How Can We Identify the Value of Personalized Medicine in Cancer? 

At Cancerscape, the Association of Community Cancer Center’s 42nd annual meeting on policy, value, and quality, held March 2-4, 2016, in Washington, DC, Kavita Patel, MD, MS, senior fellow at the Brookings Institution, spoke about the clinical imperatives of personalized medicine, with considerations for curbing healthcare costs and simultaneously demonstrating value to all stakeholders.

Patel posed the question: Can Value and Personalized Medicine in Cancer Care Co-Exist? “As a clinician, I always thought I was providing personalized medicine. So what has changed?”

Overall, Patel said, oncologists and physicians must start thinking about where they will position themselves in the new value-based payment models and value-based care. “Where can you insert value-based practices in your clinic?” she asked.

Drawing a simile with Tesla—a luxury vehicle that offers the promise of a reduced carbon footprint&mdash;Patel said that Tesla received tremendous subsidies from the federal government because of the value proposition the company presented for its expensive vehicle. “We need to come up with our own models and metrics, rather than have the government tell us what to do with respect to value,” Patel told the audience.

She said that as physicians try to prepare patients for the onslaught of costs coming from the therapies that are being developed, “we need alignment between what we are telling the various stakeholders, including physicians, payers, and patients.”

A few of the strategies that Patel proposed include:

		Targeting mechanisms that lead to cancer progression to improve outcomes

		These mechanisms are individual or personalized

		The goal should be to identify the mechanism of progression so we can specifically target it.

“Precision medicine boils down to taking each patient, identifying the best clinical evidence, identifying the molecular mechanisms, and then selecting the best algorithm that considers the longevity of treatment, screening, and follow-up,” Patel added. In her opinion, the ideal solution to improve outcomes with targeted therapies is to test the algorithm used [to develop the clinical trial] rather than the drug being used in the treatment.

How is value being defined today? Patel emphasized the utter lack of clarity around the term “value.” The definition often seems far removed from reality. “You cannot be held responsible for measures that do not make sense for the population you take care of!” Patel remarked.

“Patients trust us, we are their point person, and we are accountable for their health, not the hospital. This needs to be considered in these value-based models,” she stressed.

The Tightrope Act of Personalized Value in Cancer Care 

Most of us, who are familiar with the oncology value models proposed by organizations like the American Society of Clinical Oncology,

 the National Comprehensive Cancer Network,

 and others, realize the myriad practical questions that these models create for those on the frontlines of cancer care delivery. Unless these frameworks are implemented in the clinic, questions regarding their utility will remain. However, implementing these tools may require educating not just the providers, but also patients and payers.

To discuss these and other challenges with transitioning to value-based care, the Association of Community Cancer Centers (ACCC) invited a panel of experts during its 42nd annual meeting on policy, value, and quality, in Washington, DC. The panel, moderated by Christian Downs, JD, MHA, executive director of ACCC, included Alan Balch, PhD, chief executive officer, Patient Advocate Foundation (PAF); Thomas A. Gallo, MS, executive director, Virginia Cancer Institute, Inc; and George Kovach, MD, Iowa Cancer Specialists.

Balch explained how their foundation functions. PAF, he said, provides patient support and guidance on patient access issues as well as financial problems that patients face pertaining their care. The National Patient Advocate Fund, he explained, is their policy and advocacy wing.

Circling back to the topic at hand, Balch said, “There’s need to standardize the frameworks to improve system efficacy.” There are 2 ways to approach this, he explained. “Decide the patient’s faith beforehand or discuss the options with them and personalize their journey through the disease.” Balch believes that an ideal provider—patient conversation should discuss goals of concordant care. “Over-standardization runs the risk of losing out on goal concordance and what is valuable for the patient,” he said. However, Balch feels that discussions around cost of care and affordability, which are so important for the patient, are the most difficult to handle. “I am not sure when the right time is to introduce that conversation, because it can stress the patient, but it needs to be done in a way that is meaningful to the patient.”

Gallo provided an operational perspective on this move to value-based care. “Physicians usually stay out of the conversation on finances because they are not comfortable with it. A lot of different frameworks and programs make it difficult operationally,” Gallo said. “We are still experimenting with the various options and trying to place programs in place to bring value. The burden is huge on the clinics because it takes time away from focusing on the patient.”

Balch added that the patient is faced with a lot of information all at once when it comes to a cancer diagnosis. They are overwhelmed since they are expected to understand and make decisions on a lot of clinical issues. Discussions on the financial aspects of care just add to the burden, Balch said, adding that “it should be a precision conversation.”

“Insurance has changed and out-of-pocket costs have risen significantly,” continued Gallo. “Further, the lack of oral parity creates additional burden. It’s bad enough that patients are worried about their diagnosis, and then over and above that they are required to have the conversation on financial matters.” He said that they have a very good team of financial counselors at the Virginia Cancer Institute that provides their patients the best information and guidance to navigate the journey.

Kovach, however, raised the issue of ‘insured but not covered.’ “A problem we have missed discussing is that many of these patients have insurance, but they are not necessarily covered for their required treatments.” Balch noted that not all patients would necessarily be interested or keen on understanding or discussing the cost of care. “The pace and scale at which they would want that information is what could be operationally difficult,” he said.

Kovach added that, as a physician, he tries his best to do everything on his end to insulate patients as much as he can around issues of cost and access. “I believe that physicians really need to be involved in this,” Kovach added. Gallo raised concerns with the rising administrative burden that oncologists face. “Most are already overburdened in the clinic. The fact that some of these frameworks have an information deficit just makes it that much harder,” he said. “If we can have a global approach for harmonizing the process, it’d definitely help,” Gallo continued. “Something like a common patient assistance form would ease matters so much more for us operationally. Standardizing would be a big help.”

		Schnipper LE, Davidson NE, Wollins DS, et al. American Society of Clinical Oncology Statement: a conceptual framework to assess the value of cancer treatment options. 

. 2015;33(23):2563-2577. doi:10.1200/JCO.2015.61.6706.

		Dangi-Garimella S. Another cancer drug pricing tool, this time from NCCN. 

http://www.ajmc.com/newsroom/another-cancer-drug-pricing-tool-this-time-from-nccn

. Published August 24, 2015. Accessed March 18 2016.

Expert Advises Physicians on What to Expect From Medicare in 2016

Speaking at the 42nd annual meeting of the Association of Community Cancer Centers, Cancerscape, held in Washington, DC, Lindsay Conway, MSEd, managing director, Advisory Board Company, brought the oncologists in the audience up to speed on Medicare’s reimbursement strategies for the coming year.

“Our team takes up strategic and operational issues that our members view as problematic and seek our advice on,” said Conway, adding that the issues could range from reimbursement to financing.

