Leuprolide acetate (Lupron®, Lupron Depot ®, Lupron Depot-Ped ®, Eligard®, Fensolvi™) is a synthetic analog of gonadotropin releasing hormone (GnRH). Although leuprolide acetate 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.
The use of leuprolide acetate (Lupron) may be considered medically necessary for the following conditions:
Food and Drug Administration (FDA) Indications
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 3 months; or
Central Precocious Puberty
- For the treatment of children with central precocious puberty; or
Endometriosis
- For the management of endometriosis, including pain relief and reduction of endometriotic lesions:
- Duration of initial treatment or retreatment not to exceed 6 months; or
Prostate Cancer
- As palliative treatment of advanced prostate cancer; or
National Comprehensive Cancer Network (NCCN) Recommendations
Prostate Cancer
- As adjuvant androgen deprivation therapy (ADT) in ANY of the following:
- As a single agent in individuals with life expectancy of 5 years or less and asymptomatic with high risk or very high risk disease where complications such as hydronephrosis or metastasis can be expected within 5 years; or
- As a single agent, in combination with first-generation antiandrogen, or in combination with either abiraterone or fine-particle abiraterone with concurrent steroids in individuals with regional risk disease and life expectancy of greater than 5 years or symptomatic; or
- As a single agent for individuals in the regional risk group and life expectancy of 5 years or less and asymptomatic; or
- As adjuvant ADT as a single agent or with a first-generation antiandrogen with or without external beam radiation (EBRT) if lymph node metastasis found during pelvic lymph node dissection (PLND) for EITHER of the following:
- Individuals in the favorable or unfavorable intermediate risk group and a 10 year or greater expected survival; or
- Individuals in the high or very high risk group and greater than 5 year expected survival or symptomatic; or
- As adjuvant ADT as a single agent or in combination with a first-generation antiandrogen with EBRT if adverse features noted after radical prostatectomy for individuals in ANY of the following:
- Very low risk group and a 20 year or greater expected survival; or
- Low risk group and 10 year or greater expected survival; or
- With or without PLND and no lymph node metastases in the favorable or unfavorable intermediate risk group and a 10 year or greater expected survival; or
- With PLND and no lymph node metastases in the high risk group and greater than 5 year expected survival or symptomatic; or
- For initial ADT as a single agent or in combination with a first-generation antiandrogen with EBRT if life expectancy greater than 5 years or symptomatic in ANY of the following:
- For 4-6 months in combination with or without brachytherapy for individuals in the unfavorable intermediate risk group; or
- For 1.5-3 years in combination for individuals in the high or very high risk group; or
- For 1.5-3 years in combination followed by docetaxel in individuals in the very high risk group; or
- For 1-3 years in combination and brachytherapy for individuals in the high or very high risk group; or
- As therapy alone or in combination with either abiraterone or fine-particle abiraterone with concurrent steroid therapy for individuals in the regional risk group; or
- Initial ADT as a single agent for individuals in the regional risk group if life expectancy is greater than 5 years or symptomatic with or without:
- Abiraterone and prednisone; or
- Abiraterone and methylprednisolone; or
- As single agent treatment for individuals who progressed on observation of localized disease; or
- As ADT as a single agent or in combination with a first-generation antiandrogen for M0 Prostate-Specific Antigen (PSA) persistence/recurrence:
- After radical prostatectomy in combination with EBRT for disease without distant
metastases or imaging not performed: or
- For positive digital rectal exam (DRE) following EBRT if biopsy negative and no distant metastases; or
- As treatment for castration-naïve disease:
- As a single agent* for M0 or M1 disease; or
- In combination with a first generation antiandrogen for M0 or M1 disease; or
- In combination with ONE of the following for M1 disease:
- Docetaxel and concurrent steroid with or without a first-generation antiandrogen; or
- Abiraterone and prednisone; or
- Fine-particle abiraterone and methylprednisolone; or
- Apalutamide or enzalutamide; or
- As a single agent or in combination with a first-generation antiandrogen and EBRT to the primary tumor for low volume M1 disease; or
- For M0 or M1 castration resistant disease as ADT to maintain castrate serum testosterone levels to less than 50 ng/dL; or
Salivary Gland Tumors
·
As systemic therapy for androgen
receptor positive recurrent disease with EITHER
of the following:
o
Distant metastases in individuals
with a performance status (PS) of 0-3; or
o
Unresectable locoregional recurrent
or second primary with prior radiation therapy.
