In October 2018, the Association of Community Cancer Centers
(ACCC) hosted a pre-conference workshop at its 35th National
Oncology Conference. Sessions focused on models which show
how oncology pharmacists can best respond to rapid changes
occurring in the oncology environment, including the emergence
of molecular tumor boards. Molecular tumor boards offer a vital
resource to support delivery of precision medicine to oncology
patients. Various members of the cancer care team should be represented,
including the oncology pharmacist.
Next generation sequencing (NGS) is becoming increasingly
important for diagnosing cancer, predicting prognosis, and guiding
personalized treatment for patients. In 2006, Moffitt Cancer Center
in Tampa, Florida, launched Total Cancer CareTM (TCC). TCC is a
unique research study which entails collecting tumor specimens
and clinical data, including NGS results, throughout the lifetime
of patients to create evidence in support of precision medicine.1
As a result, a multidisciplinary, team-based service has evolved at
Moffitt to help translate this personalized cancer care approach
from research into clinical practice. In addition to pharmacists, the
team includes members from pathology, medical genetics, bioinformatics,
translational research, laboratory science, social work,
oncology and hematology physicians and nurses, and patient
representatives. Todd Knepper, PharmD, Personalized Medicine
Specialist, Department of Individualized Cancer Management at
the Moffitt Cancer Center provided an overview of this clinical
service and the in-house and external vendor NGS panels used to
test tumors for somatic mutations.
Reporting for these panels is typically patient-specific and comprehensive,
although there is considerable variation in the format
and content of reporting NGS results. At Moffitt, rather than leave
the interpretation of NGS panel results to physicians, the molecular
tumor board (MTB) offers a clinical service that reviews in-house and
commercial NGS panel results on a daily basis. The Personalized
Medicine Clinical Service and Clinical Genomics Action Committee
(CGAC) are pharmacist-led clinical programs at Moffitt Cancer
Center that meet weekly to discuss the NGS results and recommend
treatment options including the potential for clinical trial enrollment.2
Pharmacists on the team serve as attendings on the Personalized
Medicine Clinical Service and are responsible for reviewing and
interpreting NGS results, leading the MTB meetings, and documenting
MTB outcomes in the electronic health record. In addition to
reviewing off-label data, pursuing tiered therapy authorizations, and
considering drug-drug interactions to support the treating physician,
the pharmacists assist in the procurement of off-label therapies.
This Personalized Clinical Medicine Service is supported by a (CGAC)
dashboard that reports results and potential clinical implications
Cory Vela, PharmD, BCOP, is a Clinical Pharmacy Specialist, Precision
Medicine at the University of Kentucky (UK), Markey Cancer Center.
His responsibilities as a pharmacist participating in the UK MTB
include gathering and interpreting all patient-specific molecular
alteration data; outlining potential targeted therapy (on-label,
off-label, clinical trial) options based upon molecular alterations
identified, prior treatment history, or persistent toxicity from prior
therapy; facilitating treatment-oriented discussion during the UK
MTB; and presenting, or recruiting other MTB members to present
primary literature to the UK MTB to support targeted therapy
Patients who pursue clinical trials at UK are treated in the Precision
Medicine Clinic in which Dr. Vela is the clinical pharmacist. During
these visits Dr. Vela obtains a medication history, discusses treatment
calendars, addresses drug-drug interactions, explains the mechanism
of action of selected targeted therapy, outlines potential treatment-
related toxicities, and follows the patient to assist in toxicity
management. Occasionally, Dr. Vela may meet with the patient to
discuss UK MTB recommendations and explain the rationale behind
recommended treatment plans. He also works with UK Specialty
Pharmacy Services to aid with prior authorization processes and
Dr. Vela provided an overview of the MTB process at UK (Figure 2),3
and the impact of MTB decisions on patients.
UK physicians, and those at affiliate institutions in the state of
Kentucky, can order a range of tests (e.g., hotspot mutational testing,
limited polymerase chain reaction (PCR) gene panel, immunohistochemistry
(IHC), NGS panels), but in contrast to the Moffitt
model, the UK MTB does not review all reports. Rather, physicians
in all participating sites can request for the UK MTB to review a patient’s molecular data results via EMR. The MTB meets twice a month, with cases reviewed by physicians, radiologists, pathologists, researchers, and pharmacists. The interdisciplinary members present pertinent patient history, response to prior therapy, pathologic review of current and/or prior biopsies, and mutation panel results to try to identify potential patient-specific therapeutic options (e.g., standard of care, clinical trials, or off-label therapy). Following MTB discussion, recommendations and supporting literature are presented to the treating physician and documented in the electronic medical record (EMR).
