Navigating Challenges: Barriers to Adopting Genomic Testing and Targeted Therapy in Oncology
Please let us know which of these you consider to be the most significant barrier to adopting genomic testing and targeted therapies.
Tremendous progress has been made in the field of genomic testing and targeted therapies. New therapies are being launched that replace existing standards of care as well for alternate therapies that did not exist before. Genomic testing capabilities have also made progress in knowledge, technology and applicability in clinical care. Yet the adoption of genomic testing and targeted therapies in the clinical setting has not kept up with these innovations.
This blog explores system and oncologist specific barriers to adopting genomic testing and targeted therapies along with potential solutions to address these challenges.
Reasons for low adoption includes:
Information scattered across systems (not easily accessible from within the clinical workflow).
Making high quality treatment decisions requires creating context across comorbidities, family history of disease conditions , cancer stage, histopathologic biomarkers, smoking status, clinical genetic testing, and other pertinent cancer data. Accessing this information in the EHR comes with high cognitive overhead where a clinician has to construct the history of the patient in their mind by navigating across multiple screens and reviewing notes/reports from radiologist, pathologist, previous visits etc. The cognitive overhead for the clinician is further compounded by situations where the genomic test results are not present in the EHR, making it difficult and time consuming to correlate clinical features with the genomic testing results over time.
Low confidence in utilizing genomic results in treatment planning decisions.
When it comes to utilizing genomic testing to determine treatment plans for patients, oncologists have multiple options to consider from Next-Generation Sequencing, Gene Expression to Whole-Genome sequencing. Oncologists also struggle to recognize which tests will provide accurate and actionable information making it difficult to identify the right test for patients at the right time in their disease trajectory. This is observed particularly among oncologists who have not received genomic training , practice in rural communities or solo practices and have limited support in terms of ordering and interpreting genomic test results.
When genomic test reports include large amounts of unfamiliar information, clinicians struggle to consume the information and leverage it to make clinical decisions. Their varying degree of confidence in utilizing the test results depending on their training in genomic, patient volume (larger the patient volume higher the confidence in genomic testing), types of tumors they are treating (experience treating solid tumors indicating higher genomic confidence) and type of test (higher confidence in leveraging single-gene test compared to multi marker panels) . The low confidence in interpreting the testing result in turn impacts that ability for the oncologist to explain the test results to the patient thereby creating further barriers to utilizing genomic testing
Inability to keep up with rapidly changing clinical trials and therapies landscape.
Targeted therapies have been foundational to improving outcomes for cancer patients. Clinical trials have been a key enabler for developing new and effective therapies. Oncologists face multiple challenges in leveraging the latest targeted therapies and clinical trials as treatment modalities. Prominent among them is lack of awareness of available trials and therapies. There are multiple repositories that clinicians can utilize to find clinical trial details, which require manual search where specific characteristics of the patient (observed variants, stage, clinical diagnosis etc) will have to be entered into the system to find relevant trials. In the limited time that an oncologist has during a patient visit, the manual clinical trial search is time prohibitive which leads to the use of standard-of-care treatments without necessarily exploring clinical trial options.
There are multiple approaches that are being utilized to address this challenge including institutions curating a list of trials that they would like for the Oncologist to consider and genomic testing labs providing recommended clinical trial options along with the test results. While these approaches help the oncologist narrow down the list of trials, they still have to spend time reviewing the details of the trials to ensure its appropriateness for the patient and validating if the patient meets the eligibility criteria associated with the trials.
The trials that are highlighted in the genomic testing results are based on the snapshot of the patient at the time of testing and become obsolete as the patient's disease condition progresses and new trials become available. The time and effort required to keep up with the latest clinical trials and to utilize it for treatment planning is acutely manifested in the community oncology setting where the oncologists are treating different cancer types across their patient population compared to oncologists in academic medical institutions where they are focused on specific cancer types making it easier to keep track of the clinical trials.
Once the oncologist identifies a trial based on clinical and genomic criteria the next challenge they encounter is around aligning with the patient preferences. Patients will have specific expectations around the clinical trials, including distance they are willing to travel , time commitment in terms of on-site visits, phase of the trials, out of pocket expense etc. The details associated with the trials are not documented in a standard format and will require the oncologist or an office staff member to review the text and ensure the trial meets the patient's preference before they can recommend the trial to the patient. This adds further time commitment and coordination from the oncologist in identifying the appropriate clinical trial for the patient.
Administrative burden associated with ensuring insurance coverage for diagnostics and therapies.
Once the decision to order a genomic test or utilize a standard therapy in an off label context has been made, the next barrier that the oncologist and the rest of the care team has to focus on is the prior authorization (PA) from the patient's insurance company to ensure coverage for the genomic testing and or therapies. Oncologists are sensitive to recommending treatment options that create financial challenges for the patients and creating emotional distress for the patients when the prior authorization is not approved. The delays associated with prior authorization impacts the care delivery in multiple ways including delay of treatment, delay of diagnostics, use of second choice therapy and increased out of pocket cost for patients.
To address the challenges associated with prior authorization, cancer centers and oncology practices have created dedicated teams who are responsible for gathering the relevant information about the patient, preparing the required documentation and working with the insurance companies to get the prior authorization approved. In addition to the dedicated staff the oncologists also spend considerable amounts of time in drafting letters of medical necessities and in peer to peer discussion with the clinical staff at the payer for cases that are denied.
While the dedicated staff for supporting prior authorizations provide some relief to the oncologist , the process for preparing and requesting prior authorizations is very manual in nature. Once a patient has been identified as requiring prior authorization, the patient's information and requested service is communicated to the team managing prior authorizations. The PA team would review the patient's chart, validate the patient meets the criteria set by the insurance companies. This typically involves using the search capability in the EHR to look for keywords in the patient's chart (for example searching for the word “metastatic” to confirm the patient's cancer is metastatic).
After it has been validated that the patient meets the prior authorization criteria, the team creates the letters of medical necessity and supporting evidence required for submitting the PA request to the insurance company. Depending on the response from the insurance companies there will be further back and forth communication between the PA team , oncologist and the clinical team at the payer. The delays introduced by this process and the uncertainty associated with the approval process lead to clinicians not ordering the genomic testing or recommending targeted therapies and avoid disappointing their patients.
