Subject: dasatinib products 1782-A SGM P2024
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SPRYCEL
(dasatinib )
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PHYRAGO
(dasatinib )
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dasatinib
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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. Phyrago and Sprycel are indicated for newly diagnosed adults with Philadelphia
chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
2. Phyrago and Sprycel are indicated for adults with chronic, accelerated, or myeloid or
lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including
imatinib
3. Phyrago and Sprycel are indicated for adults with Philadelphia chromosome-positive
acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy
4. Sprycel is indicated for pediatric patients 1 year of age and older with Ph+ CML in
chronic phase
5. Sprycel is indicated for pediatric patients 1 year of age and older with newly diagnosed
Ph+ ALL in combination with chemotherapy
B. Compendial Uses
1. Primary treatment of advanced phase CML (accelerated phase or blast phase)
2. Additional therapy for CML patients after hematopoietic stem cell transplant (HSCT)
3. Ph+ B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma (Ph+ B-ALL/LL)
4. Maintenance therapy for Ph+ B-ALL/LL patients after HSCT
5. Relapsed or refractory Ph+ B-ALL/LL
6. Relapsed or refractory T-cell ALL/LL with ABL-class translocation
7. Induction or consolidation therapy for Ph-like B-ALL/LL with ABL-class kinase fusion
8. Consolidation therapy for Ph-like B-ALL/LL and CRLF2- with ABL-class kinase fusion
9. Metastatic and widespread chondrosarcoma
10. Recurrent chordoma
11. Gastrointestinal stromal tumor (GIST)
12. Myeloid/lymphoid neoplasms with eosinophilia and ABL1 rearrangement in chronic or
blast phase
13. Cutaneous Melanoma
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
The following information is necessary to initiate the prior authorization review:
A. For treatment of CML or Ph+ ALL/LL: results of cytogenetic and/or molecular testing for
detection of the Ph chromosome or the BCR::ABL gene
B. For treatment of Ph-like B-ALL/LL: results of cytogenetic and/or molecular testing
confirming ABL-class kinase fusion
C. For treatment of T-cell ALL/LL: results of cytogenetic and/or molecular testing confirming
ABL-class translocation
D. For members requesting initiation of therapy with the requested medication for treatment of
CML or ALL/LL after experiencing resistance to prior tyrosine kinase inhibitor (TKI) therapy:
results of BCR::ABL1 mutation testing for T315I/A, F317L/V/I/C, and V299L mutations
E. For treatment of GIST: PDGFRA exon 18 mutation testing (where applicable)
F. For members requesting initiation of therapy with the requested medication for treatment of
myeloid and/or lymphoid neoplasms with eosinophilia: results of testing or analysis
confirming ABL1 rearrangement
G. For treatment of melanoma: results of molecular testing or analysis confirming c-KIT
activating mutations
III. CRITERIA FOR INITIAL APPROVAL
A. Chronic Myeloid Leukemia (CML)
Authorization of 7 months may be granted for treatment of CML that has been confirmed by
detection of the Ph chromosome or BCR::ABL gene by cytogenetic and/or molecular testing
when any of the following criteria are met:
1. Member has not received prior therapy with a TKI (e.g., bosutinib, imatinib, nilotinib,
ponatinib)
2. Member experienced toxicity or intolerance to prior therapy with a TKI
3. Member experienced resistance to prior therapy with a TKI and results of BCR::ABL1
mutational testing are negative for all of the following: T315I/A, F317L/V/I/C, and V299L
4. Member has received HSCT for CML and results of BCR::ABL1 mutational testing are
negative for all of the following: T315I/A, F317L/V/I/C, and V299L
B. Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LL)
1. Authorization of 12 months may be granted for treatment of ALL/LL when both of the
following criteria are met:
i. The member has any of the following:
a. Ph+ ALL/LL that has been confirmed by detection of the Ph chromosome or
BCR::ABL gene by cytogenetic and/or molecular testing
b. Ph-like B-ALL/LL with ABL-class kinase fusion that has been confirmed by
cytogenetic and/or molecular testing
c. T-cell ALL/LL with ABL-class translocation that has been confirmed by
cytogenetic and/or molecular testing and the disease is relapsed or refractory
ii. The member meets any of the following:
a. Member has not received prior therapy with a TKI (e.g., bosutinib, imatinib,
nilotinib, ponatinib)
b. Member experienced toxicity or intolerance to prior therapy with a TKI
c. Member experienced resistance to prior therapy with a TKI and results of
BCR::ABL1 mutational testing are negative for all of the following: T315I/A,
F317L/V/I/C, and V299L
2. Authorization of 12 months may be granted for members who have received HSCT for
Ph+ ALL/LL and results of BCR::ABL1 mutation testing are negative for all of the
following: T315I/A, F317L/V/I/C, and V299L
C. Gastrointestinal Stromal Tumor (GIST)
Authorization of 12 months may be granted for treatment of GIST when all of the following
criteria are met:
1. Member has residual, unresectable, recurrent/progressive, or metastatic/tumor rupture
disease
2. The disease harbors a platelet-derived growth factor receptor alpha (PDGFRA) exon 18
mutation
3. Member has received prior therapy with avapritinib
4. The requested medication will be used as a single agent
D. Bone Cancer
Authorization of 12 months may be granted for treatment of widespread metastatic
chondrosarcoma or recurrent chordoma when the requested medication is used as a single
agent.