The use of leuprolide/leuprolide
acetate (Lupron) for any other indication is considered not medically
necessary, and therefore, non-covered.
The use of leuprolide acetate for
depot suspension (Lupron Depot) may be considered medically necessary for ANY of
the following conditions:
FDA Indications
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 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 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 6 months; or
Prostate Cancer
- The palliative treatment of advanced prostatic cancer; or
NCCN Recommendations
Invasive Breast Cancer
- For the treatment of
premenopausal women with hormone receptor-positive disease in combination
with:
- Adjuvant endocrine
therapy; or
- Endocrine therapy for
recurrent or metastatic disease; or
Ovarian Cancer/Fallopian Tube
Cancer/Primary Peritoneal Cancer
- Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal
Cancers:
- Epithelial Ovarian Cancer/Fallopian Tube
cancer/Primary Peritoneal Cancer:
- As single agent hormone
therapy for persistent disease or recurrence for ANY of the
following:
- As immediate treatment for
serially rising CA-125 in individuals that received chemotherapy; or
- For progression on
primary, maintenance, or recurrence therapy; or
- For stable or persistent
disease (if not on maintenance therapy); or
- For complete remission and
relapse less than 6 months after completing chemotherapy; or
- For radiographic and/or
clinical relapse in individuals with previous complete remission and
relapse after 6 months or greater, after completing prior chemotherapy;
or
- Grade 1 Endometroid Carcinoma:
- As single agent hormone therapy for grade 1
endometrioid carcinoma as EITHER
of the following:
- Primary adjuvant treatment for pathologic stage
IC-IV disease; or
- Maintenanec treatment following adjuvant
chemotherapy for pathologic stage II-IV disease; or
- Low-Grade Serous Carcinoma/Ovarian Borderline
Epithelial Tumors (Low Malignant Potential) with Invasive Implants:
- Malignant Sex Cord-Stromal Tumors:
- As single agent therapy for clinical relapse in
individuals with stage II-IV granulosa cell tumors; or
Prostate Cancer
- As adjuvant ADT in ANY of the following:
- As a single agent in
individuals with life expectancy of 5 years or less and asymptomatic with
high risk or very high risk disease where complications such as
hydronephrosis or metastasis can be expected within 5 years; or
- As a single agent, in
combination with first-generation antiandrogen, or in combination with
either abiraterone or fine-particle abiraterone with concurrent steroids
in individuals with regional risk disease and life expectancy of greater
than 5 years or symptomatic; or
- As a single agent for
individuals in the regional risk group and life expectancy of 5 years or
less and asymptomatic; or
- As adjuvant ADT as a single agent or with a
first-generation antiandrogen with or without EBRT if lymph node
metastasis found during PLND for EITHER
of the following:
- Individuals in the favorable
or unfavorable intermediate risk group and a 10 year or greater expected
survival; or
- Individuals in the high or
very high risk group and greater than 5 year expected survival or
symptomatic; or
- As adjuvant ADT as a single agent or in combination
with a first-generation antiandrogen with EBRT if adverse features noted
after radical prostatectomy for individuals in ANY of the following:
- Very low risk group and a 20
year or greater expected survival; or
- Low risk group and 10 year or
greater expected survival; or
