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When Insurers “Just Say ‘No’” to New Drugs

What if your insurance company refused to cover your medication just because it was new?

The practice is becoming more common with the proliferation of what are known as “new-to-market exclusions.”  These are health plan provisions that arbitrarily delay coverage for newly available medications.  

In some cases, the insurer postpones access for a period of time, perhaps three or six months.  In other instances, insurers refuse to cover new drugs altogether, waiting instead for the next calendar year, when the insurance company updates its formulary of covered drugs.

The general practice of excluding medications from coverage is hardly new.  Between 2014 and 2018, the number of excluded drugs grew by 160% under major national pharmacy benefit managers.  Research shows that exclusions can have negative economic consequences when they deprive patients of their regular medication.   

When insurers refuse to cover prescription drugs purely because they are new, however, exclusions can disproportionately penalize people with rare or hard-to-treat diseases.   Though a drug itself may be new, the patients who need that drug may have struggled for years.  New-to-market exclusions force them to wait still longer.      

Such policies aren’t just frustrating.  A forced waiting period can allow a disease to worsen.  A person with poorly managed migraine disease, for example, may see her attacks become chronic.  A person with untreated osteoarthritis may experience irreversible joint damage. 

Rare disease patients can be particularly hard hit.  People with a rare autoimmune condition known as thyroid eye disease could experience irreversible vision damage or loss.  People with cystic fibrosis may spend days in the hospital fighting symptoms or respiratory infections even as a viable new therapy waits right around the corner.  

If a new treatment is approved early in the year, but the insurer won’t cover new medications until the following calendar year, patients’ wait could be extensive.  So too could their disease progression or complications.

Medications that are newly available have been proven safe and effective by the Food and Drug Administration.  They are often a source of celebration for patients and their families.  But until insurance companies end arbitrary waiting periods, patients may continue to find that the medication, and the quality of life, they’ve been waiting for remains just out of reach.


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