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Signifor Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1070
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx, and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
1/1/2023 |
|
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Signifor® (pasireotide) Subcutaneous injection |
Adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative
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|
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Cushing's syndrome |
Cushing's syndrome denotes pathologic hypercortisolism as a result of excessive adrenocorticotropic hormone (ACTH) production, or autonomous adrenal production of cortisol. This potentially lethal disorder is associated with significant comorbidities, including hypertension, diabetes, coagulopathy, cardiovascular disease, infections, and fractures. As a result, even after cure of hypercortisolism, mortality rates may be increased. Because of this it is important to make the diagnosis as early in the disease course as possible, to prevent additional morbidity and residual disease. Signs and symptoms of Cushing’s syndrome are broad and often common among the general population, such as obesity, depression, diabetes, hypertension, or menstrual irregularities. Some features are more discriminatory and unique to Cushing’s syndrome, such as reddish-purple striae, plethora, proximal muscle weakness, bruising with no obvious trauma, and unexplained osteoporosis.(2) Cushing’s disease is a form of Cushing's syndrome. Cushing’s disease occurs when a benign tumor in the pituitary gland causes the pituitary gland to produce too much ACTH. Cushing's disease can also occur with diffuse growth of the pituitary gland (pituitary hyperplasia). Pituitary hyperplasia can lead to the release of too much ACTH, which then leads to over-production of cortisol by the adrenal glands.(3) The Endocrine Society indicates the following recommendations for the diagnosis of Cushing’s syndrome:(2,3)
The goal of treatment for Cushing’s syndrome is to normalize cortisol levels or normalizing the action at cortisol receptors to reduce or eliminate the signs and symptoms of Cushing’s syndrome and treat comorbidities associated with hypercortisolism. The Endocrine Society recommends the use of a multidisciplinary team, including an endocrinologist, for the diagnosis and management of Cushing’s disease.(3,4) First line treatment is surgical resection of the primary lesion(s) unless surgery is not possible or is unlikely to significantly reduce glucocorticoid excess. In patients that underwent noncurative surgery or those for whom surgery was not an option, the Endocrine Society guidelines and Pituitary Society guidelines recommend the following second-line treatment options:(2,3)
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Efficacy(1) |
A Phase III multicenter, randomized study was conducted to evaluate the safety and efficacy of two dosage levels of Signifor over a 6-month treatment period in Cushing’s disease patients with persistent or recurrent disease despite pituitary surgery or de novo patients for whom surgery was not indicated or had refused surgery. Patients with a baseline 24-hour urine free cortisol (UFC) greater than 1.5 X the upper limit of normal were randomized to receive a Signifor dosage of either 0.6 mg subcutaneous twice daily or 0.9 mg subcutaneous twice daily. After the initial six months in the study, patients entered an additional 6-month open-label treatment period. The primary efficacy endpoint was the proportion of patients who achieved normalization of mean 24-hour UFC levels after six months of treatment and did not dose increase during this period. At month 6, the percentages of responders for the primary endpoint were 15% and 26% in the 0.6 mg twice daily and 0.9 mg twice daily groups respectively. The percentages of patients with mean UFC less than or equal to ULN or greater than or equal to 50% reduction from baseline, a less stringent endpoint than the primary endpoint, were 34% in the 0.6 mg twice daily and 41% in the 0.9 mg twice daily groups. |
Safety(1) |
Signifor (pasireotide) has no FDA labeled contraindications. |
REFERENCES
Number |
Reference |
1 |
Signifor prescribing information. Novartis Pharmaceuticals Corporation. January 2020. |
2 |
Nieman LK, Biller BMK, Findling JW, et al. Treatment of Cushing’s Syndrome: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015 Aug;100(8):2807–2831. |
3 |
Fleseriu M, Auchus R, Bancos I, et al. Pituitary Society Consensus on Diagnosis and Management of Cushing's Disease: A Guideline Update. Lancet Diabetes Endocrinol. 2021;9(12):847-875. |
4 |
Nieman LK, Biller BMK, Findling JW, et al. The Diagnosis of Cushing's Syndrome: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2008 May;93(5):1526–1540. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Agent Names |
Strength |
Targeted MSC |
Available MSC |
Preferred Status |
Effective Date |
|
|||||
SIGNIFOR*pasireotide diaspartate inj |
0.3 MG/ML ; 0.6 MG/ML ; 0.9 MG/ML |
M ; N ; O ; Y |
N |
|
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POLICY AGENT SUMMARY QUANTITY LIMIT
Target Agent GPI |
Agent Names |
Strength |
QL Amount |
Dose Form |
Days Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
Effective Date |
|
||||||||||
3017007520 |
SIGNIFOR*pasireotide diaspartate inj |
0.3 MG/ML ; 0.6 MG/ML ; 0.9 MG/ML |
60.0 |
AMPULS |
30 |
Days |
|
|
|
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CLIENT SUMMARY – PRIOR AUTHORIZATION
Agent Names |
Strength |
Client Formulary |
SIGNIFOR*pasireotide diaspartate inj |
0.3 MG/ML ; 0.6 MG/ML ; 0.9 MG/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Agent Names |
Strength |
Client Formulary |
SIGNIFOR*pasireotide diaspartate inj |
0.3 MG/ML ; 0.6 MG/ML ; 0.9 MG/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: Cushing’s Disease – 6 months All other FDA approved diagnoses – 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL with PA |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: Initial: Cushing’s Disease – 6 months, All other FDA approved diagnosis – 12 months; Renewal: 12 months
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This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx, and Health Insurance Marketplace formularies.
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
Commercial _ PS _ Signifor (pasireotide) Prior Authorization with Quantity Limit _ProgSum_ 1/1/2023