Mass General Brigham Health Plan leuprolide Prior Auth | OpenPayer

Loading...

Mass General Brigham Health Plan leuprolide Prior Auth | OpenPayer

Coverage Criteria

Indication-specific initial authorization criteria

Authorization may be granted when ALL of the following are met for the requested indication (diagnosis-specific criteria below):

General new-member requirement: If member is new to the plan (coverage effective date <= 90 days), medical records must document the member is currently receiving the requested drug (excluding samples or manufacturer patient assistance).

See new-to-plan documentation requirement.

Breast Cancer: Submission of medical records demonstrating medication is being used for ovarian suppression in premenopausal women diagnosed with breast cancer.

Vabrinty requires trial and failure, contraindication, or intolerance to Eligard when requested.

Central Precocious Puberty (CPP): Submission of medical records documenting ONE of the following: (a) female <= 12 years AND confirmation of CPP by pubertal response to a GnRH agonist test or pubertal third-generation LH level AND assessment showing advanced bone age versus chronological age AND onset of secondary sexual characteristics before age 8; OR (b) male <= 13 years AND confirmation of CPP by pubertal response to a GnRH agonist test or pubertal third-generation LH level AND assessment showing advanced bone age versus chronological age AND onset of secondary sexual characteristics before age 9.

Vabrinty requires trial and failure, contraindication, or intolerance to Eligard when requested.

Endometriosis: Submission of medical records documenting diagnosis of endometriosis.

Vabrinty requires trial and failure, contraindication, or intolerance to Eligard when requested.

Uterine Leiomyomata: Submission of medical records documenting diagnosis of uterine leiomyomata (fibroids) AND ONE of the following: (a) member has anemia due to uterine leiomyomata; OR (b) Lupron Depot will be used prior to surgery for uterine leiomyomata.

Vabrinty requires trial and failure, contraindication, or intolerance to Eligard when requested.

Gender Dysphoria: Submission of medical records documenting ONE of the following: (a) adolescent (<18 years) in preparation for male-to-female gender reassignment with diagnosis of gender dysphoria and Tanner stage 2 or greater; OR (b) adult (≥ 18 years) with diagnosis of gender dysphoria where Lupron Depot will be used concomitantly with cross-sex hormones.

Vabrinty requires trial and failure, contraindication, or intolerance to Eligard when requested.

Ovarian Cancer: Submission of medical records documenting one of the following: diagnosis of epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, OR malignant sex cord-stromal tumors.

Vabrinty requires trial and failure, contraindication, or intolerance to Eligard when requested.

Prostate Cancer: Submission of medical records documenting the requested medication is being used for palliative treatment of advanced prostate cancer.

Covered products include Camcevi, Eligard, Lupron Depot, and Vabrinty; Vabrinty requires trial and failure, contraindication, or intolerance to Eligard when requested.

Salivary Gland Tumors: Submission of medical records documenting ALL of the following: recurrent, unresectable, or metastatic salivary gland tumor; tumor is androgen receptor positive; and requested medication will be used as monotherapy.

Vabrinty requires trial and failure, contraindication, or intolerance to Eligard when requested.

Continuation therapy

Continuation of therapy

Reauthorization: Requests for reauthorization will be granted when the initial criteria are met.

Reauthorization follows initial criteria.

Duration and limitations

Limitations and duration of approvals

Initial approval durations: Initial approvals are based on diagnosis: endometriosis — 6 months; uterine leiomyomata — 3 months; breast cancer, ovarian cancer, prostate cancer, central precocious puberty (CPP), salivary gland tumor, or gender dysphoria — 12 months.

See diagnosis-specific durations.

Reauthorization durations and lifetime maxima: Reauthorizations by diagnosis: endometriosis — up to 6 months (lifetime maximum 12 months total); uterine leiomyomata — up to 3 months (lifetime maximum 6 months total); breast cancer, ovarian cancer, prostate cancer, salivary gland tumor, or gender dysphoria — 12-month reauthorizations; CPP — reauthorizations at 12-month intervals up to age 12 for females and up to age 13 for males.

