Gonadotropin Releasing Hormones (GnRHs) Analogs (ARCHIVED)

Policy ID: I-16-029

Section: Injections

Effective Date: June 01, 2019

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-16-029

Section: Injections

Effective Date: June 01, 2019

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Leuprolide acetate (Lupron®, Lupron Depot ®, Lupron Depot-Ped ®, Eligard®, Lutrate Depot®, Fensolvi™) and leuprolide mesylate (Camcevi^TM) are synthetic analogs of gonadotropin releasing hormone (GnRH). Although leuprolide has potent GnRH agonist properties during short-term or intermittent therapy, the principal effect of the drug during long-term administration is inhibition of gonadotropin secretion and suppression of ovarian and testicular steroidogenesis.

Leuprolide and norethindrone (Lupaneta®) is a combination medicine used to treat symptoms of endometriosis.

Triptorelin extended-release (Triptodur®) and triptorelin pamoate (Trelstar®) are synthetic decapeptide agonist analogs of GnRH that reversibly inhibits gonadotropin secretion when administered in continuous doses.

Histrelin (Vantas®, Supprelin LA®) is a synthetic nonapeptide analog of GnRH. Contained in an implant, histrelin (Vantas, Supprelin LA) is released via a diffusion-controlled hydrogel polymer reservoir. Histrelin (Vantas, Supprelin LA) functions as a GnRH agonist, and is a potent inhibitor of gonadotropin secretion when administered in continuous doses.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

The use of leuprolide acetate (Lupron) may be considered medically necessary for the following conditions:

Anemia due to Uterine Fibroids

For the preoperative treatment of anemia due to uterine fibroids in combination with iron supplementation when iron therapy alone fails to correct the anemia:
- Duration of therapy not to exceed three (3) months; or

Central Precocious Puberty

For the treatment of children with central precocious puberty (CPP) when ALL the following criteria are met:
- Confirmed clinical diagnosis of CPP defined by any of the following:
  - Measurement of LH and FSH following stimulation with a GnRH analog; and
  - Bone age versus chronological age assessment supports diagnosis of CPP; and
- Individual has onset of secondary sexual characteristics;
  - Less than 11 years of age for females; or
  - Less than 12 years of age for males.

Reauthorization criteria

Reauthorization of leuprolide acetate (Lupron) may be considered medically necessary when ALL of the following criteria are met:
- Individual is currently receiving therapy; and
- Documentation of positive clinical response (e.g., pre-pubertal slowing or decline, normalization of FSH or LH, or normalization of bone age).

Endometriosis

For the management of endometriosis, including pain relief and reduction of endometriotic lesions:
- Duration of initial treatment or retreatment not to exceed six (6) months; or

Prostate Cancer

As palliative treatment of advanced prostate cancer; or

Compendia Sources

Leuprolide acetate (Lupron) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of leuprolide/leuprolide acetate (Lupron) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9218

The use of leuprolide acetate for depot suspension (Lupron Depot) may be considered medically necessary for ANY of the following conditions:

Anemia due to Uterine Fibroids

The preoperative treatment of anemia due to uterine fibroids in combination with iron supplementation when iron therapy alone fails to correct the anemia:
- Duration of therapy not to exceed three (3) months and limited to one injection; or

Endometriosis

The management of endometriosis, including pain relief and reduction of endometriotic lesions:
- Duration of initial treatment or retreatment not to exceed six (6) months; or
As initial management of painful symptoms of endometriosis and for management of recurrence of symptoms in combination with norethindrone acetate 5 mg tablet taken once daily as add-back therapy:
- Duration of initial treatment or retreatment not to exceed six (6) months; or

Prostate Cancer

The palliative treatment of advanced prostatic cancer; or

Compendia Sources

Leuprolide acetate for depot suspension (Lupron Depot) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of leuprolide acetate for depot suspension (Lupron Depot) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J1950

J9217

The use of leuprolide acetate for depot suspension (Lupron Depot Ped) may be considered medically necessary for the following condition:

Central Precocious Puberty

Confirmed clinical diagnosis of CPP defined by any of the following:
- Measurement of LH and FSH elevated following stimulation with a GnRH analog; and
- Assessment confirms bone age advancement beyond chronological age; and
Individual has onset of secondary sexual characteristics;
- Less than 11 years of age for females; or
- Less than 12 years of age for males.

