Subject: Purixan 2982-A SGM P2023
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
Purixan is indicated for the treatment of patients with acute
lymphoblastic leukemia (ALL) as part of a combination
chemotherapy maintenance regimen.
B. Compendial Uses
1. ALL / Lymphoblastic lymphoma (LL)
2. Acute promyelocytic leukemia (APL)
3. Moderate to Severe Crohn's Disease (CD)
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate
the prior authorization review: Documentation supporting an
intolerable adverse event with the generic alternative
mercaptopurine (the adverse event was not an expected adverse
event attributed to the active ingredient as described in the
prescribing information).
III. CRITERIA FOR INITIAL APPROVAL
A. Acute lymphoblastic leukemia (ALL)/ Lymphoblastic
lymphoma (LL)
Authorization of 12 months may be granted for treatment of
ALL/LL when either of the following criteria is met:
1. Member has a documented intolerable adverse event with
the generic alternative mercaptopurine and the adverse
event was not an expected adverse event attributed to
the active ingredient as described in the prescribing
information, OR
2. Member is unable to swallow the tablet formulation.
B. Acute promyelocytic leukemia (APL)
Authorization of 12 months may be granted for treatment of
APL when either of the following criteria is met:
1. Member has a documented intolerable adverse event with
the generic alternative mercaptopurine and the adverse
event was not an expected adverse event attributed to
the active ingredient as described in the prescribing
information, OR
2. Member is unable to swallow the tablet formulation
C. Moderate to Severe Crohn’s Disease (CD)
Authorization of 12 months may be granted for treatment of
moderate to severe CD when either of the following criteria is
met:
1. Member has a documented intolerable adverse event with
the generic alternative mercaptopurine and the adverse
event was not an expected adverse event attributed to
the active ingredient as described in the prescribing
information, OR
2. Member is unable to swallow the tablet formulation
IV. CONTINUATION OF THERAPY
A. ALL/LL and APL
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for ALL/LL
or APL when there is no evidence of unacceptable toxicity or
disease progression while on the current regimen.
B. Moderate to Severe Crohn’s Disease (CD)
1. Authorization of 12 months may be granted for all
members (including new members) who are using the
requested medication for moderately to severely active
CD and who achieve or maintain remission.
2. Authorization of 12 months may be granted for all
members (including new members) who are using the
requested medication for moderately to severely active
CD and who achieve or maintain a positive clinical
response as evidenced by low disease or improvement in
signs and symptoms of the condition where there is
improvement in any of the following from baseline:
i. Abdominal pain or tenderness
ii. Diarrhea
iii. Body weight
iv. Abdominal mass
v. Hematocrit
vi. Endoscopic appearance of the mucosa
vii. Improvement on a disease activity scoring tool (e.g.,
Crohn’s Disease Activity Index [CDAI] score)
Place of Service:
Outpatient
The above policy is based on the following references:
- Purixan [package insert]. Franklin, TN: Rare Disease Therapeutics, Inc.; April 2020.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed June 12, 2023.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Acute Lymphoblastic Leukemia. Version 1.2023. https://www.nccn.org/professionals/physician_gls/pdf/ped_all.pdf. Accessed June 12, 2023.
- IBM Micromedex® DRUGDEX ® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at https://www.micromedexsolutions.com (Accessed: June 12, 2023).
- Lichtenstein GR, Loftus Jr EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol. 2018;113:481-517.
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.
December 09, 2023
