Pharmacy Policy Bulletin
Drizalma Sprinkle (duloxetine) – Commercial and Healthcare Reform
Number: J-0214 Category: Prior Authorization
Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

Commercial:

Prior Authorization (1.)

1.  Other Managed Drugs = Yes w/ Prior Authorization

 

Healthcare Reform: Not Applicable
Region(s):

All
Delaware
New York
Pennsylvania
West Virginia

Additional Restriction(s):

None


Drugs Products
  • Drizalma Sprinkle (duloxetine) extended-release capsules
FDA-Approved Indications:
  • Major depressive order (MDD) in adults
  • Generalized anxiety disorder (GAD) in adults and pediatric patients ages 7 years to 17 years old
  • Diabetic peripheral neuropathic pain (DPNP) in adults
  • Chronic musculoskeletal pain in adults


Background:
  • Drizalma Sprinkle is a serotonin and norepinephrine reuptake inhibitor (SNRI). Though the exact mechanisms of the antidepressant, central pain inhibitor, and anxiolytic actions of Drizalma Sprinkle are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the central nervous system (CNS).
  • Prior authorization is utilized to ensure appropriate use. Other SNRI extended-release dosage forms are unable to be opened and sprinkled onto food or used via nasogastric tube. Effexor IR (venlafaxine immediate-release) tablets are able to be crushed, however, administration is two to three times daily.
  • Prescribing Considerations:
    • Antidepressants have a black box warning for increased risk of suicidal thinking and behavior in pediatric and young adult patients.
    • Drizalma sprinkle is only indicated for the treatment of GAD in the pediatric population.
    • Use of Drizalma Sprinkle should be avoided in patients with mild to severe hepatic impairment and in patients with GFR < 30 mL/min.
    • Drizalma Sprinkle pellets should be mixed with 1 tablespoonful of applesauce and the mixture should be swallowed right away; pellets should not be chewed. Excess remaining applesauce mixture should be thrown away.
    • For use in a nasogastric tube, Drizalma should be mixed with 50 mL of water only; other liquids should not be used. The mixture should not be saved for later use.


Approval Criteria

I.      Initial Authorization

When a benefit, coverage of Drizalma Sprinkle may be approved when all of the following criteria are met (A. and B.):

A.    The member meets one (1) of the following criteria (1. or 2.):

1.     The member meets all of the following criteria (a. and b.):

a.     The member is 18 years of age or older

b.    The member has a diagnosis of major depressive disorder, diabetic peripheral neuropathic pain, or chronic musculoskeletal pain.

2.     The member meets all of the following criteria (a. and b.):

a.     The member is 7 years of age or older

b.    The member has a diagnosis of generalized anxiety disorder.

B.    The member has an inability to swallow capsules.

                                         

II.   Reauthorization

When a benefit, reauthorization of Drizalma Sprinkle may be approved when the following criteria are met (A. and B.):

A.    The prescriber attests that the member has experienced positive clinical response to therapy.

B.    The prescriber attests that the member continues to have an inability to swallow tablets.

     

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


Limitations of Coverage

I.      Coverage of Drizalma Sprinkle for disease states outside of its 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, up to a 12 month authorization may be granted.


Automatic Approval Criteria

None.


Version: J-0214-001
Effective Date Begin: 12/05/2019
Effective End Begin: 09/09/2020
Original Date: 08/07/2019
Review Date: 08/07/2019


References:

  1. Drizalma Sprinkle [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries Limited; July 2019.
  2. DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; 2019.

 




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.