Barriers in access to oncology drugs — a global crisis

Barrios, Carlos H.; Lopes, Gilberto; Yusof, Mastura Md; Rubagumya, Fidel; Rutkowski, Piotr; Sengar, Manju

doi:10.1038/s41571-022-00700-7

Cited by 45 publications

(21 citation statements)

References 36 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…One important reason was that the evidence exclusively from Chinese patients underrepresented the US population (Singh et al, 2022). The reverse delay of Chinese new drugs in other regions may raise some concerns (Barrios et al, 2023), particularly for low-and middle-income countries that rely on the FDA's decisions . To reduce the access gap, coordination of drug development and approval decision-making between China and the US and EU is of much value, e.g., to establish a concurrent drug review system between China and these regions, similar to the Project Orbis (Lythgoe et al, 2023b;U.S.…”

Section: Discussionmentioning

confidence: 99%

Review time of oncology drugs and its underlying factors: an exploration in China

Zhu,

Liu

2023

Front. Pharmacol.

View full text Add to dashboard Cite

Introduction: How the launch delay of drugs and other factors of interest can influence the length of the review period by drug agencies is still unknown, and understanding this can help better strike the trade-off related to review speed.Methods: We included all new oncology drug applications submitted to China’s National Medical Product Administration (NMPA) between 1 January 2018 and 31 December 2021, and ultimately succeeded in achieving marketing approval. For each drug, the length of the NMPA review process and other major characteristics were collected, including the registration class, approval class, priority review designation, and launch delay relative to the United States, as well as the number of patients enrolled, comparator, and primary endpoint of the pivotal trials supporting the approval. Linear regression model was employed to analyze the effects of factors of interest on the NMPA review time.Results: From 2018 to 2021, NMPA received 137 oncology applications that were ultimately approved. Half of the approvals [76 (55.5%)] were first licensed in the US, leaving a median launch delay of 2.71 years (IQR, 1.03–5.59) in China. In the pivotal studies, the median enrollment was 361 participants (IQR, 131–682), and the use of control groups [90 (65.7%)] and surrogate endpoints [101 (73.7%)] was prevalent. The median review time was 304 days (IQR, 253–376). Multivariate analysis for log-transformed review time showed that larger enrollment (> 92) was associated with a drop of 20.55% in review time (coefficient = −0.230; 95% CI, −0.404 to −0.055; p = 0.010); and a short delay (0 < delay ≤ 1.95 years) was associated with a drop of 17.63% in review time (coefficient = −0.194; 95% CI, −0.325 to −0.062; p = 0.004).Discussion: The short launch delay relative to the US was one important driver to the review speed of NMPA, which might suggest its latent regulatory reliance on the other global regulator during the post-marketing period when new information on the drug’s clinical benefit was still lacking.

show abstract

Section: Discussionmentioning

confidence: 99%

Review time of oncology drugs and its underlying factors: an exploration in China

Zhu,

Liu

2023

Front. Pharmacol.

View full text Add to dashboard Cite

show abstract

“…All of these features should bring more opportunities for cancer clinical research participation. Promoting major access to clinical trials is vital to optimising cancer care [ 10 ], modifying clinical practice, bringing more treatment opportunities, increasing qualified human resources, and ultimately generating academic research initiatives that can bring secondary gains by conducting trials that certainly will address local relevant questions [ 11 ]. Therefore, the diagnosis of the different barriers to cancer clinical trial access in Brazil is crucial.…”

Section: The Worldwide Imbalance Between Burden Cancer and Cancer Cli...mentioning

confidence: 99%

Improving access to cancer clinical research in Brazil: recent advances and new opportunities. Expert opinions from the 4th CURA meeting, São Paulo, 2023

