The global landscape of availability, accessibility and affordability of essential diagnostics and therapeutics for the management of HER2-positive breast cancer: The ONCOLLEGE-001 survey

Trapani, Dario; Lengyel, Csongor György; Habeeb, Baker Shalal; Altuna, Sara C.; Petrillo, Angelica; Bairi, Khalid El; Hussain, Sadaqat; Mazher, S.; Elfaham, Essam; Curigliano, Giuseppe; Khan, Salman

doi:10.1016/j.jcpo.2021.100285

Cited by 11 publications

(3 citation statements)

References 23 publications

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“…In a survey of 191 providers, including 153 from areas termed LMICs in this publication, about 30% of providers could access HER2 testing in private, but not public settings. 40 (While trastuzumab is currently on the EML; is not available in the public systems everywhere [note: according to Fundytus et al, 35 it is only 15% universally available.])…”

Section: Discussionmentioning

confidence: 99%

Systemic Treatment of Patients With Metastatic Breast Cancer: ASCO Resource–Stratified Guideline

Al Sukhun,

Temin,

Barrios

et al. 2024

JCO Glob Oncol

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PURPOSE To guide clinicians and policymakers in three global resource-constrained settings on treating patients with metastatic breast cancer (MBC) when Maximal setting–guideline recommended treatment is unavailable. METHODS A multidisciplinary, multinational panel reviewed existing ASCO guidelines and conducted modified ADAPTE and formal consensus processes. RESULTS Four published resource-agnostic guidelines were adapted for resource-constrained settings; informing two rounds of formal consensus; recommendations received ≥75% agreement. RECOMMENDATIONS Clinicians should recommend treatment according to menopausal status, pathological and biomarker features when quality results are available. In first-line, for hormone receptor (HR)–positive MBC, when a non-steroidal aromatase inhibitor and CDK 4/6 inhibitor combination is unavailable, use hormonal therapy alone. For life-threatening disease, use single-agent chemotherapy or surgery for local control. For premenopausal patients, use ovarian suppression or ablation plus hormone therapy in Basic settings. For human epidermal growth factor receptor 2 (HER2)–positive MBC, if trastuzumab, pertuzumab, and chemotherapy are unavailable, use trastuzumab and chemotherapy; if unavailable, use chemotherapy. For HER2-positive, HR-positive MBC, use standard first-line therapy, or endocrine therapy if contraindications. For triple-negative MBC with unknown PD-L1 status, or if PD-L1–positive and immunotherapy unavailable, use single-agent chemotherapy. For germline BRCA1/ 2 mutation–positive MBC, if poly(ADP-ribose) polymerase inhibitor is unavailable, use hormonal therapy (HR-positive MBC) and chemotherapy (HR-negative MBC). In second-line, for HR-positive MBC, Enhanced setting recommendations depend on prior treatment; for Limited, use tamoxifen or chemotherapy. For HER2-positive MBC, if trastuzumab deruxtecan is unavailable, use trastuzumab emtansine; if unavailable, capecitabine and lapatinib; if unavailable, trastuzumab and/or chemotherapy (hormonal therapy alone for HR-positive MBC). Additional information is available at www.asco.org/resource-stratified-guidelines . It is ASCO's view that healthcare providers and system decision-makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement but not replace local guidelines.

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Section: Discussionmentioning

confidence: 99%

Systemic Treatment of Patients With Metastatic Breast Cancer: ASCO Resource–Stratified Guideline

Al Sukhun,

Temin,

Barrios

et al. 2024

JCO Glob Oncol

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“…For example, some promising and lifesaving biotherapeutics that have proven to considerably increase the overall survival of patients in high-burden conditions such as human epidermal growth factor receptor 2 positive breast cancer take a long time to be integrated into the public health systems. [15][16][17] This is one reason why a higher proportion of premature deaths from cancer is more prevalent in LMICs than in developed countries. 18 Therefore, as therapies are now shifting from pharmaceuticals to monoclonal antibodies and RNA-based therapies, it is high time for LMICs to start venturing into these potentially lifesaving treatment options.…”

