ModifiedmhnPolicy CP.PHAR.173

Leuprolide (acetate, mesylate) clinical coverage

Defines medical necessity and authorization criteria for leuprolide acetate (Eligard, Fensolvi, Lupron Depot, Lupron Depot‑Ped, Vabrinty) and leuprolide mesylate (Camcevi, Camcevi ETM) across multiple indications for Medicaid members.

Policy Summary

Payermhn

PolicyLeuprolide (acetate, mesylate) clinical coverage

Policy CodePolicy CP.PHAR.173

Change TypeMultiple code and duration updatesadded products and prescriber requirements

Effective DateOct 1, 2016

Next Review Date

Key ActionPrior authorization is required; provider must submit documentation demonstrating diagnosis, prescriber specialty and dosing that match the requested product and HCPCS code.

SourceLink

POLICY UPDATE CHANGES

Added Camcevi and Camcevi ETM HCPCS codes and listed Camcevi as usable for certain tumor types; added new strengths including Camcevi ETM (21 mg).

Modified Commercial approval duration to 6 months or to member's renewal date, and later revised Commercial approval duration to 3 months for uterine fibroids per label.

Added requirement that Lupron Depot for uterine fibroids be prescribed concurrently with iron therapy per FDA indication.

Added gender transition to the gender dysphoria criteria set and broadened prescriber requirements to allow experts in transgender medicine with certified training or affiliation.

Removed Lupaneta Pack as product is discontinued and added HCPCS code J1954.

Added Eligard and Vabrinty to the list of products that can be used for specified indications and added HCPCS code J9003.

12 monthsmax duration endometriosis

3 months

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12 monthsapproval duration (off-label typical)

J1950–J1954key HCPCS codes

multipleproducts listed

Coverage Criteria

Covered when ALL criteria in the applicable criteria group are met.

ALL of the following

Diagnosis of prostate cancer.
Request is for one of: Leuprolide acetate injection; Camcevi/Camcevi ETM; Eligard; Lupron Depot; or Vabrinty.
Prescribed by or in consultation with an oncologist or urologist.
Age ≥ 18 years.
For Lupron Depot requests through the pharmacy benefit, failure of Eligard unless contraindicated, intolerable adverse effects, or state regulations prohibit step therapy (see Appendix F).
Appendix F lists states restricting redirection/step therapy for advanced/metastatic cancer.
Dosing
- Leuprolide acetate injection (SC): Dose does not exceed 1 mg per day.
- Camcevi/Camcevi ETM (SC): Dose does not exceed 21 mg per 3 months or 42 mg per 6 months.
- Eligard (SC), Lupron Depot (IM), or Vabrinty (SC): Dose does not exceed 7.5 mg/month, 22.5 mg/3 months, 30 mg/4 months, or 45 mg/6 months.
- Dose supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
  Prescribed regimen must be FDA‑approved or recommended by NCCN.

ALL of the following

Diagnosis of endometriosis.
Request is for Lupron Depot (3.75 mg or 11.25 mg).
Prescribed by or in consultation with a gynecologist.
ANY of the following
- Age ≥ 18 years.
- Age < 18 years and member is postpubertal (request is following puberty).
Confirmation of endometriosis-related pain

ALL of the following

Diagnosis of anemia secondary to uterine leiomyomata (fibroids).
Diagnosis confirmed by ultrasound.
Request is for Lupron Depot (3.75 mg or 11.25 mg).
Prescribed by or in consultation with a gynecologist.
ANY of the following
- Age ≥ 18 years.
- Age < 18 years and member is postpubertal (request is following puberty).

ALL of the following

Diagnosis of salivary gland tumors that are androgen receptor positive and recurrent, unresectable, or metastatic.
Prescribed by or in consultation with an oncologist.
Request is for one of: Eligard; Lupron Depot; Camcevi/Camcevi ETM; or Vabrinty.
Dose is within FDA maximum limit for any FDA-approved indication or supported by practice guidelines/peer-reviewed literature (prescriber must submit supporting evidence).
Prescribed regimen must be FDA‑approved or recommended by NCCN.

