CurrentMass General Brigham Health PlanPolicy N/A

Mifepristone 300mg Effective 04/01/2024

Defines prior authorization, coverage criteria, quantity limits, specialty pharmacy requirement, and reauthorization rules for mifepristone 300 mg (Korlym) under the pharmacy benefit for Mass General Brigham Health Plan / MassHealth UPPL.

Policy Summary

PayerMass General Brigham Health Plan

PolicyMifepristone 300mg Effective 04/01/2024

Policy CodePolicy N/A

Change TypeBrand removed; generic added; prior PA/QL in place

Effective DateApr 1, 2024

Next Review Date

Key ActionPrior authorization is required for mifepristone 300 mg; submit required clinical documentation and contact pharmacy prior authorization via the provided phone/fax numbers.

SourceLink

POLICY UPDATE CHANGES

Brand product removed from policy.

Generic Korlym (mifepristone) added to criteria.

Program types and limits previously updated in 2020 (PA and QL).

120/30dQuantity limit

6 monthsInitial approval length

12 monthsReauthorization length

>=18Minimum age (years)

Scope: This policy defines prior authorization, coverage criteria, quantity limits, specialty pharmacy requirement, and reauthorization rules for mifepristone 300 mg (Korlym) under the pharmacy benefit for Mass General Brigham Health Plan / MassHealth UPPL. Coverage stance: Covered with prior authorization and criteria under the pharmacy benefit. Background: Mifepristone 300 mg (Korlym) is indicated to control hyperglycemia secondary to hypercortisolism in adults with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and who have failed or are not candidates for surgery. Prior authorization is required and may be granted for members already receiving therapy or for new starts who meet all coverage criteria. Effective date: 2024-04-01. Status: CURRENT.

Authorization thresholds and key stats

Minimum Age>= 18 years

Initial Approval Duration6 months

Reauthorization Duration12 months

Quantity LimitMifepristone 300 mg: 120 tablets per 30 days

Initial Therapy Criteria / New-to-Plan Continuation or New Start

Authorization Criteria / New-to-Plan Continuation or New Start

Authorization may be granted for members new to the plan who are currently receiving treatment OR if member meets ALL of the following:

ANY of the following

ALL of the following
- Member is new to the plan and is currently receiving treatment with Mifepristone (excluding product obtained as samples or via manufacturer's patient assistance programs).
ALL of the following
- Member is diagnosed with hyperglycemia secondary to hypercortisolism with endogenous Cushing's syndrome and has type 2 diabetes mellitus or glucose intolerance.
- Member is 18 years of age or older.
- ONE of
  - Member has failed surgical intervention (recurrence after surgery or failed tumor removal).
  - Surgical intervention is not appropriate (member is not a candidate for surgery).
  - Member has had an inadequate response or adverse reaction to one or has a contraindication to both of the following: ketoconazole tablets, Lysodren tablets.

Continuation / Reauthorization Criteria

Reauthorization requires submission of clinical documentation demonstrating response.

{

"operator":"all",

"children":[{

"text":"Documentation of clinical response to mifepristone (e.g., improvement in hyperglycemia related to hypercortisolism, clinical global response assessments, or other objective clinical measures) must be submitted.",

"note":"Reauthorization duration: 12 months."

}]

}

Documentation Required

Documentation for reauthorization

Specialty dispensing: This medication is designated specialty and must be dispensed through a contracted specialty pharmacy. Quantity limit enforcement: Quantity limits apply and will be enforced at the pharmacy claim level.

Specialty dispensing: Mifepristone 300 mg must be filled at a contracted specialty pharmacy.
Quantity limit enforcement: Limit = 120 tablets per 30 days; claims exceeding this will be subject to denial or prior authorization review.
Reauthorization duration: 12 months. Clinical response documentation must be submitted to support reauthorization.

Clinical Evidence

Evidence sources: Prescribing information: Korlym (mifepristone) prescribing information, Corcept Therapeutics; Nov 2019; Key trial: Fleseriu et al. J Clin Endocrinol Metab. 2012;97(6):2039-49. No quantitative trial metrics are provided in this brief.

Background & Definitions

Mifepristone (Korlym) is a glucocorticoid (cortisol) receptor antagonist indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and who have failed surgery or are not candidates for surgery.

Specialty: Medication designated specialty must be filled at a contracted specialty pharmacy.

Revision History

04/01/2024Brand product removed from policyLatest

Brand removed. Effective 4/1/24

02/14/2024Generic Korlym (mifepristone) added to criteria

Reviewed at Feb P&T; Added generic Korlym to criteria. Effective ASAP

10/01/2020Program types and limits previously updated in 2020 (PA and QL)

Effective 10/01/2020 updated Program Type to PA and QL