Pros and Cons of Vendor- and Provider-Developed Pathways
On Day 1 of the 2018 Clinical Pathways Congress, Bobby Daly, MD, MBA, Memorial Sloan Kettering Cancer Center (New York, NY), and Robin T. Zon, MD, FACP, FASCO, Michiana Hematology-Oncology, PC (Mishawaka, IN), discussed the origins of the American Society of Clinical Oncology (ASCO) Pathways Task Force Development of Criteria for High-Quality Pathways and their findings after assessing existing pathway programs in relation to their criteria.
The ASCO Clinical Pathways Taskforce, established in 2015, determined it was essential to elevate awareness that no current mechanism existed to ensure integrity, efficient implementation, and outcome assessment for these care management tools. Thus, they began determining what these criteria should entail. They then compared the established criteria to the pathways programs of Anthem, eviCore, eviti, New Century Health, Value Pathways (National Comprehensive Cancer Network), and Via Oncology.
Through their discussions with these organizations, Dr Daly said they learned that the criteria was interpreted literally; that the criteria can only be used for qualitative analysis; that there is a need for a clear definition of what defines a pathways program as well as vendor goals; and that criteria alone does not remedy all of the concerns raised by ASCO.
Dr Daly remarked that they would have liked to interview and work with many more institutions for the study, had resources permitted, but he hopes to speak with more in the future to help evolve and enhance the criteria to better serve institutions and providers.
Dr Zon picked up the conversation and transitioned to the topic of utilization management strategies in care systems and how to perform a return-on-investment analysis when determining whether to buy or build a pathways program. She commented on the many utilization management strategies that providers are expected to work under on a daily basis and proposed that clinical pathways could be used to underpin and improve those strategies while not adding to administrative burden.
In order for pathways to be used effectively in this manner, it is essential to understand the goals of each stakeholder involved, including the patient, provider, payer, employer, and system. While many of their goals overlap, they each, of course, have varying requirements to meet. She touched on each element of interest to each individual party.
Dr Zon then broke down the key buy-vs-build elements to consider. She began by emphasizing that the ASCO analysis was not designed to advise people on whether to buy or build a pathway; it is just a resource to evaluate pathways. Other important considerations include financial cost of buy vs build, which is contingent on the size of one’s practice; ownership of data (arguably the most valuable asset of a pathway program, she said); managing conflicts of interest (present in both vendor pathways or provider-created); product evolution; and what outcomes to track for your practice’s needs.
She ended by explaining other ways in which pathways and the data pathways collect can be used to improve other care processes. For example, in the ASCO patient-centered oncology payment (PCOP) model, pathway compliance serves as a quality metric, monitor resource utilization (eg, drugs), and serve as a surrogate for stage, bio/molecular/genomic marker data submission (ie, reduces data submission).—Amanda Del Signore
Incorporating Patient Experience, Financial Toxicity Into Clinical Pathways
Alan Balch, PhD, chief executive officer, National Patient Advocate Foundation, discussed the need to consider clinical pathways in helping differentiate options based on financial and logistical side effects that impact the patients’ care journey.
Dr Balch began his presentation by stating that we need to begin thinking about pathways beyond what drugs to administer to patients. There is a crucial need to incorporate patient experience and financial toxicity as fundamental pillars of pathways, much in the way that side effects have been included.
Incorporating key variables that impact patient lives in meaningful ways that are considered “indirect” or “outside the scope” of health care are the gateway to addressing pathway adherence barriers, Dr Balch added. Among the most prevalent variables for pathway inclusion include clinical benefits, side effects, total cost of clinical care for an episode, key costs related to the receipt of care not covered within insurance design, transportation requirement and burden, impact of treatment on job performance, time off work, and genomic profile. Dr Balch opted to focus on the two variables most important for pathway inclusion: transportation and employment burden.
One of the top case management issues at the Patient Advocate Foundation in 2017, based on an internal survey, was assistance with transportation expenses. Approximately 20% of patients in the Foundation reported round trip travel of 2 to 4 hours for their medical appointments, and 40% of patients reported being “usually” to “always” overwhelmed by the time and effort necessary to receive their treatment. Transportation is more than just a distance issue, Dr Balch stated, referencing only 30% of patients who attributed difficulty of traveling to and from appointments to challenges of distance.
In a financial toxicity survey conducted by the Foundation of 568 patients with a cancer diagnosis and 269 patients with HIV/AIDS, patients reported overwhelming and severe financial hardship. Health care costs related to treatment that contributed most to their hardship included office visits to specialists, oral medication, radiology services, lab testing services, and loss of income related to work. In the 12 months prior to the survey, respondents acknowledged financial hardship lead to cutting of noncritical household expenses, cutting of critical household expenses, use of credit card and loans, and sold assets, among other actions.
