Report Summary:

Precision oncology - an approach that tailors therapeutic interventions to an individual's unique molecular profile - has transformed oncology care, ushering in a new wave of therapies. Despite these advancements, geographical disparities in treatment accessibility remain a critical issue, potentially limiting benefits in patient outcomes. Without efforts to improve access, existing gaps in treatment availability and accessibility could widen as oncology therapies become increasingly biologically complex, leaving patients in certain regions underserved.

Trends in overall regulatory approvals and reimbursement have been analyzed for oncology therapies indicated in solid tumors and hematological malignancies in two Gulf Cooperation Council (GCC) nations - Saudi Arabia and United Arab Emirates (UAE) and three African countries – Algeria, Egypt, and South Africa. Important dynamics associated with the oncology therapy landscape such as the registration and reimbursement of selected innovative targeted therapies including antibody-drug conjugates (ADCs), bispecific antibodies (bsAbs), cell and gene therapies (CAGTs), and immuno-oncology checkpoint inhibitors (I/O checkpoint inhibitors) have been assessed. The associated companion diagnostic requirement to administer some of these therapies are also discussed.

This report outlines the underlying factors contributing to the oncology therapy access challenges, examines their implications, and highlights ongoing country level efforts to address them. It concludes with a call to action for various stakeholders including healthcare policymakers, physicians, and patient advocates. The findings are intended to support discussions on existing hurdles, showcase on-going initiatives, and guide strategies to enhance access to precision oncology therapies.

Key Findings

1. Our research shows that while multiple oncology drugs have launched globally from 2014 to 2023, most are not registered in the countries analyzed.
   • Of 183 oncology novel active substances globally launched and assessed between 2014 and 2023, only 52% have received market authorization in the EU. Just 31% have registered in the UAE and Saudi Arabia in the same time frame.
   • Registration is even lower in selected countries in Africa, with only 17% registered in Egypt and South Africa and 5% in Algeria.
2. Precision oncology medicines, such as immunotherapies, monoclonal antibodies, and ADCs, are available in the GCC and, to a lesser extent, in the selected countries in Africa.
   • Availability of these therapies—including registration and reimbursement—is anticipated to continue growing. That is especially true in the GCC given initiatives such as VISION 2030 in Saudi Arabia and the Emirati Genome Program in the UAE.
3. After global launch, registering an oncology product may take a median of up to 27 months in the GCC and 67 months in selected countries in Africa. Reimbursement timelines in the public channel vary.
   • UAE and Saudi Arabia have comparable time to registration following global launch with a median of 23 and 27 months, respectively. However, median reimbursement time in the UAE is much faster at six months compared to 23 months in Saudi Arabia.
   • In the selected countries in Africa, it takes Egypt a median of 29 months, South Africa 49 months, and Algeria 67 months to register oncology products. Reimbursement takes a median of 43 months in Egypt and 26 months in Algeria. In South Africa, the assessed molecules are not reimbursed through the public channel. However, discussions with local experts indicate that many of these therapies are reimbursed through the private marketplace, albeit at varying rates depending on the specific coverage plan.
4. Despite multiple barriers, including variations in clinical evaluation methodologies and healthcare budget constraints, progress has been made in approving and reimbursing oncology therapies over the past five years.
   • Proactive measures by governments, including investment, patient-level engagement, and recognition of the shift from systemic therapies to more personalized treatments, are changing the cancer care landscape in the regions.