New Drug Review

The 2005 Nebraska Medicaid Reform Plan required Medicaid to place new drugs on Prior Authorization pending review. Drugs that are included in the Preferred Drug List are reviewed by the P & T Committee, all others are reviewed by the Nebraska DUR Board. The New Drug Review process was instituted to examine new drugs and formulations. These drugs generally fall into one of the following categories:
• a safety concern or require intense monitoring.
• potential for off-label or non-covered use.
• are reformulated in an attempt to prolong patent life, without clinical benefit or for patient convenience.
• potential for abuse or misuse.
• very costly, for which lower-priced alternatives are available.
• Prior to DUR review the drug requires prior authorization.
• Coverage is limited to cases of medical necessity for recipients who:
o have failed covered therapies or covered therapies are inappropriate.
o have diagnosis within the FDA approved indications.
o are prescribed doses within FDA approved guidelines.
o are of an age approved within the FDA guidelines.
New drug products require Prior Authorization for 6 months. The 6 month Prior Authorization period begins on the date on which a valid claim for a bona fide prescription could be paid for by Medicaid through the Ne-POP system. During the 6 month-review period, prescribers may submit a Medical Necessity form to Medicaid for a patient to obtain the medication. Verification of previous therapies are documented utilizing Medicaid paid claims data. Nebraska Medicaid may request chart documentation to verify the information. A representative of the manufacturer is required to contact the Nebraska DUR Director and request a review to remove the New Drug Prior Authorization. Twenty copies of the Prescribing Information shall be provided to the DUR Director. If any additional drug information is required, it will be requested.