Aplenzin, Forfivo XL, Wellbutrin XL - NC Standard

Aplenzin® (bupropion hbr tab ER 24 hr)

Bupropion HCL 450 mg (authorized generic Forfivo XL® )

Forfivo XL® (bupropion hcl tab ER 24 hr) 

Wellbutrin XL® (bupropion hcl tab ER 24 hr)

• For the treatment of major depressive disorder (Aplenzin, Forfivo XL, Wellbutrin XL)
• Prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (Aplenzin, Welbutrin XL)

1. The patient is currently being treated with the requested agent; AND
   1. The request is for Forfivo XL, Bupropion HCl 450 mg (authorized generic Forfivo XL) or Aplenzin; AND 
      1. The patient had a sub-therapeutic or intolerant response (therapeutic failure) to a 30-day trial of generic bupropion ER 24 HR (medical record documentation required); AND 
      2. The patient has tried and failed ONE other generic antidepressant; OR
      3. The patient has a clinical contraindication or intolerance to ALL generic antidepressants; OR 
   2. The request is for Wellbutrin XL; AND
      1. The patient had a sub-therapeutic or intolerant response (therapeutic failure) to an inactive ingredient of the generic product, that is not present in the brand (medical record documentation required); OR
      2. The patient has a documented hypersensitivity to an inactive ingredient of the generic product that is not found in the brand product (medical record documentation required); OR
      3. The prescriber provides a written, clinical, explanation for the medical necessity of the brand product over the generic product; AND 
      4. The patient has tried and failed ONE other generic antidepressant; OR 
      5. The patient has a clinical contraindication or intolerance to ALL generic antidepressants; OR 
2.  The patient is new to therapy with the requested agent; AND
   1. The patient has a diagnosis of major depressive disorder; AND
      1. The request is for Forfivo XL, Bupropion HCl 450 mg (authorized generic Forfivo XL) or Aplenzin; AND 
         1. The patient had a sub-therapeutic or intolerant response (therapeutic failure) to a 30-day trial of generic bupropion ER 24 HR (medical record documentation required); AND
         2. The patient has tried and failed ONE other generic antidepressant; OR
         3. The patient has a clinical contraindication or intolerance to ALL generic antidepressants; OR
      2. The request is for Wellbutrin XL; AND 
         1. The patient had a sub-therapeutic or intolerant response (therapeutic failure) to an inactive ingredient of the generic product, that is not present in the brand (medical record documentation required); OR 
         2. The patient has a documented hypersensitivity to an inactive ingredient of the generic product that is not found in the brand product (medical record documentation required); OR 
         3. The prescriber provides a written, clinical, explanation for the medical necessity of the brand product over the generic product; AND 
         4. The patient has tried and failed ONE other generic antidepressant; OR
         5. The patient has a clinical contraindication or intolerance to ALL generic antidepressants; OR 
   2. The patient has a diagnosis of seasonal affective disorder; AND
      1. The request is for Aplenzin; AND 
         1. The patient had a sub-therapeutic or intolerant response (therapeutic failure) to a 30-day trial of generic bupropion ER 24 HR (medical record documentation required); AND
         2. The patient has tried and failed ONE other generic antidepressant; OR 
         3. The patient has a clinical contraindication or intolerance to ALL generic antidepressants; OR
      2. The request is for Wellbutrin XL; AND
         1. The patient had a sub-therapeutic or intolerant response (therapeutic failure) to an inactive ingredient of the generic product, that is not present in the brand (medical record documentation required); OR 
         2. The patient has a documented hypersensitivity to an inactive ingredient of the generic product that is not found in the brand product (medical record documentation required); OR
         3. The prescriber provides a written, clinical, explanation for the medical necessity of the brand product over the generic product; AND 
         4. The patient has tried and failed ONE other generic antidepressant; OR 
         5. The patient has a clinical contraindication or intolerance to ALL generic antidepressants; AND 
3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year) 

Quantity limitations apply to brand products only.

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

All information referenced is from FDA package insert unless otherwise noted below.

September 2022: Criteria update: Terminology of generic bupropion product switched from “SR 24HR” to “ER 24HR” in criteria and QL product list. Updated “documented intolerance” to “documented hypersensitivity” in Wellbutrin XL sections.

July 2021: Criteria change: Addition of medical record requirements of a documented intolerance to generic Wellbutrin XL.

January 2021: Criteria change: Added Aplenzin and Forfivo to policy. Require trial of generic bupropion XL and trial and failure of unrestricted antidepressant. Members new to restricted products required to have FDA approved indication. Addition of quantity limit requirements. Wellbutrin SR removed to separate policy.

Oct 2017: Wellbutrin removed from antidepressant policy and given individual criteria