- With or without PLND and no
lymph node metastases in the favorable or unfavorable intermediate risk
group and a 10 year or greater expected survival; or
- With PLND and no lymph node
metastases in the high risk group and greater than 5 year expected
survival or symptomatic; or
- For initial ADT as a single agent or in combination
with a first-generation antiandrogen with EBRT if life expectancy greater
than 5 years or symptomatic in ANY of
the following:
- For
4-6 months in combination with or without brachytherapy for individuals
in the unfavorable intermediate risk group; or
- For
1.5-3 years in combination for individuals in the high or very high risk
group; or
- For
1.5-3 years in combination followed by docetaxel in individuals in the
very high risk group; or
- For
1-3 years in combination and brachytherapy for individuals in the high or
very high risk group; or
- As
therapy alone or in combination with either abiraterone or fine-particle
abiraterone with concurrent steroid therapy for individuals in the
regional risk group; or
- Initial ADT as a single agent for individuals in the
regional risk group if life expectancy is greater than 5 years or
symptomatic with or without:
- Abiraterone
and prednisone; or
- Abiraterone
and methylprednisolone; or
- As single agent treatment for individuals who
progressed on observation of localized disease; or
- As ADT as a single agent or in combination with a
first-generation antiandrogen for M0 PSA persistence/recurrence:
- After
radical prostatectomy in combination with EBRT for disease without
distant
metastases or imaging not performed: or
- For
positive DRE following EBRT if biopsy negative and no distant
metastases; or
- As treatment for castration-naïve disease:
- As
a single agent* for M0 or M1 disease; or
- In
combination with a first generation antiandrogen for M0 or M1
disease; or
- In
combination with ONE of the
following for M1 disease:
- Docetaxel
and concurrent steroid with or without a first-generation
antiandrogen; or
- Abiraterone
and prednisone; or
- Fine-particle
abiraterone and methylprednisolone; or
- Apalutamide
or enzalutamide; or
- As
a single agent or in combination with a first-generation antiandrogen and
EBRT to the primary tumor for low volume M1 disease; or
- For M0 or M1 castration resistant disease as ADT to
maintain castrate serum testosterone levels to less than 50 ng/dL; or
Salivary Gland Tumors
- As systemic therapy for androgen
receptor positive recurrent disease with EITHER of the following:
- Distant metastases in
individuals with a PS of 0-3; or
- Unresectable locoregional
recurrence or second primary with prior radiation therapy.
The
use of leuprolide acetate for depot suspension (Lupron Depot) for any other
indication is considered not medically necessary, and therefore, non-covered.
The
use of leuprolide acetate for depot suspension (Lupron Depot Ped) may be
considered medically necessary for the treatment of children with central
precocious puberty.
The
use of leuprolide acetate for depot suspension (Lupron Depot Ped) for any other
indication is considered not medically necessary, and therefore, non-covered.
Leuprolide
and norethindrone (Lupaneta Pack) may be considered medically necessary for
women 18 years of age and older for:
- The initial
management of the painful symptoms of endometriosis; or
- The management
of recurrence of symptoms.
Initial
treatment course is limited to 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 any other indication is
considered not medically necessary, and therefore, non-covered.