Section: Health Services Insightsmentioning

confidence: 99%

Intravenous Immunoglobulin G (IVIG) Need Assessment Survey Toward Local Manufacturing of IVIG Using a Mini-Pool Plasma Fractionation Technique

Bekele

Masresha

Alemayehu

et al. 2023

Health�Serv�Insights

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Immunoglobulin therapy has a crucial role in the treatment of primary and secondary immunodeficiencies as well as in a multitude of neurologic, hematologic, infectious, and autoimmune conditions. In the current study, a preliminary pilot scale needs assessment survey was conducted to examine the need for IVIG among patients in Addis Ababa, Ethiopia, and in so doing justify local manufacturing of IVIG products. The survey was performed by administering a structured questionnaire to private and government hospitals, a national blood bank, a regulatory body, and healthcare researchers working in academia and pharmaceutical companies. The questionnaire encompassed demographics and specific IVIG-related questions designed for each institution. Responses supplied in the study provide qualitative data. Our findings indicated that IVIG has been registered by the regulatory body for use in Ethiopia and there is a demand for the product in the country. The study also highlights that patients go as far as to clandestine markets to procure IVIG products at a cheaper price. To impede such illegal routes and make the product readily accessible, a small-scale and low-cost approach such as a mini-pool plasma fractionation technique could be implemented to locally purify and prepare IVIG using plasma collected through the national blood donation program.

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“…Some cancer medicines can also cause severe adverse events for patients, further complicating the benefit-risk balance of their use in clinical practice [ 3 ]. In parallel, cancer medicines often incur high costs, challenging the financial sustainability of health systems globally, including in high-income countries [ 4 , 5 ]. For individual patients, high-cost cancer medicines expose them to the risk of catastrophic health expenditure, especially patients living in health systems with poor social protection.…”

Section: Introductionmentioning

confidence: 99%

Implications of Oncology Trial Design and Uncertainties in Efficacy-Safety Data on Health Technology Assessments

et al. 2022

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Background: Advances in cancer medicines have resulted in tangible health impacts, but the magnitude of benefits of approved cancer medicines could vary greatly. Health Technology Assessment (HTA) is a multidisciplinary process used to inform resource allocation through a systematic value assessment of health technology. This paper reviews the challenges in conducting HTA for cancer medicines arising from oncology trial designs and uncertainties of safety-efficacy data. Methods: Multiple databases (PubMed, Scopus and Google Scholar) and grey literature (public health agencies and governmental reports) were searched to inform this policy narrative review. Results: A lack of robust efficacy-safety data from clinical trials and other relevant sources of evidence has made HTA for cancer medicines challenging. The approval of cancer medicines through expedited pathways has increased in recent years, in which surrogate endpoints or biomarkers for patient selection have been widely used. Using these surrogate endpoints has created uncertainties in translating surrogate measures into patient-centric clinically (survival and quality of life) and economically (cost-effectiveness and budget impact) meaningful outcomes, with potential effects on diverting scarce health resources to low-value or detrimental interventions. Potential solutions include policy harmonization between regulatory and HTA authorities, commitment to generating robust post-marketing efficacy-safety data, managing uncertainties through risk-sharing agreements, and using value frameworks. Conclusion: A lack of robust efficacy-safety data is a central problem for conducting HTA of cancer medicines, potentially resulting in misinformed resource allocation.

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The global landscape of availability, accessibility and affordability of essential diagnostics and therapeutics for the management of HER2-positive breast cancer: The ONCOLLEGE-001 survey

Cited by 11 publications

References 23 publications

Systemic Treatment of Patients With Metastatic Breast Cancer: ASCO Resource–Stratified Guideline

Systemic Treatment of Patients With Metastatic Breast Cancer: ASCO Resource–Stratified Guideline

Intravenous Immunoglobulin G (IVIG) Need Assessment Survey Toward Local Manufacturing of IVIG Using a Mini-Pool Plasma Fractionation Technique

Implications of Oncology Trial Design and Uncertainties in Efficacy-Safety Data on Health Technology Assessments

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