Mass General Brigham Health Plan GnRH Coverage

Coverage Criteria for GnRH Analogues

General authorization rule

Authorization may be granted when ALL of the following are met; documentation must be provided:

General: Member is new to the plan and currently receiving treatment with the requested medication OR member meets indication-specific criteria with documentation provided

Authorizations reviewed case-by-case for members new to the plan

Paraphilia (Off-Label)

Covered when ALL of the following are met:

Paraphilia: Diagnosis of paraphilia; appropriate frequency of administration; prescriber is a specialist (psychiatrist, psychologist, etc.) or consult notes from a specialist are provided

Off-label indication

Advanced Prostate Cancer

Covered when ALL of the following are met:

Advanced Prostate Cancer: Diagnosis of advanced prostate cancer; prescriber is an oncologist or urologist; appropriate dose and frequency per product dosing

Applies to listed GnRH agents (e.g., Camcevi, Firmagon, Lupron)

Advanced Breast Cancer

Covered when ALL of the following are met:

Advanced Breast Cancer: Diagnosis of advanced breast cancer; appropriate dosing/frequency per product guidance

Applies to listed GnRH agents

Endometrial Thinning Prior to Endometrial Ablation

Covered when ALL of the following are met:

Pre-ablation endometrial thinning: Diagnosis of abnormal uterine bleeding; appropriate dose and frequency; anticipated surgery date provided

Anticipated surgery date may be used to inform approval duration

Premenstrual Dysphoric Disorder (PMDD)

Covered when ALL of the following are met:

PMDD: Diagnosis of premenstrual dysphoric disorder (PMDD); appropriate dose and frequency; inadequate response or adverse reaction to TWO SSRIs or contraindication to ALL SSRIs; inadequate response or adverse reaction to ONE or contraindication to ALL hormonal contraceptives

Prescriber must document prior trials or contraindications

Gender Dysphoria

Covered when ALL of the following are met:

Gender Dysphoria: Diagnosis of gender dysphoria or transgenderism; requested quantity is within specified quantity limits for the requested kit/strength (strength-specific caps apply); includes therapy after gender reassignment surgery when applicable

Quantity limits detailed by syringe/kit strength (examples: 7.5 mg <1 unit/28 days; 22.5 mg <1 unit/84 days; 30 mg <1 unit/112 days; 45 mg <1 unit/168 days; 50 mg implant <1 unit/365 days). Some uses noted as off-label requiring additional justification

Ovarian Suppression/Preservation

Covered when ONE of the following groups is met:

Ovarian suppression/preservation: Member is currently being treated with a chemotherapeutic agent, tamoxifen, or an aromatase inhibitor (anastrozole, exemestane, letrozole); OR member was treated with such agents within the last 5 years; appropriate dosing and frequency documented

Used for ovarian suppression or preservation during or after cancer therapy

Abnormal Uterine Bleeding (AUB)

Covered when ALL of the following are met:

AUB: Documentation of severity of menstrual bleeding (e.g., anemia, hemoglobin levels, pain, interference with activities); inadequate response or adverse reaction to ONE or contraindication to BOTH hormonal contraceptives and non-contraceptive estrogen-progestin formulations; inadequate response, adverse reaction, or contraindication to tranexamic acid; if surgical candidate provide expected surgery date OR if not a surgical candidate, documentation of add-back therapy for bone loss or yearly BMD showing no need for osteoporosis treatment

Prior therapy failure and bone health/add-back considerations required for duration decisions; prescriber must document trials of alternatives or provide rationale for non-rebate products when applicable

Central Precocious Puberty (CPP) / GnRH Stimulation Test

Covered when ALL of the following are met:

CPP diagnosis and testing: Diagnosis of central precocious puberty (CPP) with onset of secondary sex characteristics before age 8 years (females) or before age 9 years (males); prescriber is a pediatric endocrinologist or consult notes provided; member meets age-based treatment criteria (typically <11 years for females or <12 years for males with defined continuation/extension rules for developmental delay); appropriate dose and frequency; Fensolvi, Supprelin LA, Lupron, or Triptodur may be used per agent-specific guidance for stimulation testing or treatment