Additionally, patients reported having to dip into savings to pay for medical visits, paying medical bills instead of monthly expenses, and consideration of financial costs of taking time off work for medical care.
An additional safety net survey was administered to patients who received Patient Advocate Foundation assistance from July 2016 through June 2017. Dr Balch showed that some 50% of respondents had a disruption of employment related to their illness (ie, loss of job due to illness and loss of income due to inability to work full time). These figures helped Dr Balch explain that financial toxicity is not only about the money being taken out of patient pockets for expenses, but also the money that is no longer in their pockets in the first place because of employment-related disturbances.
In his concluding remarks, Dr Balch reiterated that transportation requirements and burdens as well as presenteeism and absenteeism are the most important variables to consider for pathway inclusion moving forward.—Zachary Bessette
Challenges in Personalization, Integration of Pathways
On Day 2 of the 2018 Clinical Pathways Congress, Linda Bosserman, MD, FASCO, FACP, City of Hope (COH) Medical Group (Duarte, CA), gave a presentation on her real-world experiences in implementing and operationalizing pathways to support value-based care.
COH’s pathways program began using Via Pathways (initiated in January 2017) and the EPIC electronic health record (EHR) system (live December 2017). Treatment pathways as well as comprehensive surgical pathways, enhanced recovery after surgery pathways, were included in this pathways discussion.
In her discussion, she touched on the practical steps as well as challenges during implementation of a pathways program, how EHRs and other decision support tools need to be leveraged alongside of pathways, and how solutions such as standardized patient-reported outcomes can efficiently address the needs of multiple stakeholders.
Integral to adding more value to care through pathways, Dr Bosserman noted, is to agree on a common set of data elements, eg, diagnosis, therapy, outcomes, as well as standardizing data element collection through the EHR and clinical workflows. Data that is produced from your pathways use and work flow should then be placed in the context of big data.
The ultimate goal, she explained, is to build the proper decision support that combines and incorporates evidence-based care and real-world data for patient-focused tools. She called out a few of the groups to look for who are developing comprehensive tools that can support patient-centered pathways, including Cota, GenomOncology, Flatiron, Philips, IBM Watson for Oncology, and My Cancer Genome.
In closing, Dr Bosserman said that with the overwhelming amount of new research coming out on medical care and treatments, in oncology care in particular, decision support tools that integrate care pathways and make use of collected data in real time will be essential for providers to keep up with the most effective treatments and recommendations.—Amanda Del Signore
Updates to the OCM Quality Measures and Lessons Learned Moving Forward
Andrew York, PharmD, JD, Center for Medicare and Medicaid Innovation (CMMI), Centers for Medicare & Medicaid Services (CMS), provided an update on the role of quality improvement in oncology value-based payment, with specific attention to Oncology Care Model (OCM) Quality Measures.
He began his presentation with an overview of the OCM, including the goals and theory of action of the program. The OCM, he explained, is a 5-year plan that utilizes real-time monthly payments for enhanced services for beneficiaries combined with Medicare fee-for-service payments. It also offers the potential for a retrospective performance-based payment based on quality and savings.
Dr York explained that the scope of the OCM consists of approximately 25% of Medicare fee-for-service chemotherapy-related cancer patients, including 184 practices, more than 6500 practitioners, more than 150,000 unique beneficiaries per year, and more than 200,000 episodes of care per year. Thirteen commercial payers are participating, he noted.
In terms of the practice redesigning activities, Dr York detailed how the OCM provides beneficiaries with enhanced services, utilizes certified electronic health record technology, and utilizes data for continuous quality improvement. However, there are numerous challenges of developing a Medicare alternative payment model in oncology, he noted, highlighting the complexity and (continued on pS9)
(continued from page S7) diversity of clinical cancer care, limitations of the Medicare claims system, the complexity of practice business models, and complexity and limitations of ICD coding systems—all of which are taken into consideration in the development of the OCM.
The conversation then turned toward the fee-for-service 2-part payment approach. He explained that, while participating practices continue to be paid Medicare fee-for-service payments during the OCM, the model also requires a 2-part payment approach involving a monthly enhanced oncology services (MEOS) payment and performance-based payment. The performance-based payment is calculated retrospectively on a semi-annual basis and is based on a practice’s achievement on quality measures and reductions in Medicare expenditures below a target price.