Reauthorization criteria

Reauthorization of leuprolide acetate (Lupron) may be considered medically necessary when ALL of the following criteria are met:
- Individual is currently receiving therapy; and
- Documentation of positive clinical response (e.g., pre-pubertal slowing or decline, normalization of FSH or LH, or normalization of bone age).

The use of leuprolide acetate for depot suspension (Lupron Depot Ped) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J1950

J9217

The use of leuprolide and norethindrone (Lupaneta Pack) may be considered medically necessary for the following condition:

Endometriosis

The initial management of the painful symptoms of endometriosis; or
The management of recurrence of symptoms.

Initial treatment course is limited to six (6) months and use is not recommended longer than a total of 12 months due to concerns about adverse impact on bone mineral density.

The use of leuprolide and norethindrone (Lupaneta Pack) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J3490

The use of leuprolide acetate (Eligard) may be considered medically necessary for the following condition:

Prostate Cancer

As palliative treatment of advanced prostate cancer; or

Compendia Sources

Leuprolide acetate (Eligard) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of leuprolide acetate (Eligard) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9217

Leuprolide acetate (Fensolvi) may be considered medically necessary for the following condition:

Central Precocious Puberty

For the treatment of pediatric individuals two (2) years of age and older with central precocious puberty when ALL of the following criteria are met:
- Confirmed clinical diagnosis of CPP defined by any of the following:
  - Measurement of LH and FSH elevated following stimulation with a GnRH analog; and
  - Assessment confirms bone age advancement beyond chronological age; and
- Individual has onset of secondary sexual characteristics;
  - Less than 11 years of age for females; or
  - Less than 12 years of age for males.
Reauthorization criteria
- Reauthorization of leuprolide acetate (Lupron) may be considered medically necessary when ALL of the following criteria are met:
- Individual is currently receiving therapy; and
- Documentation of positive clinical response (e.g., pre-pubertal slowing or decline, normalization of FSH or LH, or normalization of bone age).

The use of leuprolide acetate (Fensolvi) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J1951

Leuprolide mesylate (Camcevi) or leuprolide acetate (Lutrate Depot) may be considered medically necessary for the following condition:

Prostate Cancer

For the treatment of adult individuals with advanced prostate cancer; or

Compendia Sources

Leuprolide mesylate (Camcevi) or leuprolide acetate (Lutrate Depot) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of leuprolide mesylate (Camcevi) or leuprolide acetate (Lutrate Depot) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J1952

J1954

The use of triptorelin extended-release (Triptodur) may be considered medically necessary for the following condition:

Central Precocious Puberty

The treatment of pediatric individuals two (2) years and older with central precocious puberty when ALL of the following criteria are met:
- Confirmed clinical diagnosis of CPP defined by any of the following:
  - Measurement of LH and FSH elevated following stimulation with a GnRH analog; and
  - Assessment confirms bone age advancement beyond chronological age; and
- Individual has onset of secondary sexual characteristics;
  - Less than 11 years of age for females; or
  - Less than 12 years of age for males.

Reauthorization criteria
- Reauthorization of triptorelin extended-release (Triptodur) may be considered medically necessary when ALL of the following criteria are met:
  - Individual is currently receiving therapy; and
  - Documentation of positive clinical response (e.g., pre-pubertal slowing or decline, normalization of FSH or LH, or normalization of bone age).

The use of triptorelin extended-release (Triptodur) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J3316

The use of triptorelin pamoate (Trelstar) may be considered medically necessary for the following condition:

Prostate Cancer

The palliative treatment of advanced prostate cancer; or

Compendia Sources

Triptorelin pamoate (Trelstar) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of triptorelin pamoate (Trelstar) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J3315

The use of histrelin acetate subcutaneous implant (Vantas) may be considered medically necessary for the following condition:

Prostate Cancer

For the palliative treatment of advanced prostate cancer; or

Compendia Sources

Histrelin acetate subcutaneous implant (Vantas) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of histrelin acetate subcutaneous implant (Vantas) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9225

