Contemplating the Future of Oncology Pathways

Gordon Kuntz is a health care consultant and strategic advisor with over 30 years’ experience in a multitude of health care settings, working with payers and providers, and in technology and strategy. He began his involvement with oncology care pathways in 2004 as a consultant with US Oncology as they were deploying Level 1 pathways. He subsequently led payer strategy with ION Solutions, a division of AmerisourceBergen, where he gained familiarity with many other pathways vendors, especially in the context of the oncology medical home model. As senior director of strategy for Via Oncology, he deepened his knowledge of the pathway development process, physician adoption, and how both impact cancer center strategies. Mr Kuntz now provides support in strategy and product design as well as assistance in navigating the cancer care ecosystem to established and emerging companies.

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Pathways have come a long way since 2004 when initial forays into pathway development were paper-based and offered limited guidance outside of breast, lung, and colorectal cancers. The tools available at that time lacked the subtlety and nuance that current pathways offer.

Development of additional disease coverage emerged rapidly, and automated tools emerged in 2007/2008. By about 2015/2016, some tools—such as Via Pathways, Moffitt Pathways, and McKesson’s Clear Value Plus tool—incorporated treatment recommendations for more than 90% of cancer by disease incidence. Payers began to recognize that pathways offered a measure of quality, which helped drive adoption and the growth of payer- and provider-initiated pathways.¹ US Oncology’s Innovent Oncology, the Michigan Medical Home Demonstration Project, and Aetna’s New Jersey pathways pilot all featured the use of evidence-based medicine as a condition for participation.^2-4

Over the years, pathways vendors have come and gone, or they have progressively evolved in accordance with technology and user feedback. Via Oncology (now Elsevier ClinicalPath), US Oncology’s Level 1 Pathways, eviti, and New Century Health have all survived in some form.^5,6 ION Solutions partnered with Novologix for a time, which was then sold to CVS, and has re-emerged as a prior authorization tool.⁷ In recent years, we have seen more consolidation and acquisition, which has injected much-needed resources into the segment.

With all of this change, what lies ahead? This column will consider a few angles: what we should not expect to happen anytime soon, what I expect to happen in the next couple years, and what my hope is for the future of oncology pathways.

Please note that all opinions, predictions, and prognostications are my own. In considering how pathway programs may evolve further in the years ahead, I have relied solely on my own experience with pathways over the past 15 years in what I see as deficits to be corrected or forces that may inhibit or promote future changes.

What Not to Expect

Before moving into an exploration of the direction I expect and hope pathways to take, it is important to take a moment to discuss what is not likely to happen. These future scenarios are unlikely to happen due to economic limitations and structural norms that are so ingrained as to be definitional in our current concept of “oncology pathways.”

It is unlikely that we will see a significant investment in broader disease coverage. Having reached the 95% threshold, most major pathways vendors have reached a point of diminishing returns. Developing and maintaining new disease pathways is a labor-intensive and expensive proposition. Many small-population diseases lack easily described standards of care and rely on clinical trials, so the utility of pathways is limited. Frankly, maintaining the pathways already developed is a very significant effort for anyone who regularly updates their pathways. 

Similarly, it is highly unlikely that we will see programs that reflect radically different models of pathway determination. The efficacy/toxicity/cost model, coupled with targeting pathways for 80% of patients, is so ingrained in the oncology psyche that it will be very difficult for a re-imagining of pathways to take hold. That said, there is room for adjustments to this model to better account for important considerations lacking in this historical approach.

Along the same lines, the industry has seen a few attempts to incorporate the concept of value into the pathways themselves. This is especially problematic when trying to define value in terms of clinical outcomes (eg, defining value as outcomes over cost). The United States would seem to lack the political will to negotiate an outcomes-based, independent definition of clinical value. For example, the 2010 debate about the Affordable Care Act (ACA) quickly devolved into charges that the ACA would cause there to be bureaucratic “death panels” to decide who would live and who would die.⁸ We see this trend in the debate about health care in the current election cycle as well, with some voices charging “socialism” when there is a policy proposal about expanding health care coverage to all Americans. Imagine the furor of suggesting that quality-adjusted life year should be a factor in determining treatment recommendations. 

What We Can Hope For

On the other end of the spectrum are the pathways features and characteristics that one might hope for but that are unlikely to be widely adopted in the next couple years for a variety of reasons. Some of these require large-scale technical reconfiguration; some require a re-imagining of how pathways are represented and delivered; others still require alignment of multiple differentiated or even competing interests, which will slow or stall their adoption. Some of these wish-list items exist in a commercial or institution-specific system but are not widely available. 

