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What goes into the approval of a drug?

A combination of safety, effectiveness, and cost

Sometimes, when your doctor prescribes a medication for a health condition, you may get to the pharmacy to fill it, only to find out that it’s not covered by your health insurance company. Or, you have to get approval from your insurance before getting the prescription filled. If you’re wondering why your health insurance company has a say in the medication you take, you’re not alone.

In general, for your insurance company to approve and cover a prescription drug, it must meet certain requirements regarding its safety, effectiveness, and cost compared with any available alternatives. Let’s break it all down to help explain what goes into the approval of a drug — and what you can do to educate yourself about your prescription drug coverage.

It starts with your formulary

A formulary, also called a drug list, is a list of medications covered by your prescription drug plan. The Wellmark Drug List, which is available online Opens New Window or by logging in to myWellmark® Opens New Window, provides guidance to you, your doctor, and your pharmacist when choosing the safest and most effective treatments for the best price.

Wellmark Blue Cross and Blue Shield's Pharmacy & Therapeutics (P&T) Committee, an independent group of physicians and pharmacists located in Iowa and South Dakota, meets four or more times a year to decide which prescription drugs are on the Wellmark Drug List. They update the list by analyzing new drugs and re-evaluating existing drugs based on their safety, cost, and effectiveness.

Wellmark's Pharmacy & Therapeutics Committee reviews drugs on safety, effectiveness, cost

Depending on your prescription drug plan, the medications on the Wellmark Drug List may be organized into tiers. This means that when you fill a prescription, the amount you pay depends on the tier or level of the drug. Generally, lower tiers contain lower-cost drugs and higher tiers contain higher-cost drugs, like specialty medications.

Why isn’t my prescription covered?

It’s important for our members to get the safest and most cost-effective medication available, which helps keep drug costs in check overall. That means some medications aren’t covered. There are several reasons an insurance company may not cover a medicine. For example, the drug in question could be newer and not have proven safety record, or there may be a less expensive drug available that works the same way.

Here’s what the Wellmark P&T committee considers when making recommendations regarding medications to be included or excluded on the Wellmark Drug List:

  • Safety. If a drug is still relatively new, it may not have information available about its safety over a long period of time. Or, there may be safety concerns with a specific medicine and there are safer alternatives available.
  • Cost. There is often more than one drug available to treat the same condition. If one drug is priced lower than another, and is just as safe and effective, then the lower-cost medication is more likely to be covered. This generally happens when there are both generic and brand-name versions of a specific treatment.
  • Effectiveness. Does a drug work? Sometimes, there isn’t enough evidence that a medicine is effective and works as promised, and it doesn’t make sense to add it to the Wellmark Drug List — especially if there are just-as-effective alternatives.

Wellmark also uses something called utilization management to ensure appropriate medication use, which helps keep your costs down. These programs include:

  • Prior authorization. Some prescriptions require prior approval Opens New Window from your insurance company. This is something your doctor needs to do before prescribing the medication. While prior authorization may seem like a hassle, it helps prevent doctors from prescribing medications you may not need, ones that may be addictive or ones that may have serious interactions with your current prescriptions. In some cases, a drug may not be approved until you have tried all other alternatives. You may need to start with the safest and most cost-effective drug, and move to alternative treatments if the initial medication doesn’t work as intended (for example, if you experience adverse side effects).
  • Quantity limits. Sometimes, there are restrictions on how much of a certain medication can be dispensed at one time, based on dosing recommendations. If your doctor prescribes more than is generally recommended over a period of time, your prescription may not be covered.

What can I do if my prescription isn’t covered?

Even if your doctor reviews the Wellmark Drug List, your prescription drug benefits may not cover a certain medication. Sometimes, drugs are not covered at all — for example, if they aren’t approved by the Food and Drug Administration, they’re unlikely to be covered. Or, your prescription may be on a higher tier, meaning you pay more at the pharmacy counter, which is something you probably want to avoid.

The first thing you should do is talk to your doctor or pharmacist about your options. Your doctor can prescribe you an alternative medicine that works in the same way, while your pharmacist may be able to recommend an over-the-counter product with the same active ingredient that you can purchase without a prescription. Your doctor may also submit a formulary exception request Opens New Window, which is different from a prior authorization request, if they choose to prescribe a non-formulary drug that is not on the Wellmark Drug List.

To learn more about your prescription drug benefits and how they work, log in to myWellmark and use the prescription drug tools. You can find cost and coverage information for your prescriptions, start mail-order service or set up automatic refills, compare the difference between brand-name and generic medications, and more. You can also download your coverage manual for detailed information about your benefits, as well as explanations of limitations and exclusions. Just go to Opens New Window to get started.