CurrentPennsylvania Insurance DepartmentPolicy N/A

Prior authorization criteria for Korlym (mifepristone)

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Governs prior authorization requirements and medical necessity criteria for Korlym (mifepristone) prescriptions for Medical Assistance recipients; applies to prescribers and prior authorization reviewers within the Pennsylvania Insurance Department program.

Policy Summary

PayerPennsylvania Insurance Department

PolicyPrior authorization criteria for Korlym (mifepristone)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionAll prescriptions for Korlym must receive prior authorization; approval requires meeting the listed clinical review guidelines or physician reviewer judgment of medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

All prescriptionsrequire prior authorization

Age >= 18minimum patient age for coverage

8 monthsmaximum duration for initial approval

up to 12 monthsmaximum duration for renewals

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CurrentPennsylvania Insurance DepartmentPolicy N/A

Prior authorization criteria for Korlym (mifepristone)

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Sign up for all Pennsylvania Insurance Department policy alerts

Know when Pennsylvania Insurance Department releases new policies or updates existing guidance.

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Policy Summary

PayerPennsylvania Insurance Department

PolicyPrior authorization criteria for Korlym (mifepristone)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionAll prescriptions for Korlym must receive prior authorization; approval requires meeting the listed clinical review guidelines or physician reviewer judgment of medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

All prescriptionsrequire prior authorization

Age >= 18minimum patient age for coverage

8 monthsmaximum duration for initial approval

up to 12 monthsmaximum duration for renewals

Coverage and Medical Necessity Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met for initial therapy

Initial approval criteria: Patient has a diagnosis of Cushing's syndrome AND type 2 diabetes mellitus or glucose intolerance; prescribed by an endocrinologist; age >= 18; failed or is not a candidate for pituitary surgery; has a history of therapeutic failure as documented by HbA1c >= 8% consisting of either insulin therapy OR metformin at maximum tolerated doses in combination with insulin, sulfonylurea, TZD, and a DPP-4 inhibitor or GLP-1 receptor agonist; if female and did not have surgical sterilization, pregnancy testing and contraception requirements apply; does not have a contraindication to Korlym

Therapeutic failure defined by HbA1c >= 8%; pregnancy test required prior to starting; prescriber must be an endocrinologist

inv-02: Continuation/Renewal Therapy

Renewal approval criteria

Renewal criteria: Recipient does not have a contraindication to Korlym; if female and did not have surgical sterilization, will be using a form of non-hormonal contraception; has improved glycemic control as evidenced by the recipient's HbA1c value; prior authorization was previously approved

Renewals may be approved for up to 12 months

inv-03: Physician Discretion

Alternate approval pathway when reviewer judgment applies

Physician reviewer discretion: If the recipient does not meet the clinical review guidelines above, a physician reviewer may authorize the prescription when, in the professional judgment of the physician reviewer, the services are medically necessary to meet the medical needs of the recipient

Allows exceptions based on physician reviewer determination; prior authorization personnel will refer requests that do not meet guidelines to a physician reviewer

Recipients who have a contraindication to Korlym (mifepristone) are excluded from approval unless a physician reviewer determines otherwise. The reviewer may authorize therapy only if, in their professional judgment, the medication is medically necessary to meet the recipient's medical needs despite the contraindication.

Requests that do not meet the stated clinical review guidelines will be considered not medically necessary unless a physician reviewer documents an exception. The reviewer may authorize the service only when, based on professional judgment, the requested therapy is required to meet the recipient’s medical needs.

Initial Therapy Limits

inv-13: Initial Therapy Limits

Initial approval limits

Initial approval: All initial requests must meet the clinical criteria for medical necessity; initial approvals will be limited to 8 months of therapy8 months

Prescriber must be an endocrinologist; age >= 18; documented therapeutic failures required

Renewal and Continuation Requirements

inv-14: Renewals

Renewal requirements and durations

Renewal approval: No contraindication to Korlym; if female and did not have surgical sterilization, will be using non-hormonal contraception; demonstrated improved glycemic control as evidenced by HbA1c value; prior approval requiredup to 12 months

Renewals of previously approved prescriptions may be approved for up to 12 months

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required for Korlym

All prescriptions for Korlym (mifepristone) must receive prior authorization; approval is granted only when the request meets the clinical review guidelines in Section B or a physician reviewer determines the services are medically necessary.

Step Therapy

Document required prior therapeutic failures

Prior authorization requests must document prior therapeutic failure as specified: HbA1c ≥ 8% despite prior therapies, defined as either insulin therapy OR metformin at maximum tolerated doses plus insulin, a sulfonylurea, a TZD, and a DPP-4 inhibitor or GLP‑1 receptor agonist (all at maximum tolerated doses).

Documentation Required

Clinical Thresholds and Coding

inv-06: HbA1c — clinical threshold value for therapeutic failure

HbA1c thresholdHbA1c ≥ 8%

ContextUsed as the clinical threshold to document therapeutic failure for Korlym prior authorization

Measurement typeHemoglobin A1c (HbA1c) percentage

Definitions and Therapeutic Failure

inv-12: Therapeutic failure — documented HbA1c >= 8% despite specified therapies

DefinitionDocumented therapeutic failure = HbA1c ≥ 8% despite required therapies

Acceptable prior therapies showing failure (any of the following)a) Insulin therapy OR b) Metformin at maximum tolerated dose plus concurrently: insulin, a sulfonylurea, a thiazolidinedione (TZD), and a DPP‑4 inhibitor OR GLP‑1 receptor agonist (all at maximum tolerated doses)

PurposeRequirement for prior authorization approval of Korlym in patients with Cushing's syndrome and type 2 diabetes or glucose intolerance

Documentation requirementClinical records must include HbA1c value demonstrating ≥ 8% and history of the specified therapeutic failures

Step Therapy Requirements

Required prior therapeutic failures
Documented therapeutic failure evidenced by HbA1c ≥ 8% for one of the following:
Insulin therapy (documented inadequate glycemic control with HbA1c ≥ 8% while on insulin)
Metformin at maximum tolerated doses in combination with: insulin AND a sulfonylurea AND a thiazolidinedione (TZD) AND a DPP-4 inhibitor or GLP-1 receptor agonist (all at maximum tolerated doses)

Background

Korlym (mifepristone) is indicated for recipients with Cushing's syndrome and concomitant type 2 diabetes mellitus or glucose intolerance when prescribed by an endocrinologist and when alternative definitive treatment (pituitary surgery) has failed or the patient is not a candidate. Coverage consideration requires the recipient be ≥ 18 years of age and have documented therapeutic failure with elevated glycosylated hemoglobin (HbA1c ≥ 8%) on specified regimens (insulin alone or metformin at maximum tolerated dose plus insulin, a sulfonylurea, a thiazolidinedione, and a DPP-4 inhibitor or GLP-1 receptor agonist). For females who are not surgically sterilized, contraception and pregnancy testing requirements apply prior to initiating therapy.