Certain vial strengths not applicable for CPP diagnostic or therapy use; pediatric endocrinology involvement required

Advanced Prostate Cancer

Covered when ALL of the following are met

Diagnosis of advanced prostate cancer (applies to all strengths)
Prescriber specialty: Prescriber is an oncologist or urologist
Dosing: Requested dosing and frequency are appropriate per product dosing
Prescriber must submit documentation of trials of alternatives or clinical rationale for use of non-rebate product when applicable

Advanced Breast Cancer

Covered when ALL of the following are met

Diagnosis of advanced breast cancer
Dosing: Requested dosing and frequency are appropriate per product dosing (examples include 10.8 mg every 3 months for specific products)

Endometriosis and Endometriosis Extended Duration

Covered when ALL of the following are met (standard and extended duration rules differ)

Endometriosis and Extended Duration

Diagnosis of endometriosis (or request for endometriosis extended-duration therapy)
Dosing: Appropriate dose and frequency per product guidance
Prior therapy: Inadequate response or adverse reaction to ONE NSAID and ONE hormonal contraceptive OR contraindication to all such agents (prior trials required); prescriber must document trials of alternatives or provide rationale for non-rebate product when applicable
Extended therapy conditions: For extended-duration requests: anticipated duration of therapy provided and member is receiving add-back therapy for bone loss OR yearly BMD scan indicating no need for osteoporosis treatment

Uterine Leiomyomata (Fibroids) and Extended Duration

Covered when ALL of the following are met

Diagnosis of uterine leiomyomata (fibroids)
Dosing: Appropriate dose and frequency per product guidance
Surgical planning or rationale: Either anticipated surgery date (or notation that surgery is planned once fibroids shrink) OR clinical rationale why surgical intervention is not appropriate
If shrinkage prior to surgery is the stated goal, prior trial may be bypassed
Prior therapy: Inadequate response or adverse reaction to ONE or contraindication to ALL hormonal contraceptives (may be bypassed if pre-surgical shrinkage is the goal)
Extended duration requests require updated surgery date or rationale and bone-protection/add-back considerations

GnRH Stimulation Test for CPP Diagnosis

Covered when ALL of the following are met

GnRH stimulation test

Intended use: Medication (e.g., Lupron, Supprelin LA, Fensolvi, Triptodur) will be used as a GnRH stimulation agent to diagnose central precocious puberty (CPP)

Idiopathic or Neurogenic Central Precocious Puberty (CPP)

Covered when ALL of the following are met

Idiopathic or Neurogenic CPP

Diagnosis criteria: Diagnosis of CPP with onset of secondary sex characteristics before age 8 years (female) or before age 9 years (male)
Prescriber specialty: Prescriber is a pediatric endocrinologist or consult notes from a pediatric endocrinologist are provided
Age & continuation rules: Member is currently less than 11 years (female) or less than 12 years (male); or, for members with developmental delay, an additional year may be allowed per policy (through age 12 female / 13 male)
Dosing: Appropriate dose and frequency per dosing table; certain vial strengths not applicable

Gender Dysphoria

Covered when ALL of the following are met

Diagnosis of gender dysphoria or transgenderism
Quantity limits: Requested quantity must be within specified quantity limits by kit/strength (multiple kit/strength-specific limits listed in policy)
Examples provided for pediatric and adult kits and vial strengths
Use case: Includes therapy after gender reassignment surgery when applicable
Some uses noted as off-label requiring additional justification

Abnormal Uterine Bleeding

Covered when ALL of the following are met

Severity: Documentation of severity of menstrual bleeding (e.g., anemia, hemoglobin levels, abdominal pain, interference with daily activities)
Applies to all strengths
Prior therapy: Inadequate response or adverse reaction to BOTH hormonal contraceptives and tranexamic acid OR documented contraindication to both
Prescriber must document trials or provide contraindications
Surgical candidacy: If surgical candidate, expected date of surgery provided (may be used for approval duration); if not a surgical candidate, documentation why not or add-back/bone health documentation
For non-surgical candidates, member should be on add-back therapy or have yearly BMD demonstrating no need for osteoporosis treatment