ANY of the following

If the drug had a label change within the last 6 months not reflected in this policy, refer to formulary/no coverage or non-formulary policies (CP.PMN.255 or CP.PMN.16 for Medicaid as applicable).
If the requested use is not specifically listed under section III (non‑authorized indications) and the label-change exception does not apply, refer to the off‑label use policy CP.PMN.53 for Medicaid.

ALL of the following

Breast and Ovarian Cancer (continuation/off‑label)
- Member currently receiving medication via Centene benefit, or documentation shows member has received Lupron Depot or Eligard for the indication for at least 30 days.
- Request is for Lupron Depot; Eligard for breast cancer; or Vabrinty.
- Member is responding positively to therapy.
- ANY of the following
  - If dose increase requested, Lupron Depot new dose does not exceed 3.75 mg/month, 7.5 mg/month, 11.25 mg/3 months, or 22.5 mg/3 months.
  - Eligard or Vabrinty new dose does not exceed 7.5 mg/month, 22.5 mg/3 months, 30 mg/4 months, or 45 mg/6 months.

ALL of the following

Non‑FDA approved indications not addressed here require documentation per CP.PMN.53 for Medicaid or other applicable off‑label policies.

Initial Therapy Criteria

Initial therapy requirements — indication-specific diagnosis, prescriber specialty, age, prior therapy

Initial authorization requirements vary by indication; provider must demonstrate ALL of the following as applicable

Indication-specific diagnosis and prescriber: 1. Documentation of the specific approved or permitted indication per policy (e.g., prostate cancer, endometriosis, uterine fibroids preoperative anemia, CPP, or listed off‑label indications); 2. Prescription is written by or in consultation with the indicated specialist (oncologist, urologist, gynecologist, or pediatric endocrinologist as specified in each indication); 3. Member meets age or pubertal stage requirements for the requested indication.

Provider must submit office notes, labs, or other clinical documentation supporting criteria

Prior therapy / trials where required: When required by the indication (e.g., endometriosis), documentation of prior therapeutic trial(s) is submitted: failure of a 3‑month trial within the last year of an NSAID, an oral/injectable depot contraceptive, or a progestin unless contraindicated or clinically significant adverse effects have occurred.3 months trial where specified

See Appendix B for examples of therapeutic alternatives

Continuation and Maintenance Criteria

Continuation Therapy — Renewal criteria by indication

Continuation (renewal) criteria by indication

Prostate cancer continued therapy: 1. Member is currently receiving medication via Centene benefit or documentation supports current receipt and has received medication for at least 30 days; 2. Request is for the same product list (leuprolide acetate injection, Camcevi/Camcevi ETM, Eligard, Lupron Depot, or Vabrinty); 3. Member is responding positively to therapy; 4. If request is for a dose increase, new dose must not exceed product‑specific limits or be supported by practice guidelines/peer‑reviewed literature (prescriber must submit evidence).30 days on therapy

Approval duration: 12 months

Endometriosis continued therapy: 1. Member currently receiving medication via Centene benefit or previously met initial criteria OR continuity of care applies; 2. Request is for Lupron Depot (3.75 mg, 11.25 mg); 3. Member is responding positively to therapy as evidenced by symptom or lesion improvement; 4. Total duration has not exceeded 12 months; 5. If dose increase requested, new dose does not exceed 3.75 mg/month or 11.25 mg/3 months.12 months total duration

Provider Actions and Requirements

Prior Authorization

Prior Authorization and HCPCS mapping

Prior authorization is required for leuprolide products. Prior authorization requests must map the requested product and dose to the appropriate HCPCS code and billable units. Providers should ensure the HCPCS on the prior authorization and the claim correspond to the specific product, formulation, dose, and interval being requested or billed.

Ensure HCPCS on PA matches the specific product and dose billed (e.g., J1950, J1951, J1952, J1954, J9003, J9217–J9219).
PA must identify product, dose, administration schedule, and formulation corresponding to HCPCS billed.

Prior Authorization

PA required with product-specific coding

Prior authorization is required and must include product-specific coding. Requests should document the exact product requested (e.g., Lupron Depot, Eligard, Camcevi, Fensolvi, Vabrinty, Camcevi ETM, Lupron Depot‑Ped) and the HCPCS code that corresponds to the requested strength and interval.