Features that would dramatically improve pathways but may provide difficult to widely implement in the short run include the following:

Greater Patient Representation. Truly patient-centered pathways would prompt clinicians to thoroughly consider patient priorities earlier in treatment discussions and reflect those preferences throughout the whole process. Inherent in the design of pathways today is an assumption—often correct, of course—that the goal of treatment is curative, if possible, palliative if not. Frequently, initial and comprehensive consideration is not given to the patient’s needs, wishes, and desires, although final treatment recommendations do often reflect the patient’s wishes. A more considerate, patient-centric approach would be to engage in a dialog with patients at the very beginning of the treatment journey to understand their goals of treatment and access limitations, prior to picking a treatment plan. If patients will have logistical or financial challenges in accessing care, the treatment recommendations must reflect these issues.^9,10 Pathways ideally would reflect not only the priorities of efficacy, toxicity, and cost, but also the patient’s desire for quality of life over quantity of days or the desire to be pain-free.

Patient-Facing Tools. Additionally, pathways companies could look for ways to incorporate patient-facing tools to aid in shared decision-making. At this point, pathways are not particularly accessible to patients and personal caregivers. Translating the clinical landscape of pathways today into content that is easier to understand for patients and deals with their issues would be very useful, albeit challenging.

Enhanced Ease of Use. Having been involved in numerous pathways implementations, most oncologists and other clinicians balk at the amount of entry required to use pathways. Short of telepathic pathways that would intuit what the oncologist wanted before they had a conscious thought (which seems the desire of some doctors), there are some things that could be done much more effectively:

Improved electronic medical record (EMR) integration: the advent of Fast Healthcare Interoperability Resource and similar interface technologies will help open up the historically closed EMR systems, reducing duplicate entry.¹¹ This long-anticipated technology appears poised to emerge as reality in the next year or two but still requires significant investments and collaboration to  see widespread adoption.

More responsive interfaces: pathways interfaces need to more closely reflect how clinicians work and integrate more effectively into an optimized workflow. For example, speech-based input could be very useful in speeding entry, but questions of accuracy will follow that technology for some time. Tablet-based input could free the clinician from a workstation to communicate with a patient more easily. This would be particularly effective for list-based selection and other nontext entry.

Better Reflection of How Pathways Are Actually Used. Clinicians in different setting use pathways for different reasons. Using a question-and-answer approach with recommendations at the conclusion of the process makes sense for training and for those interested in clinical decision support, especially where the oncologist may be less familiar with a particular tumor type. However, academic oncologists, for example, may not need clinical decision support; they are primarily concerned with the ability to report their treatment selections to demonstrate quality. For users like these who are very familiar with the current literature, a “guardrail” approach may be more effective. This approach relies heavily on EMR integration or an assistant entering relevant data. Once the oncologist selects a treatment plan, the system would offer guidance as to whether the selected treatment was fully in compliance with treatment recommendations. Decision-support tools from Flatiron Health now support these two different approaches.

Head-to-Head Drug Trials for Greater Clarity in Treatment Recommendations. Many outside observers think that pathway development is an exact science, simply weighting easily quantified factors to determine the best treatment for a given patient. Instead, it is a matter of weighing and debating the relative merits of heterogenous trials with endpoints that may defy direct comparison. Head-to-head drug trials would help to resolve these difficulties but are unlikely to happen due to lack of sponsorship for these types of trials. Post-market surveillance, developed with real-world data from pathways users, may help provide these types of comparative studies.

Expanded Definition of Cost. Currently, many pathways are concerned with the drug acquisition cost, but do not take into account the cost of administration, supportive drugs, or the financial cost of side effects and their management. Cost for side effects are inferred in the toxicity consideration given to drugs evaluated for inclusion on pathways, but the economic intensity is not directly considered. Additionally, given the serious and growing cost of cancer to patients, cost models should consider the financial impact to patients. Ideally, the patient’s financial burden would be calculated to include cost-sharing based on plan design as well as likely impact to earnings based on lost work, transportation costs, etc.⁹

Adjustment for Value. In certain circumstances, pathways could adjust for value. Cynical as it may seem, the current reality of a patient’s experience with payers and health plans may be tainted by cost considerations in multiple ways. Cost is an omnipresent issue, especially with the increased cost of drugs at launch, annual increases for existing therapies, and combination therapies that add to the already high cost. The reality is that very high-cost therapies will be out of reach for some patients. At minimum, pathways should always offer alternate recommendations based on financial considerations whenever possible, and clinicians should discuss these options with patients. One additional consideration on this topic is that recent research is calling into question the incremental clinical value of recent therapies in light of the additional cost.^12,13 As discussed above, this will require a broader debate, but one can hope that we eventually resolve that debate, so that the treatments can balance the values of society with our ability to pay.

Better Payer Support. As much as I would like to see this discussion presented in the “What to Expect” section, I am concerned that it does rightly belong in the “What We Can Hope For” section. The specific elements of payer support would ideally include a recognition that the use of provider-initiated pathways is an indicator that users are trying to provide quality medicine. Payers could put in place polices that respect the oncologist’s time and cost structures related to the use of pathways.

