Prior Authorization Oncology - Imbruvica (ibrutinib tablets and capsules) - Cigna
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Cigna National Formulary Coverage Policy Prior Authorization Oncology – Imbruvica® (ibrutinib tablets and capsules) Table of Contents Product Identifier(s) National Formulary Medical Necessity ................1 42933 Conditions Not Covered.......................................3 Background ..........................................................3 References ..........................................................4 Revision History ...................................................4 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. National Formulary Medical Necessity Cigna covers ibrutinib (Imbruvica®) as medically necessary when the following criteria are met for FDA Indications or Other Uses with Supportive Evidence: Prior Authorization is recommended for prescription benefit coverage of Imbruvica. All approvals are provided for the duration noted below. FDA Indication(s) 1. Chronic Lymphocytic Leukemia. Approve for 3 years if the individual is ≥ 18 years of age. 2. Graft-Versus-Host Disease, Chronic: Approve for 1 year if the individual meets the following criteria (A and B): A) Individual is ≥ 18 years of age; AND B) Individual has tried at least one conventional systemic treatment for graft-versus-host disease. Page 1 of 5 Cigna National Formulary Coverage Policy: PA Oncology – Imbruvica
Note: Examples of conventional systemic treatments include: corticosteroids (methylprednisolone,
prednisone), imatinib, low-dose methotrexate, sirolimus, mycophenolate mofetil, and Jakafi (ruxolitinib
tablets).
3. Mantle Cell Lymphoma. Approve for 3 years if the individual meets the following criteria (A and B):
A) Individual is ≥ 18 years of age; AND
B) Individual meets the following: (i or ii):
i. Individual has tried at least one systemic regimen; OR
Note: Examples of a systemic regimen include one or more of the following products:
bendamustine, rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, cytarabine,
carboplatin, cisplatin, oxaliplatin, or Revlimid (lenalidomide capsule).
ii. Imbruvica is used in combination with rituximab prior to induction therapy.
Note: Examples of induction therapy include: rituximab, cyclophosphamide, vincristine, doxorubicin,
and dexamethasone.
4. Marginal Zone Lymphoma. Approve for 3 years if the individual meets the following criteria (A and B):
Note: Marginal zone lymphoma includes gastric MALT lymphoma, non-gastric MALT lymphoma, nodal
marginal zone lymphoma, and splenic marginal zone lymphoma.
A) Individual is ≥ 18 years of age; AND
B) Individual has tried at least one systemic regimen.
Note: Examples of a systemic regimen include one or more of the following products: bendamustine,
rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, Revlimid (lenalidomide capsule), or
Zevalin Y-90 (ibritumomab tiuxetan intravenous injection).
5. Small Lymphocytic Lymphoma. Approve for 3 years if the individual is ≥ 18 years of age.
6. Waldenström Macroglobulinemia. Approve for 3 years if the individual is ≥ 18 years of age.
Other Uses with Supportive Evidence
7. B-Cell Lymphoma. Approve for 3 years if the individual meets the following criteria (A and B):
Note: Examples of B-Cell lymphomas include follicular lymphoma, diffuse large B-cell lymphomas, Acquired
Immune Deficiency Syndrome (AIDS)-related, post-transplant lymphoproliferative disorders, double/triple hit
lymphoma, and high-grade B cell lymphoma.
A) Individual is ≥ 18 years of age; AND
B) Individual has tried at least one systemic regimen.
Note: Examples of a systemic regimen includes one or more of the following products: cisplatin,
cytarabine, rituximab, oxaliplatin, gemcitabine, ifosfamide, carboplatin, etoposide, or rituximab.
8. Central Nervous System Lymphoma (Primary). Approve for 3 years if the individual meets the following
criteria (A and B):
A) Individual ≥ 18 years of age; AND
B) Individual meets the following (i or ii):
i. According to the prescriber, the individual is not a candidate for or is intolerant to high-dose
methotrexate; OR
ii. Individual has tried at least one therapy.
Note: Examples of therapies include methotrexate; rituximab; vincristine; procarbazine; cytarabine;
thiotepa, carmustine, intrathecal methotrexate, cytarabine, or rituximab.