See lifetime maxima and age limits for CPP.

Leuprolide acetate used as an adjunct to infertility treatments is not addressed in this policy. Criteria for leuprolide used as an adjunct to infertility treatments is located within a separate fertility document. Providers requesting coverage for infertility-related use should refer to the fertility policy and submit requests under that document’s requirements rather than this leuprolide coverage policy.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for these medications. These products are designated specialty and must be dispensed through a contracted specialty pharmacy.

Plan: Commercial/Exchange
Program Type: Prior Authorization
Benefit: Pharmacy Benefit
Specialty dispensing required — fill at contracted specialty pharmacy

Documentation Required

New-member documentation required

If the member is new to the plan (coverage effective date ≤ 90 days), submit medical records showing the member is currently receiving the requested drug (records should exclude samples or manufacturer patient assistance program supply). Failure to provide required records for new members may result in denial of the request.

Initial Therapy Requirements

Initial therapy requirements

Initial authorization requires indication-specific documentation as described below.

General new-to-plan documentation: If member is new to the plan (coverage effective date <= 90 days), submit medical records documenting the member is currently receiving treatment with the requested drug (excluding samples or manufacturer's patient assistance programs).

New-member documentation requirement.

Breast Cancer documentation: Submit medical records (e.g., chart notes) demonstrating medication is being used for ovarian suppression in premenopausal women diagnosed with breast cancer.

Include relevant oncology notes.

CPP documentation: Submit medical records documenting either: (a) female <=12 years with CPP confirmed by pubertal response to GnRH agonist test or pubertal third-generation LH level and advanced bone age versus chronological age with onset of secondary sexual characteristics before age 8; OR (b) male <=13 years with analogous diagnostic confirmation and onset before age 9.

Continuation / Reauthorization Criteria

Continuation of therapy

Reauthorization requirement

Continued therapy: Reauthorization requests will be granted when the initial criteria continue to be met.

Documentation should confirm ongoing clinical need and continued fulfillment of initial criteria.

Step Therapy Requirements

Step	Required prior agent / condition	Notes
1	Trial and failure, contraindication, or intolerance to Eligard	This requirement applies when Vabrinty is requested for covered indications (breast cancer ovarian suppression, CPP, endometriosis, uterine leiomyomata, gender dysphoria, ovarian cancer, prostate cancer, salivary gland tumors).

Site-of-Care and Dispensing

Billing Rule

Specialty pharmacy dispensing required

Designated specialty medications must be filled at a contracted specialty pharmacy as these products are specialty-limited.

Dispense through a contracted specialty pharmacy per policy specialty limitations.

Background

Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) receptor agonist. With continuous administration it produces an initial surge in luteinizing hormone (LH), follicle-stimulating hormone (FSH), and sex steroids, followed by downregulation of GnRH receptors and suppression of LH/FSH release. This results in suppression of ovarian and testicular steroidogenesis, lowering sex steroid levels (in males reducing testosterone to below castrate levels). Leuprolide’s mechanism underlies its use for conditions requiring reversible medical suppression of sex hormones, including central precocious puberty, hormone-sensitive cancers, endometriosis, uterine leiomyomata, and gender-affirming care.

Definitions

CPP diagnostic confirmation — diagnostic criteria

Diagnostic confirmation methodsCPP diagnosis requires either a pubertal response to a GnRH agonist stimulation test or a pubertal-level third‑generation LH assay result.

Bone age assessmentAssessment must show bone age advanced relative to chronological age to support CPP diagnosis.

Sex-specific onset age thresholdsFemales: onset of secondary sexual characteristics before age 8 and member age ≤12 for treatment considerations; Males: onset before age 9 and member age ≤13 for treatment considerations.

Documentation requiredMedical records must document the diagnostic confirmation (GnRH agonist test or third‑generation LH) and bone‑age vs chronological‑age assessment as part of CPP criteria.

Related step‑therapy noteWhen Vabrinty is requested for CPP (where referenced), trial and failure, contraindication, or intolerance to Eligard is required prior to approval.