Difficult as it is from a technology and operational standpoint, payers would ideally find a way to waive, avoid, or minimize pre-certification requirements for on-pathway decisions and for off-pathway decisions that are validated in the practice. If that were not possible or if additional review is required, payers would be well-served to develop a standard request/review methodology and submission packet, that could be supported by pathways companies. This would help alleviate a significant administrative burden on both practices and payers. Additionally, payers could recognize the clinician time required to use pathways for all patients and could create a reasonable, consistent reimbursement methodology for related costs. 

What To Expect

Setting aside the paths we are unlikely to take, what are the changes most likely to occur in pathways programs? In the next few years, I expect modest but important incremental changes in the capabilities of pathways, to include the following elements.

Supportive Care and Nurse Triage. Some pathways systems offer triage options, but few integrate the full continuum of care, focusing instead primarily on therapeutic treatment selection. Integrating these capabilities will help practices provide the best integrated care for patients, especially those with oral or self-injected therapies.

Workup. Genomics has expended so rapidly that some payers and providers struggle to know which tests are most efficient and warranted for which patients. Incorporating workup pathways that include imaging studies and genomic testing would benefit clinicians and help assuure appropriate payer reimbursement.

Gene-Specific Therapies. Therapies with gene-specific indication have, to date, been handled within the existing body system orientation that pathways have had since the beginning. The occurrence of the same gene being expressed in multiple tumor types is treated, more or less, as coincidence, and the therapy is simply listed in the appropriate body systems. As the use of these types of therapies proliferate, however, pathways will need to evolve from soley a body-system orientation to include gene-oriented approaches in the data collection and underlying logic. 

Conclusion

Pathways remain a valuable contribution to the appropriate selection of treatment and support plans for cancer patients. As the pace of change in drug introductions, new drug indications, and other research continues to accelerate, pathways may struggle to keep up and will likely need to evolve further than anticipated here.

Over the past 15 years, pathways have changed dramatically to include more technology support, more specific and nuanced recommendations, and have become easier to use. That said, however, there is much work still to be done. In the next few years, I expect modest but important incremental changes in the capabilities of pathways but hope for much more. The challenge for pathways developers and users is to make these tools even more sensitive and responsive to the needs of all stakeholders, including patients, clinicians, payers, and practices.  

References

1. Reh G, Morris M, Shah S, Naaz. The evolution of oncology payment models: what can we learn from early experiments? https://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc-evolution-of-oncology-payment-models.pdf. London, England, UK: Deloitte Development LLC; 2016. Accessed October 9, 2019.

2. Association of Northern California Oncologists (ANCO). Realizing Pay for Performance: Moving from Fee for Service to Value Based Reimbursement. ANCO website. https://www.anco-online.org/P3Innovent.html. Published October 26, 2010. Accessed October 9, 2019.

3. Kuntz G, Tozer J, Snegosky J, Fox J, Neumann K. Michigan Oncology Medical Home Demonstration Project: first-year results. J Oncol Pract. 2014;10(2):104. doi:10.1200/JOP.2013.001109

4. Reinke T. Insurers expand usefulness of oncology pathways efforts. Managed Care. February 28, 2013. https://www.managedcaremag.com/archives/2013/2/insurers-expand-usefulness-oncology-pathway-efforts. Accessed October 9, 2019.

5. Schroeder A. Clinical pathways: a current snapshot, and the journey ahead. J Clin Pathways. 2017;3(2):33-40.

6. The US Oncology Network and Value Pathways in the evolving landscape of cancer care [interview]. J Clin Pathways. 2019;5(7):8-12. 

7. Singh S. Enabling better oncology treatment decisions [brief]. CVS Health Payor Solutions website. https://payorsolutions.cvshealth.com/insights/enabling-better-oncology-treatment-decisions. Published October 24, 2018. Accessed October 15, 2019.

8. Pear R. Obama returns to end-of-life plan that caused stir. The New York Times. December 25, 2010. https://www.nytimes.com/2010/12/26/us/politics/26death.html.
Accessed October 9, 2019.

9. Balch A. How pathways can support reimbursement for personalized decision making and care planning. J Clin Pathways. 2019;5(2):20-22. doi:10.25270/jcp.2019.03.00065

10. Williams M, Kirch R, Balch A. Can we talk? Discussing what matters with the people who matter. J Clin Pathways. 2019;5(6):24-26. doi:10.25270/jcp.2019.06.00080

11. Bresnick J. 4 basics to know about the role of FHIR in interoperability. HealthITAnalytics.com. March 22, 2016. https://healthitanalytics.com/news/4-basics-to-know-about-the-role-of-fhir-in-interoperability. Accessed October 9, 2019.

12. Kaufman HL, Atkins MB, Subedi P, et al. The promise of Immuno-oncology: implications for defining the value of cancer treatment. J Immunother Cancer. 2019;7:129.  doi:10.1186/s40425-019-0594-0

13. New studies question whether novel anti-cancer drugs are worth their extra cost [press release]. Barcelona, Spain: European Society for Medical Oncology; September 27, 2019.  https://www.esmo.org/Press-Office/Press-Releases/ESMO-Congress-anticancer-drugs-cost-Marino-Vokinger. Accessed October 15, 2019.