Precision medicine is reshaping cancer care by enabling personalized therapies based on genomic and molecular profiling. In contrast to traditional approaches that rely on tumor histology, precision oncology aims to maximize therapeutic efficacy and minimize toxicity through individualized treatment strategies.1 Within this paradigm, precision medicine oncology pharmacists have emerged as key members of the multidisciplinary care team. These professionals contribute to selecting and optimizing targeted therapies, navigating complex access pathways, educating patients, and monitoring for adverse effects (AEs)—all of which support improved clinical outcomes.2
Ali et al previously highlighted the emerging role of pharmacists in novel drug combinations and precision medicine.3 This article builds on that foundation by highlighting the work of clinical precision medicine oncology pharmacists in a large tertiary academic medical center’s Rare Cancer and Precision Medicine Clinic.
Targeted Therapy Matching and Molecular Tumor Boards
A core of precision oncology is the identification of actionable genomic or molecular alterations and developing an individualized, matched, targeted treatment plan for each patient. Molecular tumor boards (MTBs) convene to support this effort and include pharmacists, physicians, advanced practice providers, nurses, genetic counselors, and scientists. These interdisciplinary teams examine genetic sequencing and other molecular profiling to recommend targeted treatments and potential novel drug combinations.4
Pharmacists contribute to MTBs by analyzing reports from next-generation sequencing and other molecular testing and assisting in matching detected alterations with guideline-recommended therapies, novel drug combinations, or clinical trials.
Pharmacists assess the appropriateness of targeted agents based on factors such as drug metabolism, potential resistance mechanisms, coexisting comorbidities, and/or drug interactions. Within the Rare Cancer and Precision Medicine Clinic, most guideline-recommended standard-of-care options have already been exhausted upon patient presentation, as these therapies are typically managed by the primary referring oncologist. This leaves most patients being evaluated for novel drug combinations or clinical trials.
When assessing novel drug combinations, the pharmacist is a critical team member in evaluating potential overlapping toxicities that may arise. Safe dosing and toxicity of select combinations have been reported, but much of the toxicity profile of novel drug combinations remains undefined within the current literature.5-9 With the lack of robust data evaluating toxicities in novel drug combinations, it is the responsibility of the pharmacist to lead discussions regarding potential toxicities and recommend appropriate monitoring. This unique role utilizes pharmacists’ pharmacologic expertise and clinical practice experience in monitoring and treating medication toxicities. With novel combinations, the pharmacist’s role is to evaluate drug-drug interactions to ensure that the new anticancer medications and preexisting medications do not have interactions that could potentially lead to increased toxicity or reduced efficacy.
The precision medicine oncology pharmacist additionally serves as the comoderator of new FDA drug approvals for the MTB. When a new targeted treatment receives FDA approval, the pharmacist presents critical information regarding the drug target/biomarker, efficacy results from landmark trials, and key safety and monitoring information. Within these presentations, the pharmacist informs the MTB of any anticipated barriers to access or reimbursement for the newly approved drug. These presentations are essential to ensure that all members of the MTB are informed of recent FDA approvals and the availability of new treatment options.
Addressing Medication Access Barriers
Even as precision oncology promises to reshape the future, patient access to matched targeted therapy remains a significant barrier to implementation. Exorbitant drug prices, insurance restrictions, complex reimbursement policies, and restrictive manufacturer patient assistance programs often stand in the way of rapid initiation of targeted therapy. However, many patients seeking these novel therapies have aggressive cancers that are not conducive to waiting months for treatment. The precision medicine oncology pharmacist plays a leading role in overcoming these financial barriers by facilitating prior authorizations (PAs) and appeals, authoring letters of medical necessity, and supporting patient access to financial assistance programs.
PAs and appeals are frequently required for oncology-targeted medications to ensure insurance coverage. The pharmacist and a team of specialized medication access pharmacy technicians streamline this process by assisting in the preparation of comprehensive PA requests. PAs are almost always initially denied for novel drug combinations. When a PA claim is denied, the pharmacist and technicians assist providers in submitting insurance appeals, including clinical justification and drafting of letters of medical necessity with supporting documentation from genomic reports and published literature. When the appeal is denied due to insurance restrictions on off-label use of targeted agents, patient assistance programs (PAPs) are pursued as the last option for medication access. Manufacturers offer a variety of programs to help patients overcome access barriers, including co-pay assistance programs and PAPs that provide free medication through foundation support. The pharmacist identifies available manufacturer programs, assists the patient with application completion, and communicates with field reimbursement managers to overcome barriers to providing access to novel drug combinations. The medication access technicians, in collaboration with the pharmacist, also advise patients on PAP renewal and eligibility criteria to ensure continuation of therapy.