CMS calculates benchmark episodes expenditures for OCM practices, he continued, which are risk adjusted for factors that affect episodic expenditures and are available in Medicare claims data. Among these factors are age, sex, dual eligibility for Medicaid and Medicare, comorbidities, surgery, bone marrow transplant, radiation, select chemotherapy drugs, institutional status, participation in clinical trials, prior chemotherapy use, episode length, and hospital referral region. Over time, cancer staging may be incorporated into the risk-adjustment methodology as well.
After further explaining the risk arrangement options (1-sided and 2-sided) as well as the various Quality Measures affecting Performance Period 1 through Performance Period 4, Dr York detailed the OCM Learning Community, which consists of topic-specific webinars that allow OCM participants to learn from each other. The online collaboration platform is designed to support learning through shared resources, tools, ideas, discussions, and data-driven approaches to care. The Learning Community is a community of action groups, made up of practices who work together virtually to explore critical topic areas and build capability to deliver comprehensive oncology care as well as technical support to help practices overcome barriers to improvement.
“We have learned a lot about the intricacy and complexity of trying to use different technologies, including our data reporting platform and the importance of working with technology partners such as the EHR vendors and clinical pathway software vendors, to make sure we are all on the same page when trying to collect these data,” Mr York stated, in reference to the early experiences and lessons learned from the perspective of CMMI. “We have also found a systematic issue with how we were handling low- and high-risk prostate, breast, and bladder cancer. We corrected that starting in Performance Period 3.”
In his concluding remarks, Dr York reassured that CMI is “continuing to work on how [they] deliver the model and are always working on quality improvement.” Not only have practices reported that MEOS payments and care transformation elements enabled them to do what they have always wanted to do, but the OCM has reportedly helped improve care coordination, symptom management, palliative care, and end-of-life care; recognize depression and distress in patients; address financial toxicity; and improve communication with patients and other providers.—Zachary Bessette
How Do We Measure ROI for Clinical Pathways?
On Day 3 of the 2018 Clinical Pathways Congress, Ray D. Page, DO, PhD, FACOI, president & director of Research, The Center for Cancer and Blood Disorders (Fort Worth, TX), tackled the challenging subject of how to define successful outcomes and demonstrate return on investment (ROI) for a clinical pathways program.
Particularly in the oncology space, clinical pathways are increasingly being used by institutions, clinicians, and commercial organizations to improve patient care by limiting undesirable variability and reducing cost while providing for the optimal course of care for a patient’s specific diagnosis.
In addition, many large payers are partnering with oncology providers and pathway companies to implement oncology pathways as a means of reducing variation and controlling costs as the US health care system shifts to value-based models.
While acknowledging that there is not yet enough published data available on ROI and clinical pathways, he touched on many studies that do exist, which clearly demonstrate their value in reducing costs of care. One such study included 1400 patients with non-small cell lung cancer and showed that certain outpatient costs were 35% lower for those patients treated according to pathways while maintaining equivalent health outcomes (J Oncol Pract. 2010;6[1]:12-18).
Dr Page explained that pathways can also serve as a mechanism to pressure drug pricing. An ideal test case for this would be in the front-line treatment of metastatic colon cancer. The CALGB/SWOG 80405 study showed equivalent efficacy and toxicity between chemotherapy plus bevacizumab and chemotherapy plus cetuximab, yet the cetuximab arm costs $40,000 more for a treatment course. Thus, in a properly designed, value-based pathway, the pathway would give clear preference to bevacizumab and only allow cetuximab in circumstances where bevacizumab is contraindicated (eg, uncontrolled hypertension or a significant history of arterial thrombotic events). If drug costs and efficacy are presented at the point of care explicitly and transparently, manufacturers would be incentivized to bring drug costs closer to parity, he said.
There is also potential for pathways to assist in one of the main burdens physicians complain of that wastes working hours: prior authorization. For utilization management (UM), many payers use pathways-based decision-support tools, like eviCore, which drives prior authorization criteria (which are not transparent) and advises insurers what to pay based on stringent 100% compliance with their “pathways.” This results in major conflict with physician decision-making. A potential solution is to use provider-facing pathways with robust reporting of pathway compliance (80%) as a mechanism for prior authorization relief and shared savings.
Despite their relatively short time of existence, there is already mounting evidence that oncology pathways can decrease spending related to chemotherapy patients. A study by Blue Cross Blue Shield found potential systemwide savings of more than $30 million through the use of pathways. In a project involving more than 4700 patients with cancer at more than 46 sites, drug costs at sites adhering to clinical pathways were found to be 13% lower ($2440 per patient) than at sites that were not adherent (J Oncol Pract. 2013;9[5]:e241-e247).