Resende,

Arai,

Barrios

et al. 2024

ecancer Journal

View full text Add to dashboard Cite

Clinical research is the cornerstone of improvements in cancer care. However, it has been conducted predominantly in high-income countries with few clinical trials available in Brazil and other low-and-middle-income countries (LMIC). Of note, less than one-third of registered clinical trials addressing some of the most commonly diagnosed cancers (breast, lung and cervical) recruited patients from LMIC in the last years. The Institute Project CURA promoted the fourth CURA meeting, discussing barriers to cancer clinical research and proposing potential solutions. A meeting was held in São Paulo, Brazil, in June 2023 with representatives from different sectors: Brazilian Health Regulatory Agency (Anvisa), National Commission of Ethics in Research (CONEP), non-governmental organisations, such as the Latin American Cooperative Oncology Group, the Brazilian Society of Clinical Oncology (SBOC), Contract Research Organisations, pharmaceutical companies and investigators. A total of 16 experts pointed out achievements as shortening the time of regulatory processes involving Anvisa and CONEP, development of staff training programs, maintenance of the National Program of Oncological Attention (PRONON), and the foundation of qualified centres in North and Northeast Brazilian regions. Participants also highlighted the need to be more competitive in the field, which requires optimising ongoing policies and implementing new strategies as decentralisation of clinical research centres, public awareness campaigns, community-centered approaches, collaborations and partnerships, expansion of physicians-directed policies, exploring the role of the steering committee. Active and consistent reporting of the initiatives might help to propagate ongoing advances, increasing Brazilian participation in clinical cancer research. Engagement of all players is crucial to maintain continuous progress with further improvements in critical points including regulatory timelines and increments in qualified human resources which aligned with new educational initiatives focused on physicians and the general population will expand access to cancer clinical trials in Brazil.

show abstract

“…One of the most pressing problems across emerging cancer systems is ensuring access and affordability of cancer care. 8 Hence, FT and costs of cancer care are particularly challenging in LMICs. 9 While high-income countries are starting to acknowledge FT as a significant policy concern, it has been, and continues to be, a major obstacle in providing high-quality cancer care in many African countries.…”

Section: Introductionmentioning

confidence: 99%

“… 9 While high-income countries are starting to acknowledge FT as a significant policy concern, it has been, and continues to be, a major obstacle in providing high-quality cancer care in many African countries. 8 …”

Section: Introductionmentioning

confidence: 99%

Financial Toxicity: Unveiling the Burden of Cancer Care on Patients in Rwanda

Rubagumya,

Wilson,

Manirakiza

et al. 2023

The Oncologist

Self Cite

View full text Add to dashboard Cite

Introduction Cancer is a major public health problem in Rwanda and other low- and middle-income countries (LMICs). While there have been some improvements in access to cancer treatment, the cost of care has increased, leading to financial toxicity and treatment barriers for many patients. This study explores the financial toxicity of cancer care in Rwanda. Methods This prospective cross-sectional study was conducted at 3 referral hospitals in Rwanda, which deliver most of the country’s cancer care. Data were collected over 6 months from June 1 to December 1, 2022 by trained research assistants (RAs) using a modified validated data collection tool. RAs interviewed consecutive eligible patients with breast cancer, cervical cancer, colorectal cancer, Hodgkin’s and non-Hodgkin’s lymphoma who were on active systemic therapy. The study aimed to identify sources of financial burden. Data were analyzed using descriptive statistics. Results 239 patients were included; 75% (n = 180/239) were female and mean age was 51 years. Breast, cervix, and colorectal cancers were the most common diagnoses (42%, 100/239; 24%, 58/239; and 24%, 57/239, respectively) and 54% (n = 129/239) were diagnosed with advanced stage (stages III-IV). Financial burden was high; 44% (n = 106/239) of respondents sold property, 29% (n = 70/239) asked for charity from public, family, or friends, and 16% (n = 37/239) took loans with interest to fund cancer treatment. Conclusion Despite health insurance which covers many elements of cancer care, a substantial proportion of patients on anti-cancer treatment in Rwanda experience major financial toxicity. Novel health financing solutions are needed to ensure accessible and affordable cancer care.

show abstract

Barriers in access to oncology drugs — a global crisis

Cited by 45 publications

References 36 publications

Review time of oncology drugs and its underlying factors: an exploration in China

Review time of oncology drugs and its underlying factors: an exploration in China

Improving access to cancer clinical research in Brazil: recent advances and new opportunities. Expert opinions from the 4th CURA meeting, São Paulo, 2023

Financial Toxicity: Unveiling the Burden of Cancer Care on Patients in Rwanda

Contact Info

Product

Resources

About