E. Myeloid/Lymphoid Neoplasms with Eosinophilia
Authorization of 12 months may be granted for treatment of myeloid and/or lymphoid
neoplasms with eosinophilia and ABL1 rearrangement in the chronic phase or blast phase.
F. Cutaneous Melanoma
Authorization of 12 months may be granted for treatment of cutaneous melanoma when all
of the following criteria are met:
1. The disease is metastatic or unresectable
2. The tumor has c-KIT activating mutations
3. The requested medication will be used as subsequent therapy
4. Member has had disease progression, intolerance, or risk of progression with BRAF-
targeted therapy
5. The requested medication will be used as a single agent
IV. CONTINUATION OF THERAPY
A. CML
Authorization may be granted for continued treatment of CML that has been confirmed by
detection of Ph chromosome or BCR::ABL gene by cytogenetic and/ or molecular testing
when either of the following criteria is met:
1. Authorization of 12 months may be granted when any of the following criteria is met:
i. BCR::ABL1 is less than or equal to 10% and there is no evidence of disease
progression or unacceptable toxicity while on the current regimen for members who
have been receiving the requested medication for 6 months or greater
ii. Member has received HSCT and there is no evidence of unacceptable toxicity or
disease progression while on the current regimen
2. Authorization of up to 7 months may be granted when the member has completed less
than 6 months of therapy with the requested medication.
B. Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (ALL/LL)
Authorization of 12 months may be granted for continued treatment of ALL/LL when there is
no evidence of unacceptable toxicity or disease progression while on the current regimen
and any of the following criteria is met:
1. Member has Ph+ ALL/LL that has been confirmed by detection of Ph chromosome or
BCR::ABL gene by cytogenetic and/ or molecular testing.
2. Member has Ph-like B-ALL/LL with ABL-class kinase fusion that has been confirmed by
cytogenetic and/or molecular testing.
3. Member has T-cell ALL/LL with ABL-class translocation that has been confirmed by
cytogenetic testing and/or molecular testing.
4. Member has received HSCT for ALL/LL
C. GIST, Bone Cancer, Myeloid/Lymphoid Neoplasms with Eosinophilia, or Cutaneous
Melanoma
Authorization of 12 months may be granted for continued treatment of GIST,
chondrosarcoma, chordoma, myeloid/lymphoid neoplasms with eosinophilia, or cutaneous
melanoma 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:
- Sprycel [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; February 2023.
- Phyrago [package insert]. New Brighton, MN: Nanocopoeia, LLC; December 2023.
- dasatinib [package insert]. Weston, FL: Apotex Corp.; September 2024.
- The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed March 26, 2024.
- NCCN Clinical Practice Guidelines in Oncology® Chronic Myeloid Leukemia (Version 2.2024). © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 15, 2024.
- NCCN Clinical Practice Guidelines in Oncology® Acute Lymphoblastic Leukemia (Version 4.2023). © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 15, 2024.
- NCCN Clinical Practice Guidelines in Oncology® Gastrointestinal Stromal Tumors (Version 1.2024). © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 15, 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.
November 03, 2024
