AMCP Partnership Forum: Driving Value and Outcomes in Oncology

Cancer is one of the most costly medical conditions to treat in the United States due in part to increasingly innovative, but expensive, chemotherapeutic, immuno-oncologic, and biologic treatments. At the same time, health insurance in the United States is increasingly shifting a larger part of the costs to patients through higher premiums, deductibles, and coinsurance and copayment rates. These shifts are driving the need for quality measures and value measurements in oncology that assess the total effect on care and can be used to develop payment models. Measures that consider the patient’s experience are emerging as important factors for evaluating value in cancer care. To address these issues, the Academy of Managed Care Pharmacy (AMCP) convened a stakeholder forum, Driving Value and Outcomes in Oncology, on November 14-15, 2017, in Arlington, Virginia. The goals of the forum were to (a) understand which oncology-specific quality measures are important for managed care decision makers; (b) prioritize the gaps related to the use of pharmaceuticals in measuring oncology outcomes; (c) develop a list of recommendations for how a collaboration of payers, providers, and AMCP may drive improvements in oncology care; and (d) define solutions for addressing causes of patient financial burdens for cancer care. More than 30 national and regional health care leaders representing health plans, integrated delivery systems, pharmacy benefit managers, pharmacists, employers, patient advocates, national professional associations, and biopharmaceutical companies participated in the forum.


P R O C E E D I N G S
via patient-reported outcomes (PROs) is emerging as a critical factor that may help further define the value associated with a treatment. Identifying appropriate metrics that are meaningful, measurable, applicable to evolving practices, and reflect the patient experience are critical for defining value.
To address these issues, the Academy of Managed Care Pharmacy (AMCP) convened a forum on November 14-15, 2017, with the participation of key stakeholders representing health plans, integrated delivery systems, pharmacy benefit managers, pharmacists, employers, patient advocates, national professional associations, and biopharmaceutical companies Specifically, the forum's goals were to (a) understand which oncology-specific quality measures are important for managed care decision makers; (b) prioritize the gaps related to the use of pharmaceuticals in measuring oncology outcomes; (c) develop a list of recommendations for how a collaboration of payers, providers, and AMCP may drive improvements in oncology care; and (d) define solutions for addressing causes of patient financial burdens of cancer care.

