The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is for you.” The promise of personalized medicine holds allure for patients, providers, and payers alike by improving quality of care by targeting therapy, predicting disease course, mitigating risk, and reducing waste of scarce resources. However, several barriers remain that hinder adoption of PM across the globe, including industry incentive, regulatory pathways, reimbursement policies, and physician habits. In the U.S. market, there are challenges related to reimbursement, but manufacturers can take steps to overcome these barriers working with fellow stakeholders to unlock the full potential of personalized medicine.

In many cases, PM consists of a pharmaceutical product (or a medical device) coupled with a predictive companion diagnostic to help elucidate the right patient for treatment. The U.S. Food and Drug Administration describes such companion diagnostics as in vitro diagnostic or imaging tools that provide essential information for the safe and effective use of a corresponding therapeutic product1. Diagnostics generally consist of assay tests for molecular or genetic profile of the patient to determine if mutations exist that could have an impact on the efficacy of pharmaceutical treatments. These predictive tests help improve clinical outcomes by focusing treatment on those who benefit most avoiding unnecessary treatment in patients who are unlikely to benefit2. Companion diagnostics are a mainstay of PM. Without accurate diagnostic information to guide treatment, the full potential of the targeted therapy is lost.

All too often patients’ access to the promise of personalized medicine is limited by lack of coverage or affordability. As more targeted drug therapies enter the U.S. market, the level of interest in reimbursing and managing biomarker diagnostics is growing quickly among payers3. But payers may not be prepared to properly evaluate coverage for companion diagnostic tests. Research conducted by Xcenda, a strategic consulting firm that is part of AmerisourceBergen, revealed the following:

• Only 55% of U.S. pharmacy and medical directors rated their knowledge of oncology biomarkers as moderate to high (4 or above on a scale of 1-7)
• Nearly half of the payers surveyed were unfamiliar with how many requests for elective biomarker or diagnostic tests their plan receives or how often those requests were approved6
• U.S. payers prefer to cover diagnostics separately from the PM therapy itself, reiterating that there is still work to be done in the U.S. to get the companion diagnostic and the treatment covered together
• A second Xcenda market research survey asked 60 U.S. payers what factors influenced coverage of oncology biomarker diagnostics7. This study found that when payers considered making coverage decisions for oncology biomarkers, the top two factors were effectiveness and the ability to reduce the use of other expensive clinical tests. Also, in lieu of standardized guidelines or compendia directing use of companion diagnostics, U.S. payers were more likely to cover biomarker tests as the proven predictive ability increased.

So, how can diagnostic manufacturers overcome barriers to access?

• Payers rely on diagnostics manufacturers to understand how a diagnostic aids in patient management with evidence that validates the predictive ability of the test and provides real-world learnings so they can adapt utilization management measures accordingly. Generating a combination of clinical and genomic/genetic data provides stronger rationale to payers for approval and use.
• Providers, from community practices to large health systems, need regular education about new diagnostics, clinical evidence to demonstrate the effectiveness of targeted therapies, and technology solutions that make it easier to integrate PM into practice workflow.
• And patients depend on reimbursement and financial assistance support programs to overcome challenges related to coverage and affordability

While personalized medicine faces hurdles to mainstream adoption, there are solutions to expand access and integrate personalized medicine so it can reach its full potential – improving outcomes for patients while driving efficiency across the healthcare continuum. AmerisourceBergen is committed to advancing the promise of personalized medicine and supports manufacturers, providers and patients in overcoming barriers to access.

1. ^{US Food and Drug Administration. Companion diagnostic devices: in vitro and imaging tools. 27 May 2014. Available online at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm. Accessed 13 July 2014.}
2. ^{George E. HTA of companion diagnostics. Presentation at the Workshop on Pharmacogenomics: from science to clinical care. 8-9 October 2012. European Medicines Agency, London, UK. Available online at:http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2012/11/WC500134979.pdf. Accessed 10 July 2014.}
3. ^{Denno MS, Brown LM, Jackson JH. Impact of the NCCN biomarkers compendium on managed care pharmacy. J Manag Care Pharm. 2013;19(1):68-69.}
4. ^{Dandappanavar AS, Knight JM, Campbell CM, et al. Payer familiarity with oncology biomarkers, their companion diagnostics, and specific coverage practices: results of a focus group. Poster presented at the Academy of Managed Care Pharmacy Annual Meeting 2014;2-4 April 2014; Tampa, FL, USA.}
5. ^{Dandappanavar AS, Knight JM, Campbell CM, et al. Factors that infl health plan decision making in the coverage of biomarker diagnostic tests. Poster presented at the International Society for Pharmacoeconomics and Outcomes Research 19th Annual International Meeting. Poster session I, PHP95; 2 June 2014; Montreal, QC, Canada.}