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New Drugs and New Dosage Forms

DrugNew Drugs

April 2013

  • New drugs
  • New dosage forms
  • New fixed-dose combinations

Newly approved drugs as of July 1, 2005

Intent

  • To ensure that the newly approved drug is not the first drug used when other safe and effective options exist
  • To ensure that the patient is a good candidate to receive benefit from the newly approved drug

PA criteria for approval of new drugs

  • Drug is restricted to FDA approved indications AND
  • Other therapies for the disease state have been tried at a reasonable dose and duration without success (intolerance or ineffectiveness), or there is no existing therapy AND 
  • Prescribing physician must make a statement of anticipated benefit and defines when efficacy will be re-evaluated

New dosage forms

PA criteria for approval of nonpreferred dosage forms

Rapidly disintegrating tablets and oral solutions:

  • Patient cannot swallow a tablet whole and is not taking any other tablet whole by mouth OR
  • Patient experiences an acute situation of extreme anxiety or other acute disorder that prohibits the patient from swallowing a whole tablet OR
  • Patient has a history of non-compliance or “cheeking” medications OR
  • Prescriber provides another reason why the patient cannot take the dose of the medication by an oral tablet or other means, depending on primary route of administration OR
  • If a patient has a gastrostomy or other feeding tube, the rapidly disintegrating tablet will be approved if the solid oral formulation available can’t be crushed and administered via the tube or if there is no liquid formulation

Controlled-release or extended-release preparations:

  • Prescriber provides a reason why the extended-release preparation will provide better clinical results than products on the market

New fixed-dose combinations

PA criteria for approval of fixed-dose combinations

  • Prescriber provides a compelling clinical reason why a fixed-dose combination will provide superior clinical efficacy than each component taken separately

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411

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