■■ The Financial Burden of Cancer Care
A substantial financial burden affects wide segments of the population of patients with cancer, including patients with employer-sponsored health insurance. 2 The financial burden of cancer has the potential to harm patient quality of life, clinical outcomes, and adherence to treatment. A systematic review of 25 recent studies found that up to 78% of patients with cancer experienced a financial hardship due to the costs of cancer care. 3 The costs borne by patients are expanding as an increasing amount of the cost burden for health care shifts to individual patients (e.g., through deductibles, coinsurance, and copays) and overall costs increase. Forum participants noted that, in addition to the costs of health care, many patients experience reduced or lost employment, and struggle with other costs not related to treatment (e.g., transportation, housing, food, and child care), thereby compounding the financial burden. Caregivers may also be forced to reduce employment to care for patients, causing further financial pressure.
When compared with individuals without cancer history, cancer survivors also have higher out-of-pocket costs reflecting ongoing cancer care and care for late or lasting treatment effects. 4 Patients who are in remission may have ongoing increased costs due to difficulty obtaining affordable insurance and costs associated with continuous monitoring, long-term therapy, disability, or reduced employability. 5 electronic health record (EHR) systems to provide information about costs for individual patients at the point of care could improve cost transparency and facilitate such conversations. Improved interoperability of data from EHR systems would facilitate improved information sharing. Several forum participants felt that providing patients with objective information about costs, as well as other factors such as safety and efficacy, would better prepare the patient to engage in informed decision making.
Many biopharmaceutical manufacturers and nonprofit organizations offer patient-assistance programs that provide financial support for medications. Participants noted that some of these programs (e.g., copay coupons) may actually increase the total cost of care if they encourage the use of more costly medications that do not also improve quality or outcomes. In general, patient-assistance programs that are focused on disease rather than product are seen as more valuable support programs because of the greater flexibility and patient focus.
Participants also recommended using shared decision making to engage patients, address cultural competency, and to help patients realize how they may need to change their lifestyle after diagnosis because of the treatment and cost of cancer care.
Health System Interventions. The health care system is made up of silos, and there is patient cost sharing in each part of the system that will need to be addressed.
Traditional pharmacy contracting agreements do not usually directly pass along financial savings to patients or directly address patient out-of-pocket costs. Forum participants recommended evaluating the effect of pharmaceutical contract agreements on patient out-of-pocket costs. The use of multitiered formularies that provide lower cost-share access to interventions with the greatest value and a higher cost sharing for lower-valued treatments can help align incentives for patients with value. Participants also noted that value-based practice models that increase patient interactions with care providers could increase patient out-of-pocket costs (e.g., increased copays for visits or diagnostics).
Some states have experimented with mandated coverage policies such as oral chemotherapy parity laws that require payers to cover oral chemotherapeutic agents under "no less favorable" terms than intravenous chemotherapies. One publication recently found that these laws have not consistently reduced out-of-pocket spending for orally administered anticancer medications. 8 Since the parity laws do not address the affordability of cancer medications or price transparency, these laws alone are insufficient to ensure that patients are protected from high out-of-pocket medication costs.
Participants observed that the site of care also affects patient costs. For example, if patients receive treatment at inpatient or specialty centers rather than at community settings, costs will likely increase. They noted that payment models should be strategies for providing access and supporting adherence to critical cancer medications must address the patient financial burden of care and include interventions for the patient, health system, payer, and society. Patient Interventions. Several strategies were recommended to address the financial burden of cancer care, including the need to understand what patients value in their care, increasing patient education regarding the cost of treatment options, shared decision making, patient-assistance programs, and the use of value-based payment models.
Price transparency and communication with patients about the cost of care can be challenging. Forum participants noted that physicians are often underprepared to address financial issues because of the opacity of treatment costs at the point of care and the sensitive nature of discussing health care costs with patients. In addition, patients may have difficulty processing information regarding the financial effect of care at the time of diagnosis, since they may be more focused on the effect of the cancer diagnosis on their life and mortality. Ongoing conversations at various touchpoints throughout the course of treatment can assist with providing appropriate education. However, if stakeholders desire that patients are informed and engaged in their care, then health care providers will need to be supportive of efforts to have meaningful conversations with patients about the value of treatment options. All stakeholders can play a meaningful role in requiring greater cost transparency.
Because of the complexity and variability of insurance coverage, physicians may not have access to accurate information regarding the costs of treatment for individual patients. 6,7 Using Forces Driving Change in Oncology designed to incentivize providers to treat patients according to the best available evidence and at the most appropriate site of care, which should include a consideration of the level of care expertise needed and cost associated with the facility.
Payer Interventions. Participants called for rethinking insurance coverage benefits for patients with cancer and for a focus on implementing value-based insurance designs that provide incentives for patients to receive high-value therapeutic options and address the total cost of care. Similarly, they restated the need to be able to pass the savings associated with contracting strategies along to patients, as well as the need to base formulary tier structures on demonstrated value. Participants also identified the timing of annual benefit changes and lack of portability of financial risk across longer time periods and different payers as challenges to the financial burden of cancer care on patients. New and innovative insurance coverage benefit designs specific to cancer care are encouraged to address these challenges.
The forum participants suggested that the funding of financial navigators to help cancer patients avoid adverse financial consequences after a cancer diagnosis was an intervention that payers could support.
Participants noted that employers have an important stake in driving health insurance benefit designs. They felt that insurers have an opportunity to improve the education of employers regarding the implications of various benefit structures for oncology care and felt it was important to shift the discussion away from managing the pharmacy benefit and toward considering the total cost of cancer care, patient quality of life, productivity, and return to employment.
Finally, participants encouraged incentivizing oncologists to return patients to primary care providers when appropriate, so that survivors can receive their nonspecialty care needs at the most appropriate and affordable site of care.
Societal Interventions. Societal trade-offs related to the increasing costs of care and the affordability of health insurance are additional factors to consider when assessing the value of a treatment. Determinations of value should consider the needs of the individual as well as trade-offs across patient populations and other segments of the economy. Ultimately, however, when faced with increasing costs and limited evidence for a therapy, payers and purchasers of health care have demonstrated a trend towards limiting coverage.
Societal supports could include the development or expansion of safety net programs that help ensure that patient needs are addressed. Participants also called for a national conversation to define value in health care from the societal perspective, since it was noted that often patients and physicians differ in their definitions of high-value care.