The following is an outline of the tips Conway provided:

		Drug payment will hold at average sales price (ASP) + 6% for 2016. However, this may not hold true for prescription drugs covered under the Medicare Part B program. CMS has announced plans to test a model with a lower add on payment for Part B drugs, which is expected to roll-out for testing by the end of the year.

		Biosimilars could potentially lower cost of care for Medicare, and the margin of payment would stay the same for providers, Conway said.		

				Reimbursement would be ASP of biosimilar + 6% add on of reference product.

“Oncologists need to be aware that nearly 700 cancer-related biosimilars could hit the market in the near future,” Conway said, and there’s no escaping this new therapeutic option. She did agree that the current barrier seems to be physician awareness about a biosimilar product and their confidence with replacing the reference molecule with the biosimilar.

		While reimbursement is fixed for radiation therapy, overall, the more complex radiation therapy modalities are seeing a modest increase, while the less complex are seeing slight cuts in payments.

		Reimbursement for lung cancer screening has begun in 2016. This follows the release of coding and billing instructions by CMS in November 2015. “This means hospitals and clinics can find it financially sustainable to offer lung cancer screening,” Conway said.

		Hospital outpatient departments will be the testing grounds for new oncology-specific measures, Conway told the audience. This would fall under the umbrella of physician quality reporting system.

		Come 2017, patient-surveys would be widespread. While CMS is yet to finalize its decision on which survey would be used, Consumer Assessment of Healthcare Providers and Systems or CAHPS survey is being considered in the cancer realm. The CAHPS survey is an 85-question tool that includes 5 main domains: effective communication, shared decision making, patient self-management, access, and technical communication.

		Medicare Access and CHIP Reauthorization Act (MACRA) and physician payment stability. Following repeal of the sustainable growth rate (SGR) patchwork formula, a 0.5% annual increase in physician payment is expected through 2019. MACRA, the SGR replacement, helps hardwire risk-based payments for providers via 2 tracks:		

				Advanced alternate payment models (APM)

“CMS still has to iron out the details, such as performance categories, provider payment, interchange between the 2 tracks, APM participant qualification criteria, etc.” added Conway.

She ended her review on a high note, speaking to CMS’ decision to reimburse providers for the time they spend on advance-care planning (ACP) discussions with their patients. “CMS has said that all primary care physicians and advanced practitioners should be eligible for ACP conversations with their patients,” Conway said.

		Dangi-Garimella S. New payment model will test high-value prescription drug use under Part B. 

http://www.ajmc.com/newsroom/new-payment-model-will-test-high-value-prescription-drug-use-under-part-b

. Published March 8, 2016. Accessed March 18, 2016.  

Articles

Evidence-Based Oncology

Coverage of sessions held at Cancerscape, the Association of Community Cancer Center’s 42nd annual meeting on policy, value, and quality, held March 2-4, 2016, in Washington, DC.

Conference Coverage: ACCC

As clinical pathways are being actively implemented and tested by health plans, opinions differ on their usefulness and credibility, depending on whom you ask. Pathways evolved as a tool to address the lack of standardization across healthcare. They could even be visualized as a quality tool that would ensure providers strictly follow a predetermined path of care, a move that could potentially avoid waste and restrain costs. Providers disagree, however. We are the best judges of our patient’s treatment, they are saying.

Clinical pathways could prove to be an extremely useful tool for oncologists trying to keep up with the barrage of new molecular research on cancer. The complexities associated with cancer have made it quite cumbersome for physicians and other healthcare providers to stay abreast of the constant data flow on disease progression for each cancer type and connect all the dots—from genetic information, to treatments the patient may respond to, to follow-up care. However, standardization, although preventing confusion and unnecessary care, might also prevent physicians from providing a more personalized approach.

The National Pharmaceutical Council (NPC) conducted a survey and telephone interviews among medical and pharmacy directors from payer organizations, providers from a group practice or hospital, and pathway vendors. The interviews and survey responses supported the review of published literature on electronic databases, gray literature, and websites of care pathway vendors, payers, and major oncology provider networks conducted by NPC.

 The authors found that care pathway development may be triggered by:

		Disease states associated with a high cost of treatment (most common)

		Availability of multiple branded therapies

More than 50% of survey respondents shared that disease areas were selected based on cost of care (62%) and variation in treatment patterns (57%); only 33% reported selection based on clinical outcomes. With respect to evidence used for developing pathways, more than 80% of those surveyed said they turned to treatment guidelines and randomized clinical trials as their primary data sources. Those who participated in interviews identified the quality of efficacy-reporting studies as the most important consideration for inclusion in care pathway development, followed by data on safety or tolerability and, finally, costs. However, in survey responses, 81%, 71%, and 57% identified medical (nonpharmaceutical) costs, pharmaceutical costs, and healthcare resource use, respectively, as measures that are considered in care pathway development.

There is evidence to document that standardization of care delivered to treat a specific condition can be cost-effective. A study evaluating the use of clinical pathways in the treatment of lung cancer patients in an outpatient community setting was published in the 

 The study included patients with non—small cell lung cancer who were initiated on chemotherapy in practices that were a part of the US Oncology network. The study compared the cost of care and overall survival at 1 year for patients who were on- versus off-pathway, and discovered 35% lower outpatient costs for the on-pathway patients ($18,042 vs $27,737 off-pathway). The trend was mirrored among patients treated in the adjuvant and first-line settings, but not in the second-line setting, the authors reported.

Could Generics and Biosimilars Bend the Cost Curve?

If cost control is an important consideration for payers in ensuring adherence to pathways, raising provider—and patient&mdash;awareness on the availability of therapeutically equivalent generic versions of the more expensive brand-name drugs should be given priority. The American College of Physicians recently published the results of a survey that found physician and patient perceptions about the safety and efficacy of lower-cost options significantly influence the use of these medications.

 A survey among patients across the United States found that although a majority of surveyed patients understand that generic medications are less expensive and believe they can bring more value to healthcare, only 36% said they’d prefer to use the generic version themselves. Their main concerns? Safety and efficacy of the generic products. Physicians, too, were not 100% on board, with 25% of those surveyed expressing similar concerns with the safety and efficacy of generic products.

According to Lee N. Newcomer, MD, MHA, senior vice president, Oncology, Genetics, and Women’s Health, UnitedHealthcare, savings from pathways will continue only if they are supported by a reimbursement plan that pays a higher margin for generic drugs or effective, low-cost branded drugs—which will stop physicians from choosing high-cost drugs on their treatment regimen.