The use of leuprolide acetate (Eligard) may be considered medically necessary for the following conditions:
FDA Indications
Prostate Cancer
- As palliative treatment of advanced prostate cancer; or
NCCN Recommendations
Prostate Cancer
- As adjuvant ADT in ANY of the following:
- As a single agent in individuals with life expectancy of 5 years or less and asymptomatic with high risk or very high risk disease where complications such as hydronephrosis or metastasis can be expected within 5 years; or
- As a single agent, in combination with first-generation antiandrogen, or in combination with either abiraterone or fine-particle abiraterone with concurrent steroids in individuals with regional risk disease and life expectancy of greater than 5 years or symptomatic; or
- As a single agent for individuals in the regional risk group and life expectancy of 5 years or less and asymptomatic; or
- As adjuvant ADT as a single agent or with a first-generation antiandrogen with or without EBRT if lymph node metastasis found during PLND for EITHER of the following:
- Individuals in the favorable or unfavorable intermediate risk group and a 10 year or greater expected survival; or
- Individuals in the high or very high risk group and greater than 5 year expected survival or symptomatic; or
- As adjuvant ADT as a single agent or in combination with a first-generation antiandrogen with EBRT if adverse features noted after radical prostatectomy for individuals in ANY of the following:
- Very low risk group and a 20 year or greater expected survival; or
- Low risk group and 10 year or greater expected survival; or
- With or without PLND and no lymph node metastases in the favorable or unfavorable intermediate risk group and a 10 year or greater expected survival; or
- With PLND and no lymph node metastases in the high risk group and greater than 5 year expected survival or symptomatic; or
- For initial ADT as a single agent or in combination with a first-generation antiandrogen with EBRT if life expectancy greater than 5 years or symptomatic in ANY of the following:
- For 4-6 months in combination with or without brachytherapy for individuals in the unfavorable intermediate risk group; or
- For 1.5-3 years in combination for individuals in the high or very high risk group; or
- For 1.5-3 years in combination followed by docetaxel in individuals in the very high risk group; or
- For 1-3 years in combination and brachytherapy for individuals in the high or very high risk group; or
- As therapy alone or in combination with either abiraterone or fine-particle abiraterone with concurrent steroid therapy for individuals in the regional risk group; or
- Initial ADT as a single agent for individuals in the regional risk group if life expectancy is greater than 5 years or symptomatic with or without:
- Abiraterone and prednisone; or
- Abiraterone and methylprednisolone; or
- As single agent treatment for individuals who progressed on observation of localized disease; or
- As ADT as a single agent or in combination with a first-generation antiandrogen for M0 PSA persistence/recurrence:
- After radical prostatectomy in combination with EBRT for disease without distant
metastases or imaging not performed: or
- For positive DRE following EBRT if biopsy negative and no distant metastases; or
- As treatment for castration-naïve disease:
- As a single agent* for M0 or M1 disease; or
- In combination with a first generation antiandrogen for M0 or M1 disease; or
- In combination with ONE of the following for M1 disease:
- Docetaxel and concurrent steroid with or without a first-generation antiandrogen; or
- Abiraterone and prednisone; or
- Fine-particle abiraterone and methylprednisolone; or
- Apalutamide or enzalutamide; or
- As a single agent or in combination with a first-generation antiandrogen and EBRT to the primary tumor for low volume M1 disease; or
- For M0 or M1 castration resistant disease as ADT to maintain castrate serum testosterone levels to less than 50 ng/dL; or
Salivary Gland Tumors
- As systemic therapy for androgen receptor positive recurrent disease withEITHER of the following:
- Distant metastases in individuals with a PS of 0-3; or
- Unresectable locoregional recurrence or second primary with prior radiation therapy.
The use of leuprolide acetate (Eligard) for any other indication is considered not medically necessary, and therefore, non-covered.
Leuprolide acetate (Fensolvi) may be considered medically necessary for the following condition:
FDA Indication
Central Precocious Puberty
- For the treatment of pediatric individuals 2 years of age and older with central precocious puberty.
The use of leuprolide acetate (Fensolvi) for any other indication is considered not medically necessary, and therefore, non-covered.
The use of triptorelin extended-release (Triptodur) may be considered medically necessary for the following condition:
FDA Indication
Central Precocious Puberty
- For the treatment of pediatric individuals 2 years and older with central precocious puberty.
The use of triptorelin extended-release (Triptodur) for any other indication is considered not medically necessary, and therefore, non-covered.