■■ Defining Value and Maximizing Use of Quality Measures
Value-based care requires a transparent, agreed-upon set of criteria for evaluating outcomes and defining value, partial value, or no value. Health measurements are requested or required by many organizations for many purposes, including efforts to track population and individual health, assessments of health care quality and patient experience, transparency monitoring, public reporting and benchmarking, and professional performance requirements. However, definitions of value are problematic and mean different things to different stakeholders. Participants remarked that not everything that is of value can be measured and not everything that is measurable is of value. Furthermore, they observed that outcomes can be statistically significant without providing meaningful benefits to the patient. 9

The Roles of Quality Measures in Improving Care
There is general consensus within the cancer community that quality measurement and reporting are critical tools for ensuring high-quality cancer care and that quality measures should be used to improve outcomes and the patient experience, as well as make the health care system safer and more efficient. Quality measures should be meaningful to multiple stakeholders, easily measurable, and based on outcomes. During the forum, participants evaluated current oncology quality measures, discussed their importance to each represented stakeholder, and explored gaps. Participants noted that there are a wide range of available quality measures that can be difficult to manage and that some older measures are no longer relevant.
Individual quality measures have varying importance depending on the stakeholder point of view. For example, process measures that can guide improvements in practice efficiency may be most important to payers and providers, whereas patient-centered outcomes are important to payers, providers, and patients.
Participants stressed that to improve care it is critical to use quality measures to provide feedback and drive improvements rather than using them as a punitive tool. Ultimately, they reasoned, the purpose of measurement should be to improve value through quality improvement initiatives that identify and promote best practices, the provision of decision support, and the alignment of incentives.

Identified Issues for Refining Quality Measures.
Participants noted several overarching issues that will need be addressed to make quality measures effective for driving value. Consistent access to data and greater interoperability among data systems are needed for performance measurement. For example, access to information about mortality is crucial for some measures, but it may be challenging to identify the exact date of death in publicly available data, which complicates the evaluation of performance on such measures.
It also may be difficult in the future to develop treatmentspecific measures because of the small number of patients who are treated for rare cancers or with precision medicines. Therefore, measures that are tissue agnostic (i.e., they can be applied across multiple pathologies) or treatment agnostic (i.e., not specific to an intervention) may be desirable for future measure development.
Participants also noted that there should be a process for reevaluating and retiring measures at regular intervals to allow for retirement of obsolete measures and for those that have been optimized to be removed from the system. Robust, upto-date, and meaningful measures to assess oncology care are necessary, which involves, in part, shifting the focus to outcome measures that matter to patients. Participants recommended that any new quality measure development should consider patient input on value or the inclusion of PROs as appropriate.

Important Considerations for Measuring Value
High-value care is evidence-based, patient-centered, and affordable. To support the measurement of high-value care, participants were asked to list characteristics of value measurements and to propose measurements relevant for innovative pharmaceutical therapies. Participants also discussed issues related to value measurement, including timeliness, data gathering and analysis, and utilization of data to improve practice.

