Payer perceptions on the use of patient-reported outcomes in oncology decision making

Oderda, Gary M.; Brixner, Diana I.; Biskupiak, Joseph; Burgoyne, Douglas; Arondekar, Bhakti; Deal, Linda S.; Quek, Ruben G.W.; Niyazov, Alexander

doi:10.18553/jmcp.2021.21223

Cited by 2 publications

(3 citation statements)

References 9 publications

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“…Considering this use of the term by ODAC reviewers, our transcript review clearly shows that data from PROs are important to risk-benefit calculations made during drug approval process 4,25 and may guide payer decisions. 26 This is particularly true for oncologic products, given their toxicity and, often, uncertainty in the evidence available at the time of approval. 27,28 The results from this review clearly demonstrate both (1) the value of PROs for ODAC reviewers making benefit-risk calculations and (2) the importance for drug manufacturers of formulating and implementing a comprehensive PRO strategy.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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A Review of Patient-Reported Outcome Considerations in Oncologic Drugs Advisory Committee Meetings (2016-2021)

Gnanasakthy

Norcross

Clark

et al. 2023

JCO Oncology Practice

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PURPOSE: The purpose of this project was to gain insight into the role of patient-reported outcome (PRO) data in US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) reviews and recommendations by documenting PRO-related considerations that appear in transcripts of ODAC meetings over a 6-year period (2016-2021). METHODS: ODAC meeting transcripts were reviewed for any mention of PRO-related concepts. Meetings that reviewed biosimilars and meetings that discussed conceptual matters were excluded. For each identified transcript, the meeting date, brand and generic names of the drug, and indication were collected from the meeting minutes. Comments by ODAC members, FDA reviewers, and study sponsors on PRO data were captured during the review. Qualitative review of transcripts included both reading and searching for key terms, including PROs, quality of life, and health-related quality of life. Discussion of PRO-related topics was captured verbatim, organized thematically, and analyzed by two independent reviewers. RESULTS: Twenty-seven transcripts of reviews were identified for 2016-2021. Topics related to PROs were included in 12 of those 27 reviews. The ODAC was satisfied with PROs included in 2 of those 12 reviews. Reasons for dissatisfaction in 10 of the 12 reviews included key concepts not assessed (5/12), missing data (5/12), and disagreement with sponsors' interpretation (3/12). The ODAC also expressed dissatisfaction with the lack of PRO data in 6 of 15 reviews that did not include PROs. CONCLUSION: Less than half of ODAC reviews in 2016-2021 included PROs, and reviewers expressed frustration at the lack of PRO data. Even when included, evidence on the basis of PROs was rarely deemed adequate for benefit-risk assessments.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A Review of Patient-Reported Outcome Considerations in Oncologic Drugs Advisory Committee Meetings (2016-2021)

Gnanasakthy

Norcross

Clark

et al. 2023

JCO Oncology Practice

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“…Patient-reported outcomes (PRO) data now play an increasing role in anti-cancer treatment selection and in drug evaluation by payers and health technology assessment agencies. 12 , 13 Assessments of PROs capture patient perspectives on disease, treatment burden and their impact on health-related quality of life (HRQoL) and can provide a more comprehensive evaluation of the impact of cancer therapy on patient experience and quality of life, since the management of symptoms and potential adverse events is of paramount importance in NSCLC patients. 14 , 15 …”

Section: Introductionmentioning

confidence: 99%

Patient-reported outcomes for the phase 3 FURLONG study of furmonertinib versus gefitinib as first-line therapy for Chinese patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer

Shi,

Chen,

Wang

et al. 2024

The Lancet Regional Health - Western Pacific

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Payer perceptions on the use of patient-reported outcomes in oncology decision making

Cited by 2 publications

References 9 publications

A Review of Patient-Reported Outcome Considerations in Oncologic Drugs Advisory Committee Meetings (2016-2021)

A Review of Patient-Reported Outcome Considerations in Oncologic Drugs Advisory Committee Meetings (2016-2021)

Patient-reported outcomes for the phase 3 FURLONG study of furmonertinib versus gefitinib as first-line therapy for Chinese patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer

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