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Posted on 27. May 2021

What Do I Do When I Receive a Denial for an Off-Label Medication?

By Abbie Cornett

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The other day, I received a phone call from a patient asking for help with an appeal. When she explained her situation, my heart sank. Her physician had prescribed intravenous immune globulin for off-label use, and the insurance company had denied it based on the grounds that its use for the condition is "experimental."

Like many newly diagnosed patients, she didn't know what the insurance company meant by off-label use. The U.S. Food and Drug Administration (FDA) approves drugs for specific health conditions. When a doctor prescribes a drug off-label, he or she prescribes it for a different condition or at a different dosage than the FDA has approved.1 But just because the drug has not been approved for the condition the physician is prescribing it for doesn't mean it won't be effective. An off-label medication is often beneficial for patients with rare diseases who have exhausted all other approved options.

She then asked me: If it works, why is it off-label? Drug manufacturers frequently don't try to get a new FDA approval for a medication because of the time and cost involved. To obtain additional indications (approvals) for a drug already approved requires the manufacturer to submit a supplemental drug application.2 And, many manufacturers don't feel the expense of the additional approval is worthwhile.

For patients, the biggest problem with an off-label medication prescription is getting the insurance company to reimburse it! Many insurance companies will not pay for an expensive drug that's used to treat a condition that is not on the approved drug label.3

When an insurance company denies a medication, an appeal has to be filed. The appeal process is common among all insurance plans:

  • First Appeal. During the first appeal, the patient or his or her doctor can contact the insurance company to ask it to reconsider the denial. Additionally, the physician can request a peer-to-peer review with the insurance company's medical reviewer to discuss the decision.
  • Second Appeal. If the first appeal is still denied, it is typically reviewed by a medical director at the insurance company who was not involved in the claim decision. The goal of this appeal is to prove the request should be accepted within the coverage guidelines.4
  • Final Appeal. If the medication is again denied, the patient has the right to have an independent external medical reviewer and another doctor who specializes in the disease determine if the medication will be approved.

Receiving a denial letter can be frustrating, particularly when dealing with a chronic illness. But a denial letter doesn't mean there are not options. Everyone has the right to the appeal process. The insurance company's requirements for an appeal are stated in the explanation of benefits.


References:

1  MedicalNewsToday. What to Know About Off-Label Drug Use. Accessed at
https://www.medicalnewstoday.com/articles/off-label-drug-use.
2  Wittich, CM, Burkle, CM, and Lanier, WL. Ten Common Questions (and Their Answers) About Off-Label Drug Use. Mayo Clinic Proceedings, 2012 Oct; 87(10): 982–990. Accessed at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/.
3  American Cancer Society. What Is Off-Label Drug Use. Accessed at
https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/off-label-drug-use.html.
4  JDRF. Denials/Appeals: What to Do When Your Insurance Company Denies You Coverage. Accessed at
https://www.jdrf.org/t1d-resources/living-with-t1d/insurance/insurance-denials-appeals/.

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