Subject: Specialty Quantity Limit Tafinlar 1684-H P2023a

Drug

TAFINLAR  (dabrafenib)

Policy:

      I.  PROGRAM DESCRIPTION

          The standard limit is designed to allow a quantity sufficient for
          the most common uses of the medication. The recommended
          dosing parameters for all FDA-approved indications fall within
          the standard limits. Coverage of an additional quantity may be
          reviewed on a case-by-case basis upon request.

   II.  COVERED QUANTITIES

Medication	Standard Limit	FDA-recommended dosing
Tafinlar   (dabrafenib)   50 mg capsule	120 capsules   per 30 days	Adults:  150 mg twice daily   First dose reduction: 100 mg twice daily   Second dose reduction: 75 mg twice daily   Third dose reduction: 50 mg twice daily   Pediatric patients:   26-37 kg: 75 mg twice daily   38-50 kg: 100 mg twice daily   51 kg or greater: 150 mg twice daily
Tafinlar   (dabrafenib)   75 mg capsule	120 capsules   per 30 days
Tafinlar   (dabrafenib)   10 mg tablets   for oral suspension	4 bottles   (210 tabs per bottle)   per 28 days	Twice daily based on body weight:   8-9 kg   20 mg   twice daily   10-13 kg   30 mg   twice daily   14-17 kg   40 mg   twice daily   18-21 kg   50 mg   twice daily   22-25 kg   60 mg   twice daily   26-29 kg   70 mg   twice daily   30-33 kg   80 mg   twice daily   34-37 kg   90 mg   twice daily   38-41 kg   100 mg   twice daily   42-45 kg   110 mg   twice daily   46-50 kg   130 mg   twice daily   ≥ 51 kg   150 mg   twice daily

Place of Service:

Outpatient

The above policy is based on the following references:

1. Tafinlar [package insert]. East Hanover, NJ: Novartis Pharmaceutical Corporation; May 2023.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

July 15, 2023