ADVERTISEMENT
Quality Measure Concepts to Fill Gaps in Assessing Oral Oncolytic Adherence: A Multistakeholder Measurement Strategy
J Clin Pathways. 2022;8(5):30-35. doi:10.25270/jcp.2022.06.2
Abstract
Oral oncolytics affect the way oncology providers and their patients manage treatment. Patients with cancer often prefer oral therapies; however, at-home oral treatments may lead to increased non-adherence. Medication adherence quality measures have been used to monitor adherence for other medication types, but none exist for oral oncolytic therapies. A multistakeholder workgroup of oncology and quality measurement experts explored gaps in quality measures focused on oral oncolytic adherence and identified, prioritized, and refined measure concepts for further development. The workgroup prioritized measure gaps and developed measure concepts to assess priority factors impacting adherence: 1) screening for oral oncolytic medication access challenges and 2) bidirectional patient and provider communication regarding oral oncolytic treatment. They further prioritized development of medication persistence rate and discontinuation rate measures. The workgroup then identified action steps to advance the measure concepts, including evidence generation, agreement on best practices to support adherence, identification and use of patient-reported outcomes measures and tools, and integration of measurement data components into existing workflows. Pursuing these recommendations will require collaboration across stakeholders.
Introduction
Since the advent of modern cancer treatment, oral oncolytics have transformed patient care.1,2 Increasingly, patients with cancer prefer oral therapies, which allow greater flexibility to take medication(s) at home.1,3,4 Yet this freedom can decrease interaction between patients and providers,5 limiting opportunities for ongoing medication education and increasing patients’ self-management burden.5 However, decreased interaction has been a benefit within the COVID-19 context. The use of oral oncolytics allows immunocompromised patients to spend less time in health care settings, reducing potential exposure to COVID-19.6
Maintaining “patient adherence” to oral oncolytics, or the degree of conformance to provider recommendations about day-to-day treatment with respect to timing, dosage, and frequency is a primary concern, in addition to duration of therapy or persistance.7 Various components of a regimen, including a medication’s side effects, out-of-pocket cost, and treatment schedule can impact adherence.1 Patients with cancer may be older with multiple comorbidities, and oral oncolytics can impact adherence to other treatments due to potential drug interactions, competing costs of care, and regimen complexity.8-11
Studies of cancer therapy adherence rates vary substantially, with estimates ranging from 20% to 100%.1 In one study of 8769 women diagnosed with breast cancer, only 49% were fully adherent to their prescribed adjuvant hormonal therapy for the entire study period.12 A study assessing the relationship between patient activation, confidence to self-manage side effects, and adherence to oral oncolytics revealed that approximately 30% of patients reported some type of nonadherence.13 In a study of patients with metastatic castration-resistant prostate cancer, researchers found a rate of nonadherence of only 4.8% when based on pill counting and a low rate of 1.3% based on patient reporting.14
Adherence has continued to be an overarching quality priority, especially as new oral oncolytics, including targeted therapies such as tyrosine kinase inhibitors (TKIs) and cyclin-dependent kinase (CDK) 4/6 inhibitors, have been introduced as treatment options.
Medication nonadherence can lead to unnecessary treatment, higher hospitalization rates, and disease exacerbation; for oral oncolytics specifically, nonadherence may lead to worsening disease, and increased mortality.15,16 In contrast, adherence to oral oncolytics is directly associated with better outcomes across cancer types.3 In a study of patients with breast cancer who were prescribed oral oncolytics, adherence rates lower than 80% were associated with increased mortality risk.17 A separate study showed that TKI adherence rates higher than 90% were associated with a 94.5% probability of major molecular response in patients with chronic myeloid leukemia at 6 years, in comparison to a 28.4% response for patients with lower adherence.18 Patients undergoing treatment with imatinib with adherence rates lower than 85% had higher inpatient, supplemental pharmacy, and outpatient costs than those with adherence rates of 85% or more.19
The Need for Quality Measures: As the US health care system shifts toward value-based models, patients, providers, and policymakers are increasingly relying on performance measures for public reporting, value-based payment, and quality improvement.20 The Pharmacy Quality Alliance (PQA) and the Centers for Medicare & Medicaid Services (CMS) have developed and implemented adherence measures for chronic conditions such as diabetes, schizophrenia, and sleep apnea. Those measures have been implemented in physician and health plan payment models.21,22 While adherence-focused cancer measures do not yet exist, the CMS Measure Development Plan designated cancer treatment as a priority area for measure development.23 Given the increasing use of oral oncolytics, the impact of nonadherence on clinical outcomes and cost, and the demonstrated variation in adherence rates, identifying performance measure concepts to monitor adherence is essential. This workgroup was convened to better understand the gaps and challenges in oral oncolytic adherence performance measurement and provide recommendations to advance measurement for the management of oncology care. Importantly, measurement alone is insufficient to manage and improve oncology care, and other factors, including guidelines, other provider tools, and the impact of the COVID-19 pandemic, are important areas for exploration. While the authors and workgroup participants recognize the importance of these other factors, this workgroup focused on quality measurement. The objectives of the convening were to:
- Engage oncology stakeholders and adherence measurement experts to advance development of quality measures to drive oral oncolytic adherence, including novel approaches for assessing adherence rates and measures assessing factors that impact adherence.
