Our Contributors/Value-Based Care

Evidence-Based Oncology, December 2018, Volume 24, Issue 13

Two of our contributors report on what we know and still need to learn about the Oncology Care Model, and how patient perspectives should inform healthcare value measurement.

Patient Perspectives Must Meaningfully Inform Healthcare Value Measurement

Jennifer Bright, MPA, and Elizabeth Franklin, LGSW, ACSW

The United States has the most expensive healthcare system in the world, as well as a growing number of patients living with chronic illnesses.1 Further, there is an ever-expanding number of available treatment options, many of which have limited differences in efficacy and toxicity.2 In addition to rising societal costs, many patients are increasingly experiencing financial toxicity.3 High out-of-pocket (OOP) costs associated with healthcare can put patients at physical, emotional, and financial risk as they may opt to skip doses, or ultimately lose their savings and/or face bankruptcy.4 As a result, there has been a growing focus on the concept of “value” in healthcare. Yet, there is lack of consensus on a definition of value.5 Although patient-centricity has been a steady refrain in healthcare, we question whether the values, needs, and preferences of patients have been meaningfully incorporated into value assessments thus far.

Perfunctory statements are often made regarding the consideration of patient viewpoints in value assessment, but meaningful action is another matter. There is not yet agreement—or even substantial serious conversation—about processes for measuring what patients truly value in healthcare. Without collaboration and routine efforts focused on how to build patient perspectives into such assessments, we will continue to engage in sporadic and superficial conversations with patients instead of capturing meaningful data that can contribute to a healthcare system which truly places them at the center.

There are encouraging trends that show patient viewpoints and participation are beginning to be prioritized. The FDA is now conducting patient-focused drug development in order

to systematically obtain the patient perspective on diseases and their treatments.6 In a survey of pharmaceutical industry representatives last year, 77% said embracing patient-centricity is extremely important to their company.7 Additionally, in a recent report by the Center for Workforce Health and Performance examining employer use of research-based evidence in health, the authors recommended that employers look beyond cost and use evidence-based research to assess what is most important to their employees.8

When patient perspectives are sought as part of value assessment, a vital understanding regarding what is most important to patients (such as productivity, OOP spending, convenience, and the promise of hope among many other concerns) is unlocked and can be considered in value calculations. This gives healthcare decision makers—from clinical trial designers to employee benefit designers—more insight into factors affecting choice and adherence to treatment, which have an impact on outcomes. Moreover, these stakeholders gain the advantage of having more precise tools to assess how diagnostics and therapies may work for individuals, rather than being limited to population-based averages, which may overlook crucial differences in patient response. In the decentralized and increasingly value-based US healthcare marketplace, use of data, analysis, and a real-world understanding of the covered population is imperative.

Patients and patient advocates have long understood that value means more than just efficacy and cost, and it differs according to the individual being treated. Oncology is a perfect example. Oncology care is more expensive than for any other disease; with a rapidly increasing array of treatment and imaging options9,10 and many patients having numerous therapy options, there are a host of factors and trade-off decisions that influence patient choice. Cancer is a disease area that demonstrates how value factors can go beyond a therapy’s cost.

Government agencies like the FDA are increasingly interested in patient-centered drug design and incorporation of patient-centered measures in clinical trials, but these efforts remain in their infancy. Several organizations—including the National Health Council, Pharmaceutical Research and Manufacturers of America, Avalere/FasterCures, and National Pharmaceutical Council—have called for patient engagement in developing value frameworks, but significant room for improvement exists in order to incorpo- rate ongoing, meaningful, and systematic patient feedback.

Existing frameworks tend to focus on clinical and economic outcomes, overlooking key concepts of importance to patients. Research has found that identifying the value to the individual patient is considered by many to be the most important factor in any assessment; yet, individual patient disease characteristics are not considered by many of the frameworks.11 Many frameworks overlook concepts such as quality of life, severity of disease, and daily functioning.12 Simply put, value is not comprehensively assessed when patients are not partners in the process.

But still the question persists: How should patient information be collected and incorporated into value assessment?