Document the selected product, strength, and administration interval on the PA.
Confirm HCPCS code aligns with product/strength (see Coding Implications section for referenced codes).

Coding and Billing

HCPCS codes and mappingsHCPCS

J9218	Leuprolide acetate per 1 mg (used for prostate cancer and central precocious puberty)
J9217	Lupron Depot 1-month & Eligard 7.5 mg (also used for various depot regimens: 1-, 3-, 4-, 6-month mappings)
J1950	Lupron Depot (various formulations) and related products (used for endometriosis, fibroids, breast/ovarian cancer, pediatric formulations)
J1951	Fensolvi 45 mg kit (mapped for central precocious puberty)
J1952	Camcevi (6-month 42 mg) and Camcevi ETM (3-month 21 mg)

Referenced HCPCS codesHCPCS

J1950	Injection, leuprolide acetate (for depot suspension), per 3.75 mg.
J1951	Injection, leuprolide acetate for depot suspension (Fensolvi), 0.25 mg.
J1952	Leuprolide injectable, Camcevi, 1 mg.
J1954	Injection, leuprolide acetate for depot suspension (Cipla), 7.5 mg.
J9003	Leuprolide injectable (camcevi etm), 1 mg.
J9217	Leuprolide acetate (for depot suspension), 7.5 mg.
J9218	Leuprolide acetate, per 1 mg.
J9219	Leuprolide acetate implant, 65 mg

Listed HCPCS/J-codesHCPCS

J1950	Injection, leuprolide acetate (for depot suspension), per 3.75 mg.
J1951	Injection, leuprolide acetate for depot suspension (Fensolvi), 0.25 mg.
J1952	Leuprolide injectable, Camcevi, 1 mg.
J1954	Injection, leuprolide acetate for depot suspension (Cipla), 7.5 mg.
J9003	Leuprolide injectable (camcevi etm), 1 mg.
J9217	Leuprolide acetate (for depot suspension), 7.5 mg.
J9218	Leuprolide acetate, per 1 mg.
J9219	Leuprolide acetate implant, 65 mg

Endometriosis total therapy duration

Maximum total durationTotal duration of leuprolide therapy (including add-back therapy) has not exceeded 12 months

Re-authorization requirementFor reauthorization, member must be currently receiving medication via the benefit or have met initial approval criteria; total therapy still must be ≤12 months

Dose cap on reauthorizationIf a dose increase is requested at reauthorization, new dose must not exceed 3.75 mg/month or 11.25 mg per 3 months

Site of Care, Step Therapy and Quantity Limits

Step	Requirement	Notes
1
Must try Eligard prior to coverage of Lupron Depot when Lupron Depot is requested through the pharmacy benefit for prostate cancer.
Failure of Eligard is required unless contraindicated, clinically significant adverse effects occur, or the request is for cancer treatment in a State with regulations against step therapy (see Appendix F).

Appendix	Therapeutic Alternatives (examples)	Notes
Appendix B
NSAIDs (e.g., ibuprofen, naproxen), combined oral estrogen‑progestin contraceptives, progestin‑only oral contraceptives (e.g., norethindrone), depot medroxyprogesterone
Alternatives listed in Appendix B are preferred alternatives that may require prior authorization and may not be formulary for all lines of business; dosing varies by agent — refer to prescribing information.

State	Step Therapy Prohibited for Cancer Redirection?	Scope / Notes
FL
Yes
Prohibition applies for stage 4 metastatic cancer and associated conditions (see Appendix F for full details).

Requirement	Allowed Prescribers	Provider Attestation / Notes
Prescriber qualifications for gender dysphoria / gender transition
Endocrinologist or provider with expertise in transgender medicine; experts with certified training programs or affiliation with local transgender health services are acceptable.
Provider must attest to understanding current State regulations regarding transgender-related health care and that such care is coverable; documentation and multidisciplinary support per WPATH guidance recommended.