The use of histrelin acetate subcutaneous implant (Supprelin LA) may be considered medically necessary for the following condition:

Central Precocious Puberty

For treatment of children with central precocious puberty when ALL of the following criteria are met:
- Confirmed clinical diagnosis of CPP defined by any of the following:
  - Measurement of LH and FSH elevated following stimulation with a GnRH analog; and
  - Assessment confirms bone age advancement beyond chronological age; and
- Individual has onset of secondary sexual characteristics;
  - Less than 11 years of age for females; or
  - Less than 12 years of age for males.
Reauthorization criteria
- Reauthorization of leuprolide acetate (Lupron) may be considered medically necessary when ALL of the following criteria are met:
  - Individual is currently receiving therapy; and
  - Documentation of positive clinical response (e.g., pre-pubertal slowing or decline, normalization of FSH or LH, or normalization of bone age).

The use of histrelin acetate subcutaneous implant (Supprelin LA) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9226

Other Medically Accepted Non-FDA Approved Indications, Class IIb or Higher Grade Recommendations

The use of histrelin acetate (Supprelin LA, Vantas), leuprolide acetate (Lupron Depot, Lupron Depot-Ped Fensolvi), or triptorelin (Triptodur, Trelstar) may be considered medically necessary for puberty suppression in individuals with gender dysphoria when ALL of the following criteria are met:

The adolescent has demonstrated a long-lasting and intense pattern of gender non-conformity or gender dysphoria (whether suppressed or expressed); and
Gender dysphoria emerged or worsened with the onset of puberty; and
Any co-existing psychological, medical, or social problems that could interfere with treatment (e.g., that may compromise treatment adherence) have been addressed, such that the adolescent's situation and functioning are stable enough to start treatment; and
The adolescent has given informed consent and, particularly when the adolescent has not reached the age of medical consent, the parents or other caretakers or guardians have consented to the treatment and are involved in supporting the adolescent throughout the treatment process.

The use of histrelin acetate (Supprelin LA, Vantas), leuprolide acetate (Lupron Depot, Lupron Depot-Ped), or triptorelin (Triptodur, Trelstar) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J1950

J1951

J9217

J9225

J9226

J3315

J3316

J3490

NOTE*: First generation antiandrogen must be given for seven (7) or more days to prevent testosterone flare if metastases are present in weight-bearing bone.