 This parallels the healthcare system’s increasing focus on high-value care—ensuring that patient and healthcare dollars are spent on treatment regimens that significantly improve outcomes at reasonable costs. Value frameworks developed by both the American Society of Clinical Oncology and the National Comprehensive Cancer Network hope to serve this purpose: both frameworks consider clinical efficacy, toxicity, and cost to identify the most valuable care for patients.

An important argument being presented, especially by oncologists, is against the one-size-fits-all design of clinical pathways. Increasing evidence suggests that an individual tumor is a heterogeneous mix of cells that makes the disease very difficult to treat and creates a case for a more personalized approach. Via Oncology, a pathway vendor, respects this need and has a more personalized approach to the process, 

In an interview with OncLive, Ray Page, DO, PhD, president of The Center for Cancer and Blood Disorders in Fort Worth, Texas, said, “Today, we have hundreds of drugs out there, and very targeted drugs that only work in certain subsets of tumors. Drugs are very sophisticated, very targeted, have very limited indications, and are very expensive. I can’t just go pull a drug off the shelf and say, ‘Well, it’s got an indication for lung cancer, so let’s just give it.’ It’s not going to work unless you use it in the right population. Given the amount of knowledge you need to maintain an understanding of when to use the drug, we need a pathway system that’s evidence-based, that helps guide you in today’s society.”

Oncologists are pushing back. Page recently co-authored a paper in 

 that calls on oncologists to take the lead in the development of clinical pathways, rather than health plans. Additionally, the commentary demands that physicians should be allowed to develop one set of pathways that can be applied across health plans, which could reduce the administrative burden associated with using unique pathways for each plan.

 Whereas these are fledgling years for clinical pathways, with additional data and wider adoption will come a knowledgebase to adopt and improve on their development and clinical application. 

Surabhi Dangi-Garimella, PhD, is managing editor of 

		Chawla A, Westrich K, Matter S, Kaltenboeck A, Dubois R. Care pathways in US healthcare settings: current successes and limitations, and future challenges. 

		Neubauer MA, Hoverman JR, Kolodziej M, et al. Cost effectiveness of evidence-based treatment guidelines for the treatment of non-small-cell lung cancer in the community setting. 

. 2010;6(1):12-18. doi:10.1200/JOP.091058.

		Choudhry NK, Denberg TD, Qaseem A; Clinical Guidelines Committee of the American College of Physicians. Improving adherence to therapy and clinical outcomes while containing costs: opportunities from the greater use of generic medications: best practice advice from the clinical guidelines committee of the American College of Physicians. 

. 2016;164(1):41-49. doi:10.7326/M14-2427.

		Newcomer LN. Changing physician incentives for cancer care to reward better patient outcomes instead of use of more costly drugs. 

. 2012;31(4):780-785. doi:10.1377/hlthaff.2012.0002.

		Feinberg B, Lal LS, Swint JM. Is there a mathematical resolution to the cost-versus-value debate? 

		Rinde M. Oncologists say clinical pathways are too confining. OncLive website. 

http://www.onclive.com/publications/oncology-business-news/2015/September-2015/oncologists-say-clinical-pathways-are-too-confining

. Published September 10, 2015. Accessed March 28, 2016.

		Polite BN, Page RD, Nabhan C. Oncology pathways—preventing a good idea from going bad. 

. 2016;2(3):297-298. doi:10.1001/jamaoncol.2015.5778.

While clinical pathways can help standardize care, considering the multitude of options available for oncology care providers, there is significant push-back from providers as well.

The Healthcare System's Struggle With Oncology Care Pathways 

Clinical pathways remain ambiguous for much of oncology and its stakeholders. Adoption has been slow, and it is fraught with negotiations and push-back from providers. This could be due to a lack of understanding of how a treatment regimen was developed and who participated in the process, or it could be the result of reservations about the recommendations, which may clash with the oncologist’s clinical experience or opinion.

To gain an understanding of this gray area, 

 invited a panel of experts who are experienced in the creation of oncology care pathways, use them in their practice, and have researched the development and implementation of care pathways. The discussion included Robert Dubois, MD, PhD, chief science officer and executive vice president, National Pharmaceutical Council, and Blase N. Polite, MD, MPP, associate professor of medicine, chief quality officer, Section of Hematology/Oncology, University of Chicago. Polite also serves on the American Society of Clinical Oncology’s Value Task Force and their Payment Reform Working Group. The panel also included 2 experts from organizations that develop clinical pathways: Michael Fisch, MD, MPH, medical director, Medical Oncology, AIM Specialty Health (a division of Anthem), and Kathy Lokay, president and CEO, Via Oncology.

The discussion began with each panelist providing his or her perspective on what is an oncology care pathway. According to Fisch, pathways are created to provide optimal care choices from among a large pool of evidence-based choices that oncologists are faced with on a daily basis, although he said they may not be as comprehensive as the guidelines developed by the National Comprehensive Cancer Network. “I think our focus, at least with the pathways that we’re doing with AIM Specialty Health and Anthem, is on drug regimen treatment choices,” said Fisch, where the emphasis is on efficacy and safety, with cost considered only when the first 2 features overlap for the treatments being compared.

Via Oncology takes a slightly different approach, according to Lokay, but that’s only because of their customer base, she pointed out: cancer centers that are open to a more specific, case-by-case method. According to Lokay, the pathway development committee leans toward a more stratified pathway driven by a specific case presentation. In her opinion, care pathways extend beyond medical oncology and can be mirrored in all aspects of cancer care, including radiation oncology and symptom management, as long as the highest standards of evidence are used.

“If you want to be a purist, in my way of thinking about it, the element that’s unique about pathways is a longitudinal characteristic,” said Dubois, unlike guidelines that work off of a single node. The practicing oncologist in the group, Polite considers pathways a clinical decision tool that ensures care providers avoid unnecessary variability in care while also being armed with necessary flexibility. “This is a way to ensure some consistency in how we see patients, such that if a patient comes into my office or comes into one of my satellite’s offices with the same diagnosis, they’re not being treated in several different ways,” he said. “It’s not whose door [patients] choose to open on that day and what appointment they get, but much more a consensus driven opinion by experts using evidence-based medicine.”

AIM Specialty Health and Via Oncology have somewhat distinct approaches to their pathway development process, in terms of the evidence used. AIM uses published clinical data, updated in a quarterly fashion, which is then implemented based on the specific cancer type, and the outcome being evaluated (progression-free survival, overall survival, response rate, etc) may vary, according to Fisch. He added that safety and quality-of-life outcomes are also curated in the pathway development process, along with costs.