9. Hairy Cell Leukemia. Approve for 3 years if the individual meets the following criteria (A and B):
A) Individual is ≥ 18 years of age; AND
B) Individual has tried at least two systemic regimens.
Note: Examples of a systemic regimen includes one or more of the following products: cladribine,
Nipent (pentostatin injection), rituximab, or Intron A (interferon alpha-2b injection).
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Cigna National Formulary Coverage Policy: PA Oncology – ImbruvicaConditions Not Covered
Ibrutinib (Imbruvica®) is considered experimental, investigational or unproven for ANY other use.
Background
Overview
Imbruvica, a Bruton kinase inhibitor, is indicated in adults for the following uses:1
• Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
• Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with 17p deletion.
• Graft-Versus-Host Disease, chronic after failure of one or more lines of systemic therapy.
• Mantle cell lymphoma, who have received at least one prior therapy.
• Marginal zone lymphoma, who require systemic therapy and have received at least one prior anti-
CD20-based therapy.
• Waldenström Macroglobulinemia.
Guidelines
Imbruvica is discussed in guidelines from the National Comprehensive Cancer Network (NCCN):
• B-Cell Lymphomas: NCCN guidelines (version 4.2021 – May 5, 2021) address mantle cell lymphoma,
marginal zone lymphoma, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, non-gastric
MALT lymphoma, follicular lymphoma, diffuse large B-cell lymphomas, Acquired Immune Deficiency
Syndrome (AIDS)-related, and post-transplant lymphoproliferative disorders.2 For mantle cell lymphoma,
the guidelines state that Imbruvica can be used in combination with rituximab as pre-treatment in order
to limit the number of cycles of aggressive induction therapy with RHyperCVAD (rituximab,
cyclophosphamide, vincristine, doxorubicin, and dexamethasone) regimen; Imbruvica can also be used
as second-line and subsequent therapy.2 The NCCN compendium recommends Imbruvica (category
2A) as an option as a second-line and subsequent therapy for marginal zone lymphoma, gastric MALT
lymphoma, non-gastric MALT lymphoma, follicular lymphoma, diffuse large B-cell lymphomas, AIDS-
related, post-transplant lymphoproliferative disorders, double/triple hit lymphoma, and high-grade B-Cell
lymphoma.3 The NCCN compendium also recommends Imbruvica (category 2A) for treatment of
histologic transformation to non-germinal center diffuse large B-cell lymphoma in patients who have
received multiple lines of chemoimmunotherapy for indolent or transformed disease.3
• Central Nervous System (CNS) Cancers: NCCN guidelines (version 1.2021 – June 4, 2021)
recommend Imbruvica (category 2A) as one of the options for patients with relapsed or refractory
disease for primary CNS lymphoma.4 The guidelines also recommend Imbruvica (category 2A) for
induction therapy as a single agent (useful in certain circumstances) if patient is unsuitable for or
intolerant to high-dose methotrexate.4 In some clinical scenarios it is used with rituximab.4
• CLL/SLL: NCCN guidelines (version 4.2021 – April 29, 2021) recommend Imbruvica as a treatment
option in various scenarios (e.g., first-line therapy for patients with or without deletion 17p/TP53
mutation; and as second line and subsequent therapy [category 1 recommendations for many
scenarios]).5 Imbruvica plays a vital role in the management of CLL/SLL and many trials describe its
efficacy.5
• Hairy Cell Leukemia: NCCN guidelines (version 2.2021 – March 11, 2021) recommend Imbruvica
(category 2A) as one of the options for progression after therapy for with relapsed or refractory disease.6
• Graft-Versus-Host Disease: NCCN guidelines for hematopoietic stem cell transplantation (version
2.2021 – April 21, 2021) recommend Imbruvica (category 2A) as a suggested systemic agent for steroid-
refractory chronic graft-versus-host disease.7 Some other agents include imatinib, low-dose
methotrexate, sirolimus, mycophenoate mofetil, Jakafi® (ruxolitinib tablets).7
• Waldenstrom macroglobulinemia/lymphoplasmacytic lymphomas: NCCN guidelines (version
1.2022 – June 24, 2021) recommend Imbruvica, with or without rituximab, as a primary therapy option as
one of several preferred regimens (category 1).8 For previously treated patients Imbruvica, with or
without rituximab, is also cited as a preferred regimen (category 1).8
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Cigna National Formulary Coverage Policy: PA Oncology – ImbruvicaReferences
1. Imbruvica® tablets and capsules [prescribing information]. Sunnyvale, CA and Horsham, PA: Pharmacyclics
and Janssen Biotech; April 2020.