Select Oncology Quality Measure and Value Gaps and Opportunities
Participants recommended features of value measurements that included the following: • Objective • Accessible • Based on pharmaceutical or medical claims data that can be assessed regularly • Provides actionable information • Meaningful to users (patients, payers, and providers) • Based on real-world evidence and available in real time Participants recommended that, when selecting measurements of value, it is important to determine the purpose of the measures (e.g., cost, appropriateness of treatment, and quality of life).
The process for implementing value measures requires development, testing, validation in multiple settings, dissemination, and application. Because best practices are not usually well defined for innovative therapies, it can be difficult to develop measurements that are meaningful to the patient and actionable in practice, along with the infrastructure for their implementation, in a timely manner. Defining value in a rapidly changing space is difficult, so it is important to regularly assess the relevance of various measurement changes as practice changes.
Participants noted that outcomes observed in clinical trials (e.g., progression-free survival and overall survival) are not always realized in the real world or measurable within the time frame of a value-based payment system. Therefore, when using value measurements, it is important to identify efficacy and toxicity endpoints and compare real-world evidence with clinical trial findings to assess actual value. Risk Evaluation and Mitigation Strategy programs (https://www.fda.gov/Drugs/ DrugSafety/REMS/default.htm) are one mechanism for gaining a better understanding of real-world efficacy and risks.
In addition, using EHR data to perform population-level analysis can be helpful for identifying gaps in care, which can become targets for quality improvement measures. However, systems must be designed to engage patients and providers in a manner that facilitates data capture and data reporting, such as adding structured and well-defined data fields to EHR systems.

Evaluating Existing Quality Measures and Value Measurement Gaps
Selected oncology quality measures and value measurement gaps and opportunities were ranked by the participants and compared with those prioritized by the National Quality Forum, the Centers for Medicare & Medicaid Services, and the Core Quality Measure Collaborative, as shown in Table 1. 10 Participants were asked to identify gaps in oncology quality and value measurement, with a specific focus on gaps evaluating the use of pharmaceuticals and also were asked to brainstorm potential cross-cutting measures that could be developed for use regardless of a patient's disease or treatment (

Forum Participant Recommendations for New Measure Development and Reporting
Finally, participants were asked to prioritize which value measurements they felt were most useful to use in value frameworks. 10 Participants were placed in 4 groups, and each group reported their priorities. The recommended priorities are summarized in Table 3. Participants also proposed several new measurements, including the following: • Time to treatment switch • Adherence to pathways • Treatment duration • Expectations of therapy • PROs as a function of safety • Risk of long-term effects • Societal costs Participants recommended that any new measurements be used in efforts to align incentives to outcomes that are meaningful to patients. Patient surveys will be an important tool to use throughout the data-gathering process on the patient perspective.

Moving Forward
As a recognized national leader in providing education, facilitating discussions, and supporting evidence-based product evaluation and managed care advocacy, AMCP is heading a collaborative effort among key professional associations and other stakeholders to address the opportunities identified at this forum. Through education sessions at AMCP national meetings; ongoing forums with multiple stakeholders that address specific strategies and standards for ushering in an era of precision medicine; and working collaboratively with key stakeholders to identify a pathway to using PROs in a value-based health care system, these multiyear initiatives are focused on driving value and outcomes in health care, while also addressing the financial burden of care on patients and society. AMCP will also support its members' efforts to integrate health care benefits, reduce silos of care, improve the quality of care, and engage in the conversation on defining value in health care from a societal perspective.

■■ Conclusions
Oncology is often viewed differently than other disease states by society, and treatments for cancer are often valued differently than treatments for other disease states. Oncology management is undergoing a fundamental change because of innovations in treatment that are leading to practice transformation and requiring stakeholders to reevaluate payment models. The patient experience in oncology care is fundamental to assessing the value of care interventions. Efforts and metrics to quantify the patient experience, as measured by PROs, are expanding to allow for the development of payment models that recognize this value. As value-based care models evolve in oncology, they show promise for use in designing payment models for innovative treatments that emerge for other disease states.
During discussions, participants stressed that measurements addressing the patient experience may be particularly important for advanced disease and end-of-life care. In palliative care situations, quality of life and value of care, along with advanced care planning, are critical. Performing advanced care planning allows the patient's voice to be heard so that teams can adhere to patient wishes. Evidence suggests that such planning reduces burdens on patients, caregivers, and clinicians and often also reduces overall costs.

Alignment of Participant Top Prioritization Efficacy
Overall