CurrentMass General Brigham Health PlanPolicy N/A

Crenessity (crinecerfont) — Coverage Criteria

Policy governs prior authorization, specialty pharmacy designation, quantity/step therapy and medical benefit limits for Crenessity (crinecerfont) for members of Mass General Brigham Health Plan/MassHealth UPPL across commercial/exchange plans.

Policy Summary

PayerMass General Brigham Health Plan

PolicyCrenessity (crinecerfont) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNew policy

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation that member meets age, diagnosis, prescriber and chronic glucocorticoid therapy criteria or evidence of continuity if new to plan within 90 days.

SourceLink

POLICY UPDATE CHANGES

New coverage policy for Crenessity (crinecerfont) with criteria for initiation and continuation of therapy.

4 yrsminimum patient age for therapy

6 moinitial approval duration

6 moreauthorization approval duration

90 dayscontinuity window for new members

specialty

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Coverage Criteria for Crenessity (crinecerfont)

Initial Therapy

Authorization may be granted when EITHER of the following conditions is met:

Continuity for new-to-plan members: Member new to the plan within the past 90 days who is currently receiving treatment with the requested medication (excluding product obtained as samples or via manufacturer's patient assistance programs)

Allows continuation without meeting the standard initiation criteria

Standard initiation criteria

Age: Member is 4 years of age or older
Diagnosis of classic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH)
Prescriber: Requested medication is prescribed by or in consultation with an endocrinologist
Adjunct therapy: Requested medication will be used as an adjunct to glucocorticoid replacement therapy
Chronic glucocorticoid therapy: Member is receiving chronic treatment with glucocorticoid replacement therapy (e.g., dexamethasone, hydrocortisone, methylprednisolone) for adrenal insufficiency
Dose/Age specific requirement
- Pediatric branch: Member is 4 to 17 years of age
  No explicit dose threshold required in this branch per document
- Alternate high-dose pediatric branch: Daily glucocorticoid dose is greater than 12 mg/m2/day in hydrocortisone dose equivalents>12 mg/m2/day
  Listed as a dose threshold in the document
- Adult high-dose branch: Member is 18 years of age or older AND daily glucocorticoid dose is greater than 13 mg/m2/day in hydrocortisone dose equivalents>13 mg/m2/day
  Adult must meet both conditions

Continuation Therapy

Requests for reauthorization will be approved when ALL of the following are met:

Continuation criteria: Documentation demonstrating member has had a positive clinical response to therapy (e.g., decreased androgen levels, reduced daily dose of steroids) AND member continues to receive chronic treatment with glucocorticoid replacement therapy (e.g., dexamethasone, hydrocortisone, methylprednisolone)

Initial and reauthorization approvals are granted for 6 months per limitations section

Members who are new to the plan may be authorized to continue therapy with the requested medication if they were receiving the drug within the past 90 days. This continuity provision does not apply when the member obtained the medication only as samples or solely through a manufacturer patient assistance program.

Therapy with this medication is limited to patients with a diagnosis of classic 21‑hydroxylase deficiency congenital adrenal hyperplasia (CAH) and must be used as an adjunct to chronic glucocorticoid replacement therapy. Use of the drug for other conditions or as monotherapy (i.e., without concurrent chronic glucocorticoid replacement) does not meet the coverage criteria.

Designations, Dosing Equivalents, and Codes

Benefit designationmixed

specialty	This medication has been designated specialty and must be filled at a contracted specialty pharmacy
Pharmacy Benefit	Pharmacy Benefit
Medical Benefit	Medical Benefit
Quantity Limit	Quantity Limit
Step Therapy	Step Therapy
Specialty Limitations	Specialty Limitations
Prior Authorization	Prior Authorization
Commercial/Exchange	Commercial/Exchange
MassHealth UPPL	MassHealth UPPL

Hydrocortisone dose equivalents — dose thresholds by age

Pediatric threshold (ages 4–17)Member is 4 to 17 years of age (no additional explicit hydrocortisone-equivalent dose required in this branch)

Alternate pediatric high-dose threshold> 12 mg/m2/day in hydrocortisone dose equivalents (listed as a daily glucocorticoid dose threshold in the document)

Adult threshold (age ≥18)> 13 mg/m2/day in hydrocortisone dose equivalents

Glucocorticoid replacement therapy examplesIncludes dexamethasone, hydrocortisone, methylprednisolone as chronic replacement therapy

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Members new to the plan within the past 90 days who are currently receiving Crenessity may be authorized to continue therapy (excludes medication received as samples or via manufacturer's patient assistance programs).

New-to-plan continuity: within 90 days and currently receiving therapy
Excludes samples and manufacturer's patient assistance program supplies

Step Therapy

Step Therapy and Quantity Limits

This policy includes Step Therapy and Quantity Limit program types as part of the pharmacy benefit; the medication is designated specialty and must be filled at a contracted specialty pharmacy.

Program types: Step Therapy; Quantity Limit
Benefit: Pharmacy (Specialty) — specialty pharmacy fill required

Definitions

Specified diagnosis required for coverage

Required diagnosis for coverageClassic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH)

Age indication in labelAdults and pediatric patients 4 years of age and older (per product overview)

Context of useIndicated as adjunctive treatment to glucocorticoid replacement to control androgens in patients with classic CAH

Background

Crenessity (crinecerfont) is a corticotropin‑releasing factor type 1 (CRF1) receptor antagonist indicated as an adjunctive treatment to glucocorticoid replacement to help control androgen levels in patients with classic congenital adrenal hyperplasia. It is intended for use in combination with chronic glucocorticoid therapy rather than as a standalone steroid replacement.

Revision History

2025-05-14created_and_reviewed

Policy created and reviewed by the Pharmacy & Therapeutics (P&T) committee.

2025-08-01effective_dateLatest

Policy became effective for Crenessity (crinecerfont).