CurrentClover HealthPolicy 2748-A

Sandostatin LAR Depot (octreotide acetate) Coverage Criteria

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This policy governs Medicare Part B coverage and prior authorization for Sandostatin LAR Depot, including FDA-approved and compendial indications, when approval criteria are met and no exclusions apply.

Policy Summary

PayerClover Health

PolicySandostatin LAR Depot (octreotide acetate) Coverage Criteria

Policy CodePolicy 2748-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing the applicable coverage criteria are met, including a high pretreatment IGF-1 level for initial acromegaly approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization duration

3FDA-approved indication categories

9Compendial indication categories

11Additional indications

High IGF-1

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CurrentClover HealthPolicy 2748-A

Sandostatin LAR Depot (octreotide acetate) Coverage Criteria

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Policy Summary

PayerClover Health

PolicySandostatin LAR Depot (octreotide acetate) Coverage Criteria

Policy CodePolicy 2748-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing the applicable coverage criteria are met, including a high pretreatment IGF-1 level for initial acromegaly approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization duration

3FDA-approved indication categories

9Compendial indication categories

11Additional indications

High IGF-1

Acromegaly requirement

Covered Indications

Acromegaly

Authorization of 12 months may be granted for the treatment of acromegaly when <strong>all</strong> of the following criteria are met:

ALL of the following

Member has a high pretreatment insulin-like growth factor-1 (IGF-1) level for age and/or gender based on the laboratory reference range.
ONE of the following
- Member had an inadequate or partial response to surgery or radiotherapy.
- Surgery or radiotherapy are not an option for the member.

Neuroendocrine Tumors (NETs)

Authorization of 12 months may be granted for treatment when the member has one of the following neuroendocrine tumor indications:

ONE of the following

Neuroendocrine tumors of the gastrointestinal (GI) tract, lung, or thymus (carcinoid tumors).12 months
Neuroendocrine tumors of the pancreas (islet cell tumors), including gastrinomas, glucagonomas, and insulinomas.12 months
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs).12 months
Pheochromocytoma/paraganglioma.12 months

Carcinoid Syndrome

Authorization of 12 months may be granted for treatment of carcinoid syndrome.

Member has carcinoid syndrome.12 months

Vasoactive Intestinal Peptide Tumors (VIPomas)

Authorization of 12 months may be granted for management of symptoms related to hormone hypersecretion of vasoactive intestinal peptide tumors.

Member has a vasoactive intestinal peptide tumor (VIPoma) with symptoms related to hormone hypersecretion.12 months

Thymomas

Authorization of 12 months may be granted for treatment of thymomas.

Member has thymoma.12 months

Meningiomas

Authorization of 12 months may be granted for treatment of meningiomas when the member has surgically inaccessible recurrent or progressive disease.

ALL of the following

Member has meningioma.
Disease is surgically inaccessible and recurrent or progressive.

Merkel Cell Carcinoma

Authorization of 12 months may be granted as a single agent for treatment of somatostatin receptor-positive Merkel cell carcinoma when the member has a contraindication to anti-PD-L1 or anti-PD-1 therapy and one of the following criteria is met:

ALL of the following

Treatment is being provided as a single agent for somatostatin receptor-positive Merkel cell carcinoma.
Member has a contraindication to anti-PD-L1 or anti-PD-1 therapy.
ONE of the following
- Member has regional or metastatic disease.
- Member has disease progression while on anti-PD-L1 or anti-PD-1 therapy.

Hepatocellular Carcinoma

Authorization of 12 months may be granted for treatment of hepatocellular carcinoma.

Member has hepatocellular carcinoma.12 months

Bowel Obstruction Due to Peritoneal Carcinomatosis

Authorization of 12 months may be granted for treatment of bowel obstruction due to peritoneal carcinomatosis.

Member has bowel obstruction due to peritoneal carcinomatosis.12 months

Postgastrectomy Dumping Syndrome

Authorization of 12 months may be granted for treatment of postgastrectomy dumping syndrome.

