) for providers who are participating in oncology medical homes. Via is also moving from drug-specific to regimen-specific education materials. Continuing their waterfall test concept, in which regimens are first compared on the basis of efficacy followed by safety, Via Oncology reports that only in < 4% of cases is there a need to additionally compare regimens on the basis of cost.
The pathway company eviti, Inc, is contracting with AIM Specialty Health, which provides management of drugs and radiology for Blue Cross Blue Shield plans within and outside of Anthem, Inc. eviti, Inc, and eviti decision support are now associated with NantHealth, which combines the decision support of eviti with NantHealth’s technology platform. Pharmacy benefit managers such as Prime Therapeutics, OptumRx, and Express Scripts have also contracted with eviti to collaborate on oncology drug management, which is then marketed to medical plan clients. Eviti works with its payer customers to streamline the reimbursement approval process for drug regimens that align with the payer’s preferences. From the perspective of the network providers of payers using eviti, denial of reimbursement for selections that fall outside the payer’s preferences (ie, mandatory participation) is a concern. eviti’s medical library team determines the content, but the payer-customer ultimately decides the preferred regimens. eviti Advisor is the decision support tool for providers, accessed through eviti.com. eviti Advisor Enterprise aligns care across large provider networks and health systems, showing preferred treatment options at that higher level.
McKesson Specialty Health (MSH) has rolled out Clear Value PlusSM (CVP) technology to historical US Oncology (USO) users of iKnowMed and is also marketing this technology to practices outside of the USO network. Value Pathways powered by NCCN (Value Pathways) are included in the CVP platform. This is the first clinical pathways program with a transparent submission process, with instructions posted on their website for the submission of pharmacoeconomic data. MSH is also actively involved in the Center for Medicare & Medicaid Innovation (CMMI) Oncology Care Model (OCM) pilot, offering a CVP “tool kit” for practices that did not have a structured evidence-based decision process in place when the OCM started. MSH will market CVP as a “one-stop shop.” MSH is listening to their provider customers and has enhanced CVP to include options for providers to enter their own preferred pathway regimens, if not currently using CVP, as well as the preferences of the payers they encounter most often.
New Century Health (NCH) has modified its market focus over time, based on the increase in providers’ development and utilization of pathways. NCH is expanding support for risk-bearing groups, such as IPAs, medical services organizations, and groups needing help managing specialty care risk (eg, accountable care organizations [ACOs] and patient-centered medical homes [PCMHs]). NCH pathways will soon link to and pull information directly from select EMRs, and NCH also has a mobile app under development. NCH expanded their pathways to include supportive care and more cancers and is also piloting an effort to identify high-risk patients for early intervention.
EviCore was formed from a merger between MedSolutions International and CareCore, both of which were leaders in radiology management. EviCore is quickly entering the clinical pathways space with some large payer contracts, allowing health care providers flexibility in their treatment choices that follow NCCN guidelines. Although their primary target audience is payers, they are expanding toward serving providers as well, and they are sharing risk with their customers. Their approach integrates a peer-to-peer process to select appropriate patient care, and they are acquiring technologies to enhance their program offerings at the point of care.
Oncology Provider Collaborations With Clinical Pathway Vendors
Providers review clinical literature, clinical drug compendia, guideline recommendations, health technology assessments, and payer coverage policies when selecting patient treatment options. What these resources do not provide on their own is a method of tracking the consistency in assessment of clinical quality and the provision of cost-effective care.
For some health care providers, directly contracting with clinical pathway vendors is a beneficial way to obtain guidance on the most appropriate treatment options for patients and to document those decisions. DKP research has documented the location of 71 active provider–pathway vendor collaborations, including their vendor of choice (Figure 6). The biggest footprint on this map continues to be from US Oncology practices and those transitioning over to using Value Pathways powered by NCCN.
Our analysis of geographic penetration of provider–pathway vendor collaborations shows that the Central region continues to lag other regions in terms of their implementation of these programs (Figure 6).
Payer Collaborations With Clinical Pathway Vendors
Payers are continuing to engage in collaborations with clinical pathway vendors, with the biggest footprint still belonging to eviti. Figure 7 shows the geographical distribution of the 55 active payer–pathway vendor collaborations as of early Q4 2016.
A new finding, reported in 2016, is an acknowledgement from payers that clinical drug compendia (eg, NCCN Compendium, DrugDex) ratings are being used as criteria for determining adherence to pathway-preferred regimens. These ratings may differ from those ratings being used for drug coverage/reimbursement requirements; for example, NCCN Category 2A may be used for pathway adherence determination while NCCN Category 2B is used for coverage/reimbursement determination. Confirmation of whether or not this is indeed a trend has become an integral component of our ongoing research.
For most clinical pathways offered by payers, participation by network oncology providers remains voluntary. More specifically, participation in the clinical pathways program is not required for coverage/reimbursement of drugs and/or biologics, but participation is required in order for additional payer program incentives (eg, shared savings, patient management fee, removal of additional prior authorization steps) to be implemented.