The use of triptorelin pamoate (Trelstar) may be considered medically necessary for the following conditions:
FDA Indications
Prostate Cancer
- The palliative treatment of advanced prostate cancer; or
NCCN Recommendations
Prostate Cancer
- As adjuvant ADT in ANY of the following:
- As a single agent in individuals with life expectancy of 5 years or less and asymptomatic with high risk or very high risk disease where complications such as hydronephrosis or metastasis can be expected within 5 years; or
- As a single agent, in combination with first-generation antiandrogen, or in combination with either abiraterone or fine-particle abiraterone with concurrent steroids in individuals with regional risk disease and life expectancy of greater than 5 years or symptomatic; or
- As a single agent for individuals in the regional risk group and life expectancy of 5 years or less and asymptomatic; or
- As adjuvant ADT as a single agent or with a first-generation antiandrogen with or without EBRT if lymph node metastasis found during PLND for EITHER of the following:
- Individuals in the favorable or unfavorable intermediate risk group and a 10 year or greater expected survival; or
- Individuals in the high or very high risk group and greater than 5 year expected survival or symptomatic; or
- As adjuvant ADT as a single agent or in combination with a first-generation antiandrogen with EBRT if adverse features noted after radical prostatectomy for individuals in ANY of the following:
- Very low risk group and a 20 year or greater expected survival; or
- Low risk group and 10 year or greater expected survival; or
- With or without PLND and no lymph node metastases in the favorable or unfavorable intermediate risk group and a 10 year or greater expected survival; or
- With PLND and no lymph node metastases in the high risk group and greater than 5 year expected survival or symptomatic; or
- For initial ADT as a single agent or in combination with a first-generation antiandrogen with EBRT if life expectancy greater than 5 years or symptomatic in ANY of the following:
- For 4-6 months in combination with or without brachytherapy for individuals in the unfavorable intermediate risk group; or
- For 1.5-3 years in combination for individuals in the high or very high risk group; or
- For 1.5-3 years in combination followed by docetaxel in individuals in the very high risk group; or
- For 1-3 years in combination and brachytherapy for individuals in the high or very high risk group; or
- As therapy alone or in combination with either abiraterone or fine-particle abiraterone with concurrent steroid therapy for individuals in the regional risk group; or
- Initial ADT as a single agent for individuals in the regional risk group if life expectancy is greater than 5 years or symptomatic with or without:
- Abiraterone and prednisone; or
- Abiraterone and methylprednisolone; or
- As single agent treatment for individuals who progressed on observation of localized disease; or
- As ADT as a single agent or in combination with a first-generation antiandrogen for M0 PSA persistence/recurrence:
- After radical prostatectomy in combination with EBRT for disease without distant
metastases or imaging not performed: or
- For positive DRE following EBRT if biopsy negative and no distant metastases; or
- As treatment for castration-naïve disease:
- As a single agent* for M0 or M1 disease; or
- In combination with a first generation antiandrogen for M0 or M1 disease; or
- In combination with ONE of the following for M1 disease:
- Docetaxel and concurrent steroid with or without a first-generation antiandrogen; or
- Abiraterone and prednisone; or
- Fine-particle abiraterone and methylprednisolone; or
- Apalutamide or enzalutamide; or
- As a single agent or in combination with a first-generation antiandrogen and EBRT to the primary tumor for low volume M1 disease; or
- For M0 or M1 castration resistant disease as ADT to maintain castrate serum testosterone levels to less than 50 ng/dL.
Other Medically Accepted Non-FDA Approved Indications, Class IIb or Higher Grade Recommendations
The use of triptorelin pamoate (Trelstar) may be considered medically necessary for the following conditions:
Breast Cancer
- For the treatment of premenopausal women with hormone-sensitive advanced breast cancer; or
Endometriosis
- For the treatment of endometriosis:
- Note: clinical guidelines suggest the addition of hormonal add-back therapy to triptorelin pamoate (Trelstar) as an effective means of reducing the bone mineral loss that occurs with triptorelin therapy alone; or
- For the treatment of endometrial hyperplasia.
