Genetic Testing – A New Frontier for Patient Assistance Programs

Posted by Michael Zilligen from Ogilvy CommonHealth Worldwide — North America on July 12, 2018


The introduction of many high-cost specialty pharmaceuticals has resulted in payers more closely scrutinizing the cost and value of these expensive treatment advances. What has transpired is more intense utilization management of specialty products in an effort to control costs as well as shifting more of the financial burden to patients. As a result, manufacturers have developed a variety of solutions to help streamline the process, from prescription to fulfillment. A core element of these industry efforts is patient assistance (PA) programs, which typically include a drug copay assistance component to “ease the financial pain.”


Many of these new, higher-cost specialty medications are precision treatments that allow a more targeted treatment approach based on gene mutations or alternations in gene or protein expression unique to a given patient and his/her disease. Although such treatments may ultimately help control costs by selecting patients most likely to benefit from a given treatment, testing adds a new layer of financial complexity for physicians, payers, and patients. For example, upfront testing for genetic alterations in EGFR, ALK, and ROS-1 is now standard practice for patients with advanced non-squamous NSCLC. Immune checkpoint inhibitors are also revolutionizing the treatment of multiple cancers, including advanced NSCLC. Several of these treatments are approved or in trials for advanced NSCLC, with pembrolizumab being approved as a frontline treatment with or without chemotherapy in patients with advanced NSCLC whose tumors express PD-L1 by immunohistochemistry (IHC) and who do not have EGFR or ALK mutations. Therefore, testing for PD-L1 expression at diagnosis has also become routine for patients with advanced NSCLC. More recently, high tumor mutational burden (TMB) has also been associated with improved response to immune checkpoint inhibitors in CHECKMATE 227 – requiring yet another testing modality, next generation sequencing (NGS).


So genetic testing and other predictive biomarkers are advancing as quickly as the new treatments and are now becoming more important, as these promising therapeutic advances create a more direct clinical rationale and value for testing. The Centers for Medicare & Medicaid Services’ announcement in May on the National Coverage Determination for the FoundationOne CDx NGS test is further validation of their importance to precision medicine and guiding treatment selection. But again, this comes at a price to patients. Depending on the type of test (eg, IHC, RTPCR, NGS, etc) the cost to the patient is not insignificant. Patients are typically responsible for 20% of the cost of the test (under their medical benefit), which highlights another potential “speedbump” in the patient’s journey to get on therapy. This out-of-pocket cost to the patient could range from $50 for IHC to $300 for a lung panel to $700+ for NGS. Furthermore, the confirmation of a specific mutation may be required as part of the PA process to get the specific therapy. And oncology is just one example. Emerging treatments in many areas may require testing for biomarkers linked to a treatment’s mechanism of action or disease biology to help guide providers’ decisions on the most effective treatment for the patient in front of them.


What does this mean to marketers? Having an effective support program to assist patients with the costs of not just the drug but also the genetic test(s) is more important than ever. But these programs need to be built into the prescribing pathway for maximum utility. Leveraging technology and EHRs can streamline this process. Significant HCP and staff time, normally spent printing, complet¬ing, and faxing forms, could be saved if enrollment queues for a patient support program were built directly into the EHR system and triggered at the time of ordering a diagnostic test. This would be especially helpful for patients with known coverage or affordability challenges, or those in need of additional support from the manufacturer’s programs. And don’t neglect the need for branding, awareness creation, and support tools to properly equip the field reimbursement managers when engaging HCP and office support staff on genetic testing reimbursement.


New, biomarker-driven treatments are helping us get closer to the promise of precision medicine, but we need to recognize and overcome the new hurdles that come with these treatments to fully realize the potential of this promise. Evolving the patient assistance program is a vital part of meeting these challenges.