CurrentCareSourcePolicy N/A

Lupaneta Pack (leuprolide acetate / norethindrone acetate) pharmacy coverage

Governs prior authorization, coverage criteria, quantity and duration limits for Lupaneta Pack under the pharmacy benefit for CareSource members in Arkansas PASSE.

Policy Summary

PayerCareSource

PolicyLupaneta Pack (leuprolide acetate / norethindrone acetate) pharmacy coverage

Policy CodePolicy N/A

Change TypeMaterial revisions (created 10/08/2020restrictions removed 12/21/2021)

Effective Date

Next Review Date

Key ActionSubmit prior authorization with a valid NDC and documentation supporting endometriosis diagnosis and required criteria.

SourceLink

POLICY UPDATE CHANGES

New policy for Lupaneta Pack created.

Removed prescriber specialty requirement; age and premenopausal requirement; and trials of NSAIDs and hormonal contraceptives.

6 moinitial approval duration

12 momax total duration

3.75 / 11.25 mgleuprolide doses (IM)

5 mgnorethindrone add-back

Arkansas PASSEprogram variant

Coverage Criteria for Lupaneta Pack

Initial Authorization

Covered when ALL of the following are met for endometriosis:

Diagnosis: Member has a clinical diagnosis of endometriosis (documentation required)

Pregnancy planning constraint: Patient is not pregnant and does not plan to become pregnant while taking the medication

Policy lists pregnancy or plan to become pregnant while taking medication as a required element

No undiagnosed abnormal uterine bleeding: Member does not have undiagnosed abnormal uterine bleeding

Dosage and duration: Dose limited to leuprolide acetate 3.75 mg IM monthly or 11.25 mg IM every 3 months together with norethindrone acetate 5 mg orally once daily for up to 6 months for initial approval

Policy Summary

PayerCareSource

PolicyLupaneta Pack (leuprolide acetate / norethindrone acetate) pharmacy coverage

Policy CodePolicy N/A

Change TypeMaterial revisions (created 10/08/2020restrictions removed 12/21/2021)

Effective Date

Next Review Date

Key ActionSubmit prior authorization with a valid NDC and documentation supporting endometriosis diagnosis and required criteria.

SourceLink

On This Page

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Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required (non-preferred product; NDC required)

Prior authorization is required for Lupaneta Pack as a non-preferred pharmacy product. A valid NDC code must be used on the prior authorization request.

Benefit type: Pharmacy; Site of service allowed: Home/Office (see policy for details).
Billing code requirement: Must use a valid NDC code.

Step Therapy

Step therapy / trial requirements removed

Per the 12/21/2021 policy action, requirements for prescriber specialty, patient age/premenopausal status, and trials of NSAIDs or hormonal contraceptives were removed and are not enforced.

Removed requirements: prescriber specialty; age and premenopausal requirement; trials of NSAIDs and hormonal contraceptives (12/21/2021).

Documentation Required

Required clinical documentation for authorization/reauthorization

Clinical documentation must support a diagnosis of endometriosis and the specific criteria for initial authorization or reauthorization, including documentation of recurrence for reauthorization and duration of prior therapy.

For initial authorization: documentation of diagnosis of endometriosis and absence of undiagnosed abnormal uterine bleeding.
For reauthorization: documentation of recurrence of endometriosis symptoms after the first course and total duration of therapy to confirm it has not exceeded 12 months.

Denial Risk

Denial triggers: non‑listed indications and >12 months of therapy

Requests for Lupaneta Pack for indications not listed in the policy or for treatment that exceeds a total of 12 months will be considered not medically necessary and will be denied.

Use for diagnoses not listed (non-endometriosis indications) is not medically necessary.
Reauthorization will not be allowed after 12 months of therapy.

Background

Lupaneta Pack combines a GnRH agonist (leuprolide acetate) with add-back therapy (norethindrone acetate) to manage endometriosis by suppressing ovarian hormone production and reducing endometriosis‑related pain, while the progestin add‑back mitigates hypoestrogenic side effects. The policy recognizes dosing of leuprolide acetate as 3.75 mg IM monthly or 11.25 mg IM every 3 months used together with norethindrone acetate 5 mg orally once daily. Initial approval is for up to 6 months of therapy; reauthorization may be granted for an additional 6 months if symptoms recur, but total therapy is limited to 12 months.

OpenPayer

Lupaneta Pack (leuprolide acetate / norethindrone acetate) pharmacy coverage

Coverage Criteria for Lupaneta Pack

Coding and Quantity Limits

Provider Actions, Prior Authorization, and Documentation

Product Dosing and Definitions

Background

Revision History and Policy Changes