- Define barriers and opportunities to specifying and testing measures for oral oncolytic adherence.
- Identify 1 to 3 measure concepts to advance measurement of oral oncolytic adherence, prioritized by both impact and feasibility.
Methods
Preliminary Research: To inform the multistakeholder workgroup’s discussion, the workgroup facilitators researched key drivers of oncolytic non-adherence, derived from clinical guidelines and literature, and cataloged available quality measures. Through this process, the facilitators sorted factors impacting adherence into 4 general categories: predisposing factors, health literacy, treatment factors, and system factors (Table 1).1,24-28
Next, the facilitators compared the adherence factors to value-based program measure sets to identify available quality measures and gaps. The facilitators then reviewed measure development and endorsement processes and criteria (eg, CMS Measure Development Blueprint, National Quality Forum Evaluation Criteria) to guide conceptualization of new measures. This preliminary research was shared with the multistakeholder workgroup to inform discussion of quality measure gap priorities and conceptualization of new measures.
Workgroup Selection: Given the workgroup’s objectives to define barriers and opportunities for measurement of oral oncolytic adherence, the workgroup included experts in cancer care delivery, particularly those with knowledge in oral therapy management (oncologists and nurses), health policy experts, measure developers, pharmacists and pharmacy benefit manager subject matter experts, adherence researchers, and patients diagnosed with cancer, as well as patient advocates. This multistakeholder approach aimed to bring together a wide range of opinions and perspectives relevant to the intersection of quality measurement science and cancer care delivery. Pharmacist and nurse representation was prioritized, given their roles in care processes focused on dispensing and monitoring of oral oncolytics. The workgroup participants, representing a range of oncology and pharmacy organizations, are listed in Table 2.
Workgroup Convenings: The facilitators convened the workgroup participants for 5 virtual sessions and encouraged active participation through a combination of structured discussion, small breakout group activities, virtual whiteboarding, dot voting, and polling methods. Members’ interests in certain concepts were expressed and in certain cases quantified through these methods. Each session was designed to build on prior workgroup discussion to ultimately generate prioritized quality measure concepts for development:
Session 1: Prioritize 2–3 important measure gaps for subsequent conceptualization.
Session 2: Brainstorm measure concepts that monitor key care processes related to factors impacting adherence.
Session 3: Refine measure concepts based on data availability and feasibility.
Session 4: Consider measure usability and implementation.
Session 5: Finalize consensus-based action steps to advance measure development.
Results
Performance Measure Gaps: Following review of the existing measures and gaps, including measures and concepts developed by the PQA and the American Society of Clinical Oncology (ASCO), the workgroup prioritized conceptualization of measures for screening for perceived need and help-seeking, shared decision-making for therapy selection, and screening for medication access challenges (Figure 1).
The prioritization process occurred through the aforementioned active engagement methods. After a review of the measure gaps, the participants separated into breakout groups, each of which selected priority gaps through dot voting and polling. Next, each group used virtual whiteboarding to identify potential measure concepts for each of their prioritized gaps. Finally, facilitators quantified workgroup participant’s prioritization of the 4 preliminary gaps defined from the literature, and high-priority concepts were discussed further among the entire group.
Conceptualizing Measures and Identifying Barriers: In considering the prioritized gaps, the workgroup undertook a measure conceptualization process that included discussion of potential measurement barriers, level of impact, and feasibility considerations for future measure implementation. During conceptualization, the workgroup considered the difference between adherence and compliance. “Compliance” may imply one-sided directives in which failure to take a medication as directed is the responsibility of the patient alone.29 The workgroup preferred the term “adherence,” as it rearranges the therapeutic relationship between patient and provider to include the patient’s active involvement.30 The resulting prioritized measure package included 2 concepts to assess factors impacting adherence, and a third concept to assess adherence rates (Figure 2).
