FDA-approved, for example:

• central precocious puberty (CPP)  – Fensolvi, Lupron Ped, Supprelin LA, Synarel, Triptodur 
• endometriosis – Lupron, Myfembree, Orilissa, Synarel
• prostatic cancer (advanced) – Camcevi, Eligard, Firmagon, leuprolide 22.5 mg vial, Lupron, Trelstar
• prostatic cancer (castration-sensitive, metastatic) – Orgovyx
• uterine leiomyomata – Lupron, Myfembree, Oriahnn

Non-FDA-approved, for example:

• abnormal uterine bleeding – Eligard, Fensolvi, leuprolide 22.5 mg vial, Lupron, Myfembree, Orilissa, Synarel, Triptodur
• catamenial epilepsy – Trelstar
• endometriosis - extended duration of therapy – Lupron, Myfembree, Orilissa, Synarel
• Gender Dysphoria – Eligard, Fensolvi, leuprolide 22.5 mg vial, Lupron, Lupron Ped, Supprelin LA, Triptodur
• GnRH stimulation test for CPP diagnosis – Fensolvi, Lupron Ped, Supprelin LA, Synarel, Triptodur
• ovarian suppression/preservation – Eligard, Fensolvi, Lupron
• paraphilia – Camcevi, Eligard, Fensolvi, Firmagon, leuprolide 22.5 mg vial, Lupron, Myfembree, Oriahnn, Orgovyx, Orilissa, Supprelin LA, Synarel, Trelstar, Triptodur
• premenstrual dysphoric disorder (PMDD) – Eligard, leuprolide 22.5 mg vial, Lupron, Myfembree, Orilissa, Synarel
• uterine leiomyomata - extended duration of therapy – Lupron, Myfembree, Oriahnn

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

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 (Eligard, Fensolvi, leuprolide 22.5 mg vial, 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 one of the following: Eligard, leuprolide 22.5 mg vial, Lupron; and
  • for Lupron Depot 7.5 mg, Lupron Depot 22.5 mg every three months, Lupron Depot 30 mg, and Lupron Depot 45 mg every six months, clinical rationale for use instead of the equivalent dose of Eligard; 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 Myfembree; or
      • member is being treated with add-back therapy for bone loss; or
      • yearly BMD scan has been performed to indicate that the member does not need to be treated for osteoporosis.

Advanced prostate cancer (Camcevi, Eligard, Firmagon, leuprolide 22.5 mg vial, Trelstar) 

• 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, and Firmagon 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
  • for Lupron Depot 7.5 mg, Lupron Depot 22.5 mg, Lupron Depot 30 mg, and Lupron Depot 45 mg, clinical rationale for use instead of the equivalent dose of Eligard.

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, adverse reaction, or contraindication to Firmagon; and
  • inadequate response, adverse reaction, or contraindication to Eligard, leuprolide 22.5 mg vial, or Lupron.

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 (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 (Lupron, Myfembree, Orilissa, Synarel)

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

Gender dysphoria (Eligard)

• Documentation of the following is required:
  • diagnosis of one of the following:
    • gender dysphoria; or
    • transgenderism; 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); or
    • for the 45 mg syringe, requested quantity is ≤ one unit/168 days (six months).

SmartPA: Claims for Eligard 7.5 mg, 22.5 mg, 30 mg, and 45 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 dysphoria or personal history of gender reassignment surgery.^†

Gender dysphoria (Fensolvi, Triptodur)

• Documentation of the following is required:
  • diagnosis of one of the following:
    • gender dysphoria; or
    • transgenderism; 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 dysphoria or personal history of gender reassignment surgery.^†

Gender dysphoria (leuprolide 22.5 mg vial, Lupron, Lupron Ped)

• Documentation of the following is required:
  • diagnosis of one of the following:
    • gender dysphoria; or
    • transgenderism; or
    • therapy after gender reassignment surgery; and
  • for Lupron 7.5 mg, 22.5 mg, 30 mg, and 45 mg adult kit, clinical rationale for use instead of the equivalent dose of Eligard; and
  • one of the following:
    • for leuprolide 14 mg 2-week kit, and 14 mg 2-week vial, requested quantity is ≤ two units/28 days (one month); or
    • for the 3.75 mg kit, 7.5 mg kit, 11.25 mg pediatric 1-month kit, and 15 mg pediatric kit, requested quantity is ≤ one unit/28 days (one month); or
    • for the 11.25 mg 3-month kit, 22.5 mg kit, 30 mg pediatric kit, and leuprolide 22.5 mg vial, 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); or
    • for the 45 mg kit, requested quantity is ≤ one unit/168 days (six months).

