CurrentCignaPolicy N/A

Cushing's - Signifor Prior Authorization Policy

Prior authorization policy describing medical necessity criteria and coverage stance for Signifor (pasireotide subcutaneous injection) for adults with Cushing's disease or endogenous Cushing's syndrome under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyCushing's - Signifor Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial revision (added endogenous Cushing's syndromeconsolidated indicationsclarified PA requirement)

Effective DateN/A

Next Review DateApr 9, 2025

Key ActionObtain prior authorization and document diagnosis, age ≥18, surgical candidacy rationale, and prescriber consultation with an endocrinologist or Cushing's specialist.

SourceLink

POLICY UPDATE CHANGES

Endogenous Cushing's Syndrome: This condition and criteria for approval were added under Other Uses with Supportive Evidence.

Endogenous Cushing's Syndrome - Patient Awaiting Surgery and - Patient Awaiting Therapeutic Response After Radiotherapy were removed from standalone entries and consolidated under Endogenous Cushing's Syndrome.

Prior authorization is recommended and therapy must be prescribed by or in consultation with an endocrinologist or physician specializing in Cushing's syndrome.

18+minimum patient age for coverage

4 monthsinitial therapy approval duration

1 yearcontinuation / endogenous approval duration

Specialist required

Policy Summary

PayerCigna

PolicyCushing's - Signifor Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial revision (added endogenous Cushing's syndromeconsolidated indicationsclarified PA requirement)

Effective DateN/A

Next Review DateApr 9, 2025

Key ActionObtain prior authorization and document diagnosis, age ≥18, surgical candidacy rationale, and prescriber consultation with an endocrinologist or Cushing's specialist.

SourceLink

On This Page

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prescriber requirement

Not medically necessarynon-covered uses

Coverage Criteria for Signifor (pasireotide)

inv-01: FDA-Approved Indication

Covered when ONE of the following is met:

FDA-Approved Indication: Cushing's Disease

ALL of the following
- i. Patient is >= 18 years of age;
- ii. According to the prescriber, the patient is not a candidate for surgery or surgery has not been curative;
- iii. The medication is prescribed by or in consultation with an endocrinologist or a physician who specializes in the treatment of Cushing's syndrome.
B) Patient is Currently Receiving Signifor/Signifor LAR: Approve for 1 year if the patient has had a response, as determined by the prescriber, and is continuing therapy to maintain response.

inv-02: Other Uses with Supportive Evidence

Covered when ALL of the following are met for Endogenous Cushing's Syndrome:

Endogenous Cushing's Syndrome

A) Patient is >= 18 years of age;
B) Surgical status
- i. According to the prescriber, the patient is not a candidate for surgery or surgery has not been curative;
- ii. Patient is awaiting surgery for endogenous Cushing's syndrome;
- iii. Patient is awaiting therapeutic response after radiotherapy for endogenous Cushing's syndrome;

Signifor (pasireotide subcutaneous injection) is not medically necessary for any use(s) other than those specifically listed in this policy. This non-coverage applies to all indications beyond the FDA‑approved and Other Uses with Supportive Evidence criteria described in the policy. The policy will be updated as new published data become available that could change coverage determinations.

Any use(s) not explicitly described in the coverage criteria of this policy are considered not medically necessary. Claims for Signifor submitted for indications outside the listed criteria are subject to denial.

Provider Requirements and Authorization

Prior Authorization

Prior authorization recommended; time-limited approvals and prescriber specialty required

Prior authorization is recommended for Signifor. Approvals are time-limited: initial therapy approvals are for 4 months; approvals for patients currently receiving Signifor (or Signifor LAR) are for 1 year. Therapy must be prescribed by or in consultation with an endocrinologist or a physician who specializes in the treatment of Cushing's syndrome.

Initial approval: 4 months for new therapy when criteria for Initial Therapy (A.i–iii) are met
Continuation/current users: approve for 1 year if prescriber determines the patient has had a response and is continuing therapy
Medication must be prescribed by or in consultation with an endocrinologist or Cushing's specialist

Step Therapy

Position in treatment pathway: surgery first-line; medical therapy for non‑surgical or persistent disease

The policy follows guideline-based sequencing: transsphenoidal tumor resection (surgery) is first-line for Cushing's syndrome/disease. Medical therapy, including pituitary‑directed agents such as Signifor, is used when surgery is not possible or is not curative (or as a second-line option per guidelines).

Clinical Background

Cushing's disease is a form of ACTH‑dependent hypercortisolism caused by pituitary adenomas; clinical goals are to normalize cortisol levels, control disease-related signs and symptoms, and reduce long‑term morbidity. When surgery is not an option or is not curative, medical therapy is used to control cortisol production and manage symptoms.

Signifor (pasireotide) is a somatostatin analog indicated for adults with Cushing's disease when pituitary surgery is not an option or has not been curative. The policy aligns with guideline‑based sequencing where transsphenoidal pituitary surgery is first‑line and pituitary‑directed medical therapies are considered for patients who are not surgical candidates, have persistent disease after surgery, or are awaiting other interventions.

Treatment decisions focus on prescriber assessment of surgical candidacy and clinical response. Under this policy, the minimum age for coverage is 18 years, and approvals are time‑limited: initial therapy approvals up to 4 months for new starts and continuation approvals up to 1 year for patients currently receiving therapy or for the Endogenous Cushing's Syndrome indication.

Key Terms and Drug Information

Definition: Cushing's Disease

TermCushing's disease

DefinitionHypercortisolism caused by pituitary adenomas (ACTH-dependent)

Clinical noteMost common type of ACTH-dependent Cushing's syndrome; treatment aims to normalize cortisol, control disease long-term, avoid recurrence, and reverse clinical features.

Drug indication: Signifor (pasireotide)

ProductSignifor (pasireotide subcutaneous injection)

Drug classSomatostatin analog

FDA‑approved indication

C) The medication is prescribed by or in consultation with an endocrinologist or a physician who specializes in the treatment of Cushing's syndrome.

First-line: tumor resection/surgery unless not possible or unlikely to meaningfully reduce cortisol
Second-line options include medical therapy (e.g., pituitary‑directed treatments such as Signifor) when surgery is not an option or persistent after surgery

Documentation Required

Required documentation for prior authorization

For prior authorization, the provider must document the diagnosis and that the patient is an adult (≥18 years). The provider must also state whether the patient is not a candidate for surgery or surgery was not curative (or, for endogenous Cushing's syndrome, that the patient is awaiting surgery or awaiting therapeutic response after radiotherapy) and confirm the medication is prescribed by or in consultation with an endocrinologist or specialist.

Document patient age ≥ 18 years
Document diagnosis of Cushing's disease or endogenous Cushing's syndrome
Provide prescriber statement that patient is not a surgical candidate or that surgery was not curative; or indicate awaiting surgery or awaiting radiotherapy response (for endogenous Cushing's syndrome)
Document that medication is prescribed by or in consultation with an endocrinologist or physician who specializes in Cushing's syndrome

Denial Risk

Denial triggers: unsupported codes or uses not meeting criteria

Claims for services billed without covered diagnosis/procedure codes or that do not meet the policy's coverage criteria will be denied. Use of Signifor for any indication not explicitly listed in the policy is considered not medically necessary and will not be covered.

Claims submitted without covered code(s) under the policy will be denied as not covered
Signifor is considered not medically necessary for any uses beyond those listed in this policy

Indicated for treatment of Cushing's disease in adults for whom pituitary surgery is not an option or has not been curative

Prescriber requirement (policy)Therapy must be prescribed by or in consultation with an endocrinologist or physician specializing in Cushing's syndrome (per policy requirements).