Why Does a Drug Need Pre-Approval?

Some drugs must be approved by your health plan before they will be covered. That’s to make sure they are safe and used right. If you are told a drug needs pre-approval (sometimes called prior authorization), that does not mean it isn’t covered by your plan. It means there is one more step in the process and more information is needed.

Like hospital stays and some types of procedures and treatments, some drugs need pre-approval. Your doctor’s office, using the information on your ID card, may tell you pre-approval is required for a certain drug. Or your pharmacy will let you know when it’s needed. Some reasons include:

• Side Effects: Does the drug have serious or severe side effects? Some steroids, pain relievers and sleeping meds have serious side effects for some people.
• It’s New: It may lack a long safety record.
• Misuse: Some drugs, like controlled substances, can be unsafe when not used the right way.
• Interactions: Is the drug unsafe when it’s combined with other drugs or over-the-counter medicines?
• Dose: Is the drug being prescribed as a higher dose than normal?
• Medical Necessity: Why did the doctor write the prescription? Is the drug needed for good health?
• Cost: Does an expensive brand-name drug have a lower-cost or generic version available that’s used for the same health problem?

When reviewing drugs and their use, we weigh these things and more. It’s a good idea for you and your doctor to study your prescription drug list when making choices about how to manage your health.

Keep in mind that some drugs may not ever be covered. That may include:

• When they are used for a cosmetic rather than medical reason, like a face cream.
• If they are used off-label. That means the drug was approved by the FDA to treat a specific health issue you don’t have. For example, using a diabetes medicine for weight loss by someone who hasn’t been diagnosed with diabetes.
• If the same medicine is available over the counter without a prescription, like an allergy medicine.

There are hundreds of medications. More are becoming available each day. The pre-approval process helps you get a safe drug that works at the lowest available cost.

Sources: Medication Safety Program,  Centers for Disease Control and Prevention, 2024; Use Medicines Safely,  U.S. Department of Health and Human Services, 2022; How to Obtain Prior Authorizations,  Breakthrough T1D (formerly the Juvenile Diabetes Research Foundation)

Originally published 10/13/2023; Revised 2024