By Deborah Borfitz
November 1, 2019 | Precision medicine promises treatment strategies tailored to individual patient characteristics and tumor biology. But improved health outcomes won’t happen without access to healthcare and molecular testing, which can differ substantially by geography and even within individual countries, according to Lourdes Barrera, senior director of precision medicine in the oncology business unit of Novartis. The biggest challenge may be convincing clinical practices to adopt the latest diagnostic tests and targeted treatments.
In introducing the topic at the 2019 Next Generation Dx Summit, Barrera started with the latest health statistics and some of the glaring inequalities. Since the 1900s, life expectancy globally has more than doubled to about 70 years, she says. But the range country to country is vast—from 53 years in the Central African Republic to 83 years in Japan.
Cancer rates are also uneven, she continues. Prevalence of cancer country to country ranges from approximately 5.5% of the population, down to around 0.4%. Worldwide, 8.9 million people died from cancer in 2016. It is the leading cause of death in high-income countries where, excepting the U.S., full healthcare coverage is also available.
Novartis is highly data-driven and embraces partnerships to drive innovation and improve research and development, Barrera says, and that includes the use of machine learning and predictive analytics in clinical trials. “Precision oncology is on the right track,” she adds, with new targeted therapies that improve survival versus the current standard of care and recent regulatory approval of a companion diagnostic (CDx) for patients in the chronic phase of chronic myeloid leukemia.
Molecular testing is underutilized in clinical settings and can be a “big barrier” to the adoption of targeted therapies, says Barrera. One recent survey found that less than one-third of oncology clinics thought CDx tests were needed and 6% were prescribing targeted therapies.
Reimbursement and regulatory policies are influencing factors, she adds. Payer coverage policies are mixed in Singapore, for example, while in China, single-biomarker adoption is challenging. Many countries, excepting Australia and Japan, do not yet have a CDx-specific regulatory framework.
According to an example presented on the business innovation cycle, precision medicine could also apply this approach developing partnerships with providers and payers ensuring health data collection and feedback, Barrera says. As described in the company’s annual precision oncology report, payers want to see proof of the clinical validity and utility of biomarker tests and that results change patient management. “Early evidence development is key, including biomarker trials.”
Inequity gaps also must close, Barrera concludes, and may require different models of technology adoption. Corrective actions need to include standardizing global data collection practices and developing patient education strategies that take regional differences into account.
Novartis is doing its part with a program to expand treatment access to lower-income countries. In July, it also launched an initiative in collaboration with Quest Diagnostics to offer genetic mutation testing at no cost for all patients with stage III or stage IV melanoma.
Editor's Note: A change was made in the 7th paragraph. An example presented is not necessarily the view of Novartis.