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Table 2: Hormones - Gonadotropin-Releasing Hormone Analogs


A    B    C    D    E    F    G    H    I    J    K    L    M    N    O    P    Q    R    S    T    U    V    W    X    Y    Z


Drug Category: Hormones

Medication Class/Individual Agents: Gonadotropin-Releasing Hormone Analogs

I. Prior-Authorization Requirements

 Hormones – Gonadotropin-Releasing Hormone Analogs

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

degarelix Firmagon PA  
elagolix Orilissa PA  
elagolix / estradiol / norethindrone Oriahnn PA  
histrelin Supprelin LA PA  
histrelin Vantas PA  
leuprolide Camcevi PA  
leuprolide Eligard PA  
leuprolide Fensolvi PA  
leuprolide Lupron PA  
leuprolide / norethindrone Lupaneta Pack PA  
nafarelin Synarel PA  
relugolix Orgovyx PA  
relugolix / estradiol / norethindrone Myfembree PA  
triptorelin-Trelstar Trelstar PA   MB
triptorelin-Triptodur Triptodur PA  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

Class Contraindication:

  • pregnancy category X 
 
Table Footnotes
MB This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable.
 

II. Therapeutic Uses

FDA-approved, for example:

  • central precocious puberty (CPP)  – Fensolvi, Lupron, Supprelin LA, Synarel, Triptodur 
  • endometriosis – Lupaneta Pack, Lupron, Orilissa, Synarel
  • prostatic cancer (advanced) – Camcevi, Eligard, Firmagon, Lupron, Trelstar, Vantas
  • prostatic cancer (castration-sensitive, metastatic) – Orgovyx
  • uterine leiomyomata – Lupron, Myfembree, Oriahnn

Non-FDA-approved, for example:

  • abnormal uterine bleeding – Fensolvi, Lupaneta Pack, Lupron, Myfembree, Orilissa, Synarel, Triptodur
  • catamenial epilepsy – Trelstar
  • endometriosis - extended duration of therapy – Lupaneta Pack, Lupron, Orilissa, Synarel
  • Gender Identity Disorder (GID) – Eligard, Fensolvi, Lupron, Supprelin LA, Triptodur
  • GnRH stimulation test for CPP diagnosis – Fensolvi, Lupron, Supprelin LA, Synarel, Triptodur
  • ovarian suppression in breast cancer – Fensolvi, Lupron
  • paraphilia – Camcevi, Eligard, Fensolvi, Firmagon, Lupaneta Pack, Lupron, Myfembree, Oriahnn, Orgovyx, Orilissa, Supprelin LA, Synarel, Trelstar, Triptodur, Vantas
  • uterine leiomyomata - extended duration of therapy – Lupron, Myfembree, Oriahnn

Note: The above lists may not include all FDA-approved and non-FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

  

Abnormal uterine bleeding (Fensolvi, Lupaneta Pack, Lupron, Myfembree, Orilissa, Synarel, Triptodur)

  • Documentation of the following is required:
    • severity of menstrual bleeding (e.g., anemia, hemoglobin levels, abdominal pain, interference with daily activities); and
    • inadequate response or adverse reaction to one or contraindication to both of the following: hormonal contraceptives, non-contraceptive estrogen-progestin formulations; and
    • inadequate response, adverse reaction, or contraindication to tranexamic acid; and
    • for Fensolvi, Myfembree, Orilissa, and Triptodur, inadequate response, adverse reaction, or contraindication to Lupron; and
    • one of the following:
      • if member is a surgical candidate, expected date of surgery; or
      • if member is not a surgical candidate, one of the following:
        • requested agent is Lupaneta Pack or Myfembree; or
        • member is being treated with add-back therapy for bone loss; or
        • BMD scan has been performed to indicate that the member does not need to be treated for osteoporosis.

 

Advanced prostate cancer (Camcevi, Eligard, Firmagon, Trelstar, Vantas) 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or urologist; and
    • appropriate dose and frequency of the requested agent.

SmartPA: Claims for Camcevi, Eligard, Firmagon, Trelstar, and Vantas will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for prostate cancer.

 

Advanced prostate cancer (Lupron) 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or urologist; and
    • appropriate dose and frequency; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: Camcevi, Eligard, Supprelin LA, Trelstar.

  

Advanced prostate cancer (Orgovyx)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or urologist; and
    • appropriate dose and frequency; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: Lupron depot, Supprelin LA, Trelstar; and
    • inadequate response, adverse reaction, or contraindication to Firmagon.

 

Catamenial epilepsy (Trelstar)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is a neurologist or endocrinologist or consult notes from a neurologist or endocrinologist are provided; and
    • inadequate response or adverse reaction to two anticonvulsants; and
    • inadequate response or adverse reaction to one or contraindication to all progesterone therapy or synthetic progestin therapy; and
    • requested dose is 3.75 mg every four weeks.

   

Endometriosis (Lupaneta Pack, Lupron, Synarel)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dose and frequency of the requested agent; and
    • inadequate response or adverse reaction to one or contraindication to all non-steroidal anti-inflammatory drugs (NSAIDs); and
    • inadequate response or adverse reaction to one or contraindication to all hormonal contraceptives.

    

Endometriosis (Myfembree, Orilissa)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dose and frequency of the requested agent; and
    • inadequate response or adverse reaction to one or contraindication to all non-steroidal anti-inflammatory drugs (NSAIDs); and
    • inadequate response or adverse reaction to one or contraindication to all hormonal contraceptives; and
    • inadequate response, adverse reaction, or contraindication to Lupron; and
    • for Myfembree, requested quantity is ≤ one unit/day.