The Innovation and Value Initiative (IVI) makes incorporation of patients’ perspectives a priority in developing open-source, transparent value models, with multiple opportunities for patients to participate in model development and provide feedback.

Incorporating these perspectives into IVI’s mathematical models is often challenged by a lack of detailed data—although increasing use of patient-reported outcomes and patient expe- rience metrics in trials and studies could begin to change this. However, IVI has demonstrated how robust qualitative research utilizing focus groups and in-depth, structured interviews, leads to the collection and incorporation of patient experiences and perspectives.

IVI recently released qualitative research on patients with metastatic nonsquamous non—small cell lung cancer (NSCLC) who had received systemic therapy within the past 5 years.13 This research explored drivers of value, preferences in treatment, and other key contextual questions, which helped inform the structure and content of IVI’s Open-Source Value Platform (OSVP) decision models for assessing the relative value of sequential treatments for epidermal growth factor receptor—positive NSCLC.

According to the research, patients reported valuing treatments that would help increase overall or progression-free survival, help stop or slow progression of their disease, as well as the degree to which treatment efficacy would allow them to maintain functional ability and their quality of life with minimal adverse effects.

Incorporating these findings into IVI’s OSVP model from the onset is an important development for the science and implementation of value assessment and a step that those involved in assessing risk, value, and cost should analyze.

Still, the fact that best practices to collect real- world patient experience and preference data are not defined is evidence enough that we must prioritize ways to systematically capture and measure what is most meaningful to patients. It is no longer acceptable to say that this data is “messy” or challenging to quantify. If we are assessing a treatment or test specific to a patient population, it is our responsibility to collaborate with one another to better understand what the patients who are being impacted by these assessments have experienced and what they value most.

Value is not just the catch phrase of the moment in healthcare; rather, it has a direct impact on the lives of patients. All stakeholders need to step forward and embrace the challenge to find a way to routinely measure and include patient experiences and perspectives in treatment development and surveillance, and, ultimately, in value assessment. Accelerating action will ensure we can deliver better results for employers, plans, providers, and most importantly, patients.

AUTHOR INFORMATION:

Jennifer Bright, MPA, is executive director for the Innovation and Value Initiative. Elizabeth Franklin, LGSW, ACSW, is executive director of the Cancer Policy Institute at the Cancer Support Community in Washington, DC.

REFERENCES:

  1. Waters H, Graf M; Milken Institute. The cost of chronic diseases in the US. Milken Institute website. milkeninstitute.org/publications/view/910. Published May 25, 2018. Accessed November 2018.
  2. Schnipper LE, Davidson NE, Wollins DS, et al. Updating the American Society of Clinical Oncology value framework: revisions and reflections in response to comments received. J Clin Oncol. 2016;34(24):2925-2934. doi: 10.1200/JCO.2016.68.2518.
  3. Zafar SY. Financial toxicity of cancer care: it’s time to intervene. J Natl Cancer Inst. 2016;108(5). doi: 10.1093/jnci/djv370.
  4. Bach PB, Pearson SD. Payer and policy maker steps to support value-based pricing for drugs. JAMA. 2015;314(23):2503-2504. doi: 10.1001/ jama.2015.16843.
  5. Neumann PJ, Cohen JT. Measuring the value of prescription drugs. N Engl J Med. 2015;373(27):2595-2597. doi: 10.1056/NEJMp1512009.
  6. Patient-focused drug development: disease area meetings held in fiscal years 2013-2017. FDA website. fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm347317.htm. Updated March 23, 2018. Accessed November 2018.
  7. Miseta E. Is patient centricity just a buzzword? Clinical Leader website. clinicalleader.com/doc/is-patient-centricity-just-a-buzzword-0001. Published September 18, 2017. Accessed November 2018.
  8. Parry T, Jinnett K; The Center for Workforce Health and Performance. The employer’s role in using research-based healthcare evidence. CWHP website. https://www.tcwhp.org/sites/default/files/reports/CWHP%20Report%20June%202018.pdf. Published June 2018. Accessed November 2018.
  9. Adelson KB, Velji S, Patel K, Chaudhry B, Lyons C, Lilenbaum R. Prepar- ing for value-based payment: a stepwise approach for cancer centers. J Oncol Pract. 2016;12(10):e924-e932. doi: 10.1200/JOP.2016.014605.
  10. Ganz PA. Improving the quality and value of cancer care: a work in progress—The 2016 Joseph V. Simone Award and Lecture. J Oncol Pract. 2016;12(10):876-879. doi: 10.1200/JOP.2016.015339.
  11. Slomiany M, Madhavan P, Kuehn M, Richardson S. Value frameworks in oncology: comparative analysis and implications to the pharmaceutical industry. Am Health Drug Benefits. 2017;10(5):253-260.
  12. Sorenson C, Lavezzari G, Daniel G, et al. Advancing value assessment in the United States: a multistakeholder perspective. Value Health. 2017;20(2):299-307. doi: 10.1016/j.jval.2016.11.030.
  13. IVI’s patient research reveals importance of quality of life in assessing non-small cell lung cancer therapy sequence value [press release]. Los Angeles, CA: Innovation Value Initiative website; November 15, 2018. thevalueinitiative.org/patient-research-reveals-importance-of-quality-of-life/. Accessed November 27, 2018.

