Bhuvana Sagar, MD: When new clinical trial evidence comes out, we do get alerts from the FDA. We get alerts through the American Society of Clinical Oncology e-mailers. We also get alerts through NCCN [National Comprehensive Cancer Network] flash updates. Any time a drug gets FDA approval or if there’s an NCCN guideline change, they immediately make a change in our coverage policy.
When we make a positive change for drug approvals—let’s say the FDA sends us an alert and we start covering the drug—we don’t make a specific outreach to the providers to let them know that we’re starting coverage for that particular indication. I think the providers also receive alerts from the FDA and ASCO when they sign up for them. So, we rely on that for the providers to be educated and able to place a request for drug authorization when new FDA approvals come out.
We have implemented a patient decision support tool in practice. The providers have access to a portal where they enter patient data. It collects detailed information on the patient’s performance status, age, and demographic information. It also collects information on their cancer subtype and all the other relevant details that are required to make a drug approval decision. Once that information is collected, it leads them to a list of choices that are in the NCCN guidelines. If the provider is able to pick one of those drug regimens, there’s an automatic authorization. In situations where the provider is not able to pick one of those regimens, for whatever clinical reason, and they want to deviate from one of the regimens that are in the guidelines, he or she has the availability to put in a custom regimen request. All of those requests will be reviewed, and the provider has the option to have a peer-to-peer discussion with a board-certified medical oncologist to understand any nuances that may be going on with that particular patient to see if there’s a reason for a clinically valid exception in that particular scenario. If there is a reasonable clinical reason, then we do allow an exception.
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