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) delayed-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
  • Fibromyalgia in adults


Background:
  • Drizalma Sprinkle is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). Although 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.
    • In the pediatric population, the only FDA approved indication for Drizalma Sprinkle is for for the treatment of GAD.
    • Use of Drizalma Sprinkle should be avoided in patients with mild to severe hepatic impairment and in patients with severe renal impairment.
    • Drizalma Sprinkle should be opened and the pellets sprinkled onto one tablespoonful of applesauce; the mixture should be swallowed right away. Drizalma pellets should not be crushed or chewed. Do not save the applesauce and pellet mixture for later use.
    • For use in a nasogastric tube, the Drizalma should be opened and the contents mixed with 50 mL of water in a plastic catheter tip syringe; other liquids should not be used. Gently shake for 10 seconds, then administer the mixture through the nasogastric tube. The mixture should be used promptly. Ensure no pellets are left in the syringe. Rinse with additional water, about 15 mL, if needed. Do not save the mixture for later use


Approval Criteria

I.      Generalized Anxiety Disorder (GAD)

A.    Initial Authorization

When a benefit, coverage of Drizalma Sprinkle may be approved when all of the following criteria are met (1., 2., and 3.):

1.     The member is 7 years of age or older

2.     The member has a diagnosis of GAD ICD-10: F41.1

3.     The member has an inability to swallow capsules/tablets

 

B.    Reauthorization

When a benefit, reauthorization of Drizalma Sprinkle may be approved when all of the following criteria are met (1. and 2.):

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

2.     The prescriber attests that the member continues to have an inability to swallow capsules/tablets.

 

II.    Major Depressive Disorder (MDD), Diabetic Peripheral Neuropathic Pain (DPNP) or Chronic Musculoskeletal Pain

A.    Initial Authorization

When a benefit, coverage of Drizalma Sprinkle may be approved when all of the following criteria are met (1., 2., and 3.):

1.     The member is 18 years of age or older

2.     The member has a diagnosis of MDD, DPNP, or chronic musculoskeletal pain ICD-10: F32-F33, E11.40, M79.1

3.     The member has an inability to swallow capsules/tablets

 

B.    Reauthorization

When a benefit, reauthorization of Drizalma Sprinkle may be approved when all of the following criteria are met (1. and 2.):

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

2.     The prescriber attests that the member continues to have an inability to swallow capsules/tablets.

 

     

III       Fibromyalgia

           A.   Initial Authorization

                   When a benefit, coverage of Drizalma Sprinkle may be approved when all of the following criteria are met:

            1.   The member is 18 years of age or older.

            2.   The member has a documented diagnosis of fibromyalgia (ICD-10: M79.7)

            3.   There is clinical documentation (i.e., chart notes) of the fibromyalgia diagnosis including all of the following (a., b., and c.):

                  a.   Widespread bilateral pain above and below the waist

                  b.   Pain of at least 3 months duration

                  c.   At least one (1) fibromyalgia-related symptoms from the following (i. through v.):

                        i.    Cognitive impairment

                        ii.   Fatigue

                        iii.  Sleep disturbance

                        iv.  Neurological symptoms

                        v.   Exercise intolerance

            4.   The member has an inability to swallow capsules/tablets.

           B.   Reauthorization

           When a benefit, reauthorization of Drizalma Sprinkle may be approved when all of the following criteria are met (1. and 2.):

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

   2.   The prescriber attests that the member continues to have an inability to swallow capsules/tablets.

 

IV.   An exception to some or all of the criteria above may be granted for select members and/or circumstances based on state and/or federal regulations.

      


Limitations of Coverage

I.  Coverage of drug(s) addressed in this policy for disease states outside of the FDA-approved indications should be denied based on the lack of clinical data to support effectiveness and safety in other conditions unless otherwise noted in the approval criteria.

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-0214-004
Effective Date Begin: 10/15/2021
Effective End Begin: 10/31/2021
Original Date: 08/07/2019
Review Date: 10/06/2021


References:

  1. Drizalma Sprinkle [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries Inc.; July 2021.
  2. DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; 2021. Accessed June 4, 2021.
  3. Clinical Pharmacology On-Line, Tampa, FL: Elsevier 2021. Accessed June 4, 2021.

 




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.