Premenstrual Dysphoric Disorder (PMDD)

Covered when ALL of the following are met

PMDD

Diagnosis of PMDD (applies to all strengths)
Dosing: Appropriate dose and frequency per product guidance
Prior therapy: Inadequate response or adverse reaction to TWO SSRIs or contraindication to ALL SSRIs; and inadequate response or adverse reaction to ONE or contraindication to ALL hormonal contraceptives
Prescriber must document prior trials and may need to provide rationale for non-rebate product use

Ovarian Suppression/Preservation

Covered when ALL of the following are met

Ovarian suppression/preservation

Indication of ovarian suppression or preservation is documented
Treatment context: Member is currently being treated with or has been treated within the last 5 years with chemotherapy, tamoxifen, or an aromatase inhibitor (anastrozole, exemestane, letrozole)
Dosing: Appropriate dosing and frequency are documented

GnRH Stimulation Test for CPP Diagnosis

Covered when used as GnRH stimulation agent for CPP diagnosis

GnRH stimulation test agents: Use of Supprelin LA, Triptodur (triptorelin), Lupron, or Fensolvi as a stimulation agent to diagnose central precocious puberty (CPP)

Some vial strengths not applicable for stimulation testing per document

Idiopathic or Neurogenic CPP (Initial / continuation criteria)

Covered for idiopathic or neurogenic central precocious puberty when ALL of the following are met

CPP criteria: Diagnosis of CPP with onset before age 8 years (females) or before age 9 years (males); prescriber is a pediatric endocrinologist or pediatric endocrinology consult provided; appropriate dosing and frequency per dosing table; continuation rules apply with age cutoffs and possible extension for developmental delay

Certain vial strengths not applicable

Gender Dysphoria / Transgenderism

Covered for gender dysphoria/transgender care when ALL of the following are met

Gender dysphoria criteria: Diagnosis of gender dysphoria or transgenderism; requested quantity within specified quantity limits for the product/kit/strength (examples include 50 mg implant <1 unit/365 days; 22.5 mg vial kit <1 unit/112 days); may include therapy after gender reassignment surgery

Some uses are noted as off-label and may require additional justification

Advanced Breast Cancer

Covered for advanced breast cancer when ALL of the following are met

Advanced breast cancer: Diagnosis of advanced breast cancer; appropriate dosing and frequency per product guidance (example: 10.8 mg every three months for select product dosing)

Advanced Prostate Cancer

Covered for advanced prostate cancer when ALL of the following are met

Advanced prostate cancer: Diagnosis of advanced prostate cancer; prescriber is an oncologist or urologist; appropriate dose and frequency; prescriber must submit documentation of trials of alternatives or clinical rationale for use of non-rebate product when applicable

Non-rebate product rationale may be required per guideline

Catamenial Epilepsy

Covered for catamenial epilepsy when ALL of the following are met

Catamenial epilepsy criteria: Diagnosis of catamenial epilepsy; prescriber is a neurologist or endocrinologist or consult notes from such specialist provided; inadequate response or adverse reaction to TWO anticonvulsants; inadequate response or contraindication to progesterone or synthetic progestin therapy; requested dose is 3.75 mg every 4 weeks

Applies to specified product dosing (Trelstar example)

Ovarian Suppression/Preservation

Covered for ovarian suppression/preservation when ONE of the following is met and dosing is appropriate

Ovarian suppression/preservation criteria: Member is currently being treated with a chemotherapeutic agent, tamoxifen, or an aromatase inhibitor; OR member has been treated with such agents within the last 5 years; appropriate dosing and frequency required

