Doptelet®- NC Standard

Restricted Product(s): 

• Doptelet (avatrombopag)

FDA Approved Use: 

• For the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
• For the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

Criteria for Approval of Restricted Product(s):

1. The patient is 18 years of age or older; AND
2. The patient has been diagnosed with thrombocytopenia with chronic liver disease [please provide Child-Pugh score]; AND
   1. The patient is scheduled to undergo a surgery/procedure; AND
      1. The patient will NOT be undergoing any of the following procedures:
         1. Cosmetic surgery/procedure
         2. Neurosurgical intervention
         3. Thoracotomy
         4. Laparotomy
         5. Organ resection; AND
   2. The patient will be undergoing their procedure within 5-8 days of the last dose of Doptelet; AND
   3. The patient’s platelet count is ≤ 50 x 10⁹ /L [medical record documentation required]; AND
   4. The patient has been prescribed 10 tablets for 5 days; OR
   5. The patient has been prescribed 15 tablets for 5 days with a platelet count < 40 x 10⁹ /L; OR
3. The patient has been diagnosed with thrombocytopenia with chronic immune thrombocytopenia; AND
   1. The patient has had an insufficient response to a previous treatment; AND
   2. The patient’s dosage will be adjusted to achieve a platelet count > 50 x10⁹ /L; AND
4. The patient will not be using Doptelet in combination with another Thrombopoietin Receptor Agonists (e.g., Mulpleta, Nplate, Promacta, Tavalisse); AND
5. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 

• Thrombocytopenia with chronic liver disease: 5 days per 12 weeks (see quantity limitations)
• Thrombocytopenia with chronic immune thrombocytopenia:  182 days (6 months)

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. If the request is for the diagnosis of thrombocytopenia with chronic liver disease and the patient is undergoing a procedure/surgery; AND
   1. The member is requesting a second approval within 12 weeks; AND
   2. The member meets criteria for approval; AND
   3. The procedure is NOT the same as the initial approval; OR
2. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
3. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
4. 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
5. 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).

Duration of Approval:

• Thrombocytopenia with chronic liver disease: 5 days per 12 weeks (see quantity limitations)
• Thrombocytopenia with chronic immune thrombocytopenia: 182 days (6 months)

References:

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

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

April 2022: Criteria change: Added Doptelet cannot be used in combination with another Thrombopoietin Receptor Agonist

May 2020: Criteria change: Removed requirement of Mulpleta for diagnosis of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure.

Jan 2020: Criteria change: Added requirement of Mulpleta for diagnosis of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure.

Aug 2019:  Criteria update:  Added new indication for chronic immune thrombocytopenia; updated quantity limit language to be specific for chronic liver disease versus ITP.

June 2018: Original utilization management criteria issued.