2. The NCCN B-Cell Lymphomas Guidelines in Oncology (version 4.2021 – May 5, 2021). © 2021 National
Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed on June 9, 2021.
3. The NCCN Drugs and Biologics Compendium. © 2021 National Comprehensive Cancer Network, Inc.
Available at: http://www.nccn.org. Accessed June 24, 2021. Search term: ibrutinib.
4. The NCCN Central Nervous System Cancers Guidelines in Oncology (version 1.2021 – June 4, 2021). ©
2021 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed on June
25, 2021.
5. The NCCN Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Clinical Practice Guidelines in
Oncology (version 4.2021 – April 29, 2021). © 2021 National Comprehensive Cancer Network, Inc.
Available at http://www.nccn.org. Accessed on June 9, 2021.
6. The NCCN Hairy Cell Leukemia Guidelines in Oncology (version 2.2021 – March 11, 2021). © 2021
National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed on June 25,
2021.
7. The NCCN Hematopoietic Cell Transplantation (HCT): Pre-Transplantation Recipient Evaluation and
Management of Graft-Versus-Host Disease (version 2.2021 – April 21, 2021). © 2021 National
Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed on June 24, 2021.
8. The NCCN Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma Clinical Practice Guidelines in
Oncology (version 1.2022 –June 24, 2021). © 2021 National Comprehensive Cancer Network, Inc.
Available at: http://www.nccn.org. Accessed on June 24, 2021.
Revision History
Type of Summary of Changes Approval Date
Revision
Annual Graft-Versus-Host Disease, Chronic: A requirement was added that the patient is 06/30/2021
Revision ≥ 18 years of age.
Marginal Zone Lymphoma: A requirement was added that the patient is ≥ 18
years of age. A Note was added with the types of marginal zone lymphoma. A
requirement was added that the patient has to try at least one systemic regimen. A
Note was added with the examples of systemic regimens.
B-Cell Lymphoma: A requirement was added that the patient is ≥ 18 years of age.
The requirement that the “ according to the prescribing physician, the patient is
using the agent as second line or subsequent therapy” was changed to “patient has
tried at least one systemic regimen.” A Note was added with examples of systemic
regimens.
Central Nervous System Lymphoma (Primary): A requirement was added that
the patient is ≥ 18 years of age. The requirement that the “according the prescribing
physician, the patient has relapsed or refractory disease” was changed to “patient
has tried at least one therapy,” and a Note was added with examples of therapies.
Also, the following qualifier was added, “according to the prescriber, the patient is
not a candidate for or is intolerant to high-dose methotrexate.”
Hairy Cell Leukemia: A requirement was added that the patient is ≥ 18 years of
age. The requirement that “according to the prescribing physician the patient has
relapsed or refractory disease” was changed to “patient has tried at least two
systemic regimens.” A Note was added with examples of systemic regimens.
Selected Automation was updated to include an age requirement that the patient is ≥ 18 07/28/2021
Revision years of age. Mantle cell lymphoma was removed from the automation.
Chronic Lymphocytic Leukemia: A requirement was added that the patient is ≥
18 years of age.
Mantle Cell Lymphoma: A requirement was added that the patient is ≥ 18 years of
age. A requirement was added that the patient has to try at least one systemic
regimen or that Imbruvica is used in combination with rituximab prior to induction
Page 4 of 5
Cigna National Formulary Coverage Policy: PA Oncology – Imbruvicatherapy . A Note was added with the examples of systemic regimens. A note was
added with examples of induction therapy.
Small Lymphocytic Lymphoma: A requirement was added that the patient is ≥ 18
years of age.
Waldenström Macroglobulinemia: A requirement was added that the patient is ≥
18 years of age.
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