Prescriber must document indication and appropriate dosing

Abnormal Uterine Bleeding

Covered for abnormal uterine bleeding (AUB) when ALL of the following are met

AUB criteria: Documentation of severity of menstrual bleeding (e.g., anemia, hemoglobin levels, abdominal pain, interference with activities); inadequate response or adverse reaction to specified alternatives (tranexamic acid, NSAIDs, hormonal contraceptives, or non-contraceptive estrogen-progestin formulations) OR documented contraindication to required alternatives; if surgical candidate, anticipated surgery date; if not surgical candidate, documentation regarding bone health (add-back therapy) or yearly BMD as applicable; prescriber must document trials of alternatives or provide clinical rationale for non-rebate product when applicable

Prior therapy failure and documentation required; lack of documentation may prompt denial

Endometrial Thinning Prior to Ablation

Covered for endometrial thinning prior to endometrial ablation when ALL of the following are met

Endometrial thinning criteria: Diagnosis of abnormal uterine bleeding; appropriate dose and frequency; anticipated surgery date provided

Anticipated surgery date is required when therapy is for endometrial thinning prior to endometrial ablation

Endometriosis (including extended duration)

Covered for endometriosis and extended-duration therapy when ALL of the following are met

Endometriosis criteria: Diagnosis of endometriosis; appropriate dose and frequency; inadequate response or adverse reaction to ONE or contraindication to ALL hormonal contraceptives; inadequate response or adverse reaction to ONE or contraindication to ALL NSAIDs; for extended duration: anticipated duration of therapy and either add-back therapy for bone loss or yearly BMD scan indicating no need for osteoporosis treatment; prescriber must submit documentation of trials of alternatives or rationale for non-rebate products when applicable

Certain vial strengths not applicable for extended-duration therapy (e.g., 22.5 mg vial)

Premenstrual Dysphoric Disorder (PMDD)

Covered for premenstrual dysphoric disorder (PMDD) when ALL of the following are met

PMDD criteria: Diagnosis of PMDD; appropriate dose and frequency; inadequate response or adverse reaction to TWO SSRIs or contraindication to ALL SSRIs; inadequate response or adverse reaction to ONE or contraindication to ALL hormonal contraceptives; prescriber must document prior trials or provide rationale for non-rebate product use when applicable

Initial and reauthorization durations defined in limitations

Ovarian suppression/preservation

Ovarian suppression/preservation covered when ALL of the following are met:

Ovarian suppression/preservation criteria: Indication of ovarian suppression/preservation; member is currently being treated with a chemotherapeutic agent, tamoxifen, or an aromatase inhibitor OR has been treated with one of these within the last 5 years; appropriate dosing and frequency documented

Used for preservation during/after cancer therapy

Abnormal uterine bleeding

Abnormal uterine bleeding covered when ALL of the following are met:

Abnormal uterine bleeding initial criteria: Severity of menstrual bleeding documented (e.g., anemia, hemoglobin levels, abdominal pain, interference with activities); inadequate response or adverse reaction to ONE or contraindication to BOTH hormonal contraceptives and non-contraceptive estrogen-progestin formulations; inadequate response, adverse reaction, or contraindication to tranexamic acid; if surgical candidate, expected date of surgery provided; prescriber must also submit documentation of trials of alternatives with rebate or clinical rationale for non-rebate product when applicable

Applies to initial approval decisions and documentation requirements

Continuation of Therapy

Continuation of therapy

Continuation: Resubmission by the prescriber will infer a positive clinical response to therapy

Reauthorization information and durations are provided in policy limitations

Some GnRH analogue products listed in this policy are managed on the pharmacy benefit rather than the medical benefit. Refer to the MassHealth Drug List for pharmacy-specific coverage, prior authorization criteria, and benefit routing for agents such as Camcevi, Eligard, Firmagon, Lupron, Lutrate, and Triptodur.

Certain vial strengths are excluded from extended-duration approvals or are not applicable for specific indications. Examples include the 22.5 mg vial, which is noted as not applicable for some extended-duration endometriosis and fibroid therapy entries; extended-duration requests must also document anticipated duration and bone-protection measures where required.