SmartPA: Claims for leuprolide 14 mg 2-week kit, 14 mg 2-week vial, leuprolide 22.5 mg vial, Lupron 3.75 mg kit, 7.5 mg pediatric kit, 11.25 mg kit, 15 mg kit, 22.5 mg pediatric kit, 30 mg pediatric kit, and 45 mg pediatric 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 dysphoria or personal history of gender reassignment surgery.^†

Gender dysphoria (Supprelin LA)

• Documentation of the following is required:
  • diagnosis of one of the following:
    • gender dysphoria; or
    • transgenderism; 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 dysphoria or personal history of gender reassignment surgery.^†

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

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

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

• Documentation of the following is required:
  • diagnosis of CPP with onset of secondary sex characteristics before age eight years (female sex assigned at birth/biologic females) or nine years (male sex assigned at birth/biologic males); and 
  • prescriber is a pediatric endocrinologist or consult notes from a pediatric endocrinologist are provided; and 
  • appropriate dose and frequency; and
  • one of the following: 
    • member is currently less than 11 years of age (female sex assigned at birth/biologic females) or 12 years of age (male sex assigned at birth/biologic males); or
    • member is ≥ 11 years of age and less than 12 years of age (female sex assigned at birth/biologic females) or ≥ 12 years of age and less than 13 years of age (male sex assigned at birth/biologic males) and requires one additional year of prolonged therapy due to developmental delay; and
  • for Fensolvi and Triptodur, inadequate response, adverse reaction, or contraindication to Lupron Ped.
• For recertification, member must be less than 11 years of age (female sex assigned at birth/biologic females) or less than 12 years of age (male sex assigned at birth/biologic males), or for member with developmental disability that requires extended treatment, member must be less than 12 years of age (female sex assigned at birth/biologic females) or less than 13 years of age (male sex assigned at birth/biologic males).

Ovarian suppression/preservation (Eligard, Fensolvi, Lupron)

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is currently being treated with a chemotherapeutic agent; and
  • appropriate dose and frequency; and
  • for Lupron Depot 7.5 mg, Lupron Depot 22.5 mg every three months, Lupron Depot 30 mg, and Lupron Depot 45 mg every six months, clinical rationale for use instead of the equivalent dose of Eligard.

Paraphilia (Camcevi, Eligard, Fensolvi, Firmagon, leuprolide 22.5 mg vial, Lupron, Myfembree, Oriahnn, Orgovyx, Orilissa, Supprelin LA, Synarel, Trelstar, Triptodur)

• 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.

Premenstrual Dysphoric Disorder (PMDD) (Eligard, leuprolide 22.5 mg vial, Lupron, Myfembree, Orilissa, Synarel) 

• Documentation of the following is required:
  • appropriate diagnosis; and
  • appropriate dose and frequency; and
  • inadequate response or adverse reaction to two or contraindication to all SSRIs; and
  • inadequate response or adverse reaction to one or contraindication to all hormonal contraceptives; and
  • for Lupron Depot 7.5 mg, Lupron Depot 22.5 mg, Lupron Depot 30 mg, and Lupron Depot 45 mg, clinical rationale for use instead of the equivalent dose of Eligard; and
  • for Myfembree and Orilissa, inadequate response or adverse reaction to one or contraindication to all of the following: Eligard, leuprolide 22.5 mg vial, Lupron; and
  • for Myfembree, requested quantity is ≤ one unit/day.

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
  • 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
        • yearly 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.