Via Oncology, on the other hand, defragments individual case presentations to identify the subpopulations of patients for which a specific treatment can be defined. Then, this is corroborated with published literature and included as a pathway recommendation, Lokay said. Their committee also considers alternate scenarios for patients that might warrant a different approach, although she agreed with Fisch in that efficacy, toxicity, and cost are considered, in that order, when comparing treatments. “So for us, really if we look across all the end branches, the primary end branches of our medical oncology pathways at least, the cost decision really only comes into account about 5% of the time.”

Dubois referenced a recent analysis that was published by the National Pharmaceutical Council (NPC) in 

 that stemmed out of a survey conducted by NPC among the various stakeholders—developers to end users.

 “What we found was extremely variable approaches to both the development and the implementation of the pathway,” said Dubois. As of yet, there are no stringent guidelines for developing these pathways, he added, saying that the variability is multifactorial and may lend itself in the form of evidence used, outcomes evaluated, or whether expert assessment versus consensus is used. Dubois believes there needs to be more consideration for heterogeneity of patient response, and the granularity of guidance should be driven by the extent of compliance that is expected.

Polite responded, saying that from a policy standpoint, clinical pathways—whether used to ensure quality or for preauthorization&mdash;“should have some sort of deeming process where we essentially bless pathways and say if you’re using a blessed pathway, then that pathway should be considered by all payers.” This process would also blend with healthcare’s movement to value-based pricing. Polite, however, does not believe that clinical pathways have matured enough to be a useful tool for a shared decision-making process. Fisch and Lokay agreed that pathways are a general guide and that the final decision should be made by the physician in discussions with the patient.

When queried on the increased administrative burden of pathways, Polite said, “Well, there’s no question it can be a very clunky process as you start a pathway.” However, some pathways, like the ones used by practices within the US Oncology network, have been around long enough that they are a part of the clinic’s regular workflow. When used as a stand-alone, pathways can add to the administrative burden, Polite said, but he expects this will improve with time.

“If we’re facing a situation where I have to use a different pathway based on whether my patient is a Blue Cross patient or an Aetna patient or Medicare Advantage patient, and each one of those has a different order set and different priority, that is going to create significant frustration and blowback from the oncology community,” said Polite, adding that the field is moving in the direction of a consensus for which payers, the pharmaceutical industry, and providers all need to lend an equal voice.

Doctors are concerned that they would be penalized for wavering from the recommended treatment regimen, based on patient response or if they want to include a new and innovative treatment. Lokay explained that 100% pathway adherence is never the goal. “Really what you’re doing is you’re saying ‘Can we really develop pathways to address about 80% of the patients within a given disease?’ There’s always the ability to go off-pathway.”

According to Lokay, the pathway program developed by Via Oncology offers physicians the option to explain why they chose to go off-pathway and to document the alternative treatment being used. Lokay said that newer therapies are included in the bucket of therapies that can be used if a physician decides to go off-pathway. Depending on the impact of the new treatment, the decision committee could either meet immediately or discusses the inclusion of the new treatment at its quarterly meeting. “Ultimately, everything comes back to that shared decision making between the physician and the patient,” added Lokay. “The pathway should never drive an inappropriate decision.”

Fisch agreed with Lokay on the need for flexibility in pathways, especially in the scenario that a uniform set of pathways could be used across health plans to allow nimbleness to the process as new evidence builds. He said that clinical pathways will never be exhaustive because they are built “to make adjustments in real time.”

Can the standardized, evidence-based regimens proposed by care pathways provide assurance of high-value care? According to Polite, the definition of the term “value” is muddled at best. Technically, value is a ratio of efficacy and cost, and he believes pathways prevent oncologists from being penalized for offering the optimal treatment to their patients. Citing biomarker-driven treatment as an example, Polite said that if oncologists use anaplastic lymphoma kinase (ALK) expression or programmed cell death protein 1 (PD-1) expression to decide that their patient should be treated with an ALK inhibitor or a PD-1 inhibitor, respectively, being on- or off-pathway becomes a moot point.

On the other hand, pathways stop physicians from repeatedly administering expensive treatments that are less efficacious, he said. “There may be one or two patients that you decide that’s appropriate for, but if that becomes your pattern of care, that’s not going to be acceptable.”

Dubois agreed, but emphasized that clinical trial data—the evidence most commonly used to develop pathways&mdash;are a snapshot in time, which contradicts the longitudinal nature of pathways. Collecting evidence to support the continual impact of following a pathway to treat a patient would require quality measures that out healthcare system currently lacks, according to Dubois.

Lokay argued that clinical pathways are embedded with quality checks—from the tests to be ordered to the drugs to be used based on mutational analysis. She believes that empirical evidence is built into the pathways. When Dubois argued that these are actually process measures and do not provide a window into patient performance and effectiveness of a treatment, Fisch responded that there is opportunity to gather evidence over time. He reasoned that one can collect patient performance data over time from clinical trials and by following clinical guidelines as well as Choosing Wisely recommendations. Additionally, hospitalization data, other outcomes data, cost of care data that assimilate over time can be fed back to modify the pathways, resulting in a learning healthcare system, Fisch said. Polite pointed out that it is often missed that pathways provide granularity to data collection that would otherwise be impossible to assemble with claims data, such as the pathological detail, performance status, or biomarker expression.

Is it harder to implement pathways in a small community center versus in a bigger place like an academic cancer center? According to Polite, who works in an academic hospital setting, a bigger cancer center might witness more resistance from physicians. “The struggle that you have at an academic medical center is that the people who are treating these cancers are all justifiably experts in their field,” said Polite, and they can have strong clinical opinions, making it difficult to drive consensus. So the approach devised by several cancer centers is to be flexible and to involve the experts at the institute in pathway creation, in tandem with the pathway vendor, he explained. “I think it’s about having a process, like at Via Oncology, where people can be at the table and express their opinions on why they think things should be done differently.”

Fisch would like to see academic centers break their mold and focus on ways to distinguish themselves beyond having the most renowned experts on the roster. He said they need to highlight their unique research environment, which creates a melting pot of diverse medical experts such as in surgery and pathology. These centers would gain from emphasizing the extent of communication and patient-centered care that they provide and the various resources that are coalesced to improve patient outcomes, Fisch said.

Dubois highlighted another important and interesting finding from their survey, which was the level of transparency for the patients being treated on pathways.

 The survey found that patients are not necessarily aware that doctors are making treatment recommendations based on pathways. “I think what is probably the least transparent are the financial incentives to pathway compliance and whether the patients are aware of that,” Dubois noted. He believes that patients should be told if their treatment follows a predetermined pathway, and they should also be made aware of financial incentives that may be associated with adherence to pathways.

Polite, however, did not agree. He said that he does not share this information with his patients and has not thought of doing so in his clinic. “If you want to start [sharing this information], then it comes down to [us] telling our patients about our compensation packages, our productivity packages, how much money we get for enrolling patients in clinical trials,” Polite said.

