Pharmacoeconomics Evaluations of Oral Anticancer Agents: Systematic Review of Characteristics, Methodological Trends, and Reporting Quality

e20596 Background: With the increasing number of orally administered anticancer agents, evaluation of treatment adherence is critical to assess efficacy and adverse events. When patients enrolled in registration clinical trials do not adhere to the investigational agent(s), conclusions made regarding efficacy and safety may be inaccurate and translate poorly to broader use. We performed a systematic review of adherence reporting in phase III trials of oral anticancer agents. Methods: We selected all oral anticancer agents approved by the FDA between 1996 and 2012. A PubMed search for generic name, with limits to "title" and "clinical trials", was performed. Publications from phase III trials were identified from the results. Medication adherence data were abstracted searching for the roots “compli” and “adher” and were categorized as follows: 1) mentioned or not, 2) methods described or not and 3) results reported or not. Results: Overall, publications or reports with 24 agents were identified. The search strategy yielded 5383 articles, of which 504 reporting on phase III trials were included for analysis. Of these, 106 (21%) mentioned either adherence or compliance to medications. Only 33 (7%) publications described methods of measuring adherence (e.g., diaries, interviews, pill counts), while 37 (7%) reported medication adherence results. Trials specifically identifying quantitative or qualitative rates of adherence in phase III trials involved abiraterone, anastrozole, capecitabine, dasatinib, exemestane, imatinib, lapatinib, letrozole, tamoxifen, thalidomide, topotecan, and toremifene (50% of agents). Within the 37 trials reporting adherence, 12 were qualitative (e.g., excellent, poor), 23 were quantitative, and 2 used pharmacokinetically-defined adherence measures. Conclusions: Medication adherence is infrequently reported in phase III trials of oral anti-cancer agents, leading to a knowledge gap in translation to clinical use. Our study underscores the need for standard metrics on measuring and reporting adherence to oral anticancer agents.

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Assessment of adherence with oral anticancer agents in oncology clinical trials: A systematic review

Journal of Oncology Pharmacy Practice ◽

10.1177/1078155214567163 ◽

2015 ◽

Vol 22 (1) ◽

pp. 105-113 ◽

Cited By ~ 5

Author(s):

JJ Bergsbaken ◽

JC Eickhoff ◽

BA Buss ◽

MS Mably ◽

JM Kolesar

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Anticancer Agents ◽

Oncology Clinical Trials ◽

Oral Anticancer Agents

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Real-World Utilization of Oral Anticancer Agents Costs in Older Adults with Metastatic Renal Cell Carcinoma in the United States

Kidney Cancer ◽

10.3233/kca-210119 ◽

2021 ◽

pp. 1-13

Author(s):

Lauren E. Wilson ◽

Lisa Spees ◽

Jessica Pritchard ◽

Melissa A. Greiner ◽

Charles D. Scales ◽

...

Keyword(s):

United States ◽

Anticancer Agents ◽

Patient Characteristics ◽

The United States ◽

Socioeconomic Indicators ◽

Economic Implications ◽

Southern Us ◽

Race Ethnicity ◽

Nationally Representative ◽

Oral Anticancer Agents

Background: Substantial racial and socioeconomic disparities in metastatic RCC (mRCC) have persisted following the introduction of targeted oral anticancer agents (OAAs). The relationship between patient characteristics and OAA access and costs that may underlie persistent disparities in mRCC outcomes have not been examined in a nationally representative patient population. Methods: Retrospective SEER-Medicare analysis of patients diagnosed with mRCC between 2007–2015 over age 65 with Medicare part D prescription drug coverage. Associations between patient characteristics, OAA receipt, and associated costs were analyzed in the 12 months following mRCC diagnosis and adjusted to 2015 dollars. Results: 2,792 patients met inclusion criteria, of which 32.4%received an OAA. Most patients received sunitinib (57%) or pazopanib (28%) as their first oral therapy. Receipt of OAA did not differ by race/ethnicity or socioeconomic indicators. Patients of advanced age (> 80 years), unmarried patients, and patients residing in the Southern US were less likely to receive OAAs. The mean inflation-adjusted 30-day cost to Medicare of a patient’s first OAA prescription nearly doubled from $3864 in 2007 to $7482 in 2015, while patient out-of-pocket cost decreased from $2409 to $1477. Conclusion: Race, ethnicity, and socioeconomic status were not associated with decreased OAA receipt in patients with mRCC; however, residing in the Southern United States was, as was marital status. Surprisingly, the cost to Medicare of an initial OAA prescription nearly doubled from 2007 to 2015, while patient out-of-pocket costs decreased substantially. Shifts in OAA costs may have significant economic implications in the era of personalized medicine.

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What is the content of virtually delivered pain management programmes for people with persistent musculoskeletal pain? A systematic review

British Journal of Pain ◽

10.1177/20494637211023074 ◽

2021 ◽

pp. 204946372110230

Author(s):

Gregory Booth ◽

Deborah Williams ◽

Hasina Patel ◽

Anthony W Gilbert

Keyword(s):

Systematic Review ◽

Pain Management ◽

Musculoskeletal Pain ◽

Clinical Guidelines ◽

Reporting Quality ◽

Skills Training ◽

Evidence Based ◽

Core Element ◽

Multidisciplinary Pain Management ◽

Pain Services

Introduction: Virtual consultations (VC) have been embraced by healthcare organisations during the COVID-19 pandemic. VC allows continuation of patient care while adhering to government advised restrictions and social distancing measures. Multidisciplinary pain management programmes (PMPs) are a core element of many pain services and utilising virtual methods to deliver PMPs has allowed them to continue to provide care. This systematic review aimed to explore the content of existing virtually delivered PMPs and discuss if and how these findings can be used to guide clinical delivery. Methods: Eligible studies included adults (aged ⩾18 years) with persistent musculoskeletal pain and any virtually delivered intervention that was described as a PMP or that had components of PMPs. Databases were searched from inception until July 2020. We performed a content analysis comparing existing interventions with established evidence-based clinical guidelines published by the British Pain Society (BPS). Intervention reporting quality was assessed using the Template for Intervention Description and Replication (TIDieR) checklist: an established checklist developed to improve the completeness of the reporting of interventions. Results: Eight studies were included. One intervention included six of the seven components recommended by the BPS; none included all seven. ‘Skills training and activity management’ was present in all eight interventions; ‘education’ and ‘cognitive therapy methods’ were present in six interventions; ‘graded activation’ and ‘methods to enhance acceptance, mindfulness and psychological flexibility’ were present in four interventions; ‘physical exercise’ was present in two interventions and ‘graded exposure’ was present in one intervention. None of the studies described all 12 items of the TIDieR checklist adequately enough for replication. Conclusion: Published virtual PMPs partially meet established clinical guidelines. Future virtual PMPs should be based on evidence-based clinical guidelines, and more research is needed to explore the effectiveness of virtually delivered PMPs and each recommended component.

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