In terms of costs to implement a pathway program, Dr Page said costs are highly variable, depending on staff size, location, practice environment, and vendor relationships, but it can range anywhere between $3000 to $10,000 per full-time equivalent physician per year. Unexpected costs would include IT costs, electronic health record vendor costs with interphases, and negative staff productivity costs if the pathways system is not fully efficient and integrated.
In this time of shrinking budgets and less discretionary income, ROI is a necessary consideration in practice management strategies and budget planning. Typically, ROI is calculated in terms of financial gain beyond the original investment over a defined time period. However, the ROI of oncology clinical pathways, in principle, should extend beyond financial consideration and be calculated in terms of patient-centered ROI. Stated differently, pathways may have extra financial value that is not ordinarily reflected in conventional financial accounting statements.
Pathways may realize tremendous benefits by improving performance when measured as the increase in the quality of care, efficient use of resources, and better outcomes. This translates into better patient outcomes, which, in turn, favorably impact practices financially under new value-driven payments that will come from MACRA legislation.—Amanda Del Signore
Incorporating New Data Into Standard of Care for Multiple Myeloma
On Day 3 of the 2018 Clinical Pathways Congress, Noopur S. Raje, MD, director, Center for Multiple Myeloma Massachusetts General Hospital Cancer Center (Boston, MA), gave an update on the treatment for multiple myeloma (MM) and also discussed how the most recent data should be integrated into clinical pathway development/adoption.
MM is the second most common hematologic malignancy with 30,330 estimated new diagnoses annually and a 5-year survival of 47%. She touched on the current FDA-approved drugs available to treat MM as well as the treatment paradigm for newly diagnosed MM. In transplant-eligible patients, treatment begins with induction therapy, followed by transplant consolidation, maintenance therapy, and eventual treatment of relapsed disease. In transplant ineligible patients, patients should receive their initial therapy and maintenance therapy, followed by treatment for relapsed disease. Dr Raje was careful to underline that supportive care should accompany patients at all stages of treatment.
She then presented a question to attendees, asking whether minimal residual disease (MRD) negativity should be the goal of treatment. MRD is a highly sensitive measure of the effectiveness of therapy for MM; a patient who tests “MRD negative” after treatment for myeloma has less than one myeloma cell per million bone marrow cells. She presented the available research regarding the effect that MRD status actually has on progression-free survival (PFS) and overall survival (OS), which imply that MRD-positive patients and MRD-negative patients have almost the same PFS and OS (JAMA Oncol. 2017;3[1]:28-35.).
Dr Raje also presented data comparing continuous therapy vs fixed duration therapy in 1218 patients with newly diagnosed MM. The data showed significant benefit in PFS2 with no differences in second PFS, indicating that the continuous therapy did not induce more resistant relapses in patients (J Clin Oncol. 2015;33(30):3459-3466.)
After presenting and discussing the National Comprehensive cancer Network Guidelines for transplant and nontransplant candidates with MM, Dr Raje noted triplet therapy for induction, maintenance therapy after transplant, and continuous therapy should all be standard treatment. On the question of whether a fourth drug should be added to the 3-drug induction standard, she said that there are four onging phase 2 studies investigating the following regimens: daratuzumab-ixazomib-lenalidomide-dexamethasone (IRd); elotuzumab-lenalidomide/bortezomib/dexamethasone (RVd); panobinostat-RVd; and daratuzumab-carfilzomib/lenalidomide/dexamethasone (KRd).
Transitioning to a discussion on how to confront disease relapse in myeloma, she said that the data show we need to greatly improve in this area. She noted that the phase 3 OPTIMISMM trial, which compared pomalidomide/bortezomib/dexamethasone (PVd) vs bortezomib/dexamethasone (Vd) in an entirely post-lenalidomide-treated population, demonstrated a 39% reduced risk of progression or death with PVd.
Dr Raje also addressed costs of drug treatment, for patients and society in general. The total lifetime costs to treat all patients diagnosed in 2017 was $22.4 billion, which excludes spending on hospital, infusion, laboratory, imaging, physician, nursing, and ancillary costs. This calculation also excludes quality-adjusted life-years (QALYs) gained and productivity in society.
In conclusion, she said drug combinations will allow us to improve responses and cure a higher fraction of patients. Combination strategies will also help overcome drug resistance and allow deep and durable responses. Tests such as MRD will allow us to either escalate or de-escalate therapy; therefore, the paradigm of continuous therapy may change, which will impact economic burden. Novel therapies will be incorporated earlier in disease course and current pathways will change. As the measurement of value shifts, QALY will be considered as opposed to sticker prices of drugs.
