Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Adcetris (Brentuximab) requires pre-authorization.

2)    Adcetris is considered a specialty medication.

3)    Adcetris is used to treat several different types of lymphoma and mycosis fungoides/Sezary syndrome.

I.             Initial Approval Criteria

Adcetris is considered medically necessary for members > 18 years old who meet the following criteria:

a)    Diagnosis of classical Hodgkin’s lymphoma (C81.00-C81.99) in Adults (> 18 years*) who meet one of the following criteria:

*If the age is between 2 to 21 years, consider using criteria below for cHL in Pediatric and Adolescent Patients

i)      Dose does not exceed:

(1)  Previously untreated Stage III or IV cHL: 1.2mg/kg up to 120mg every 2 weeks for maximum of 12 doses;

(2)  cHL consolidation: 1.8mg/kg up to 180mg every 3 weeks for a maximum of 16 cycles;

(3)  Relapsed cHL: 1.8mg/kg up to 180mg every 3 weeks;

ii) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).; OR

b)    Classical Hodgkin Lymphoma in Pediatric and Adolescent Patients (must meet all):

i)     Diagnosis of previously untreated pathologically confirmed cHL meeting one of the following Ann Arbor stages:

(1)  Stage IIB with bulk tumor;

(2)  Stage IIIB;

(3)  Stage IVA;

(4)  Stage IVB;

ii)    Prescribed by or in consultation with an oncologist or hematologist;

iii)   Age > 2 years to 21 years;

iv)   Request meets one of the following:*

(1)  Dose does not exceed 1.8mg/kg up to 180mg every 3 weeks for a maximum of 5 doses;

(2)  Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

*Prescribed regimen must be FDA-approved or recommended by NCCN

c)    T-Cell Lymphomas (must meet all)

i)   Diagnosis of one of the following:

(1)  Peripheral T-cell lymphoma (PTCL) – any of the following subtypes/histologies;

(a)  SALCL

(b)  PTCL, including but not limited to the following:

(i)    Angioimmunoblastic T-cell lymphoma;

(ii)  Enteropathy-associated T-cell lymphoma;

(iii) Monomorphic epitheliotropic intestinal T-cell lymphoma;

(iv) Nodal PTCL with TFH phenotype;

(v)  Follicular T-cell lymphoma;

(2)  Breast implant-associated ALCL (off-label);

(3)  Adult t-cell leukemia/lymphoma (off-label);

(4)  Relapsed or refractory extranodal NK/T-cell lymphoma (off-label);

(5)  Hepatosplenic T-cell lymphoma after failure of two first-line therapy regimens (off-label);

ii)    Prescribed by or in consultation with an oncologist or hematologist;

iii)   Age > 18 years;

iv)   Disease is CD30-positive;

v)    Request meets one of the following:*

(1)  Previously untreated sALCL or other CD30-positive PTCL ihncluding angioimmunoblastic T-cell lymphoma: Dose does not exceed 1.8mg/kg up to 180 mg every weeks with each cycle of chemotherapy for 6 to 8 doses;

(2)  Relapsed sALCL: Dose does not exceed 1.8mg/kg up to 180mg every 3 weeks;

(3)  Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regiment must be FDA-approved or recommended by NCCN

d)    Primary Cutaneous CD30+ T-cell Lymphomproliferative Disorder

i)   Diagnosis of one of the following:

(1)  pcALCL

(2)  Cutaneous ALCL and lymph node positive (off-label);

(3)  Lymphomatoid papulosis (LyP) – as subsequent therapy for relapsed/refractory disease (off-label);

ii)    Prescribed by or in consultation with an oncologist or hematologist;

iii)   Age > 18 years;

iv)   Disease is CD30-positive;

v)    Request meets one of the following:*

(1)  Relapsed pcALCL: dose does not exceed 1.8mg/kg up to 180mg every 3 weeks for a maximum of 16 cycles;

(2)  Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN.

e)    Mycosis Fungoides/Sezary Syndrome

i)   Diagnosis of one of CD 30-expressing mycosis fungoides or Sezary syndrome

ii)  Prescribed by or in consultation with an oncologist or hematologist;

iii) Age >18 years;

iv) Request meets one of the following:*

(1)  Relapsed CD30-positive MF: Dose does not exeed 1.8mg/kg up to 180 mg every 3 weeks for a maximum of 16 cycles;

(2)  Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen just be FDA-approved or recommended by NCCN

f) B-Cell Lymphomas (off-label) (must meet all):

            i) Diagnosis of one of the following:

                        a. Diffuse large B-cell lymphooma, including but not limited to:

                                    i. Follicular lympohoma that has undergone histologic transformation to diffuse large B-cell lymphoma;

                                    ii. Marginal zone lympohoma that has undergone histologic transformation to diffuse large B-cell lympohoma;

                                    iii. Primary Mediastinal large B-cell lymphoma

            ii) Prescribed by or in consultation with an oncologist or hematologist;

            iii) Age > 18 years;  

      iv)For subtypes other than monomorphic PTLD (T-cell type), adcetris is prescribed as subsequent therapy;

                        v)Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label used (prescriber must submit supporting evidence)*