The use of triptorelin pamoate (Trelstar) for any other indication is considered not medically necessary, and therefore, non-covered.
The use of histrelin acetate subcutaneous implant (Vantas) may be considered medically necessary for the following conditions:
FDA Indication
Prostate Cancer
- For the palliative treatment of advanced prostate cancer; or
NCCN Recommendations
Prostate Cancer
- As adjuvant ADT in ANY of the following:
- As a single agent in individuals with life expectancy of 5 years or less and asymptomatic with high risk or very high risk disease where complications such as hydronephrosis or metastasis can be expected within 5 years; or
- As a single agent, in combination with first-generation antiandrogen, or in combination with either abiraterone or fine-particle abiraterone with concurrent steroids in individuals with regional risk disease and life expectancy of greater than 5 years or symptomatic; or
- As a single agent for individuals in the regional risk group and life expectancy of 5 years or less and asymptomatic; or
- As adjuvant ADT as a single agent or with a first-generation antiandrogen with or without EBRT if lymph node metastasis found during PLND for EITHER of the following:
- Individuals in the favorable or unfavorable intermediate risk group and a 10 year or greater expected survival; or
- Individuals in the high or very high risk group and greater than 5 year expected survival or symptomatic; or
- As adjuvant ADT as a single agent or in combination with a first-generation antiandrogen with EBRT if adverse features noted after radical prostatectomy for individuals in ANY of the following:
- Very low risk group and a 20 year or greater expected survival; or
- Low risk group and 10 year or greater expected survival; or
- With or without PLND and no lymph node metastases in the favorable or unfavorable intermediate risk group and a 10 year or greater expected survival; or
- With PLND and no lymph node metastases in the high risk group and greater than 5 year expected survival or symptomatic; or
- For initial ADT as a single agent or in combination with a first-generation antiandrogen with EBRT if life expectancy greater than 5 years or symptomatic in ANY of the following:
- For 4-6 months in combination with or without brachytherapy for individuals in the unfavorable intermediate risk group; or
- For 1.5-3 years in combination for individuals in the high or very high risk group; or
- For 1.5-3 years in combination followed by docetaxel in individuals in the very high risk group; or
- For 1-3 years in combination and brachytherapy for individuals in the high or very high risk group; or
- As therapy alone or in combination with either abiraterone or fine-particle abiraterone with concurrent steroid therapy for individuals in the regional risk group; or
- Initial ADT as a single agent for individuals in the regional risk group if life expectancy is greater than 5 years or symptomatic with or without:
- Abiraterone and prednisone; or
- Abiraterone and methylprednisolone; or
- As single agent treatment for individuals who progressed on observation of localized disease; or
- As ADT as a single agent or in combination with a first-generation antiandrogen for M0 PSA persistence/recurrence:
- After radical prostatectomy in combination with EBRT for disease without distant
metastases or imaging not performed: or
- For positive DRE following EBRT if biopsy negative and no distant metastases; or
- As treatment for castration-naïve disease:
- As a single agent* for M0 or M1 disease; or
- In combination with a first generation antiandrogen for M0 or M1 disease; or
- In combination with ONE of the following for M1 disease:
- Docetaxel and concurrent steroid with or without a first-generation antiandrogen; or
- Abiraterone and prednisone; or
- Fine-particle abiraterone and methylprednisolone; or
- Apalutamide or enzalutamide; or
- As a single agent or in combination with a first-generation antiandrogen and EBRT to the primary tumor for low volume M1 disease; or
- For M0 or M1 castration resistant disease as ADT to maintain castrate serum testosterone levels to less than 50 ng/dL.
The use of histrelin acetate subcutaneous implant (Vantas) for any other indication is considered not medically necessary, and therefore, non-covered.
The use of histrelin acetate subcutaneous implant (Supprelin LA) may be considered medically necessary for the following condition:
FDA Indication
Central Precocious Puberty
- For treatment of children with central precocious puberty.
