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Coverage criteria policies

Somatostatin analogues for acromegaly (Sandostatin LAR®, Somatuline Depot®, Signifor LAR®, Somavert®)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan will be used to determine your coverage.

Administrative Process

Somatuline Depot®, Signifor LAR®, and Somavert® require prior authorization for use in Acromegaly from HealthPartners Pharmacy Administration. Prior authorization is not required for select oncology uses (i.e., carcinoid syndrome and VIPomas).

Coverage

Sandostatin and Sandostatin LAR® do not require prior authorization.

Somatuline Depot®, Signifor LAR®, and Somavert® are generally covered when used for the treatment of (1) patients with acromegaly for whom surgery is not an option or has not been curative and (2) who have failed one somatostatin analogue.

Initial approvals are for six months. Approvals will be provided annually thereafter for responders with demonstrated effect.

Definitions

Sandostatin LAR Depot (octreotide acetate for injectable suspension) is a somatostatin analogue indicated for Treatment in patients who have responded to and tolerated subcutaneous immediate-release Sandostatin Injection for:

  • Long-term maintenance therapy in acromegalic patients who have had inadequate response to surgery and/or radiotherapy or for whom surgery and/or radiotherapy is not an option (the goal of treatment in acromegaly is to reduce GH and IGF-1 levels to normal)
  • Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors
  • Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors.

In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and Sandostatin LAR Depot on tumor size, rate of growth and development of metastases has not been determined.

Somatuline Depot (lanreotide) Injection is a somatostatin analog indicated for:

  • Long-term maintenance therapy in acromegalic patients who have had inadequate response to or cannot be treated with surgery and/or radiotherapy
  • Treatment of patients with unresectable, well-or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
  • Treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

Signifor LAR is a somatostatin analog indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

Somavert (pegvisomant for injection) is a growth hormone receptor antagonist indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-I (IGF-1) levels.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

HCPCS

Code

Description

J2502

Injection, pasireotide long acting, 1 mg (Signifor LA)

J2353

Injection, octreotide, depot form for intramuscular injection, 1 mg (Sandostatin LAR)

J2354

Injection, octreotide, non-depot form for subcutaneous or intravenous injection, 25 mcg (Sandostatin)

J1930

Injection, lanreotide, 1 mg (Somatuline Depot)

J3490

Unclassified drugs (Somavert)

C9399

Unclassified drugs or biological (Somavert)

NDC

Code

Description

00078018001

SandoSTATIN 50 MCG/ML SOLN

00078018061

SandoSTATIN 50 MCG/ML SOLN

00078018101

SandoSTATIN 100 MCG/ML SOLN

00078018161

SandoSTATIN 100 MCG/ML SOLN

00078018201

SandoSTATIN 500 MCG/ML SOLN

00078018261

SandoSTATIN 500 MCG/ML SOLN

00078018325

SandoSTATIN 200 MCG/ML SOLN

00078018425

SandoSTATIN 1000 MCG/ML SOLN

00078064661

SandoSTATIN LAR Depot 10 MG KIT

00078064681

SandoSTATIN LAR Depot 10 MG KIT

00078064761

SandoSTATIN LAR Depot 20 MG KIT

00078064781

SandoSTATIN LAR Depot 20 MG KIT

00078064861

SandoSTATIN LAR Depot 30 MG KIT

00078064881

SandoSTATIN LAR Depot 30 MG KIT

00078081181

SandoSTATIN LAR Depot 10 MG KIT

00078081881

SandoSTATIN LAR Depot 20 MG KIT

00078082581

SandoSTATIN LAR Depot 30 MG KIT

15054112003

Somatuline Depot 120 MG/0.5ML SOLN

15054106003

Somatuline Depot 60 MG/0.2ML SOLN

15054109003

Somatuline Depot 90 MG/0.3ML SOLN

00078063306

Signifor 0.3 MG/ML SOLN

00078063320

Signifor 0.3 MG/ML SOLN

00078063361

Signifor 0.3 MG/ML SOLN

00078063406

Signifor 0.6 MG/ML SOLN

00078063420

Signifor 0.6 MG/ML SOLN

00078063461

Signifor 0.6 MG/ML SOLN

00078063506

Signifor 0.9 MG/ML SOLN

00078063520

Signifor 0.9 MG/ML SOLN

00078063561

Signifor 0.9 MG/ML SOLN

00078064161

Signifor LAR 20 MG SRER

00078064181

Signifor LAR 20 MG SRER

00078064261

Signifor LAR 40 MG SRER

00078064281

Signifor LAR 40 MG SRER

00078064361

Signifor LAR 40 MG SRER

00078064381

Signifor LAR 60 MG SRER

00009517502

Somavert 10 MG SOLR

00009517602

Somavert 10 MG SOLR

00009716601

Somavert 10 MG SOLR

00009517802

Somavert 15 MG SOLR

00009716801

Somavert 15MG SOLR

00009518002

Somavert 20 MG SOLR

00009718801

Somavert 20 MG SOLR

00009519901

Somavert 25 MG SOLR

00009520104

Somavert 25 MG SOLR

00009719901

Somavert 25 MG SOLR

00009520001

Somavert 30 MG SOLR

00009537604

Somavert 30 MG SOLR

00009720001

Somavert 30 MG SOLR

J1930 and J2502: do not require an authorization for the following ICD10 codes. An authorization is required for all other ICD10 codes.

ICD-10 CM Codes

Code

Description

C22

Malignant neoplasm of liver and intrahepatic bile ducts

C22.0

Liver cell carcinoma

C25.0 - C25.9

Malignant neoplasm of pancreas

C4A.0 – C4A.9

Merkel cell carcinoma

C73

Malignant neoplasm of thyroid gland

C7A

Malignant neuroendocrine tumors

C7A.01

Malignant carcinoid tumors

C7A.00

Malignant carcinoid tumor of unspecified site

C7A.010 - C7B.8

Malignant neuroendocrine tumors

D25

Leiomyoma of uterus

D25.0

Submucous leiomyoma of uterus

D25.1

Intramural leiomyoma of uterus

D25.2

Subserosal leiomyoma of uterus

D25.9

Leiomyoma of uterus, unspecified

D3A

Benign neuroendocrine tumors

D3A.0

Benign carcinoid tumors

D3A.00 – D3A.098

Benign carcinoid tumors

D3A.8

Other benign neuroendocrine tumors

E16.4

Increased secretion of gastrin [Zollinger-Ellison syndrome]

E24.0 - E24.9

Cushing's syndrome [non-adrenocorticotropic hormone-dependent tumors]

E34.0

Carcinoid syndrome

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Sandostatin LAR Depot [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; July 2016.
  2. Somatuline Depot [Prescribing Information]. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc; February 2018.
  3. Signifor LAR [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation March 2018.
  4. Somavert [Prescribing Information]. New York, NY: Pfizer, Inc; April 2016.
  5. Acromegaly: An Endocrine Society Clinical Practice Guideline. Laurence Katznelson, Edward R. Laws, Jr, Shlomo Melmed, Mark E. Molitch, Mohammad Hassan Murad, Andrea Utz, and John A. H. Wass
  6. Schmid HA1, Brueggen J. Effects of somatostatin analogs on glucose homeostasis in rats.
  7. National Endocrine and Metabolic Diseases Information Service (NEMDIS). A service of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH). “Acromegaly Page.”

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Policy activity

  • 08/17/2015 - Date of origin
  • 08/13/2018 - Effective date
Review date
  • 08/2018
Revision date
  • 08/13/2018

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