Fail First

"Fail first" is the informal name for a step-therapy protocol, where a health plan or PBM requires a patient to try (and demonstrate lack of efficacy or intolerance for) a lower-cost drug before it will cover a higher-cost alternative for the same condition. The patient literally has to "fail" on the first-line therapy — meaning the drug doesn't work well enough or produces intolerable side effects — before the second-line, more expensive option is authorized.

The rationale from the plan's side is cost containment: many first-line therapies are effective for most patients, so requiring a documented trial ensures the plan doesn't pay for expensive drugs before proven alternatives have been tried. The frustration from the patient and prescriber side is the delay in getting to a drug the prescriber already believes is the right choice, particularly when the prescriber has clinical experience with the patient and knows the first-line option is unlikely to work. Step-therapy protocols are most common in the rheumatoid arthritis, multiple sclerosis, migraine, and psoriasis categories, where multiple approved therapies exist across a wide price range. Many state laws now require plans to grant a medical-necessity exception when a prescriber attests that step therapy would harm the patient or is medically inappropriate given the patient's specific history.

The takeaway: if a plan requires you to try a drug your prescriber doesn't think will work, ask the prescriber to file a step-therapy exception on medical-necessity grounds. Most states now require plans to have an expedited exception pathway when the prescriber attests the requirement is clinically inappropriate.