June 5, 2001

 

The FDA has recently given preliminary approval to mandating that the antihistamines Allegra, Claritin, and Zyrtec be sold OTC or without a prescription.  Since they are free of side effects and generally do not interact with other medications, it seems to be a reasonable development.  However, on closer exam this move may have the following unintended consequences for patients.

 

1. Cost:  A Wellpoint Insurance executive testified that a 30-day supply of the medications might cost $10 to $15 if sold OTC.  In the real world, Dimetapp, Chlortrimeton, and other OTC allergy medications now cost $35 to $45 per month.  Allegra, Claritin, and Zyrtec work better and are side effect free so they will be priced at a premium.  My guess is that the cost will be at least $50 per month and, it will, of course, be paid out of pocket rather than covered by insurance.
2. The argument is made that individuals without insurance will save money.  As noted above, the cost will not change that much.  Also consider that studies show  80% of patients without insurance today will have insurance within 5 years.
3. Forcing pharmaceutical companies to sell their product over the counter against their wishes and before their patent expires sets a precedent which will have a “chilling effect” on the development of new medications.  Why spend millions of dollars to develop a totally safe drug if a private company can be forced to market it according to the government’s wishes? 

 

Patents on these drugs will expire within the next 1 ½ to 4 years.  I would be inclined to let well enough alone.

 

Additional comments 12/28/02

 

All Claritin formulations are now sold OTC and will not be covered by medical insurance.  The cost varies but appears to be $30 to $40 for a one month supply.  There will soon be generic versions (of loratadine) available and probably priced less.

 

Forcing Claritin OTC may have unintended consequences.  Several insurers now either will not reimburse Allegra, Clarinex, or Zyrtec prescriptions or have instituted a higher co pay.  Their rationale is “studies show Claritin is just as potent and effective” and Claritin is sold OTC so it can be purchased out-of-pocket.  Claritin may suppress SKIN histamine tests equal to Allegra and Zyrtec.  Truth be told, multiple studies have shown an individual difference in response of clinical symptoms involving eye and respiratory membranes from patient to patient to various antihistamines.  The respiratory membranes have different histamine properties which is why patients will have a better response to a specific antihistamine.  They are not all equal.

 

If you are caught in the bind of your insurer favoring Claritin OTC then I suggest you bring this up with your employer or benefits manager.

 

12/28/02