Quantity limits vary by product

Leuprolide acetate (SC) ceiling≤ 1 mg per day (per product labeling) where applicable

Camcevi / Camcevi ETM ceilingCamcevi ≤ 42 mg per 6 months (Camcevi ETM ≤21 mg per 3 months)

Eligard / Lupron Depot / Vabrinty ceilingDose options not to exceed 7.5 mg per month; 22.5 mg per 3 months; 30 mg per 4 months; 45 mg per 6 months

Various leuprolide products — billable units and day supply

Mapping principleBillable units and day supply are product- and indication-specific; use the HCPCS unit mapping that corresponds to the product and dosing interval billed

Administration Setting

Note

Match product formulation to appropriate administration setting (office/infusion/clinic)

Products are available as kits, prefilled syringes, or injectable emulsions; select the administration setting (office, infusion center, clinic) that matches the product labeling and documentation.

Identify formulation (kit, prefilled syringe, emulsion) in the PA and match to site‑of‑care.
Ensure administration setting follows product instructions (IM or SC) and payer/site‑of‑care rules.

Step Therapy

Pharmacy redirection — some Lupron Depot requests may be redirected to Eligard

Per internal redirection policy, some Lupron Depot prostate cancer requests may be redirected to Eligard through the pharmacy benefit; when redirection applies, document trial/failure of Eligard or a contraindication.

If pharmacy benefit redirection is in effect, provide evidence of Eligard trial or contraindication.
Check Appendix F for state rules that may override redirection requirements.

Background

Leuprolide acetate and leuprolide mesylate are gonadotropin‑releasing hormone (GnRH) receptor agonists that act on the pituitary to down‑regulate gonadotropin release and suppress gonadal hormone production. They are formulated as long‑acting depot suspensions or injectables and are indicated across multiple conditions including advanced prostate cancer, endometriosis, preoperative management of uterine fibroids, central precocious puberty (CPP), and selected oncologic and gender‑related uses described in this policy.

Definitions

GnRH receptor agonists definition

DefinitionGnRH receptor agonists are agents that act on the pituitary to downregulate gonadotropin release resulting in suppression of sex hormones (leuprolide acetate and leuprolide mesylate are examples)

Included agentsLeuprolide acetate (Eligard, Fensolvi, Lupron Depot, Lupron Depot‑Ped, Vabrinty) and leuprolide mesylate (Camcevi, Camcevi ETM)

Primary effectSuppression of gonadal hormone production via pituitary downregulation

CPP (abbreviation)

AbbreviationCPP = central precocious puberty

ContextUsed in pediatric indications and appendices of the policy

Policy Summary

Payermhn

PolicyLeuprolide (acetate, mesylate) clinical coverage

Policy CodePolicy CP.PHAR.173

Change TypeMultiple code and duration updatesadded products and prescriber requirements

Effective DateOct 1, 2016

Next Review Date

Key ActionPrior authorization is required; provider must submit documentation demonstrating diagnosis, prescriber specialty and dosing that match the requested product and HCPCS code.

SourceLink

On This Page

Surgically confirmed.

ALL of the following

Clinically suspected endometriosis.
Failure of a 3-month trial within the last year of one of: an NSAID; an oral or injectable depot contraceptive; or a progestin, unless adverse effects or contraindications.

For members currently receiving leuprolide, total duration of therapy has not exceeded 12 months.

Dose does not exceed 3.75 mg per month or 11.25 mg per 3 months.

Lupron Depot is prescribed concurrently with iron therapy.

Prescribed preoperatively to reduce fibroid size and improve hematologic control.

For members currently receiving leuprolide, total duration of therapy has not exceeded 3 months per treatment course.

Dose does not exceed 3.75 mg per month or 11.25 mg per 3 months.

New dose supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

Gender Dysphoria / Gender Transition (continuation/off‑label)

Member currently receiving medication via Centene benefit or previously met initial approval criteria, or in a state/product with continuity of care regulations (see state addendums).
Member is responding positively to therapy (continues to meet individual goals of therapy).
If dose increase requested, new dose is within FDA maximum for any FDA‑approved indication or supported by practice guidelines/peer‑reviewed literature (prescriber must submit supporting evidence).

Salivary Gland Tumors (continuation/off‑label)

Member currently receiving medication via Centene benefit, or documentation shows member has received Eligard, Lupron Depot, or Camcevi for at least 30 days.
Request is for Eligard; Lupron Depot; Camcevi/Camcevi ETM; or Vabrinty.
Member is responding positively to therapy.
If dose increase requested, new dose is within FDA maximum for any FDA‑approved indication or supported by practice guidelines/peer‑reviewed literature (prescriber must submit supporting evidence).