Fisch pointed out the minimal understanding and concern that patients and physicians often have with the cost of cancer care. He cited the example of clinical fellows making treatment choices without any knowledge on how much the regimen costs. “There are dozens of choices that are evidence-based, and the fellow makes a recommendation and I ask—that’s perfectly acceptable&mdash;‘How much do you think 12 weeks of that therapy costs? The fellow has not even a point estimate.” Physicians are also quite unaware of their patients’ insurance plan and their liability.

Fisch doesn’t believe transparency is a problem with clinical pathways. “AIM or Anthem pathways are completely transparent—what they are, what the nature of the program is&mdash;and we encourage doctors to talk to patients about it and for patients and families to understand it,” he said. Fisch believes it is important to educate patients and their families on which pathway choices can be optimal based on efficacy, safety, and costs.

When asked to comment on the incorporation of palliative care in pathways, Fisch said that the pathways approach can extend beyond just drug regimens to other realms as well. With widespread acknowledgement of the benefits of palliative care to patient outcomes, he thinks principles of palliative care will soon be included on pathways to promote value and quality care.

“I don’t think there’s any one right answer,” said Lokay. “We’ve tried a number of things, using the software decision support tool, to ask physicians to document the treatment intent and whether it was discussed with the patient as a proxy for encouraging those discussions,” she said. Via Oncology, Lokay said, has struggled to figure out the right pieces to incorporate in pathways that would make an impact on palliative care in oncology.

Polite believes that although the oncology community has lagged in providing better options to patients for palliative care, pathways could force a more formal process for “thinking through some of the issues that perhaps either we don’t think about or maybe sometimes don’t want to think about.” He believes that pathways will have a very important role to play as healthcare increasingly moves toward alternate payment models. Polite is personally against the bundled payment models. He argues that oncologists are not responsible for the launch price of drugs and should not be penalized for using these high-priced drugs if they are using them appropriately. “I think [pathways] have a lot of ability to help us in new payment worlds,” he said.

Agreeing with Polite, Lokay said that helping individuals understand that they do not necessarily have to take risks with the way they use drugs and treatments is important. “Maybe pathways are a better way to control utilization, and they don’t really put the physician and the patient in the middle when costs go up.”

Fisch emphasized that pathways are a value framework, in a sense, because they summarize clinical evidence while weighing-in costs and outcomes. He added that despite the differences in specific choices, there is enough concordance between pathways created by different pathway developers, considering that the pool of clinical evidence is the same. While pathways will continue to evolve with the accumulation of longitudinal data, “there’s widespread acceptance of the specific choices that are involved in the pathways because they’re familiar and evidence-based,” Fisch said.

Dubois believes clinical pathways is a relatively young field that requires improvements in multiple aspects. In addition to gathering more long-term data, outcome measures that ensure patient performance are necessary, he said. “As we progress [in this field], we need to compare different sites that are using pathways or not, patients that are on the pathways or not. Making certain that patient outcomes are the way they need to be. If they’re not, then we revise the pathways and move forward accordingly.”

You can access the panel discussion here: 

http://www.ajmc.com/panel-discussion/clinical-pathways-in-oncology

		Chawla A1, Westrich K, Matter S, Kaltenboeck A, Dubois R. Care pathways in US healthcare settings: current successes and limitations, and future challenges. 

Evidence-Based Oncology invited a panel of experts who are experienced in the creation of oncology care pathways, use them in their practice, and have researched the development and implementation of care pathways, to exchange ideas on the topic.

Are Oncology Clinical Pathways a Value Framework in the Making?

Cancer care outcomes continue to improve significantly. Based on data from 2005 to 2011, the National Cancer Institute estimates that 66.5% of patients diagnosed with cancer will survival 5 or more years.

 However, despite the fundamental advances in cancer care technology and care delivery that have made these improvements possible, our delivery system remains quite inefficient and frequently falls short of being truly patient-centered. The Institute of Medi&shy;cine estimates that 30% of all healthcare dollars are spent on unnecessary tests, procedures, and doctor and hospital visits. The key drivers of higher-cost, less patient-centered care in&shy;clude the use of technologies of dubious clinical value; unnec&shy;essary variability in clinical decision making and therapeutic selection; care delivery in higher-cost settings; overuse of im&shy;aging, molecular diagnostics, and laboratory studies; and the use of treatments with low cost-to-benefit ratios; ineffective care coordination; and ineffective end-of-life care strategies. These represent systemic failures that both drive up costs and the patient centeredness of care.

Although the quest to improve value delivery is widely touted as an essential goal of healthcare reform, there is little agreement on what this really means and how best to accom&shy;plish it. A Google search of the term “cancer care value” yield&shy;ed 5.9 million results. Payers, pharmacy benefit managers, managed care organizations, state and federal governments, healthcare systems, physicians, and (most importantly) pa&shy;tients have distinct—and sometimes nonoverlapping&mdash;ideas of what a system for value-based, patient-centered cancer care should look like. Much of the recent flurry of activity in the cancer value domain has focused on the application of novel value tools and alternative payment systems. The Na&shy;tional Comprehensive Cancer Network’s Evidence Blocks and the recent American Society of Clinical Oncology’s Value Framework are proposed as tools for navigating the effective&shy;ness and value conundrum.

 Similarly, calls by HHS Secretary Sylvia Burwell to shift our payment system from one that re&shy;wards volume to one that rewards value delivery is meant to drive transformation of our care delivery system.

Unfortunately, too little of the focus on enhancing value has been on how best to build robust systems for supporting and sustaining a high-functioning, highly effective, cost-efficient cancer care delivery. Systems delivery breakdowns include failing to consistently perform patient risk assessments and establish patient-centered goals of care, failures in intra-team communication and communication between team and pa&shy;tient, technology/goals of care mismatches, scope of care/ goals of care mismatches, technology/risk mismatches, and failure to reevaluate patient/goals of care on an iterative basis. Absent a system-based solution for ensuring consistent appli&shy;cation of a coherent vision of enhanced value delivery, these piecemeal efforts are unlikely to bring sustainable systemic change.

The ultimate goal of a patient-centered, value-based, cancer care system is to create a deeply integrated healthcare sys&shy;tem that brings systemness to care delivery. This includes the regular application of a model of care that can make rigorous clinical risk/appropriate technology assessments, establish clear goals of care, and construct an evidence-based care plan tailored on individualized patient needs. Ideally this would also entail multidisciplinary team engagement centered upon patient care needs, seamless communication between team members, and an “eyes-on-the-prize” care perspective, with care focused on coherent, patient-centered goals rather than on the next intervention.

