Subject: Specialty Quantity Limit Tafinlar 1684-H P2025

Drug

TAFINLAR  (dabrafenib)

Policy:

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.

Covered Quantities

Medication	Standard Limit
Tafinlar (dabrafenib) 50 mg capsule	120 capsules per 30 days
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

FDA-recommended Dosing

Capsules

• Adults: 150 mg twice daily
• Dose reduction may be needed for adverse reactions.
• Pediatric patients:
  • 26-37 kg: 75 mg twice daily
  • 38-50 kg: 100 mg twice daily
  • 51 kg or greater: 150 mg twice daily

Tablets for oral suspension

Twice daily based on body weight.

Body weight	Dose
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
Greater than or equal to 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; July 2024.

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.

April 18, 2025