Uterine Sarcoma (continuation/off‑label)

Member currently receiving medication via Centene benefit, or documentation supports member has received Lupron Depot for uterine sarcoma for at least 30 days.
Request is for Lupron Depot.
Member is responding positively to therapy.
If dose increase requested, new dose is within FDA maximum for any FDA‑approved indication or supported by practice guidelines/peer‑reviewed literature (prescriber must submit supporting evidence).

Dose and product match: Requested product, dose and dosing interval must match product‑specific limits and the HCPCS/J‑code billed; doses exceeding listed maxima require supporting evidence from guidelines or peer‑reviewed literature.see product dosing tables

Claims may be impacted if coding does not match HCPCS descriptions

Initial Therapy (CPP dosing)

Initial dosing ceilings and titration for CPP

CPP dosing limits: 1. Diagnostic use: leuprolide acetate 20 mcg/kg (or as needed); 2. Therapeutic leuprolide acetate SC: initial 50 mcg/kg/day; titrate upward by 10 mcg/kg/day if down‑regulation not achieved (higher mg/kg doses may be required in younger children); 3. Fensolvi therapeutic option: 45 mg per 6 months; 4. Lupron Depot‑Ped formulations use weight‑based monthly starting doses and 3‑ and 6‑month options as specified in product dosing tables.assay and weight dependent

Prescriber must document weight and response metrics

Initial therapy rules — Initial dosing differs by product and indication (weight-based for pediatrics; standard depot regimens for adults)

Initial dosing differs by product and indication

Pediatric weight-based dosing: Pediatric dosing is weight‑based for Lupron Depot‑Ped and leuprolide SC: monthly starting doses and titration per weight categories; Fensolvi uses mg/kg dosing with titration if needed.weight-based limits per product

See product dosing tables for exact mappings

Adult depot regimens: Adult initiation uses depot regimens per product: monthly to 6‑month intervals depending on product (e.g., Lupron Depot 3.75/11.25 mg for gynecologic uses; Eligard/ Vabrinty/ Lupron Depot adult depot options for oncology).product regimen dependent

HCPCS codes should reflect dosing interval

Initial authorization durations

Initial authorization durations: Commercial approval duration was modified in 4Q2022 to 6 months or to member's renewal date (whichever is longer) and was subsequently updated for specific indications (e.g., uterine fibroids per label to 3 months); approval durations for continuation/off‑label indications are commonly 12 months as noted in the policy.

Refer to individual indication nodes for exact approval durations

Continuation therapy (off-label uses)

Continuation/maintenance therapy coverage is allowed for listed off-label indications when specific continuity and response criteria are met

Continuation for off-label indications: Member is currently receiving medication via Centene benefit or has documentation of at least 30 days of prior therapy (for specified off‑label uses); member is responding positively to therapy; dose increases must be within FDA maximum limits for any FDA indication or be supported by practice guidelines/peer‑reviewed literature with prescriber evidence; prescribed regimen should be FDA‑approved for the indication or recommended by NCCN when applicable.30 days for many off‑label continuations

Approval duration commonly 12 months

Maintenance dosing

Continuation dosing follows the product-specific depot interval appropriate to the initial regimen

Maintenance dosing: Continue the same product and dosing interval if clinical response and tolerability are documented; use the HCPCS/J‑code corresponding to the dosing interval supplied (monthly, q3 months, q4 months, q6 months) and ensure billable units/day supply match product formulation.

See Appendix E for HCPCS codes and billable units

Continuation for gender dysphoria

Continuation criteria notes for gender dysphoria/gender transition

Gender dysphoria continuation notes: Continuation is permitted when member is currently receiving therapy via the benefit or previously met initial approval and is responding positively; prescriber requirements were broadened to allow experts in transgender medicine with certified training or affiliation; provider attestation of understanding state regulations is required when applicable.

Approval duration: 12 months

Documentation Required

Documentation requirement

Providers must submit supporting clinical documentation with the prior authorization. Acceptable documentation includes office chart notes, laboratory results, imaging, operative reports, and other pertinent clinical information demonstrating the member meets the approval criteria.