Screening for Oral Oncolytic
Medication Access Challenges: The workgroup agreed that screening for medication access challenges before prescribing oral oncolytics, and throughout treatment, is essential to address factors impacting adherence (eg, predisposing factors like socioeconomic status). Regular screening should be completed in conjunction with other processes to resolve identified adherence barriers and opportunities to improve adherence. The workgroup recommended measuring documentation of screening and accompanying referrals in medical records. A barrier for advancing this measure concept is the lack of best practices for screening and resolving access challenges. Gaps in standardized screening tools that can be routinely used and documented are also barriers.
Bidirectional Patient and Provider
Communication for Oral Oncolytic Treatment: The workgroup also agreed that patient and provider communication about oral oncolytic treatment options and risks is a priority for measurement and quality improvement. A multidisciplinary approach is crucial to managing care for patients taking oral oncolytics. “Provider” refers to all members of the care team supporting a patient treated with oral oncolytics (eg, prescribing oncologist, advanced practitioners, oncology nurses, patient/care navigators, pharmacists) and their caregivers. Bidirectional exchange is vital to ensure patients and caregivers understand treatment options and accompanying risks, care teams understand threats to adherence, and all parties are positioned to manage these risks throughout the care journey. The lack of established best practices for communication techniques about oral oncolytic benefits and risks among and between care teams, patients, and caregivers is a barrier to advancing this measure concept.
Assessment of Oral Oncolytic Adherence Rate: Participants expressed concerns with traditional methods of adherence measurement. They agreed that common methods for assessing adherence, such as medication possession ratio (MPR) and proportion of days covered (PDC), may not be ideal for oral oncolytics given the variety of therapies and unique challenges associated with cancer care. The participants also agreed that this type of adherence rate measure alone is insufficient to improve care. The group recommended a 2-pronged approach, measuring adherence rates in conjunction with processes that can improve adherence. The approaches of most interest to the group were medication persistence and discontinuation rates.
The participants debated about readiness to advance an adherence rate measure for oral oncolytics. Some emphasized the need to close critical evidence gaps, while others stressed the need to drive toward consensus on the most feasible measurement approach using currently available data. Challenges for the adherence rate concept include a shortage of integrated clinical and pharmacy data, lack of clarity about the ideal persistence rate for various oncolytic drug classes, and how to account for curative vs noncurative treatment intent.
Action Steps to Advance Concepts: The workgroup identified action steps to advance the recommended measure concepts, and highlighted the need for a diverse group of stakeholders, including researchers, providers, patients and caregivers, technology vendors, and policymakers to collaborate to:
Identify and establish best practices to screen patients for medication access and adherence challenges. While the workgroup agreed that screening is essential to improving adherence, they agreed well-defined standards for assessing medication access challenges are not available. The workgroup recommended using the Medication Access Framework for Quality Measurement, developed by the PQA with support from the National Pharmaceutical Council (NPC), to advance best practices.31
Once standards for screening are defined, there is also a need to create standardized, validated screening tools that can be routinely adopted in clinical care.
Support integration of screening for medication access and adherence challenges into routine workflow and electronic data collection. Electronic sources of data used for quality measure reporting (eg, electronic medical records [EMRs]) do not routinely include structured data relating to medication access challenges. While some EMRs provide fields to integrate patient information and intent of treatment, the output may not support reliable measurement. Some integrated systems, including Oncology Care Model (OCM) practices, have tested ways to capture quality measure components in their existing workflows and EMR systems. While these methods have yet to be standardized, such practice sites may be ideal candidates for piloting measures.
Identify and establish best practices for care teams to communicate with patients and caregivers about oral oncolytic therapy and risk factors for nonadherence (eg, financial/insurance considerations, self-management/responsibility, adverse event reporting, and management). While there was consensus among the workgroup that meaningful, bidirectional patient and care team communication about treatment and treatment barriers is essential for improving adherence, there are not yet defined best practices for these conversations. The workgroup reinforced that providers should initiate conversations relevant to adherence throughout the treatment process, including before and after selection of a regimen, rather than only at the time of prescribing. Ultimately, health information technology should support bidirectional communication, and allow for standardization and measurement of the effectiveness of these discussions.
Determine if existing patient-reported outcome measures (PROMs) (including patient experience surveys) can be leveraged to support data collection for future measures assessing bidirectional communication, or if new patient-reported tools should be developed and validated. Patient-reported tools for oncology treatment include PROMs evaluating quality of life, as well as the Agency for Healthcare Research and Quality’s Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey.32 The National Institute of Health Common Fund’s Patient-Reported Outcomes Measurement Information System (PROMIS) includes measures for pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality of life across a variety of chronic diseases.33 The workgroup recommended evaluating these tools for refinement opportunities or assessing if new tools are needed to measure bidirectional patient and care team communication effectiveness, beyond documentation that discussions occurred.