*Prescribed regiment must be FDA-approved or recommended by NCCN

f)     B-Cell Lymphomas (off-label) (must meet all):

i)     Diagnosis of one of the following (1 or 2):

(1)  Diffuse large B-cell lymphoma, including but not limited to:

(a)  Follicular lymphoma that has undergone histologic transformation to diffuse large B-cell lymphoma;

(b)  Marginal zone lymphoma that has undergone histologic transformation to diffuse large B-cell lymphoma;

(c)  Primary mediastinal large B-celllymphom;

(2)  High-grade B-cell lymphoma;

(3)  AIDS-related B-cell lymphoma;

(4)  Post-transplant lymphoproliferative disorder – monomorphic PTLD (T-cell type);

ii)    Prescribed by or in consultation with an oncologist or hematologist;

iii)   Age > 18 years;

iv)   Disease is CD30-positive;

v)    For subtypes other than monomorphic PTLD (T-cell type, Adcetris is prescribed as subsequent therapy;

vi)   Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).*

*Prescribed regimen must be FDA-approved or recommended by NCCN

Approval Duration: 6 months

I.     Continued Therapy

A.   All Indications in Section I (must meet all):

1.    Currently receiving medication via QualChoice benefit, or documentation supports that member is currently receiving Adcetris for a covered indication and has received this medication for at least 30 days;

2.    Member is responding positively to therapy;

3.    If request is for a dose increase, request meets one of the following (a or b):*

a.    New dose does not exceed (i, ii, iii, iv, v, vi, or vii):

i.      Previously untreated Stage III or IV cHL in adults: 1.2 mg/kg up to 120 mg every 2 weeks for a maximum of 12 doses;

ii.    Previously untreated high risk cHL in pediatric and adolescent patients: 1.8 mg/kg up to 180 mg every 3 weeks for a maximum of 5 doses;

iii.   cHL consolidation in adults: 1.8 mg/kg up to 180 mg every 3 weeks for a maximum of 16 cycles;

iv.   Relapsed cHL in adults: 1.8 mg/kg up to 180 mg every 3 weeks;

v.    Previously untreated sALCL or other CD30-positive PTCL including angioimmunoblastic T-cell lymphoma in adults: 1.8 mg/kg up to 180 mg every 3 weeks with each cycle of chemotherapy for 6 to 8 doses;

vi.   Relapsed sALCL in adults: 1.8 mg/kg up to 180 mg every 3 weeks;

vii.  Relapsed pcALCL in adults: 1.8 mg/kg up to 180 mg every 3 weeks for a maximum of 16 cycles;

viii. Relapsed CD30-positive MF in adults: 1.8 mg/kg up to 180 mg every 3 weeks for a maximum of 16 cycles;

b.    New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN

Approval Duration: 12 months  

Codes Used In This BI:

J9042   Injection, brentuximab vedotin, 1mg

1)    Adcetris Prescribing Information. Bothell, WA: Seagen, Inc.; November 2022. Available at: http://adcetrisupdate.com/. Accessed November 30, 2022.

2)    Castellino, SM, et al. Brentuximab vedotin with chemotherapy in pediatric high-risk Hodgkin’s lymphoma. New Engl J Med 2022; 387(18):1649-1660.

3)    National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at www.nccn.org. Accessed May 2, 2022.

4)    National Comprehensive Cancer Network. Hodgkin Lymphoma Version 2.2022. Available at https://www.nccn.org/professionals/physician_gls/pdf/hodgkins.pdf. Accessed May 2, 2022.

5)    National Comprehensive Cancer Network.Pediatric Hodgkin Lymphoma Version 1.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/ped_hodgkin.pdf. Accessed May 2, 2022.

6)    National Comprehensive Cancer Network. Primary Cutaneous Lymphomas Version 1.2022. Available at https://www.nccn.org/professionals/physician_gls/pdf/primary_cutaneous.pdf. Accessed May 2, 2022.

7)    National Comprehensive Cancer Network. T-Cell Lymphomas Version 2.2022. Available at https://www.nccn.org/professionals/physician_gls/pdf/t-cell.pdf. Accessed May 2, 2022.

8)    National Comprehensive Cancer Network. B-Cell Lymphomas Version 3.2022. Available at https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed May 2, 2022.

Addendum:

9)    Effective 06/01/2019: Removed requirement for failure of at least one multi-agent chemo regimen for sALCL based on NCCN preferred treatment recommendation.

10) Effective 10/01/2019: Updated coverage criteria for Non-Hodgkins T-Cell Lymphomas, Primary Cutaneous CD30+ T-cell Lymphoproliferative Disorder, and Mycosis Fungoides/Sezary Syndrome.

11) Effective 05/01/2023: Updated criteria for classical Hodgkins for adults and added criteria for classical Hodgkins for peds/adolescents. Updated criteria for T-cell lymphoma, Primary Cutaneous CD30+ T-cell Lymphomproliferative Disorder, and Mycosis Fungoides/Sezary Syndrome. Added continuation criteria for all covered diagnoses.

12) Effective 10/01/2023: Updated to add criteria for off-label indication of B-cell lymphoma.