Use of GnRH analogues for some gender dysphoria indications is documented as off-label in the policy. Off-label requests may require additional supporting documentation or justification and remain subject to the stated quantity limits and prior authorization requirements.

Approvals for Zoladex in members with no dyspareunia or with moderate hepatic impairment are limited to a maximum of 6 months unless the request meets the policy's extended-duration approval criteria and supporting documentation is provided.

Provider Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required; authorizations may be granted when all specified criteria for the indication are met and documentation is provided. Documentation supporting diagnosis, prescriber specialty, dosing/frequency, prior therapy failures or surgical dates as applicable must be supplied. Authorizations are reviewed case-by-case; provider must supply documentation to support criteria or request may be denied.

Prior authorization required for listed indications; include indication, dosing, and prior therapies or contraindications.
Documentation must include diagnosis, appropriate dose/frequency, prescriber specialty (when required), and dates (e.g., anticipated surgery date) as applicable.
Authorizations for members new to the plan currently receiving treatment may be reviewed case-by-case; include source of current supply (exclude samples or manufacturer patient assistance).

Documentation Required

CPP Prior Authorization and Specialty/Age Documentation

Prior authorization for central precocious puberty (CPP) requires that the prescriber is a pediatric endocrinologist or that consult notes from a pediatric endocrinologist are provided. Requests must include diagnosis details including age-of-onset criteria and appropriate dosing/frequency. Authorizations for CPP will be considered only when age and specialty criteria are met.

Initial Therapy Requirements

Initial therapy trial requirements

Initial therapy conditions and required prior trials where applicable

Initial therapy trials: Inadequate response or adverse reaction to specified first-line therapies (e.g., NSAIDs, hormonal contraceptives, tranexamic acid, SSRIs) is required for many gynecologic indications prior to approval

Exceptions noted when pre-surgical shrinkage is the stated goal

Initial therapy

Initial therapy requirements where specified (prescriber specialty, dosing limits, prior trials)

Initial therapy prerequisites: Diagnosis confirmation and inadequate response or contraindication to specified prior therapies (e.g., SSRIs for PMDD, hormonal contraceptives for endometriosis, anticonvulsants for catamenial epilepsy); prescriber specialty requirements where applicable (pediatric endocrinologist for CPP; neurologist/endocrinologist for catamenial epilepsy; oncologist/urologist for advanced prostate cancer); appropriate dosing and frequency

Prescriber specialty or consult notes required as documented

Continuation and Reauthorization Rules

Extended duration therapy requirements

Conditions for extended-duration continuation

Extended duration requirements: Anticipated duration of therapy must be provided for extended-duration requests; member must be treated with add-back therapy for bone loss OR annual BMD indicating no need for osteoporosis treatment; some vial strengths excluded from extended-duration approvals

Applicable to endometriosis and uterine leiomyomata extended-duration requests

Continuation / Extended Duration

Continuation and extended duration rules referenced in indications

Continuation/extended duration: Extended therapy allowed when member meets specified age/developmental delay criteria for CPP or when anticipated duration and bone protection measures/BMD documentation are provided for endometriosis or fibroid extended therapy

Refer to dosing table and limitations for reauthorization durations

Required Prior Trials and Step Therapy

Requirement	Details
Severity documentation
Inadequate response or adverse reaction to ONE hormonal contraceptive (oral, IUD, Depo‑Provera) AND to non‑contraceptive estrogen‑progestin formulations, or documented contraindication to BOTH
Inadequate response, adverse reaction, or contraindication to tranexamic acid
If surgical candidate, expected date of surgery (may be used to determine approval duration)
If not surgical candidate, member must be treated with estrogen/progestin add‑back therapy for bone loss OR have yearly BMD showing no need for osteoporosis treatment
Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of non‑rebate product