Clinical pathways are a set of systems-based tools for cre&shy;ating greater cohesion in cancer care. They do so by creating greater transparency around care decision making, therapeu&shy;tic selection, and care delivery, and also help to improve qual&shy;ity and efficiency by reducing nonvalue-added intra-provider variability in care. Care pathways have the potential to help patients and physicians successfully navigate the tension between personalized medicine and population-based care models. Moreover, they provide systems-based tools that can move us from cost-insensitive to effective, value-based care at the lowest-priced care setting; articulate rationale care escala&shy;tion schemes; systemize opportunities for increasing efficien&shy;cy; consistently help to reduce duplicative testing and imag&shy;ing; and helps to define and avoid the use of nonvalue-added care. Care pathways have the potential to evolve as medical technologies advance so that physicians can practice effective stewardship of healthcare resources, including molecular di&shy;agnostic and imaging studies and high-cost pharmaceuticals.

we explore the po&shy;tential of clinical pathways as systems-based tools that bring us closer to a model of patient-centered, economically sus&shy;tainable care. Bernardo Goulart, MD, MPH, reviews the evi&shy;dence for improved patient outcomes and cost-effectiveness of care through the use of clinical pathways. Peter Ellis, MD, a medical oncologist at UPMC CancerCenter and medical director at Via Oncology, describes the development and ap&shy;plication of cancer care pathways at his institution. Finally, our multi-stakeholder expert panel explores the importance of clinical pathways in cancer care delivery and discuss the challenges with their development and implementation.

While we navigate the enormity of creating a more effec&shy;tive and efficient cancer care system that can better and more sustainably address the needs of our patients, cancer care pathways are one of the tools that can help to empower this transformation. As healthcare primes to make the quantum leap from a system that has aligned economic incentives with a transactional model of cancer care to one that focuses on effective longitudinal, sustainable, patient-centered decision making, we can ensure that the system serves our patients and their families in increasingly transformative ways. 

Joseph Alvarnas, MD, is associate clinical professor and director of medical quality and quality, risk, and regulatory management, City of Hope, Duarte, CA. He is also the editor in chief of 

1. SEER Stat fact sheets: all cancer sites. National Cancer Institute website. http://seer. cancer.gov/statfacts/html/all.html. Accessed April 4, 2016.

2. Schnipper LE, Davidson NE, Wollins DS, et al; American Society of Clinical Oncology. American Society of Clinical Oncology statement: a conceptual framework to assess the value of cancer treatment options. 

. 2015;33(23):2563-2577. doi:10.1200/ JCO.2015.61.6706.

3. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) with NCCN Evidence Blocks. National Comprehensive Cancer Network website. http://www.nccn.org/evidence&shy;blocks/. Accessed April 4, 2016.

4. Joszt L. HHS sets goals to move Medicare payments from volume to value. 

website. http://www.ajmc.com/newsroom/hhs-sets-goals-to-move-medicare-payments-from-volume-to-value. Published January 26, 2015. Accessed April 4, 2016.

Despite the fundamental advances in cancer care technology and care delivery that have made these improvements possible, our delivery system remains quite inefficient and frequently falls short of being truly patient-centered. Is a system-based solution the answer?

Clinical Pathways: A Systems Approach Toward More Patient-Centric Cancer Care Delivery

UPMC CancerCenter (UPMC) experienced significant expansion between 2000 and 2004, growing to a network of 25 medical oncology sites of service that cover a geographic area extending more than 250 miles in Western Pennsylvania. During this time, an extensive management team was developed to drive operational standards of care consistent with the expectations of a major National Cancer Institute—designated Comprehensive Cancer Center.

Surveys of clinical care patterns completed by practicing physicians at those 25 sites of service during 2004 revealed substantial variation in clinical decision making. Although this variation is to be expected in a geographically diverse network that includes physicians who received training at academic institutions throughout the country, this was not deemed to be in the best interest of the patients served by UPMC. We felt strongly that our entire network should, where possible, standardize care around best evidence for all the patients of UPMC, regardless of location, and that care should be measured and reported. This decision led to the creation of what eventually became Via Pathways.

In late 2004, UPMC physician staff included academic domain experts and community clinician experts in the various medical oncology subspecialties, such as breast cancer, lung cancer, etc. Using this expertise, we created a methodology to establish a UPMC-wide standard for the best evidence-based care of patients. Disease-specific committees were organized with academic and community co-chairs and membership made up of willing UPMC oncologists. These committees were charged with defining 2 things:

		The various patient clinical presentations of disease

		The best evidence-based care for those presentations

The committees were to reach consensus on a “single best” therapy for each defined presentation. They were also encouraged to outline common comorbidities existing in these patients and to define sub-pathways for patients with those comorbidities as well. When determining the “single best” therapy, committees were asked to consider efficacy first, followed by toxicity; if all else was equal, they were asked to include cost in their deliberations.

Developing clinical pathways was a daunting task, but more vital was the need to keep them current in a rapidly changing oncology environment. This demanded the development of a system where committees were subsequently convened quarterly to review new literature and make appropriate alterations to the content of the pathway. That quarterly committee process continues to be an ongoing standard for Via Pathways today. Conflicts of interest are minimized through disclosure at each meeting along with public disclosures on the Via Oncology (the parent company) website. Pharmaceutical companies are not allowed to participate in the pathways process except to submit published data. Administrative and pharmacy support are provided to each committee to help it complete its task. The decisions of the committee are then converted into a decision support algorithm by a content management team at Via Oncology and sent back to the committees for verification and approval. Currently there are 18 medical oncology disease committees, 12 radiation oncology disease committees, and 6 surgical oncology disease committees (covering well over 90% of all cancers). The chairs of these committees rotate on roughly a 2-year cycle.

Once we had developed pathways for the various disease entities, we turned our focus to their integration into physician work flow (knowing that otherwise, they would gather dust on the shelf). In the early years, a manual process was implemented to identify patients and subsequently append a paper copy of the appropriate pathway to the chart. During the course of a patient visit, the physician was asked to mark his or her therapeutic decision on the paper pathway, based upon a decision support algorithm. As the number of pathways expanded, however, this manual process quickly became overwhelming and the need for a Web-based portal to deliver the pathways at the point-of-care became self-evident.

Through many years of multiple iterations and much trial and error within the UPMC network, a simple user interface that integrates with the practice management system was eventually developed to present the appropriate pathway to the physician within his/her daily workflow. This interface (called the Via Portal) pulls patient schedules and demographics from the management system and presents a complete daily schedule to the physician. From that schedule, the physician charts the outcome of that day’s interaction with the patient, choosing from options such as:

Under appropriate circumstances, the portal presents the decision support algorithm in real time, for whichever action is taken, to allow the practitioner to initiate the desired therapy. The results of that decision are then communicated back to the practice’s electronic health record, if one is in use. All the information about the patient’s disease status and treatment are databased into discrete fields within the Via Portal for subsequent reporting and analysis.

