Subject: Turalio 3151-A SGM P2021 (1)

Drug

TURALIO  (pexidartinib)

Policy:

1. 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 Indication
        Turalio is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. 
   
   B.  Compendial Uses
        1.  Pigmented villonodular synovitis (PVNS)
        2.  Histiocytic Neoplasms:
             a.  Erdheim-Chester Disease (ECD)
             b.  Langerhans Cell Histiocytosis (LCH)
             c.  Rosai-Dorfman Disease
    
   All other indications are considered experimental/investigational and not medically necessary. 
   
   
2. DOCUMENTATION 
   
   Submission of the following information is necessary to initiate the prior authorization review: Documentation of the presence of colony stimulating factor 1 receptor (CSF1R) mutation (where applicable).
   
   
3. CRITERIA FOR INITIAL APPROVAL
    
   A.  Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor (PVNS/TGCT)
   Authorization of 12 months may be granted for the treatment of pigmented villonodular synovitis (PVNS)/ tenosynovial giant cell tumor (TGCT) as a single agent.
   
   B.  Histiocytic Neoplasms
   Authorization of 12 months will be granted for any of the following histiocytic neoplasm subtypes as a single agent in members with a CSF1R mutation:
   1.  Symptomatic or relapsed/refractor Erdheim-Chester Disease (ECD)
   2.  Symptomatic or relapsed/refractory Rosai-Dorfman Disease
   3.  Langerhans Cell Histiocytosis (LCH)
    
4. CONTINUATION OF THERAPY 
     
   Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section III 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:

1. Turalio [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; April 2020.
2. The NCCN Drugs & Biologics Compendium 2021 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed March 1, 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.

August 01, 2021