The New Oncology Bundle Model: What We Know and Don't Know

Alyssa Dahl, MPH, CPH

It's always exciting to see new episodic bundling models being considered, as it’s indic- ative of the industry’s movement toward getting better value out of the healthcare system. It’s also

a validation of all the work of early adopters of bundled payment models over the past 5 years (See SP572). With HHS Secretary Alex Azar’s November 8, 2018, announcement of an upcoming bundle in radiation oncology,1 CMS is showing its continued commitment to creating innovative ways of transforming care.

CMS’ announcement wasn’t a surprise—the payer has been vocal that their work in oncology isn’t done yet. However, it has been heartening to see that, despite political changes in the Trump administration and the time taken to re-evaluate these programs and how they’re being implemented, the play button for bundled payment models has been pressed again.

Here is what we know so far:

This new bundle will be specific to patients undergoing radiation treatment. Patients being treated with radiation therapy alone are currently excluded from the Oncology Care Model (OCM), and patients who may be undergoing both chemotherapy and radiation can have periods of their cancer journey omitted from an OCM episode. Having a radiation oncology bundle will help oncology practices cover a larger pool of patients in a care transformation model. Radiation oncology episodes will also likely be shorter in duration than OCM episodes, to reflect the length of radiology treatment regimens and a period of monitoring for complications.

The 2 major unknowns:

1. A looming question is: Will this bundle remain mandatory, as Azar stated during his announcement? It’s an aggressive decision because CMS hasn’t developed this kind of bundle in the past, and the agency does not have the benefit of experience from participants in a voluntary version to serve as a foundation. There are a few radiation oncology bundles in the private sector that could dissuade CMS from making this model mandatory, but we will have to wait and see how those play out.

2. Questions remain around the alignment of this bundle with the current OCM. If the models run concurrently, some patients may fall into both an OCM and radiation oncology episode. CMS will need to determine how to calculate savings and how to allow for cross-participation across the 2 models. Episode attribution to either program will not be as simple as when the Comprehensive Care for Joint Replacement program was introduced while the original Bundled Payments for Care Improvement program was still running. For these 2 oncology bundles, there are many ways CMS could go.

Participants should stay tuned to see if there is anything in CMS’ rulemaking that could possibly exclude their participation or affect their attributed OCM population. If there is, they may want to provide commentary to CMS to help shape the future of both programs. Over the coming weeks, we will be evaluating what can be modeled using the current and forthcoming program details; we encourage participants to be ready to have conver- sations around any new information we receive about this program in the coming weeks.

AUTHOR INFORMATION:

Alyssa Dahl, MPH, CPH, is manager of Healthcare Data Analytics at DataGen.

REFERENCE:

1. Caffrey M, Inserro A. Azar announces mandator oncology payment model is coming. The American Journal of Managed Care® website. ajmc.com/ newsroom/azar-announces-mandatory-oncology-payment-model-is-coming. Published November 8, 2018. Accessed November 21, 2018.