    

Endometriosis - extended duration of therapy (Lupaneta Pack, Lupron, Myfembree, Orilissa, Synarel)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • anticipated duration of therapy; and
    • for Lupron, Orilissa, Synarel and Zoladex one of the following:       
      • member is being treated with add-back therapy for bone loss; or
      • bone mineral density (BMD) scan has been performed to indicate that the member does not need to be treated for osteoporosis.

   

Gender identity disorder (GID) (Eligard)

  • Documentation of the following is required:
    • diagnosis of one of the following:
      • gender identity disorder; or
      • gender dysphoria; or
      • transsexualism; or
      • therapy after gender reassignment surgery; and 
    • one of the following:
      • for the 7.5 mg syringe, requested quantity is ≤ one unit/28 days (one month); or
      • for the 22.5 mg syringe, requested quantity is ≤ one unit/84 days (three months); or
      • for the 30 mg syringe, requested quantity is ≤ one unit/112 days (four months).

SmartPA: Claims for Eligard 7.5 mg, 22.5 mg, and 30 mg syringe within quantity limits will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for gender identity disorder or personal history of gender reassignment surgery.

      

GID (Fensolvi, Triptodur)

  • Documentation of the following is required:
    • diagnosis of one of the following:
      • gender identity disorder; or
      • gender dysphoria; or
      • transsexualism; or
      • therapy after gender reassignment surgery; and
    • requested quantity is ≤ one unit/112 days (four months).

SmartPA: Claims for Fensolvi and Triptodur within quantity limits will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for gender identity disorder or personal history of gender reassignment surgery.

         

GID (Lupron)

  • Documentation of the following is required:
    • diagnosis of one of the following:
      • gender identity disorder; or
      • gender dysphoria; or
      • transsexualism; or
      • therapy after gender reassignment surgery; and
    • one of the following:
      • for the 3.75 mg kit and 7.5 mg kit, requested quantity is ≤ one unit/28 days (one month); or
      • for the 11.25 mg kit, 22.5 mg kit, and 30 mg pediatric kit, requested quantity is ≤ one unit/84 days (three months); or
      • for the 30 mg adult kit, requested quantity is ≤ one unit/112 days (four months).

SmartPA: Claims for Lupron 3.75 mg kit, 7.5 mg kit, 11.25 mg kit, 22.5 mg kit, 30 mg pediatric kit, and 30 mg adult kit within quantity limits will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for gender identity disorder or personal history of gender reassignment surgery.

       

GID (Supprelin LA)

  • Documentation of the following is required:
    • diagnosis of one of the following:
      • gender identity disorder; or
      • gender dysphoria; or
      • transsexualism; or
      • therapy after gender reassignment surgery; and
    • requested quantity is ≤ one unit/365 days (one year).

SmartPA: Claims for Supprelin LA within quantity limits will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for gender identity disorder or personal history of gender reassignment surgery.

       

GnRH stimulation test for CPP diagnosis (Fensolvi, Lupron, Supprelin LA, Synarel, Triptodur)

  • Documentation of the following is required:
    • product will be used for a stimulation test to diagnosis CPP.

   

Idiopathic or neurogenic central precocious puberty (CPP) (Fensolvi, Lupron, Supprelin LA, Synarel, Triptodur)

  • Documentation of the following is required:
    • diagnosis of CPP with onset of secondary sex characteristics before age eight years (biologic females) or nine years (biologic males); and 
    • prescriber is a pediatric endocrinologist or consult notes from a pediatric endocrinologist are provided; and 
    • member is currently less than 11 years of age (biologic females) or 12 years of age (biologic males) of age; and
    • for Fensolvi or Triptodur, inadequate response, adverse reaction, or contraindication to Lupron.
  • For recertification, member must be less than 11 years of age (biologic females) or 12 years of age (biologic males) of age.

  

Ovarian suppression in breast cancer (Fensolvi, Lupron)

  • Documentation of the following is required:
    • appropriate diagnosis; and 
    • member is currently being treated with one of the following: anastrazole, exemestane, letrozole, tamoxifen.

   

Paraphilia (Camcevi, Eligard, Fensolvi, Firmagon, Lupaneta Pack, Lupron, Myfembree, Oriahnn, Orgovyx, Orilissa, Supprelin LA, Synarel, Trelstar, Triptodur, Vantas)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is under the care of a specialist (or being prescribed by specialist) to treat the disorder.

   

Uterine leiomyomata (Lupron, Myfembree, Oriahnn)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • anticipated surgery date or clinical rationale why surgical intervention is not appropriate; and
    • inadequate response or adverse reaction to one or contraindication to all hormonal contraceptives; and
    • for Oriahnn, both of the following: 
      • inadequate response, adverse reaction, or contraindication to Lupron; and
      • requested quantity is ≤ two units/day; and
    • for Myfembree, both of the following:
      • inadequate response, adverse reaction, or contraindication to both of the following: Lupron, Oriahnn; and
      • requested quantity is ≤ one unit/day; and
    • appropriate dose and frequency.

 

Uterine leiomyomata - extended duration of therapy (Lupron, Myfembree, Oriahnn)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • anticipated surgery date or clinical rationale why surgical intervention is not appropriate; and
    • inadequate response or adverse reaction to one or contraindication to all hormonal contraceptives; and
    • for Myfembree and Oriahnn, one of the following:
      • updated surgery date; or
      • clinical rationale why surgery is not an option; or
    • for Lupron, one of the following: 
      • updated surgery date; or
      • all of the following:
        • clinical rationale why surgery is not an option; and
        • one of the following:
          • member is being treated with add-back therapy for bone loss; or
          • bone mineral density (BMD) scan has been performed to indicate that the member does not need to be treated for osteoporosis.

 

Note: The decision on whether PA is required is based on information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 05/2001

Last Revised Date: 03/2024


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Last updated 06/24/24

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