Subject: Ukoniq 4501-A SGM P2021b
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that all the
approval criteria are met and the member has no exclusions to the
prescribed therapy.
A. FDA-Approved Indications
1. Marginal Zone Lymphoma (MZL)
Ukoniq is indicated for the treatment of adult patients with
relapsed or refractory MZL who have received at least one prior
anti-CD20-based regimen.
2. Follicular Lymphoma (FL)
Ukoniq is indicated for the treatment of adult patients with
relapsed or refractory FL who have received at least three prior
lines of systemic therapy.
B. Compendial Uses
1. Marginal zone lymphoma
2. Follicular lymphoma
All other indications are considered experimental/investigational and not
medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Marginal Zone Lymphoma (MZL)
Authorization of 12 months may be granted for treatment of relapsed,
refractory, progressive MZL in members who have received at least
one prior anti-CD20-based regimen (e.g., rituximab, obinutuzumab)
when the requested medication is used as a single agent.
B. Follicular Lymphoma (FL)
Authorization of 12 months may be granted for treatment of relapsed,
refractory, or progressive FL as third-line and subsequent therapy
when the requested medication is used as a single agent.
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in
members requesting reauthorization for an indication listed in Section II
when there is no evidence of unacceptable toxicity or disease progression
while on the current regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Ukoniq [package insert]. Edison, NJ: TG Therapeutics, Inc.; February 2021.
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 17, 2022