Other Oncology Care Models
Overall, the trend shown in Figure 5 does not necessarily mean a stagnation in number of active pathway vendor–driven programs, but rather a shift to other oncology management models. Much of this has arisen from the move toward implementation of the CMMI OCM. As providers and payers prepared themselves for participation, many saw the opportunity to take an introspective assessment of their own historical experience in patient care (as in the case of providers) and the review of internal utilization (as in the case of payers).
We now document 59 other active cancer management models on record, some with a presence in multiple states (Figure 8). This includes episode-of-care pilot programs, oncology ACOs, oncology benefit management programs, and oncology PCMHs. All of these may include clinical pathways as a component; we were able to confirm that 26 do in fact include pathways. So far, DKP has heard that some (but not all) OCM participants are using or developing clinical pathways, but many are meeting the OCM requirements with their current evidence-based decision processes.
One limitation of our research has been the ability to identify every single pathway activity and to determine what qualifies as a clinical pathways program. Our goal is to capture a representative sample of payers and providers across the United States within each update.
Another key limitation is the challenge of documenting the number of lives potentially affected by pathways. On the payer side, we can calculate the potential number of lives impacted by payer-driven clinical pathways. However, enrollment data does not account for the number of members with a cancer diagnosis or the number of plans where an employer has opted out of clinical pathways, nor does it distinguish whether providers are always participating in a payer’s voluntary pathway program. Additionally, we have not been able to determine the number of patients impacted by provider-driven clinical pathways selected by community oncology practices and academic institutions. In recent conversations with ASCO, we have discussed our joint quest for sources of this information. With many variables still undefined (eg, number of plan enrollees with cancer, which plans have selected a clinical pathways option), the most accurate way to calculate the number of lives impacted by clinical pathways remain undetermined. DKP will continue to research other resources to calculate these figures more accurately.
The findings of our research suggest that the clinical pathways environment is continuously evolving. The trends that we have identified may change as pathway activities become more prevalent. This supports the need to continue our research. In 2017, our research on clinical pathways as well as other cancer care models will expand to capture new market dynamics and will attempt to answer important questions such as:
How participating OCM practices are managing the definition of evidence-based decisions for patient care, and how this is affecting design and utilization of EMRs;
What level of oncology provider burden exists for clinical pathway compliance, with the potential of multiple payer pathway programs as well as internally-developed pathways; and;
How ASCO’s intended clinical pathway certification process will guide and change the path of pathway development and utilization in the future.
As our research continues, we hope to document that incorporating clinical pathways into value-based models will shift care of patients to a more consistent, evidence-based, and cost-effective standard, particularly through effective reporting and the publications of results from clinical pathway programs.
1. Express Scripts. Drug Trend Report. https://lab.express-scripts.com/lab/drug-trend-report/previous-reports. Published October 2013. Accessed January 10, 2017.
2. The Express Scripts Lab. The 2013 Drug Trend Report. https://lab.express-scripts.com/lab/drug-trend-report/previous-reports. Published April 2014. Accessed January 10, 2017.
3. The Express Scripts Lab. The 2014 Drug Trend Report. https://lab.express-scripts.com/lab/drug-trend-report/previous-reports. Published March 2015. Accessed January 10, 2017.
4. The Express Scripts Lab. Express Scripts 2015 Drug Trend Report. https://lab.express-scripts.com/lab/drug-trend-report/previous-reports. Published March 2016. Accessed January 10, 2017.
5. Forastiere AA, Flood WA, Yedwab E, et al. The cost per patient of deviations from evidence-based standards of oncology care. J Clin Oncol. 2013;31(suppl):abstr 6515.
6. Goodman DC, Fisher ES, Chang C, et al. Quality of end-of life cancer care for Medicare beneficiaries: regional and hospital-specific analyses. The Dartmouth Institute for Health Policy & Clinical Practice. http://www.rwjf.org/content/dam/farm/reports/reports/2010/rwjf68851. Published November 16, 2010. Accessed January 10, 2017.
7. Goodman DC, Morden NE, Chang C, Fisher ES, Wennberg JE. Trends in cancer care near the end of life: a Dartmouth Atlas of Health Care brief. The Dartmouth Institute for Health Policy & Clinical Practice. dartmouthatlas.org/downloads/reports/Cancer_brief_090413.pdf. Published September 4, 2013. Accessed January 10, 2017.
8. Schroeder, A. Cancer management systems—are we headed down the right road? Results of qualitative research with payer, provider, and oncology pathways stakeholders. Oncology Issues. 2012(Sep/Oct):30-37.
9. Zon RT, Frame JN, Neuss MN, et al. American Society of Clinical Oncology policy statement on clinical pathways in oncology. J Oncol Pract. 2016;12(3):261-266.
10. DK Pierce & Associates, Inc. DKP Critical Insights®—Clinical Pathways and Other Cancer Management Models – Vendor, Provider, and Payer Perspectives, 2011-2016. Published January 4, 2017. Accessed January 10, 2017.
11. AISHealth. AIS’s Directory of Health Plans: 2016.