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes J1950 and J9217

C06.9

C07

C08.0

C08.1

C08.9

C48.1

C48.2

C48.8

C50.011

C50.012

C50.019

C50.021

C50.022

C50.029

C50.111

C50.112

C50.119

C50.121

C50.122

C50.129

C50.211

C50.212

C50.219

C50.221

C50.222

C50.229

C50.311

C50.312

C50.319

C50.321

C50.322

C50.329

C50.411

C50.412

C50.419

C50.421

C50.422

C50.429

C50.511

C50.512

C50.519

C50.521

C50.522

C50.529

C50.611

C50.612

C50.619

C50.621

C50.622

C50.629

C50.811

C50.812

C50.819

C50.821

C50.822

C50.829

C50.911

C50.912

C50.919

C50.921

C50.922

C50.929

C56.1

C56.2

C56.3

C56.9

C57.00

C57.01

C57.02

C57.10

C57.11

C57.12

C57.20

C57.21

C57.22

C57.3

C57.4

C57.7

C57.8

C57.9

C61

C79.63

D25.0

D25.1

D25.2

D25.9

D50.0

D50.9

E22.8

F64.0

F64.1

F64.2

F64.8

F64.9

N80.00

N80.01

N80.02

N80.03

N80.101

N80.102

N80.103

N80.109

N80.111

N80.112

N80.113

N80.119

N80.121

N80.122

N80.123

N80.129

N80.201

N80.202

N80.203

N80.209

N80.211

N80.212

N80.213

N80.219

N80.221

N80.222

N80.223

N80.229

N80.30

N80.311

N80.312

N80.319

N80.321

N80.322

N80.329

N80.331

N80.332

N80.333

N80.339

N80.341

N80.342

N80.343

N80.349

N80.351

N80.352

N80.353

N80.359

N80.361

N80.362

N80.363

N80.369

N80.371

N80.372

N80.373

N80.379

N80.381

N80.382

N80.383

N80.389

N80.391

N80.392

N80.399

N80.3A1

N80.3A2

N80.3A3

N80.3A9

N80.3B1

N80.3B2

N80.3B3

N80.3B9

N80.3C1

N80.3C2

N80.3C3

N80.3C9

N80.40

N80.41

N80.42

N80.50

N80.511

N80.512

N80.519

N80.521

N80.522

N80.529

N80.531

N80.532

N80.539

N80.541

N80.542

N80.549

N80.551

N80.552

N80.559

N80.561

N80.562

N80.569

N80.A0

N80.A1

N80.A2

N80.A41

N80.A42

N80.A43

N80.A49

N80.A51

N80.A52

N80.A53

N80.A59

N80.A61

N80.A62

N80.A63

N80.A69

N80.B1

N80.B2

N80.B31

N80.B32

N80.B39

N80.B4

N80.B5

N80.B6

N80.C0

N80.C10

N80.C11

N80.C19

N80.C2

N80.C3

N80.C4

N80.C9

N80.D0

N80.D1

N80.D2

N80.D3

N80.D4

N80.D5

N80.D6

N80.D9

Z87.890

Covered Diagnosis Codes for Procedure Code J9218:

C06.9

C07

C08.0

C08.1

C08.9

C61

D25.0

D25.1

D25.2

D25.9

D50.0

D50.9

E22.8

N80.00

N80.01

N80.02

N80.03

N80.101

N80.102

N80.103

N80.109

N80.111

N80.112

N80.113

N80.119

N80.121

N80.122

N80.123

N80.129

N80.201

N80.202

N80.203

N80.209

N80.211

N80.212

N80.213

N80.219

N80.221

N80.222

N80.223

N80.229

N80.30

N80.311

N80.312

N80.319

N80.321

N80.322

N80.329

N80.331

N80.332

N80.333

N80.339

N80.341

N80.342

N80.343

N80.349

N80.351

N80.352

N80.353

N80.359

N80.361

N80.362

N80.363

N80.369

N80.371

N80.372

N80.373

N80.379

N80.381

N80.382

N80.383

N80.389

N80.391

N80.392

N80.399

N80.3A1

N80.3A2

N80.3A3

N80.3A9

N80.3B1

N80.3B2

N80.3B3

N80.3B9

N80.3C1

N80.3C2

N80.3C3

N80.3C9

N80.40

N80.41

N80.42

N80.50

N80.511

N80.512

N80.519

N80.521

N80.522

N80.529

N80.531

N80.532

N80.539

N80.541

N80.542

N80.549

N80.551

N80.552

N80.559

N80.561

N80.562

N80.569

N80.A0

N80.A1

N80.A2

N80.A41

N80.A42

N80.A43

N80.A49

N80.A51

N80.A52

N80.A53

N80.A59

N80.A61

N80.A62

N80.A63

N80.A69

N80.B1

N80.B2

N80.B31

N80.B32

N80.B39

N80.B4

N80.B5

N80.B6

N80.C0

N80.C10

N80.C11

N80.C19

N80.C2

N80.C3

N80.C4

N80.C9

N80.D0

N80.D1

N80.D2

N80.D3

N80.D4

N80.D5

N80.D6

N80.D9

Covered Diagnosis Codes for Procedure Code J3316:

E22.8

F64.0

F64.1

F64.2

F64.8

F64.9

Z87.890

Covered Diagnosis Codes for Procedure Code J3315:

C61

C50.011

C50.012

C50.019

C50.021

C50.022

C50.029

C50.111

C50.112

C50.119

C50.121

C50.122

C50.129

C50.211

C50.212

C50.219

C50.221

C50.222

C50.229

C50.311

C50.312

C50.319

C50.321

C50.322

C50.329

C50.411

C50.412

C50.419

C50.421

C50.422

C50.429

C50.511

C50.512

C50.519

C50.521

C50.522

C50.529

C50.611

C50.612

C50.619

C50.621

C50.622

C50.629

C50.811

C50.812

C50.819

C50.821

C50.822

C50.829

C50.911

C50.912

C50.919

C50.921

C50.922

C50.929

F64.0

F64.1

F64.2

F64.8

F64.9

N80.00

N80.01

N80.02

N80.03

N80.101

N80.102

N80.103

N80.109

N80.111

N80.112

N80.113

N80.119

N80.121

N80.122

N80.123

N80.129

N80.201

N80.202

N80.203

N80.209

N80.211

N80.212

N80.213

N80.219

N80.221

N80.222

N80.223

N80.229

N80.30

N80.311

N80.312

N80.319

N80.321

N80.322

N80.329

N80.331

N80.332

N80.333

N80.339

N80.341

N80.342

N80.343

N80.349

N80.351

N80.352

N80.353

N80.359

N80.361

N80.362

N80.363

N80.369

N80.371

N80.372

N80.373

N80.379

N80.381

N80.382

N80.383

N80.389

N80.391

N80.392

N80.399

N80.3A1

N80.3A2

N80.3A3

N80.3A9

N80.3B1

N80.3B2

N80.3B3

N80.3B9

N80.3C1

N80.3C2

N80.3C3

N80.3C9

N80.40

N80.41

N80.42

N80.50

N80.511

N80.512

N80.519

N80.521

N80.522

N80.529

N80.531

N80.532

N80.539

N80.541

N80.542

N80.549

N80.551

N80.552

N80.559

N80.561

N80.562

N80.569

N80.A0

N80.A1

N80.A2

N80.A41

N80.A42

N80.A43

N80.A49

N80.A51

N80.A52

N80.A53

N80.A59

N80.A61

N80.A62

N80.A63

N80.A69

N80.B1

N80.B2

N80.B31

N80.B32

N80.B39

N80.B4

N80.B5

N80.B6

N80.C0

N80.C10

N80.C11

N80.C19

N80.C2

N80.C3

N80.C4

N80.C9

N80.D0

N80.D1

N80.D2

N80.D3

N80.D4

N80.D5

N80.D6

N80.D9

Z87.890

Covered Diagnosis Codes for Procedure Code J9225:

C61

F64.0

F64.1

F64.2

F64.8

F64.9

Z87.890

Covered Diagnosis Codes for Procedure Codes J1951 and J9226:

E22.8

F64.0

F64.1

F64.2

F64.8

F64.9

Z87.890

Covered Diagnosis Codes for Procedure Codes J1952 and J1954

C61

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-15-2019 Adopted policy

Internal Medical Policy Committee 1-22-2020

Added gender dysphoria criteria; and
Added diagnosis codes

Internal Medical Policy Committee 7-22-2020

Added new product, Fensolvi,
Revised criteria,
Added additional diagnosis code, C06.9

Internal Medical Policy Committee 7-22-2021 Effective July 01, 2021

Added new code J1951 for leuprolide acetate (Fensolvi) to policy

Internal Medical Policy Committee 9-21-2021

Added additional diagnosis codes C56.3 and C79.63 to J1950 and J9217

Internal Medical Policy Committee 9-28-2022 - Effective October 03, 2022

Added leuprolide mesylate (Camcevi) to the policy,
Added CPP criteria and CPP reauthorization criteria,
Update Diagnosis codes as follows:
- Procedure codes J1950 and J9217
  - Removed Z85.43 and Z85.46,
- Procedure code J9218
  - Removed Z85.46; and
  - Added D50.0 and D50.9,
- Procedure code J3315
  - Removed Z85.46;
- Procedure code J9225
  - Removed Z85.46,
- Procedure code J1952
  - Added C61
  - Removed NCCN recommendations; and
  - Added this statement "[Drug] may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations." and
  - Updated experimental/investigational statement

Internal Medical Policy Committee 1-26-2023 - Effective January 1, 2023

Added new code J1954 for leuprolide acetate (Lutrate Depot) to the policy
Updated experimental/investigational statements

Internal Medical Policy Committee 1-16-2024 Effective March 01, 2024

Added CPP criteria for Triptodur

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

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References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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Gonadotropin Releasing Hormones (GnRHs) Analogs (ARCHIVED)

This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.

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Professional Statements and Societal Positions Guidelines

ND Committee Review

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Disclaimer

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**