Impact of Geographic Region on Benefit of Approved Anticancer Drugs Evaluated in International Phase III Clinical Trials

Al-Hashem, Hashem; Al-Mubarak, Mustafa; Templeton, Arnoud J.; Ocaña, Alberto; Šeruga, Boštjan; Amir, Eitan

doi:10.1016/j.clon.2015.09.010

Cited by 3 publications

(2 citation statements)

References 26 publications

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“…Clinical trials are not frequently conducted in the Arab World including Saudi Arabia. A recent meta -analysis examining approved oncological agents evaluated in international Phase III Clinical Trials revealed that only Egypt was included in two studies ( AlHashem et al, 2016 ). This is despite the fact that The Arab World comprises around 422 million people, approximately 6% of the global population ( Yoruk and Tetik, 2014 ).…”

Section: Resultsmentioning

confidence: 99%

Cancer Management in Saudi Arabia: Recommendations by the Saudi Oncology HeAlth Economics ExpeRt GrouP (SHARP)

Alkhudair

Alshamrani

Samarkandi

et al. 2021

Saudi Pharmaceutical Journal

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Cancer is widely recognized as a major global health problem and is estimated to rank as one of the leading causes of death worldwide. Saudi Arabia has undergone remarkable socioeconomic development in the past 40 years which has contributed to the increase in cancer incidence. The high costs of new oncology medications in combination with uncertainty of long-term effectiveness and safety outcomes highlight the importance of considering value, in terms of clinical outcomes, relative to cost. We convened a group of experts to discuss key factors impacting the current state of cancer management in Saudi Arabia and to agree on a list of recommendations, with a focus on value-based care, considering evidence, patients, and costs.

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Section: Resultsmentioning

confidence: 99%

Cancer Management in Saudi Arabia: Recommendations by the Saudi Oncology HeAlth Economics ExpeRt GrouP (SHARP)

Alkhudair

Alshamrani

Samarkandi

et al. 2021

Saudi Pharmaceutical Journal

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“…Even within the constraints of clinical trials offering the same treatment and monitoring, outcomes are often worse in LMICs. 18 With this in mind, it may be advantageous to reconsider the definitions applied for RSG category-based recommendations, prioritizing the value of a therapy in addition to the strength of evidence, and further incorporating trial and real-world data from LMICs.…”

Section: Discussionmentioning

confidence: 99%

Are NCCN Resource-Stratified Guidelines for Breast Cancer Systemic Therapy Achievable? A Population-Based Study of Global Need and Economic Impact

Wilson

Jacob

et al. 2021

JCO Global Oncology

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PURPOSE Resource-stratified guidelines (RSG) for cancer provide a hierarchy of interventions, based on resource availability. We quantify treatment need and cost if National Comprehensive Cancer Network (NCCN) RSGs for breast cancer (BC) are adopted globally. METHODS We developed decision trees for first-course systemic therapy, merged with SEER and Global Cancer Observatory 2018 incidence data to estimate treatment need and cost if NCCN RSG are implemented globally based on country-level income. Simulations were used to quantify need and cost of globally scaling up services to Maximal. RESULTS Based on NCCN RSG, first-course chemotherapy is indicated in 0% (Basic), 87% (Core), and 86% (Enhanced) but declined to 50% (Maximal) because of incorporation of genomic profiling. First-course endocrine therapy (ET) is indicated in 80% in all settings. In 2018, treatment need was 1.4 million people for chemotherapy, 183,943 for human epidermal growth factor receptor 2 (HER2) therapies and 1.6 million for ET. The cost per person for chemotherapy or HER2 or immunotherapy increased by 17-fold from Core to Maximal ($1,278-$22,313 Australian dollars [AUD]). The cost of ET per person rose eight-fold from Basic to Maximal ($1,236-$9,809 AUD). If all patients with BC globally were treated with Maximal resources, the need for chemotherapy would decline by 28%, whereas cost of first-course treatment would rise by 1.8-fold ($21-$37 billion AUD) because of more costly therapies. CONCLUSION NCCN RSGs for BC could result in chemotherapy overtreatment in Core and Enhanced settings. The absence of chemotherapy in Basic settings should be reconsidered, and future iterations of RSG should perform cross-tumor comparisons to ensure equitable resource distribution and maximize population-level outcomes. Our model is flexible and can be tailored to the costs, population attributes, and resource availability of any institution or country for health-services planning.

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Relevance of randomised controlled trials in oncology

Tannock

Amir

Booth

et al. 2016

The Lancet Oncology

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Impact of Geographic Region on Benefit of Approved Anticancer Drugs Evaluated in International Phase III Clinical Trials

Cited by 3 publications

References 26 publications

Cancer Management in Saudi Arabia: Recommendations by the Saudi Oncology HeAlth Economics ExpeRt GrouP (SHARP)

Cancer Management in Saudi Arabia: Recommendations by the Saudi Oncology HeAlth Economics ExpeRt GrouP (SHARP)

Are NCCN Resource-Stratified Guidelines for Breast Cancer Systemic Therapy Achievable? A Population-Based Study of Global Need and Economic Impact

Relevance of randomised controlled trials in oncology

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