Pharmacy Policy Bulletin

Wellbutrin (bupropion) - Commercial
Number: J-0002	Category: Prior Authorization
Line(s) of Business: Commercial Healthcare Reform Medicare	Benefit(s): Commercial (1.): Wellbutrin = Yes w/ Prior Authorization
Region(s): All Delaware New York Pennsylvania West Virginia	Additional Restriction(s): None

Wellbutrin (bupropion) - Commercial

Number: J-0002

Category: Prior Authorization

Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

Commercial (1.):

Wellbutrin = Yes w/ Prior Authorization

Region(s):

All
Delaware
New York
Pennsylvania
West Virginia

Additional Restriction(s):

None

Drugs Products	Wellbutrin Wellbutrin SR Wellbutrin XL Bupropion Bupropion SR Bupropion XL Aplenzin Forfivo XL
FDA-Approved Indications:	Major Depressive Disorder (ICD-9 311, ICD-9 296.3, ICD-10 F33.x, ICD-10 F32.9) Wellbutrin XL and Aplenzin are also indicated for Seasonal Affective Disorder (SAD) (ICD-9 296.99, ICD-10 F34.8)

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.
Prescribing Considerations:
- None

Approval Criteria
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. I. For Commercial and HCR 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.

Approval Criteria

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.

I. For Commercial and HCR 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 (Wellbutrin, Wellbutrin SR, Wellbutrin XL, bupropion, bupropion SR, bupropion XL, Aplenzin, and Forfivo XL) 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 or HCR 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.

Limitations of Coverage

I. Coverage of bupropion (Wellbutrin, Wellbutrin SR, Wellbutrin XL, bupropion, bupropion SR, bupropion XL, Aplenzin, and Forfivo XL) 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 or HCR 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 and HCR Plans: If approved, a 12 month authorization may be granted.

Automatic Approval Criteria
None

Version: J-0002-016

Effective Date Begin: 03/05/2015

Effective End Begin: 01/30/2019

Original Date: 03/01/1999

Review Date: 02/01/2018

References:

1. Bupropion (Wellbutrin) prescribing information. GSK. Research Triangle Park, NC. 2014.

2. Bupropion (Aplenzin, Wellbutrin, Zyban). Clinical Pharmacology. Tampa, FL: Gold Standard Multimedia; 2006. Updated October 3, 2017.

3. Bupropion (Wellbutrin). DRUGDEX System. New York: Thomson Reuters; 2015. Last Modified: December 15, 2016.

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.