Subject: Specialty Quantity Limit Mekinist 1682-H P2025

Drug

MEKINIST  (trametinib)

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 the treatment of 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
Mekinist (trametinib) 0.5 mg tablet	90 tablets per 30 days
Mekinist (trametinib) 2 mg tablet	30 tablets per 30 days
Mekinist (trametinib) 4.7 mg (0.05 mg/mL reconstituted) for oral solution	12 bottles per 28 days

FDA-recommended Dosing

Tablets

• Adults: 2 mg once daily
• Dose reductions may be needed for adverse reactions.
• Pediatric patients:
  • 26-37 kg: 1 mg once daily
  • 38-50 kg: 1.5 mg once daily
  • 51 kg or greater: 2 mg once daily

Solution reconstituted

Once daily based on body weight.

Body weight	Dose
8 kg	6 mL (0.3 mg)
9 kg	7 mL (0.35 mg)
10 kg	7 mL (0.35 mg)
11 kg	8 mL (0.4 mg)
12-13 kg	9 mL (0.45 mg)
14-17 kg	11 mL (0.55 mg)
18-21 kg	14 mL (0.7 mg)
22-25 kg	17 mL (0.85 mg)
26-29 kg	18 mL (0.9 mg)
30-33 kg	20 mL (1 mg)
34-37 kg	23 mL (1.15 mg)
38-41 kg	25 mL (1.25 mg)
42-45 kg	28 mL (1.4 mg)
46-50 kg	32 mL (1.6 mg)
Greater than or equal to 51 kg	40 mL (2 mg)

Place of Service:

Outpatient

The above policy is based on the following references:

1. Mekinist [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; October 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