Failure to provide required documentation may result in denial or deferral.
Include documentation supporting diagnosis, prior therapies tried, response to therapy, and any safety or contraindication information.

Step Therapy

State prohibitions on step therapy/redirection

State laws may prohibit step therapy redirects or redirection between products for certain oncology indications (for example, some states prohibit redirection for stage 4 metastatic cancer). Check Appendix F and state-specific addendums when step therapy or redirection is involved in oncology cases.

Appendix F lists states with prohibitions on redirection/step therapy (e.g., FL, GA, IA, LA, NV, PA, TN, TX).
If the member is in a state or product with prohibitions, redirection (including requirements to fail an alternate product) may not apply.

Documentation Required

Off-label documentation

For off‑label uses addressed by this policy, providers must document that the member is currently receiving the medication or has met initial approval criteria and provide supporting evidence (peer‑reviewed literature or guideline support) when dosing outside standard FDA‑approved regimens is requested.

Continuation requests for off‑label indications require evidence the member has been receiving therapy (typically ≥30 days) and is responding to treatment.
If dose exceeds standard FDA limits for an off‑label use, prescriber must submit supporting guidelines or peer‑reviewed literature.

Documentation Required

Product and dosing documentation

Document the specific product, dose, administration schedule, and formulation for all requests. Dose limits in the policy must be followed unless the prescriber provides guideline or peer‑reviewed literature justification for a different regimen.

Include product name (brand/generic), strength, dosing interval, and route (SC vs IM).
If requesting a dose increase, clearly state prior dose, reason for increase, and clinical justification; indicate whether the new dose is within FDA limits or supported by evidence.

Lupron Depot 1-month (3.75 mg)

J1950 = 1 billable unit / 28-day supply

Lupron Depot 3-month (11.25 mg)J1950 = 3 billable units / 84-day supply

Lupron Depot-Ped 15 mg

ProductLupron Depot-Ped 15 mg

Billable units4 billable units

Day supply28 days (1-month formulation)

Lupron Depot-Ped 30 mg

ProductLupron Depot-Ped 30 mg

Billable units8 billable units

Day supply84 days (3-month formulation)

Lupron Depot-Ped 45 mg

ProductLupron Depot-Ped 45 mg

Billable units12 billable units

Day supply168 days (6-month formulation)

Fensolvi 45 mg kit

ProductFensolvi 45 mg kit

HCPCS codeJ1951

Billable units / day supply12 billable units / 168 days (6-month supply)

Lupron Depot 1-Month 3.75 mg

ProductLupron Depot 1-Month 3.75 mg

Billable units1 billable unit

Day supply28 days

Lupron Depot 3-Month 11.25 mg

ProductLupron Depot 3-Month 11.25 mg

Billable units3 billable units

Day supply84 days

See LH (luteinizing hormone) diagnostic criteria in policy dosing section

GnRH (abbreviation)

AbbreviationGnRH = gonadotropin-releasing hormone

RolePituitary hormone regulating LH/FSH release; target of GnRH receptor agonists

RelevanceReferenced in diagnostic and dosing sections for CPP and other indications

CPP (product notes)

Products notedFensolvi and Lupron Depot‑Ped are indicated for CPP with weight-based and titratable dosing regimens

Fensolvi dosingTherapeutic: initial 50 mcg/kg/day titrate by 10 mcg/kg/day; 45 mg every 6 months as a treatment option

Lupron Depot‑Ped dosingMonthly weight-based starting doses (7.5 mg ≤25 kg; 11.25 mg >25–37.5 kg; 15 mg >37.5 kg); 3-month and 6-month options also available

Depot suspension

Formulation typeDepot suspension: long-acting IM or SC formulations (kits, prefilled syringes, injectable emulsions)

Dosing intervalsAdministered at intervals ranging from monthly up to every 6 months depending on product

Administration settingAdministration setting should match product instructions (IM or SC) and payer/site-of-care rules

Concurrent iron therapy (uterine fibroids)

Uterine fibroids requirementLupron Depot must be prescribed concurrently with iron therapy per FDA indication

Policy change noteRequirement added in 4Q 2023 annual review per policy history

ApplicabilityApplies to preoperative uterine fibroids initial therapy criteria where Lupron Depot is requested