Discussion
Given oral oncolytic adherence variation and its impact on both clinical and cost outcomes, adherence quality measure development should be prioritized. Barriers to oral oncolytic adherence include disease characteristics, health literacy, and treatment and system factors. Quality measures are a necessary tool to understand and address these factors impacting patients before and during treatment, especially as value-based models promoting cost control are increasingly adopted.
A multistakeholder workgroup developed oral oncolytic adherence measure concepts and subsequent action recommendations to advance measure development. The priority measure concepts identified, including screening for medication access challenges, bidirectional patient-provider communication, and assessment of adherence rate, each come with data collection and implementation challenges. Meeting these challenges, and advancing measurement for oral oncolytic adherence, will require collaboration across oncology stakeholders.
References
1. Geynisman DM, Wickersham KE. Adherence to targeted oral anticancer medications. Discov Med. 2013;15(83):231–241.
2. Lindsey H. Improving adherence to oral oncolytics. Oncology Times. 2011;33(20): 5-7.
3. Journal of Oncology Navigation & Survivorship. The importance of medication adherence in patients with chronic hematologic malignancies. Accessed June 7, 2022. http://jons-online.com/special-issues-and-supplements/2019/best-practices-in-hematologic-malignancies-december-2019-vol-10/2729-the-importance-of-medication-adherence-in-patients-with-chronic-hematologic-malignancies.
4. Eek D, Krohe M, Mazar I, et al. Patient-reported preferences for oral versus intravenous administration for the treatment of cancer: a review of the literature. Patient Prefer Adherence. 2016;10:1609–1621. doi: 10.2147/PPA.S106629.
5. Hansen LA. Impact of nonadherence to cancer therapy. Journal of Hematology Oncology Pharmacy website. Accessed June 7, 2022. http://jhoponline.com/ton-online-first/3639-ton-3639.
6. Alwardt M, Stutz S. Medically integrated pharmacies, oral oncolytic agents grow in importance during COVID-19. Pharmacy Times. 2021;3(5).
7. Cramer JA, Roy A, Burrell A, et al. Medication compliance and persistence: terminology and definitions. Value Health. 2008;11(1):44–47. doi: 10.1111/j.1524-4733.2007.00213.x.
8. Dashputre AA, Gatwood KS, Schmidt J, Gatwood J. Impact of oral oncolytic initiation on medication adherence for pre-existing comorbid chronic conditions. J Oncol Pharm Pract. 2020;26(4):835–845. doi: 10.1177/1078155219875206.
9. Ogle KS, Swanson GM, Woods N, Azzouz F. Cancer and comorbidity: redefining chronic diseases. Cancer. 2000;88(3):653–663. doi: 10.1002/(sici)1097-0142(20000201)88:3<653::aid-cncr24>3.0.co;2-1.
10. Zhao J, Zheng Z, Han X, et al. Cancer history, health insurance coverage, and cost-related medication nonadherence and medication cost-coping strategies in the United States. Value Health. 2019;22(7):762–767. doi: 10.1016/j.jval.2019.01.015.
11. Campen CJ, Vogel WH, Shah PJ. Managing drug interactions in cancer therapy: a guide for the advanced practitioner. J Adv Pract Oncol. 2017;8(6):609–620.
12. Hershman DL, Kushi LH, Shao T, et al. Early discontinuation and nonadherence to adjuvant hormonal therapy in a cohort of 8,769 early-stage breast cancer patients. J Clin Oncol. 2010;28(27):4120-4128. doi:10.1200/JCO.2009.25.9655
13 Salgado TM, Mackler E, Severson JA, et al. The relationship between patient activation, confidence to self-manage side effects, and adherence to oral oncolytics: a pilot study with Michigan oncology practices. Support Care Cancer. 2017;25(6):1797-1807. doi:10.1007/s00520-017-3584-0
14. Banna GL, Urzia V, Benanti C, et al. Adherence to abiraterone or enzalutamide in elderly metastatic castration-resistant prostate cancer. Support Care Cancer. 2020;28(10):4687-4695. doi:10.1007/s00520-020-05311-5
15. Hohneker J, Shah-Mehta S, Brandt PS. Perspectives on adherence and persistence with oral medications for cancer treatment. J Oncol Pract. 2011;7(1):65–67. doi: 10.1200/JOP.2010.000076/.