Additionally, multiple resources are imbedded into the pathway navigation to facilitate quality care for the patient, including links to full text articles that inform pathway decisions; concise summaries of pathway committee deliberations around appropriate care; 1-page overviews of regimens outlining effectiveness, toxicities, and appropriate dose reductions; patient educational materials; and chemotherapy consents. The system also simplifies the generation of treatment summaries and survivorship plans.

It is standard practice to place locally available clinical trials first in the decision algorithm and at the appropriate point in the pathway to facilitate accrual. If the practitioner does not enroll a patient in the trial, he or she must choose, from a drop down menu, the reason for nonaccrual before the standard of care option is presented to the physician. The data around the number of patients seen by the practice who may be eligible for a given clinical trial, and reasons for nonaccrual, are regularly provided to the research team for analysis. Our research colleagues have found this a useful tool to drive clinical trial accrual.

There are no financial incentives or penalties for compliance with pathway treatments (“on-pathway rates”). It is our philosophy that the pathway is likely to be appropriate for roughly 80% of patient presentations but cannot account for 100% of patient presentations and, therefore, physicians are free to choose “off-pathway” therapies as they deem appropriate. The software requires that the practitioner record the reason for the “off-pathway” decision from a drop-down list and document the actual treatment administered. The system is set up to facilitate the work flow so that “off-pathway” decisions are not more burdensome to document than “on-pathway” decisions.

UPMC does employ financial incentives for all practitioners to use (“chart”) the Via Portal. This results in over 94% of all patient Evaluation and Management (E&M) visits across all sites being reported in the pathway system. In instances where the Via Portal detects a visit in the practice management system that was not charted in the pathway system, a reminder e-mail is sent daily to the practitioner to complete the pathway charting.

Across all diseases and all presentations, the network average “on-pathway” rate is 79.6% (based on all new treatment starts). Reports are presented to all physicians outlining their “on” and “off-pathway” rates each month and lists their performance in relation to their peers.

The success of a pathways program ultimately depends on physician acceptance of the content and the delivery tool (the Portal). When polled, very few physicians ask for limitations on their autonomy or to integrate another piece of software into their work flow. As such, obtaining physician buy-in to the value proposition for pathways is paramount. Leadership and transparency around the goals of pathways—to reduce unwarranted variation, drive standardization around evidence-based care, measure performance, and drive clinical trial accrual&mdash;are essential. Most physicians today are cognizant of the need for cost containment in oncology care and understand that “if we do not take the lead, someone else will for us, and we will not like the outcome.”

The open and democratic pathway development process, the fact that clinical pathways are physician-rather than payer-driven, and the ability for each user to contribute to pathway content enhance acceptance of the product. Keeping software design simple and as useful as possible to facilitate clinical care is important, so that practitioners are not burdened. Finally, it is important to always point out to reluctant practitioners that the alternative to a physician-led solution to the cost crisis is a payer- or government-led decision and that status quo is not an option!

Throughout the 10 years following the initiation of clinical pathways at UPMC, our “on-pathway” rates have been in the 70%-to-80% range (based on treatment start) and we have consistently captured more than 90% of patient visits to ensure completeness. For the 12 months ended December 31, 2015, we captured over 94% of all E&M visits (n = 241,520) within the pathways database and achieved an on-pathway rate of 81.4% for all treatment decisions (n = 16,484).

Several factors contribute to the high compliance rates. First, physicians are provided a monthly performance feedback compared with UPMC overall and the Via Network overall. Second, the Via disease committees review the pathway compliance reports each quarter to identify poor performing branches and determine a course of action. This action could be:

		An e-mail to all physician users to clarify the rationale for the pathway recommendation

		Delineation of a new alternate patient presentation to address a commonly occurring comorbidity or other factor driving off-pathway use.

With an expansion of Via Oncology’s customer base throughout the United States, we have also diversified representation on the disease committees to reflect the views of Via Oncology’s many customers. By allowing all Via Network physicians to participate in every meeting and having co-chairs representing the various customers, we have not only created a vehicle for strong physician buy-in, but also improved the quality of our pathway programs.

We have also worked with Via Oncology to expand the concept of pathways beyond drugs. Our clinical care pathways also cover radiation oncology, surgical oncology, and the continuum of care from work-up to symptom management, survivorship, and advanced care planning. Finally, we have the resources and datasets to begin publishing the results of our efforts and are demonstrating the impact of pathways on quality and cost of care by presenting our data at national/international meetings and in manuscripts. We are also supporting our research efforts through prospective trial promotion within the Via Portal as well as retrospective analysis of accrual opportunities by physician, site, and disease. 

Peter G. Ellis, MD, is medical oncologist, UPMC CancerCenter and medical director, Via Oncology.

An overview of the oncology clinical pathways development program at the UPMC CancerCenter and how it led to the creation of Via Oncology, a clinical pathways vendor. 

Developing an Oncology Clinical Pathways Program - the UPMC Case Study

The oncology landscape is rapidly changing, in great part due to unprecedented innovations in diagnostic and treatment technologies.

Ironically, the same advances in cancer therapeutics that now benefit many patients also dramatically increase the complexity and costs of oncologic care.

The latter have forced stakeholders to develop new strategies to provide high-quality, state-of-the-art cancer care while simultaneously bending the cost curve.

Among the several new models of cancer care delivery and reimbursement that are currently under evaluation, cancer care pathways (CCPs) are emerging as a strategy to provide evidence-based oncology care at lower costs through reductions in unnecessary treatment variations.

The rationale for adopting CCPs departs from the following assumptions:

		Cancer care and costs vary substantially across clinics and providers, a concern that many studies have confirmed to be true.

		Low-value treatments account for at least a fraction of the variation, including the use of costly, but marginally effective, drug regimens.

		Adoption of CCPs can change physician behavior to prioritize the use of high-value evidence-based treatments, thereby improving patient outcomes and reducing the use of costly therapies that are either marginally effective or more toxic.

To the extent that these assumptions hold true, CCPs have great potential to succeed as a model for the delivery of high-value cancer care. But do they hold true?

As an increasing number of cancer care clinics are adopting CCPs, either voluntarily or as required by payers, an early look at pathways’ performance becomes necessary to inform stakeholders whether the investments in CCPs have resulted in the expected returns and what efforts need to take place to optimize pathway development, if any.

