Improving Access to Molecular Testing to Enable Personalized Treatment in Oncology

Brittany Carson, PhD, MHEcon, SystemOne, New York, NY, USA; Jessica Roydhouse, PhD, Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia; Alison Urvalek, PhD, Loxo@Lilly, New York, NY, USA

Molecular testing as an access barrier

The introduction of targeted therapy for the treatment of cancer has significantly benefited eligible individuals.^1-4 As these therapies target key driver alterations to increase tumor response and minimize toxicity, the benefit-risk ratio is optimized for individuals expressing the associated actionable alteration but not for those who do not. Consequently, the use of targeted therapy first necessitates molecular testing, such as genomic profiling, to identify those who will benefit from treatment. Although approved targeted therapies span multiple tumor types and numerous guidelines recommend molecular testing for key alterations to improve patient outcomes, testing rates continue to vary across clinical practice and regions.^5,6 Thus, for many individuals with cancer, limited access to molecular testing remains a critical barrier preventing optimal care. Given the widespread recognition of this issue, there are various efforts to address barriers to access, spanning from industry to the patient level. As the practice of molecular status assessment continues to expand with the discovery of additional actionable alterations and methods continue to evolve in technical complexity,⁷ we must not only consider current but also future access barriers.

The industry perspective

Pharmaceutical companies are undertaking a multifaceted approach to address barriers to comprehensive genomic profiling and access to precision medicine for all patients. One key effort focuses on the implementation of quality improvement studies to assess appropriate molecular testing practices at specific hospitals or institutions. These studies include the identification of a specific barrier to testing at the site, a proposed approach to overcome that barrier, and development of a study plan to measure the impact of the change. Current efforts have led to recommendations such as the introduction of nurse navigators and molecular tumor boards to enhance testing and interpretation of molecular reports, the use of innovative in-house sequencing technologies to reduce processing times, the incorporation of reflexive test ordering within the electronic medical record system, and the elimination of cost barriers at locations with in-house testing in traditionally underserved patient populations.

"Although approved targeted therapies span multiple tumor types and numerous guidelines recommend molecular testing for key alterations to improve patient outcomes, testing rates continue to vary across clinical practice and regions."

As these studies progress, publication of these data and use of this evidence will support advocacy for practice pattern changes, including increased adoption and utilization of high-quality comprehensive biomarker testing for patients who need it most.

The patient experience

While molecular testing efforts are focused on enabling use of a targeted therapy, data from genetic testing to determine prognosis of individuals with cancer have helped highlight challenges with testing at the patient level. For example, there are concerns that undergoing a genetic test and receiving an uncertain result could have a psychological impact on individuals with cancer.⁸ Understanding patients’ opinions, expectations, and perceptions about genetic testing in cancer is particularly important to make oncology care patient centered.

Although precision medicine has been life-changing for millions of patients, particularly in the breast cancer space, there are numerous barriers to its equitable implementation. Specifically, there is evidence of racial and geographic disparities in molecular testing in cancer in the United States, as well as disparities between Indigenous and non-Indigenous populations in accessing clinical genetic care in Australia.^9,10 When eliciting patient perspectives and addressing barriers to genetic testing in oncology, it is important to avoid exacerbating existing disparities.

"There are numerous barriers to access to molecular testing to enable precision medicine, and addressing these barriers will require collaboration across many stakeholders, including HEOR groups and pharmaceutical companies."

An example of current work to better understand geographic disparities in molecular testing is the Precision Care for Men With Prostate Cancer in Tasmania—PC4PC-TAS Study. The ongoing study is led by investigators at the Menzies Institute for Medical Research, University of Tasmania, and national and international collaborators. A major component of this study, which focuses on individuals with prostate cancer living in a regional area, is gaining insight into the experience and perceptions of patients regarding genetic testing. In the recently completed first phase, researchers spoke with participants to understand their knowledge of “precision medicine” and gain insight into their concerns and expected support needs when undergoing genetic testing for their cancer. In the second phase, the team will work with participants, their caregivers, and clinicians to identify important patient-centered outcomes. Outcomes in this study will be published and presented at future scientific meetings to further the evidence base in this area.

Summary

Precision medicine is an exciting development in oncology that has been life-changing for millions of individuals with cancer. There are numerous barriers to access to molecular testing to enable precision medicine, and addressing these barriers will require collaboration across many stakeholders, including HEOR groups and pharmaceutical companies. In addition, collaborations within stakeholder groups through consortiums and advocacy groups will help develop more informed studies to address these barriers to testing. It will also be essential to engage patients in these studies to ensure that the questions being asked are meaningful to individuals with cancer and address their needs. By working together, we will address barriers to molecular testing and get the right therapy to the right patients at the right time.

References

1. Falzone L, Salomone S, Libra M. Evolution of cancer pharmacological treatments at the turn of the third millennium. Front Pharmacol. 2018:9:1300.
2. Mok TS, Wu Y-L, Ahn MJ, et al. Osimertinib or platinum-pemetrexed in EGFR T790M-positive lung cancer. N Engl J Med. 2017;376(7):629-640.
3. Wu Y-L, Zhou C, Liam C-K, et al. First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Ann Oncol. 2015;26(9):1883-1889.
4. Robson M, Im S-A, Senkus E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017;377(6):523-533.
5. Malone ER, Oliva M, Sabatini PJB, Stockley TL, Siu LL. Molecular profiling for precision cancer therapies. Genome Med. 2020;12(1):8.
6. Bayle A, Bonastre J, Chaltiel D, et al. ESMO study on the availability and accessibility of biomolecular technologies in oncology in Europe. Ann Oncol. 2023;34(10):934-945.
7. Imyanitov EN, Iyevleva AG, Levchenko EV. Molecular testing and targeted therapy for non-small cell lung cancer: current status and perspectives. Crit Rev Oncol Hematol. 2021:157:103194.
8. De Silva DL, Stafford L, Skandarajah AR, et al. Universal genetic testing for women with newly diagnosed breast cancer in the context of multidisciplinary team care. Med J Aust. 2023;218(8):368-373.
9. Qin X, Chen J. Racial and geographic disparities in the use of molecular testing among older Medicare beneficiaries with lung cancer. JCO Oncology Practice. 2023;19(suppl 11):Abstract 125. https://doi.org/10.1200/OP.2023.19.11_suppl.125
10. Luke J, Dalach P, Tuer L, et al. Investigating disparity in access to Australian clinical genetic health services for Aboriginal and Torres Strait Islander people. Nat Commun. 2022;13(1):4966.