Step Therapy is often required because it an effective way for your insurance company to control and low its costs. When you are prescribed a GLP-1 like Zepbound or Mounjaro, your insurance may ask you try a cheaper alternative medication first. Only after you demonstrate that the drug failed to be effective will your insurance cover your originally prescribed GLP-1 on your behalf.

If your insurance denied coverage for your GLP-1 prescription based on a request for step therapy, you have the legal right to ask your insurance to reconsider the coverage denial by sending an ‘appeal’. It almost always makes sense to appeal, but many people don’t. A study from September 2023 found that 69% of people who were denied coverage by their insurance didn’t know they could appeal, and 85% of people never tried to appeal.
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Honest Care has you covered with our guide to Step Therapy Denials and Appeals for Ozempic, Mounjaro, Wegovy and Zepbound. Feel free to skip the sections of this guide that are most relevant to you.

Need Help Appealing a Step Therapy Denial? Explore Honest Care's GLP-1 appeal service.‍

Guide: Step Therapy Insurance Denials For GLP-1s

• How to find out if you were denied because of Step Therapy?
• How to appeal a Step Therapy denial?
• Which Step Therapy medications are required for GLP-1 coverage?
• How to make a Step Therapy Exception Request?

What is an example of a step therapy denial?

Let's say you have been prescribed Zepbound (tirzepatide) and denied coverage for Zepbound by your insurance with a denial reason of failure to meeting step therapy requirements and a request for you to try alternative medications first. This means that instead of (or in addition to) Zepbound, your insurance provider has listed generic and/or "preferred" weight-loss medications on your plan's formulary (list of covered medications) that they request you try first. Your denial letter may include an explanation similar to the below:

Step Therapy Denial Letter Example

Your plan only covers this drug when you meet one of these options: A) You have tried other drugs your plan covers (preferred drugs), and they did not work well for you, or B) Your doctor gives us a medical reason you cannot take those other drugs. For your plan, you may need to try up to three preferred drugs. We have denied your request because you do not meet any of these conditions. We reviewed the information we had. Your request has been denied. Your doctor can send us any new or missing information for us to review. The preferred drugs for your plan are: orlistat, QSYMIA, SAXENDA, WEGOVY (Requirement: 3 in a class with 3 or more alternatives, 2 in a class with 2 alternatives, or 1 in a class with only 1 alternative). Your doctor may need to get approval from your plan for preferred drugs. For this drug, you may have to meet other criteria. You can request the drug policy for more details. You can also request other plan documents for your review.‍

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Let's break down how the medications mentioned in the above denial example fall into "steps" or "tiers" on common, 3-tier formulary plan. Some plans include 4 or 5-tier formulary plans that may slightly differ from the below.

• Tier 1: Generic medications, often referred to as first-in-line medications, are frequently listed as Tier 1 step therapy medications on formulary. Orlistat is a generic medication that is FDA-approved for weight loss and is mentioned in this example. Phentermine and Metformin are other generic medications commonly required for GLP-1 step therapy.
• Tier 2: Medications in Tier 2 are often referred to referred to as "preferred" medications by your insurance and tend to be brand-name medications. These medications don't have 'generic' alternatives, but tend to be less expensive for your insurance. In this example, medications "preferred" by insurance include Qsymia, Saxenda and Wegovy instead of Zepbound. Even if a medication is "preferred", prior authorization may still be required by your insurance. In this case, Wegovy most likely still requires prior authorization despite being preferred.
• Tier 3: Medications in Tier 3 are "non-preferred" medications, meaning your insurance will seek to avoid covering them as much as possible due to cost. These medications will always require prior authorization. This example, Zepbound has been denied to its status as a "non-preferred" medication.

How to find out if you were denied because of step therapy?

If you have been denied coverage for Ozempic, Mounjaro, Wegovy or Zepbound, it may be because you did not meet the ‘step therapy’ requirements outlined by your insurance plan. The easiest way to understand if this is why you were denied is to review the coverage denial letter sent by your insurance, often referred to as an “Explanation of Benefits”. Read the section "What is an example of Step Therapy denial?" above for more details.

• ‍Zepbound & Wegovy: If you were denied coverage for either Zepbound or Wegovy, review your denial letter for any mention of medications including Orlistat (Xenical), Phentermine, Qsymia, Contrave or Plenity. If these medications are mentioned and you have never tried these medications, or have not tried the medications within the last few years, you may have been denied due to step therapy requirements.‍
• Mounjaro & Ozempic: If you were denied coverage for either Mounjaro or Wegovy, review your denial letter for medications including Metformin, Victoza, Rybelsus or Byetta. If these medications are mentioned and you have never tried these medications, or have not tried the medications within the last few years, you may have been denied due to step therapy requirements.

