BlueCross BlueShield of Tennessee Medical Policy Manual

Pasireotide Pamoate

NDC CODE(S)

00078-0641-XX - Signifor LAR 20mg kit (Novartis)

 

00078-0642-XX - Signifor LAR 40mg kit (Novartis)

 

00078-0643-XX - Signifor LAR 60mg kit (Novartis)

DESCRIPTION

Pasireotide pamoate 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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Starting Dose

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.

Patients 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 patients.

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).

No controlled studies were found in the published literature that validate the use of pasireotide pamoate for the treatment or prevention of other conditions or diseases.

SOURCES

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016). Pasireotide. Retrieved November 23, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2014, December). Center for Drug Evaluation and Research. Signifor® LAR (pasireotide pamoate) for injectable suspension, for intramuscular use. Retrieved November 23, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203255s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  7/1/2015

MOST RECENT REVIEW DATE:  12/1/2016

ID_MRx

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.

Pharmaceutical Decision Support Tree

Pasireotide Pamoate (Signifor® LAR)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #5

  1. Is the individual 18 years of age or older with a diagnosis of acromegaly and ANY ONE of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have ALL of the following?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 60 billable units every 28 days for dosage of 40 mg by intramuscular injection once every 4 weeks (28 days) titrated up to a maximum 60 mg every 4 weeks for an authorization period of six months with possible renewal?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is response to treatment indicated by reduction of growth hormone (GH) and/or IGF-I blood levels from baseline?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the drug such as severe adrenal insufficiency (evidenced by weakness, fatigue, anorexia, nausea, vomiting, hypotension, hyponatremia or hypoglycemia); uncontrolled hyperglycemia; bradycardia; QT prolongation; liver test elevations (elevations of ALT of 5 times the ULN or 5 times baseline); or gallstones (cholelithiasis)?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.