Should Insurance Companies Pay for Off-Label Drugs?

Usually, we doctors give you advice.   In this case, I’d like readers to offer an opinion on an issue that patients and I face regularly.

First, let’s acknowledge the huge reservoir of frustration and anger directed against insurance companies concerning their coverage decisions.  I have willingly entered this arena to wage battles for patients.  Despite my vigorous prosecutions of these contests, the outcomes have been variable.  Indeed, these competitions are not for the causal physician combatant.  The doctor must have the mettle, determination, skill and endurance of a Navy SEAL if there is to be any prospect of success.

Some of my prior duels against Big Pharma and Big Insurance are chronicled in the Pharmaceutical Quality category on this blog. 

Considering many insurance company coverage actions and decisions, it is understandable that patients do not believe that these companies prioritize the health of their members. 

Although it is understandable to demonize this industry, insurance companies are businesses, not charitable organizations.  While they deserve opprobrium for many of their practices, they are not always in the wrong.  We cannot expect them to pay for every medical treatment that we doctors recommend or that patients desire. 

For example, should insurance companies be required to cover medicines that are prescribed off-label?  Every prescription drug has been approved by the Food and Drug Administration (FDA) only for certain specific conditions.  For example, gastroenterologists see many patients with nausea.  We commonly prescribe Zofran (ondansetron), an effective anti-nausea medicine.  The FDA has approved this medicine for nausea resulting from chemotherapy, surgery, and radiation treatment.  Most of the patients for whom I prescribe ondansetron fall outside of this FDA list of indications.  I am prescribing the medicine off-label, albeit for the same symptom of nausea.  In this instance, insurance companies have generally covered the drug.

Should off-label prescriptions be covered?

There are other instances where the off-label use is for an entirely different purpose.  For instance, gastroenterologists commonly prescribe a drug that is FDA-approved to lower cholesterol to patients with certain types of diarrhea.  Often, insurance companies will not cover this off-label use for a medical complaint entirely distinct from the drug’s approved role, even though this off-label use is considered to be routine use. 

These can be difficult issues that may have medical-ethical dimensions. We have all heard of agonizing situations when an insurance company declines to pay for an experimental medicine for a patient who is desperate to receive it.  And to make it more complex, there may be a dispute within the medical community if the treatment is experimental or is actually an established therapy. 

Should a drug that is effective for a medical condition but is not FDA-approved for it be covered by insurance companies?  If so, would we all be willing to pay much higher premiums to accommodate this greatly expanded list of off-label treatments?

What do readers think about all of this?  Should any drug prescribed by your doctor be covered?  If not, when are insurance companies justified to refuse?