Non-formulary generics: what to do when coverage is denied

When your doctor prescribes a generic medication and the pharmacy says it’s not covered, it’s not a mistake. It’s a non-formulary generic-a drug that’s cheap, effective, and FDA-approved, but your insurance plan doesn’t list it. And when that happens, you’re left paying full price-sometimes hundreds of dollars more than you should. This isn’t rare. In 2022, over 12% of all generic prescriptions faced some kind of formulary restriction. For people managing chronic conditions like diabetes, Crohn’s disease, or high blood pressure, this isn’t just an inconvenience. It’s a health risk.

Why are generic drugs excluded from formularies?

Formularies are lists of drugs your insurance plan agrees to cover. They’re designed to control costs, not to limit care. But here’s the catch: even though a drug is generic, it might still be left off the list. Why? Insurance companies often favor certain brands or versions of the same drug because they get rebates from manufacturers. That means two identical pills-one covered, one not-can cost you $300 more a month. It’s not about safety or effectiveness. It’s about contracts and money.

Medicare Part D plans, for example, are required to cover at least two drugs in each therapeutic category. But that doesn’t mean they cover every generic. A 2023 CMS report showed that 37% of non-formulary denials happened because the plan had chosen a different generic version, even when the one your doctor prescribed worked better for you. And in states like California and New York, where regulations are stricter, patients still face the same problem. The system isn’t broken-it’s designed this way.

What you can do: the exceptions process

You’re not stuck. Federal law requires every insurance plan to have an exceptions process. That means you can ask your plan to cover the non-formulary drug if your doctor proves it’s medically necessary. This isn’t a loophole. It’s a right. And the success rate? It’s higher than most people think. According to the Crohn’s & Colitis Foundation, nearly 6 out of 10 denials are overturned when properly appealed.

Here’s how it works:

1. Get the denial in writing from the pharmacy. They’re required to give you this within 24 hours.
2. Ask your doctor to fill out a Coverage Determination Request form. This isn’t just a signature-it needs details. Not just “this drug works better.” You need specifics: previous medications tried, dates, lab results (like A1c levels for diabetes or fecal calprotectin for IBD), and why alternatives caused side effects or failed.
3. Submit the request. Most plans respond within 72 hours. If it’s urgent-like you’re about to run out of medication or your condition is worsening-you can ask for an expedited review. They must respond in 24 hours.

Doctors spend an average of 22.7 minutes completing a full request. A rushed one? About 14 minutes. And guess what? The rushed ones get denied. The difference isn’t just time-it’s evidence.

What your doctor needs to include

Your doctor isn’t just writing a note. They’re building a case. The Crohn’s & Colitis Foundation’s template says they must document four things:

• Why every formulary alternative won’t work for you
• Which drugs you’ve tried before and when they failed
• Specific clinical data proving your need (e.g., blood pressure readings, inflammation markers, seizure frequency)
• Potential harm if you switch-like worsening symptoms, hospitalization risk, or allergic reactions

Dr. Jane Sarasohn-Kahn, a healthcare economist, says the most successful appeals include numbers, not opinions. “Don’t say ‘this drug works better.’ Say ‘I’ve tried three formulary options. My A1c dropped from 9.2 to 6.8 only after switching to this specific metformin ER. The others kept it above 8.5.’” That’s the language that gets approvals.

What happens if you’re denied

If your first request is denied, you don’t give up. You appeal. You have 60 days to file an internal appeal. Your plan must respond within 30 days. If they say no again, you can request an external review by an independent third party. This step is free, and you don’t need a lawyer. The Bleeding Disorders Advocacy Alliance found that 74% of properly documented requests get approved on the first try. But if you skip the details? Your chance drops to under 30%.

And here’s something most people don’t know: even if your drug gets approved, your plan doesn’t have to put it on a lower cost tier. You might still pay more than if it were on-formulary. That’s a loophole. Dr. Mark Parisi at MMIT warns that many patients think “approved” means “affordable.” It doesn’t. You might need a second request-this time for a tiering exception-just to lower your copay.

Emergency help while you wait

If you’re running out of medication and the 72-hour wait is too long, you’re entitled to an emergency supply. Federal rules say your plan must give you up to 72 hours’ worth of the drug while your request is reviewed. But here’s the problem: 37% of plans ignore this rule, according to QuickRx’s 2023 compliance report. If you’re denied, call your plan’s member services. Say: “I’m requesting an emergency supply under CMS guidelines. I need 72 hours of [drug name] immediately.” Keep a record of the call. If they refuse, file a complaint with CMS or your state insurance department.

Real stories: what works

On Reddit, a user named PharmTechSarah spent four tries to get her generic mesalamine approved. Each time, she and her doctor added more detail: flare dates, colonoscopy results, and a note that the formulary alternative caused severe nausea. On the fifth try, it worked.

Another patient, DiabetesWarrior, paid $417 out of pocket for 90 days of metformin ER after a denial. When they appealed with A1c data showing a drop from 9.2 to 6.8, the plan approved it-and refunded the overpayment.

These aren’t outliers. The GoodRx 2023 survey found 63% of people who appealed got their drug covered. But only 29% knew they could ask for an urgent review. That’s the gap.

What’s changing in 2025

Things are slowly getting better. In October 2023, CMS rolled out standardized clinical criteria for common conditions-diabetes, hypertension, IBD, epilepsy. This means doctors now have clearer guidelines on what evidence to include. The agency expects denial rates to drop by 15-20%.

Starting in 2024, Medicare Part D must automatically approve exceptions for insulin and naloxone. No forms. No delays. Just access.

By 2025, CMS plans to connect the exceptions process directly to electronic health records. That means your doctor’s notes will auto-fill into the request. No more handwritten forms. No more lost paperwork. Processing times could drop by 40%.

But there’s a new risk: specialty pharmacies are now handling more generic drugs-like bioidentical hormones or compounded thyroid meds. These are often excluded from standard formularies, and the rules are still unclear. Watch for these gaps.

What to do right now

If you’ve been denied:

• Don’t stop taking your medication. Ask your doctor about samples or patient assistance programs.
• Get the denial letter. It’s your starting point.
• Call your doctor’s office. Ask them to complete the form. Don’t let them say “it’s too much work.” It’s your health.
• Use templates from patient advocacy groups like the Crohn’s & Colitis Foundation or the Bleeding Disorders Advocacy Alliance. They’re free and proven.
• File an appeal. Even if you’re scared. 63% of people who try win.

And if you’re a caregiver, help your loved one track their meds. Keep a log: what was prescribed, what was denied, what worked before. That history is your strongest tool.

Generic drugs are supposed to be the affordable backbone of healthcare. When they’re denied, it’s not about medical need. It’s about system design. But you have power. Use it.