CurrentmhnPolicy CP.PHAR.101

Mifepristone (Korlym)

Defines medical necessity criteria, authorization requirements, dosing limits, contraindications, and approval durations for mifepristone (Korlym) to control hyperglycemia secondary to endogenous Cushing's syndrome in adults. Affects prescribers, pharmacists, and utilization management staff for Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyMifepristone (Korlym)

Policy CodePolicy CP.PHAR.101

Change TypeAdded generic-first redirection for brand Korlym requests

Effective DateMay 1, 2012

Next Review Date

Key ActionPrior authorization required; if request is for brand Korlym, member must use generic mifepristone 300 mg tablet unless contraindicated or adverse effects.

SourceLink

POLICY UPDATE CHANGES

Added redirection to generic 300 mg tablet for brand Korlym requests and revised policy/criteria to include generic mifepristone.

300 mgtablet strength available

≥18minimum age for approval

1,200 mg/daymaximum daily dose

4maximum tablets per day

12 moinitial approval duration (Commercial)

6 moinitial approval duration (Medicaid/HIM)

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Approval Criteria for Cushing's Syndrome

1: Diagnosis of uncontrolled hyperglycemia secondary to endogenous Cushing's syndrome
2: Evidence of type 2 diabetes mellitus, impaired glucose tolerance, or pre-diabetes as evidenced by a fasting blood glucose, oral glucose tolerance test, or hemoglobin A1c
3: Prescribed by or in consultation with an endocrinologist
4:

Policy Summary

Payermhn

PolicyMifepristone (Korlym)

Policy CodePolicy CP.PHAR.101

Change TypeAdded generic-first redirection for brand Korlym requests

Effective DateMay 1, 2012

Next Review Date

Key ActionPrior authorization required; if request is for brand Korlym, member must use generic mifepristone 300 mg tablet unless contraindicated or adverse effects.

SourceLink

On This Page

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Continuation Therapy

Covered when ALL of the following are met:

Continued Therapy Criteria for Cushing's Syndrome

1: Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations
2: Member is responding positively to therapy as evidenced by improvement in fasting blood glucose, oral glucose tolerance test, or hemoglobin A1c since initiation of therapy
3: Member must use generic mifepristone 300 mg tablet unless contraindicated or clinically significant adverse effects are experienced (prior authorization may be required for generic)
4: If request is for a dose increase, new dose does not exceed both: (a) 1,200 mg per day; (b) 4 tablets per day

Provider Actions & Requirements

Prior Authorization

Prior Authorization & Generic Redirection

Prior authorization is required. Requests for brand Korlym should be redirected to generic mifepristone 300 mg tablet unless contraindicated or clinically significant adverse effects are experienced. Prior authorization may be required for generic mifepristone.

Brand Korlym requests should be redirected to generic mifepristone 300 mg unless contraindicated
Prior authorization may be required for generic mifepristone

Documentation Required

Required Clinical Documentation

Provider must submit documentation (e.g., office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria for initial or continued therapy. Lack of submitted documentation proving the patient meets all approval criteria may result in denial.

Submit office chart notes, lab results, or other clinical information supporting diagnosis of uncontrolled hyperglycemia secondary to endogenous Cushing's syndrome
Documentation must demonstrate type 2 diabetes mellitus, impaired glucose tolerance, or pre-diabetes (fasting glucose, OGTT, or hemoglobin A1c)
Failure to provide required documentation may result in denial

Documentation Required

Continued Therapy Documentation

For continued therapy, provider must document that the member is responding positively to treatment. Evidence of response includes improvement in fasting blood glucose, oral glucose tolerance test, or hemoglobin A1c since initiation of therapy. Continued use of generic mifepristone 300 mg is required unless contraindicated or adverse effects necessitate the brand.

Document improved fasting blood glucose, OGTT, or hemoglobin A1c compared to baseline
Member must be currently receiving medication via Centene benefit or previously met initial approval criteria
Continued therapy approvals: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less

Denial Risk

Documentation & Contraindications May Trigger Denial

At the time of request, verify that the member does not have contraindications (e.g., pregnancy, concurrent use of CYP3A substrates with narrow therapeutic ranges, concurrent long-term corticosteroid use, known hypersensitivity). Presence of listed contraindications will preclude approval and may trigger denial.

Contraindications include pregnancy, known hypersensitivity to mifepristone, certain concurrent CYP3A substrates, concurrent systemic corticosteroids for lifesaving purposes, women with history of unexplained vaginal bleeding or endometrial pathology
Requests with contraindications should be denied per policy

OpenPayer

Mifepristone (Korlym)

Coverage Criteria

Dosing and Limits

Provider Actions & Requirements

Definitions & Indication

Background