16. DiMatteo MR, Giordani PJ, Lepper HS, Croghan TW. Patient adherence and medical treatment outcomes: a meta-analysis. Med Care. 2002;40(9):794–811. doi: 10.1097/00005650-200209000-00009.
17. McCowan C, Shearer J, Donnan PT, et al. Cohort study examining tamoxifen adherence and its relationship to mortality in women with breast cancer. Br J Cancer. 2008;99(11):1763–1768. doi: 10.1038/sj.bjc.6604758.
18. Bazeos A, Khorashad J, Mahon F-X, et al. Long term adherence to imatinib therapy is the critical factor for achieving molecular responses in chronic myeloid leukemia patients. Blood. 2009;114(22):3290. doi: 10.1182/blood.V114.22.3290.3290.
19. Wu EQ, Johnson S, Beaulieu N, et al. Healthcare resource utilization and costs associated with non-adherence to imatinib treatment in chronic myeloid leukemia patients. Curr Med Res Opin. 2010;26(1):61–69. doi: 10.1185/03007990903396469.
20. Quality Measures. Centers for Medicare & Medicaid Services. Updated April 14, 2022. Accessed June 7, 2022. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures
21. 2021 Quality Measure List. Centers for Medicare & Medicaid Services. Accessed June 7, 2022. https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/1246/2021%20MIPS%20Quality%20Measures%20List.xlsx
22. Medicare 2021 Part C and D Star Ratings, Technical Notes. Centers for Medicare & Medicaid Services. Updated October 1, 2021. Accessed June 7, 2022. https://www.cms.gov/files/document/2021technotes20201001.pdf-0
23. 2021 MDP Annual Report and Appendices. Centers for Medicare & Medicaid Services. Accessed June 7, 2022. https://www.cms.gov/files/zip/2021-mdp-annual-report-and-appendices.zip
24. Divakaruni A, Saylor E, Duffy AP. Assessing the need for improved strategies and medication-related education to increase adherence for oral anticancer medications in the young adult oncology population. J Oncol Pharm Pract. 2018;24(5):337–342. doi: 10.1177/1078155217703790
25. Krikorian S, Pories S, Tataronis G, et al. Adherence to oral chemotherapy: challenges and opportunities. J Oncol Pharm Pract. 2019;25(7):1590–1598. doi: 10.1177/1078155218800384.
26. Jacobs JM, Pensak NA, Sporn NJ, et al. Treatment satisfaction and adherence to oral chemotherapy in patients with cancer. J Oncol Pract. 2017;13(5):e474–e485. doi: 10.1200/JOP.2016.019729.
27. Decker V, Spoelstra S, Miezo E, et al. A pilot study of an automated voice response system and nursing intervention to monitor adherence to oral chemotherapy agents. Cancer Nurs. 2009;32(6):E20–E29 doi: 10.1097/NCC.0b013e3181b31114
28. Jacobs JM, Ream ME, Pensak N, et al. Patient experiences with oral chemotherapy: adherence, symptoms, and quality of life. J Natl Compr Canc Netw. 2019;17(3):221–228. doi: 10.6004/jnccn.2018.7098
29. Gdcamp. Key ethics term – adherence vs compliance. Ecology of Health and Medicine. Published July 12, 2017. Accessed June 7, 2022. https://blogs.uw.edu/somehm/2017/07/12/key-ethics-term-adherence-vs-compliance/
30. Chakrabarti S. What’s in a name? Compliance, adherence and concordance in chronic psychiatric disorders. World J Psychiatry. 2014;4(2):30–36. doi: 10.5498/wjp.v4.i2.30
31. Schmitz R. New medication access framework identifies opportunities for quality measurement to address social determinants of health. Pharmacy Quality Alliance. Published March 7, 2019. Accessed June 7, 2022. https://www.pqaalliance.org/medication-access-framework
32. CAHPS Cancer Care Survey. Agency for Healthcare Research and Quality. Updated July 2020. Accessed DJune 7, 2022. https://www.ahrq.gov/cahps/surveys-guidance/cancer/index.html
33. Patient-Reported Outcomes Measurement Information System (PROMIS). National Institutes of Health Office of Strategic Coordination – The Common Fund. Updated January 29, 2019. Accessed June 7, 2022. https://commonfund.nih.gov/promis/index
34. NCPDP. Specialty pharmacy. National Council for Prescription Drug Program. Accessed June 7, 2022. https://ncpdp.org/Specialty-Pharmacy