Indication group	Prior trial(s) required
Diagnosis of endometriosis; inadequate response or adverse reaction to ONE NSAID and to ONE hormonal contraceptive (or contraindication to ALL); appropriate dose/frequency
Diagnosis of uterine leiomyomata; inadequate response or adverse reaction to ONE hormonal contraceptive (unless goal is pre‑surgical shrinkage), appropriate dose/frequency; provide anticipated surgery date or clinical rationale if not surgical candidate
Diagnosis of PMDD; inadequate response or adverse reaction to TWO SSRIs (or contraindication to ALL SSRIs) and to ONE hormonal contraceptive (or contraindication to ALL); appropriate dose/frequency
Many gynecologic indications require prior inadequate response or contraindication to specified first‑line therapies (e.g., NSAIDs, hormonal contraceptives, tranexamic acid, SSRIs) before approval

Indication / scenario	Alternatives trialed or contraindicated
Inadequate response or adverse reaction to ONE hormonal contraceptive and ONE NSAID (or contraindication to ALL of these) prior to approval; prescriber must document trials
Inadequate response or adverse reaction to TWO SSRIs (or contraindication to ALL SSRIs) and to ONE hormonal contraceptive (or contraindication to ALL) prior to approval; prescriber must document trials
Inadequate response or adverse reaction to TWO anticonvulsants and inadequate response or contraindication to progesterone or synthetic progestin therapy prior to approval; prescriber specialty/consultation required

Coverage condition	Required trial(s) or documentation
Trial and failure or adverse reaction to ONE hormonal contraceptive (e.g., oral contraceptives, IUD, Depo‑Provera) or documented contraindication to ALL hormonal contraceptives
Trial and failure or adverse reaction to non‑contraceptive estrogen‑progestin formulation(s) or documented contraindication to these formulations
Inadequate response, adverse reaction, or contraindication to tranexamic acid must be documented prior to approval for AUB
Documentation of severity of bleeding (e.g., anemia, hemoglobin, pain, interference with activities) and if surgical candidate, expected surgery date; if not surgical candidate, documentation of add‑back therapy or yearly BMD as applicable
Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of non‑rebate product

Quantity Limits and Strength-Specific Restrictions

Syringe/strength-specific quantity limits

7.5 mg syringe< 1 unit per 28 days (1 month)

22.5 mg syringe< 1 unit per 84 days (3 months)

30 mg syringe< 1 unit per 112 days (4 months)

45 mg syringe< 1 unit per 168 days (6 months)

Kit/strength-specific quantity limits

3.75 mg kit / 7.5 mg 1-month pediatric kit / 11.25 mg 1-month pediatric kit / 15 mg pediatric kit< 1 unit per 28 days (1 month)

11.25 mg 3-month kit / 22.5 mg pediatric kit / 30 mg pediatric kit / 22.5 mg adult kit

Key Definitions

GnRH analogues — definition

TermGnRH analogues (gonadotropin-releasing hormone analogues)

UseUsed for hormonal indications including prostate cancer, breast cancer, endometriosis, uterine fibroids, and central precocious puberty (CPP)

FormulationsInclude depot and implant formulations for disease suppression, symptom control, fertility preservation, and pubertal suppression

Central Precocious Puberty (CPP) — definition and criteria

Age-based diagnostic cutoffOnset of secondary sex characteristics before age 8 years in females assigned at birth or before age 9 years in males assigned at birth

Prescriber requirementPrescriber is a pediatric endocrinologist or pediatric endocrinology consult notes provided

Background and Clinical Context

Gonadotropin-releasing hormone (GnRH) analogues are a class of medications used to suppress gonadal hormone production for multiple indications. Common clinical uses include treatment of prostate cancer, breast cancer, management of endometriosis and uterine fibroids, pubertal suppression and diagnostic/staging use in central precocious puberty (CPP), as well as fertility preservation and other hormonal indications.

OpenPayer

Gonadotropin-releasing hormone (GnRH) analogues coverage

Coverage Criteria for GnRH Analogues

Provider Requirements and Authorization Actions

Initial Therapy Requirements

Continuation and Reauthorization Rules

Required Prior Trials and Step Therapy

Quantity Limits and Strength-Specific Restrictions

Key Definitions

Background and Clinical Context