Our goal here is to discuss the impact of adoption of CCPs on treatment variation, patient outcomes, and cancer care costs, based on published literature. This review focuses on commercially available CCPs (ie, computer-based treatment decision programs offered by vendors as part of oncology management programs) because most of the available literature pertains to this particular type of pathway. Several academic cancer centers have developed their own CCPs for internal use, including the University of Washington, Dana-Farber Cancer Institute, and University of Tennessee, to name a few.

A review of these programs is beyond the scope of this article, as very little published literature is available to inform their performance. Although this review is by no means comprehensive or exhaustive, it provides some insights about the promises and concerns regarding adoption of CCPs.

The Process of Developing Cancer Care Pathways

To ensure an informed discussion of how CCPs impact outcomes, a brief explanation is in order to define CCPs and clarify the process by which pathways are developed. Pathways consist of complex electronic treatment decision support tools that provide evidence-based treatment recommendations to physicians at the point-of-care for individual patients. These tools are often integrated with electronic health records (EHRs) in a manner that allows managers to evaluate whether the treatments actually delivered were concordant or discordant with pathway recommendations. This information is relevant for monitoring pathway adherence. Pathways, in general, cover several cancers at all stages. With a primary focus on drug regimens, some CCP programs have also developed content for supportive care and radiation therapy.

CCP programs typically apply a hierarchical order of criteria to select the treatments to be included in the pathways. The first criterion is treatment efficacy, wherein regimens of superior efficacy receive top priority for pathway inclusion. As a side note, the available literature does not clearly specify the disease endpoints used to measure efficacy (eg, overall vs progression-free survival, response rates, etc.). Toxicity is the next selection criterion applied to regimens of similar efficacy; those with lower toxicity and similar efficacy receive priority. Drug cost is the third and last selection criterion; pathways prioritize regimens of lower cost when efficacy and toxicity are similar.

Most CCPs emanate from collaborative efforts involving physician network groups, healthcare payers, and oncology management—program consulting firms. Physicians elect disease-specific committees that appraise the current evidence and select the treatments for pathway inclusion. Leaders of several CCP programs have publically declared that the committees offer an opportunity to all physicians using the pathways to comment on the contents and participate in the process of pathway treatment selection.

The committees are also in charge of continuously updating pathway contents—as evidence becomes available&mdash;to support the use of novel therapies.

Once physician committees decide on the contents of a pathway, the oncology management programs integrate the treatments into the electronic supporting tools and offer technical assistance to network physicians using the pathways in daily practice. Oncology management programs also assist clinics in reporting pathway adherence to healthcare payers, and help monitor patient outcomes and costs. Payers offer financial incentives to maximize pathway adherence, usually in the form of higher fees for on-pathway drugs and by increasing the reimbursement for evaluation and management charges for adherent physicians.

Cancer Care Pathways and Treatment Variation

The central hypothesis for CCP use is that adherence to pathways reduces costs and maintains quality of care by curtailing the use of unnecessary and costly oncologic treatments. Surprisingly, there is very scant published evidence to support or reject this hypothesis. After a short PubMed literature search, I could only retrieve 1 article reporting on the impact of the Cardinal Health Specialty Solutions (formerly, P4 Healthcare) pathway on treatment variations. The study compared the number of chemotherapy regimens used for breast, lung, and colorectal cancers in the year preceding and the year following pathway implementation, in several practices located in Michigan.

Physicians used 168 and 136 distinct regimens in the years pre- and post-pathways implementation, respectively, which represents an 8% absolute reduction in treatment variation (

). Interestingly, 10% of the study population accounted for 81% of the reduction in the number of drug regimens used, suggesting that a minority of patients drive most of the treatment variation, perhaps because of higher disease complexity. Although this single report does not provide any firm conclusions about the effects of pathways on treatment variation, the reduction in the number of chemotherapy regimens used was quite modest. An important point to note is that the report does not provide any information on the cost of the chemotherapy regimens avoided to establish a causal relationship between reductions in treatment variation and costs.

Cancer Care Pathways and Patient Outcomes

At least 1 report indicates that adherence to CCPs reduces the number of emergency department (ED) visits and hospital admissions for treatment-related complications (

). Kreys et al evaluated the effect of adherence to the Cardinal Health Specialty Solutions supportive care pathways on ED visits and hospitalizations for neutropenia, anemia, and chemotherapy-induced nausea and vomiting in patients with breast, lung, and colorectal cancers. Compared with patients who received off-pathway supportive care, pathway adherence was associated with a 15% absolute reduction in ED visits and hospitalizations for neutropenia (adjusted odds-ratio, 0.42; 95% CI, 0.30-0.58).

The study demonstrated no clinically or statistically significant differences in admissions for anemia or chemotherapy-induced nausea and vomiting. Pathway adherence was associated with lower expenditures for hospitalizations to manage neutropenia and anemia, and with lower expenditures related to the use of granulocyte colony—stimulating factors and antiemetics.

Current evidence suggests that adherence to CCPs results in either a neutral or favorable effect on survival outcomes, depending on the disease and treatment setting (adjuvant vs metastatic) (

). Using EHR and pathway reporting data, Neubauer et al conducted a cost-effectiveness analysis of adherence to Level I Pathways among 1409 patients with non-small cell lung cancer (NSCLC) treated at several US Oncology network clinics. After adjusting for patient characteristics and line of therapy, the study showed no statistically significant difference in 1-year overall survival (OS) (HR, 0.95; 95% CI, 0.77-1.16) between patients treated on- versus off-pathway.

Hoverman et al also utilized EHR and claims data to compare disease-free survival (DFS) and OS in patients treated on versus off Level I Pathways with adjuvant and palliative chemotherapy for stage III and IV colorectal cancer, respectively.

Pathway adherence was associated with a substantial increase in DFS (HR, 4.98; 95% CI, 2.11-11.74 for non-adherence) in the adjuvant setting and prolongation of OS (HR, 1.57; 95% CI, 1.04-2.39 for non-adherence) in the metastatic setting, respectively.

Cancer pathways can potentially improve patient outcomes and reduce costs. Recent concerns about pathway adoption deserve attention, including excessive administrative burden to clinics. 


April 2016

Conference Coverage: ACCC

The Healthcare System's Struggle With Oncology Care Pathways

Are Oncology Clinical Pathways a Value Framework in the Making?

Clinical Pathways: A Systems Approach Toward More Patient-Centric Cancer Care Delivery

Developing an Oncology Clinical Pathways Program - the UPMC Case Study

Cancer Care Pathways: Hopes, Facts, and Concerns

Recommendations for the Role of Clinical Pathways in an Era of Personalized Medicine

The Oncology Medical Home - Beyond Clinical Pathways

ASCO Policy Statement on Clinical Pathways in Oncology: Why Now?