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Physician Regulatory Issues Team (PRIT)

Physician Regulatory Issues Team (PRIT)

Active PRIT Issues

  Details for Coverage Problems for Revatio at Doses Higher than the FDA Recommend Dosage
  

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Issue Name Coverage Problems for Revatio at Doses Higher than the FDA Recommend Dosage
Issue A Pulmonologist contacted us concerning problems she was having when her patients required doses of Revatio highter than the FDA recommended dosage. PDPs and pharmacists carefully check the dosage of drugs when they fill prescriptions. If the dosage exceeds dosages described on the FDA label then the pharmacist and the plan must verify that the prescriber intended to prescribe the medication at the higher dosage. Revatio is frequently used at doses higher than the FDA label for the treatment of pulmonary artery hypertension. Until the FDA label is modified, prescriptions for dosages in excess of the label will continue to trigger denials of coverage and therefore the need for appeals.
Status See below.
Date Issue Created 04/11/2008

April 11: A citizen petition for a label change is a possible solution to this recurrent problem. We have provided the pulmonologist with contact information at the FDA and will work with her if she decides to submit a citizen's petition.

June 6: The pulmonologist who brought us the issue is working with the FDA to increase the label's maximum recommended dose.


 
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Last Modified Date : 06/10/2008
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