The use of histrelin acetate subcutaneous implant (Supprelin LA) for any other indication is considered not medically necessary, and therefore, non-covered.
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:
o
The adolescent has demonstrated a
long-lasting and intense pattern of gender non-conformity or gender dysphoria
(whether suppressed or expressed); and
o
Gender dysphoria emerged or worsened
with the onset of puberty; and
o
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
o
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 any other indication is considered not
medically necessary, and therefore, non-covered.
J1950
|
J9217
|
J9225
|
J9226
|
J3315
|
J3316
|
J3490
|
NOTE*: First
generation antiandrogen must be given for 7 or more days to prevent
testosterone flare if metastases are present in weight-bearing bone.
**
NOTE:
Men
with breast cancer should be treated similarly to postmenopausal women, except
that use of an aromatase inhibitor is ineffective without concomitant
suppression of testicular steroidogenesis.
**
NOTE: In
addition to the above criteria, product specific dosage and/or frequency limits
may apply in accordance with the U.S. Food and Drug Administration
(FDA)-approved product prescribing information, national compendia, Centers for
Medicare and Medicaid Services (CMS) and other peer reviewed resources or
evidence-based guidelines. Highmark may deny, in full or in part, reimbursement
for utilization that does not fall within the applicable dosage and/or
frequency limits.
See Medical Policy Bulletin G-16 for information on chemotherapy for malignant disease.
Covered Diagnosis Codes for Procedure Code J1950, 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
|
C56.9
|
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
|
D25.0
|
D25.1
|
D25.2
|
D25.9
|
D50.0
|
D50.9
|
E22.8
|
F64.0
|
F64.1
|
F64.2
|
F64.8
|
F64.9
|
Z87.890
|
N80.0
|
N80.1
|
N80.2
|
N80.3
|
N80.4
|
N80.5
|
N80.6
|
N80.8
|
N80.9
|
Z85.43
|
Z85.46
|
|
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
|
E22.8
|
N80.0
|
N80.1
|
N80.2
|
N80.3
|
N80.4
|
N80.5
|
N80.6
|
N80.8
|
N80.9
|
Z85.46
|
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
|
Z87.890
|
N80.0
|
N80.1
|
N80.2
|
N80.3
|
N80.4
|
N80.5
|
N80.6
|
N80.7
|
N80.8
|
N80.9
|
Z85.46
|
|
|
|
|
|
Covered Diagnosis Codes for Procedure Code J9225:
C61
|
F64.0
|
F64.1
|
F64.2
|
F64.8
|
F64.9
|
Z85.46
|
Z87.890
|
|
|
|
|
|
|
Covered Diagnosis Codes for Procedure Code J9226:
E22.8
|
F64.0
|
F64.1
|
F64.2
|
F64.8
|
F64.9
|
Z87.890
|
Covered Diagnosis Codes for Procedure Code J3490:
E22.8
|
F64.0
|
F64.1
|
F64.2
|
F64.8
|
F64.9
|
Z87.890
|
Place of Service: Outpatient
The administration of gonadatropin releasing hormone (GnRH) analogs is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
The policy position applies to all commercial lines of business
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract, and subject to the applicable laws of your state.
Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
- Provides free aids and services to people with disabilities to communicate effectively with us, such as:
- Qualified sign language interpreters
- Written information in other formats (large print, audio, accessible electronic formats, other formats)
- Provides free language services to people whose primary language is not English, such as:
- Qualified interpreters
- Information written in other languages
If you need these services, contact the Civil Rights Coordinator.
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
Provides free aids and services to people with disabilities to communicate effectively with us, such as:
Qualified sign language interpreters Written information in other formats (large print, audio, accessible electronic formats, other formats)
Provides free language services to people whose primary language is not English, such as:
Qualified interpreters Information written in other languages
If you need these services, contact the Civil Rights Coordinator.
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295
, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