How to appeal a step therapy denial?

Key Takeaway: Step therapy denials can be overturned with an effective appeal strategy. Need help navigating step therapy denial? Try Honest Care appeal services.

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Even if you have not tried the step therapy medications required by your insurance, coverage denials can still be overturned through an effective appeal. Exceptions to step therapy requirements can be made based on several conditions which can be detailed in your appeal, including:

1. You already tried the medication under a previous insurance plan: Most people change insurance plans every 2-3 years. As a result, even if you have already tried a required step therapy medication, your current insurance may not be know this because you were prescribed the medication on a previous plan.‍
2. The medication is contraindicated or expected to cause you physical or mental harm: In simple terms, this means that the risks of using the medication likely outweigh the potential treatment benefits. This may apply based on:
   • Drug interactions: Some medications can interact negatively with other drugs. If a person is already taking a certain medication, introducing another medication that interacts with it might be contraindicated.
   • ‍Medical conditions: Certain medical conditions might make the use of a specific medication dangerous. For example, a medication might be contraindicated in people with heart disease, liver disease, or certain allergies.‍
   • Patient characteristics: Factors such as age, pregnancy, breastfeeding, or specific genetic markers can make the use of certain medications risky.
   • ‍Side effects: If a medication has side effects that could exacerbate an existing condition or cause severe reactions in a specific group of patients, it would be contraindicated for those individuals.
3. ‍The medication is expected to be ineffective: Step Therapy policies help insurance save money because the step therapy medications are cheaper than GLP-1, and these medications are cheaper because they are also less effective than GLP-1s. Within an appeal, clinical research demonstrating the inferiority of a required medication compared to the denied GLP-1 can be included. For example, you might cite research studies showing that Orlistat or Phentermine is a less effective weight loss medication than Wegovy or Zepbound within your appeal.‍
4. You are already demonstrating positive treatment on the GLP-1 you were prescribed: If you already started taking the GLP-1 you were denied coverage for and have experienced positive clinical results, this can be a reason for your insurance to drop your step therapy requirement. If this is the case for you, you’ll want to share details on the clinical progress you have made while on treatment. For example, your reduction in HbA1c while taking Ozempic or Mounjaro, or your weight loss while taking Zepbound or Wegovy.

What medications are required for GLP-1 step therapy ?

Each insurance provider establishes their own step therapy requirements, including which medications are included within each step therapy "tier" on their formulary. Below we've listed the most common medications mentioned by insurance

Zepbound & Wegovy step therapy medications:

• Contrave
• Orlistat (Xenical)
• Phentermine (Adipex-P)
• Plenity
• Qsymia
• Saxenda

Mounjaro & Ozempic step therapy medications:

• Metformin
• Rybelsus
• Victoza
• Byetta
• Trulicity‍

How to make a step therapy exception request?

Key Takeaway: Depending on which state you live in, your doctor may be able to file a request for a step therapy exception with your insurance. While you can submit appeals on your own or through your doctor, only your doctor can file a step therapy exception for on your behalf.

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Certain US states have put in place protections to help patients bypass step therapy requirements by filing for a “Step Therapy Exception.” Step Therapy Exception Requests must be filed by your doctor.

Step Therapy Exception rules vary not only by state, but also type of insurance. In most cases, state laws apply to anyone covered by a commercial insurance plan, including employer-sponsored plans, individuals plans through insurance exchange (Affordable Care Act), and fully-insured employer plans. Certain state Medicaid programs also have adopted step therapy protections.

Here is a list of states where some level of step therapy protections in place as of 2023, and a link to the state's step therapy exception request form if available. This list is not exhaustive, so please talk to your doctor for more information.

Arizona (exclusion form)‍

Arkansas (exclusion form)

California (exclusion form)

Connecticut (exclusion form)

Delaware (exclusion form)

Florida (exclusion form)

Georgia (exclusion form)

Illinois (exclusion form)

Indiana (exclusion form)

Iowa (exclusion form)

Kansas

Kentucky (exclusion form)

Louisiana (exclusion form)

Maine (exclusion form)

Maryland (exclusion form)

Massachusetts

Minnesota (exclusion form)

Mississippi (exclusion form)

Missouri (exclusion form)

Nebraska (exclusion form)

Nevada

New Mexico (exclusion form)

New York (exclusion form)

North Carolina (exclusion form)

Ohio (exclusion form)

Oklahoma (exclusion form)

Oregon (exclusion form)

Pennsylvania

South Dakota (exclusion form)

Tennessee

Texas (exclusion form)

Washington (exclusion form)

West Virginia (exclusion form)

Wisconsin (exclusion form)