BlueCross BlueShield of Tennessee Medical Policy Manual

Pasireotide

NDC CODE(S)

00078-0641-XX Signifor LAR 20 MG SRER (NOVARTIS)

 

00078-0642-XX Signifor LAR 40 MG SRER (NOVARTIS)

 

00078-0643-XX Signifor LAR 60 MG SRER (NOVARTIS)

 

00078-0741-XX Signifor LAR 30 MG SRER (NOVARTIS)

 

00078-0748-XX Signifor LAR 10 MG SRER (NOVARTIS)

DESCRIPTION

Pasireotide for injectable suspension is a long-acting release somatostatin analog with pharmacologic properties which mimic the activity of the natural hormone somatostatin.  Its activity is exerted by binding to somatostatin receptors (SSTRs) found in many tissues including neuroendocrine tumors such as growth hormone secreting pituitary adenomas.  Pasireotide binds with high affinity to four of the five known human SSTRs and by binding to SSTR2 and SSTR5 subtype receptors, growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels in individuals with acromegaly are lowered.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Acromegaly

Initiate at 40 mg by intramuscular injection once every 4 weeks (28 days). 

Titrate dosage based on treatment response and tolerability up to maximum 60 mg every 4 weeks for individuals who have not normalized GH and/or IGF-1 levels after 3 months of treatment with the 40 mg dose. 

Individuals with Hepatic Impairment:

Child Pugh B: 20 mg every 4 weeks and maximum dose is 40 mg every 4 weeks.

Child Pugh C: Avoid use in these individuals.

Cushing’s disease

Initiate at 10 mg by intramuscular injection once every 4 weeks (28 days).

Titrate dosage based on treatment response and tolerability up to maximum 40 mg every 4 weeks for patients who have not normalized 24-hour urinary free cortisol (UFC).

Individuals with Hepatic Impairment

Child Pugh B: 10 mg every 4 weeks and maximum dose is 20 mg every 4 weeks.

Child Pugh C: Avoid use in these individuals.

LENGTH OF AUTHORIZATION

Coverage will be provided for 6 months and may be renewed

Refer to DOSAGE LIMITS below

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES

American Association of Neurological Surgeons. (2018, September). Neurosurgical conditions and treatments: Cushing’s syndrome/disease. Retrieved September 25, 2018 from https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Cushings-Disease.

Lexicomp Online. (2018). AHFS DI. Pasireotide diaspartate. Retrieved September 25, 2018 from Lexicomp Online with AHFS.

Lugo, G., Pena, L., Cordido, F. (2012). Clinical Manifestations and Diagnosis of Acromegaly. International Journal of Endocrinology, PMC3296170/pdf/IJE2012-540398. Retrieved September 25, 2018 from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3296170/pdf/IJE2012-540398.pdf.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, July). Pasireotide. Retrieved September 25, 2018 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2018, June). Center for Drug Evaluation and Research. Signifor® LAR (pasireotide) for injectable suspension, for intramuscular use. Retrieved November 23, 2016 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s004lbl.pdf.

ORIGINAL EFFECTIVE DATE:  7/1/2015

MOST RECENT REVIEW DATE:  1/31/2019

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1 mg

DIAGNOSIS

MAXIMUM UNITS

Acromegaly

60 billable units every 28 days

Cushing’s disease

40 billable units every 28 days