Subject: Specialty Quantity Limit Nerlynx 2179-H P2023
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 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.
II. COVERED QUANTITIES
|
Medication
|
Standard Limit
|
FDA-recommended dosing
|
|
Nerlynx (neratinib)
40 mg tablet
|
180 tablets
per 30 days
|
For extended adjuvant treatment of
early-stage breast cancer: The
recommended dose is 240 mg (six
tablets) orally once daily, continuously
for one year.
For advanced or metastatic breast
cancer: The recommended dose is 240
mg (six tablets) orally once daily on
Days 1-21 of a 21-day cycle until
disease progression or unacceptable
toxicity.
A two-week dose escalation schedule
may be considered instead of starting
at 240 mg daily dose.
Dose escalation schedule: once daily
dosing
Week 1 (days 1-7) - 120 mg
(three tablets)
Week 2 (days 8-14) - 160 mg
(four tablets)
Week 3 and onwards - 240 mg
(six tablets)
|
Place of Service:
Outpatient
The above policy is based on the following references:
- Nerlynx [package insert]. Los Angeles, CA: Puma Biotechnology, Inc.; March 2022.
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.
June 18, 2023
