Pharmacy Policy Bulletin
Wellbutrin (bupropion) - Commercial
Number: J-0002 Category: Prior Authorization
Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

1. Wellbutrin = Yes w/ Prior Authorization
Region(s):

All
Delaware
New York
Pennsylvania
West Virginia

Additional Restriction(s):

None


Drugs Products
  • Aplenzin (bupropion HBr)
  • bupropion
  • bupropion ER
  • Forfivo XL (bupropion XL)
  • Wellbutrin SR (bupropion SR)
  • Wellbutrin XL (bupropion XL)
FDA-Approved Indications:
  • Major Depressive Disorder
  • Wellbutrin XL and Aplenzin are also indicated for Seasonal Affective Disorder (SAD)


Background:
  • Bupropion is an oral antidepressant agent available in immediate-release, sustained-release and extended release dosage forms; please see above for FDA approved diagnosis information. Bupropion is also available under the proprietary name Zyban which is an oral sustained-release formulation indicated as an aid to nicotine cessation therapy solely. Zyban does not carry the labeled FDA approved indication for depression or SAD. Many groups do not include smoking cessation therapy as part of their prescription drug benefit.  To prevent the use of bupropion containing products for nicotine cessation therapy when there is no coverage under the prescription drug benefit, groups may choose to require prior authorization on any bupropion-containing product to ensure that it is being used for non-nicotine cessation purposes.


Approval Criteria

I.  Initial and Reauthorization

When a benefit, coverage of bupropion products may be approved when the following criterion is met (A):

A.    Bupropion products (listed above) are being used for any FDA-approved indication with the exception of smoking cessation therapy.

 

II.    For Commercial members enrolled in a West Virginia Plan, an exception to the step therapy within this policy may be made base on Policy J-513 – West Virginia – Step Therapy Override Exception – Commercial and Healthcare Reform.

 


Limitations of Coverage

I.  Coverage of bupropion products for disease states outside of their FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions.

II.  For Commercial members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.


Authorization Duration
  • Commercial Plans: If approved, a 12 month authorization may be granted.


Automatic Approval Criteria

None


Version: J-0002-018
Effective Date Begin: 02/17/2020
Effective End Begin: 02/08/2021
Original Date: 03/01/1999
Review Date: 01/29/2020


References:

1.  Wellbutrin [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline;  August 2017.

2.   Bupropion (Aplenzin, Wellbutrin, Zyban). Clinical Pharmacology. Tampa, FL: Gold Standard Multimedia; 2018. Updated December, 2017.

3.   Bupropion (Wellbutrin). DRUGDEX System. New York: Thomson Reuters; 2018 Last Modified: November 2018.

4.     Aplenzin [prescribing information].  Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; May 2017.

5.     Forfivo XL [prescribing information].  Pine Brook, NJ: Almatica Pharma, Inc.; May 2017.

 




Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.