What is the best time to use NGS testing, which patients should we be testing, and what could we do to improve the testing process?
Typically, physicians order an NGS panel when they know a patient is a candidate for additional therapy. The best timing for testing is a difficult question to answer; however, Dr. Vela noted that testing at diagnosis is optimal and FDA approved for many cancers (e.g., lung). In other cancer types, test timing is less clear cut. Some baseline mutations are associated with genetic shift and can change over time from primary therapy to relapse depending on the kind of therapy patients have received. In addition, given the costs of testing and potential for off-label therapies, especially in later lines of therapy, some commercial testing companies have started to request pre-test evidence of utility to justify potential cost. Current best practice involves discussion between patients and their providers, and providers’ discussion with members of the MTB, prior to ordering mutational testing.
In a previous retrospective study of Moffitt patients, Drs. Vela, Knepper, and colleagues reviewed the CGAC database for solid tumor patients and reported that lung cancer was the most common tumor type for which molecular testing was ordered, followed by brain and colorectal cancer. The retrospective analysis identified that 16.3% (n=175) of patients were eligible for on- or off-label therapy based upon 17 potentially actionable mutations.3 Dr. Vela suggested that perhaps the number of patients eligible for targeted therapy would have been greater if clinical trial eligibility had been assessed or if a larger number of genes was evaluated.
Financial toxicity is increasingly common among patients receiving cancer treatment; therefore, treatment cost estimates are often discussed at MTBs and molecular testing information is included in pre-authorization documentation. Clara Lambert, BBA, OPN-CG, Oncology Financial Navigator at Advocate Good Samaritan Bhorade Cancer Center, presented an overview of how financial advocates (e.g., patient/financial navigators, social workers, nurses) can represent patients’ financial concerns in the MTB setting and how their advocacy role is evolving. Financial advocates represent the patient voice at the MTB. Ms. Lambert noted, “I have found that if the patient has already expressed financial concerns to me, and the tumor board is discussing options in treatment, that I need to speak up and let them know of the concerns, and the potential costs of the treatments they are considering. When I make this statement, I also make sure that I know what available assistance the patient can qualify for. Ultimately, it is up to the physician and the patient to determine the best treatment, but I do think that both need to do this with all of the information available to include efficacy, side effects, cost, and assistance available.”
Who explains the financial implications of
treatment to patients?
Financial advocates can help patients understand insurance
coverage, what their plan is likely to cover, and what
the potential out-of-pocket costs are likely to be. To avoid
treatment delays, oncology financial navigator Lambert also
advises advocates to gather as much complete information
as possible up front to submit to payers, including NGS testing
results, and treatment regimen(s), including dosages. It
is important to explain to patients the rationale for including
this information in authorization submissions and to keep
them in an ongoing communication loop. Sometimes
patient responses are non-verbal and signal extreme anxiety.
Lambert finds it instructive to watch a patient’s body
language and to acknowledge there are instances where a
social work referral might be great.
In order to represent patient concerns and support access to recommended
treatment, financial advocates need to be familiar with
compendia (e.g., Micromedex, Lexicomp, National Comprehensive
Cancer Network) and patient insurance coverage and understand
how the treatment plan will work with the patient’s insurance (e.g.,
not only on-label, but also off-label, clinical trial enrollment, and
multi-year treatment). Financial navigation software tools can be
invaluable in streamlining and automating financial processes,
identifying patients at financial risk, and suggesting personalized
Financial advocates work alongside oncology pharmacists to ensure
selected therapy is affordable/available prior to treatment initiation.
Advocates will work with both on- and offsite specialty pharmacy representatives
and continue to provide financial navigation assistance
to ensure continuity for patients. Several portals allow advocates to
monitor the prescription, financial assistance status, and the authorization
process and determine when it might be necessary to find
new assistance funds and patient support services.
This in-depth knowledge is key in treatment planning discussions,
especially as NGS panels often report off-label therapies as potential
treatment outside of guidelines/compendia. Ms. Lambert noted that
in the case of combination treatment that involves off-label therapy,
pre-emptive navigation is prudent to identify free medication prior
to treatment initiation. She also emphasized that financial advocates
should establish regular communication with patients throughout
the treatment planning and delivery process to keep them apprised
of insurance coverage and funding assistance. Financial advocates
can help to alleviate patient anxiety through regular communication
about the authorization, denials, and appeals processes.