Member has postgastrectomy dumping syndrome.12 months

Zollinger-Ellison Syndrome

Authorization of 12 months may be granted for treatment of Zollinger-Ellison syndrome.

Member has Zollinger-Ellison syndrome.12 months

Covered Indications

Coverage includes FDA-approved indications listed in the prescribing information for Sandostatin LAR and octreotide acetate for injectable suspension, in addition to the following indications:

ONE of the following covered indications

An FDA-approved indication listed in the prescribing information for Sandostatin LAR and octreotide acetate for injectable suspension.
Neuroendocrine tumors of the gastrointestinal tract, lungs, or thymus.
Neuroendocrine tumors of the pancreas (islet cell tumors).
Gastroenteropancreatic neuroendocrine tumors.
Pheochromocytoma/paraganglioma.

Continuation Therapy

All members, including new members, requesting authorization for continuation of therapy must be currently receiving therapy with the requested agent. Authorization of 12 months may be granted when <strong>all</strong> of the following criteria are met:

ALL of the following

The member is currently receiving therapy with the requested medication.
The requested medication is being used to treat an indication in the coverage criteria section.
Member is receiving benefit from therapy, defined as ONE of the following
- For acromegaly: decreased or normalized IGF-1 level since initiation of therapy.
- For all other indications: improvement or stabilization in clinical signs and symptoms since initiation of therapy.

Authorization and Documentation Requirements

Prior Authorization

Acromegaly Authorization

Authorization for 12 months may be granted for acromegaly when the member has a high pretreatment insulin-like growth factor-1 (IGF-1) level for age and/or gender and had an inadequate or partial response to surgery or radiotherapy, or surgery or radiotherapy are not an option.

All applicable criteria must be met and no exclusion to the prescribed therapy may apply.

Prior Authorization

Neuroendocrine Tumor Authorization

Authorization for 12 months may be granted for treatment of neuroendocrine tumors (NETs) of the gastrointestinal tract, lung, thymus, pancreas, or gastroenteropancreatic system, including specified tumor types, and for pheochromocytoma or paraganglioma.

GI, lung, and thymus carcinoid tumors
Pancreatic islet cell tumors, including gastrinomas, glucagonomas, and insulinomas
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
Pheochromocytoma/paraganglioma

Clinical Background

Sandostatin LAR Depot is the long-acting injectable formulation of octreotide acetate. It is used for hormone-mediated disorders and for neuroendocrine and other tumors, including acromegaly, carcinoid tumors and associated syndrome, vasoactive intestinal peptide-secreting tumors (VIPomas), and selected neuroendocrine, adrenal, hepatic, and other tumor-related conditions.

FDA-approved uses include long-term maintenance treatment of acromegaly when surgery or radiotherapy has produced an inadequate response or is not an option, severe diarrhea and flushing associated with metastatic carcinoid tumors, and profuse watery diarrhea associated with VIPomas. The policy also recognizes compendial uses involving neuroendocrine tumors, thymomas, meningiomas, Merkel cell carcinoma, hepatocellular carcinoma, bowel obstruction due to peritoneal carcinomatosis, postgastrectomy dumping syndrome, and Zollinger-Ellison syndrome.

Policy Definitions

Benefit from therapy

AcromegalyDecreased or normalized IGF-1 level since initiation of therapy.

All other indicationsImprovement or stabilization in clinical signs and symptoms since initiation of therapy.

Applies toContinuation of therapy for the requested medication.

Initial Therapy

Initial Acromegaly Therapy

Initial acromegaly authorization requires all criteria below.

Initial acromegaly criteria

Surgery or radiotherapy status
- Member had an inadequate or partial response to surgery or radiotherapy.
- Surgery or radiotherapy are not an option for the member.

Thymoma

Authorization of 12 months may be granted for treatment of thymomas.

Member requires treatment of thymoma.

Continuation Therapy

Acromegaly Continuation Therapy

Continuation coverage for acromegaly requires documentation of biochemical response.

Continuation acromegaly response

Current IGF-1 levels are normal.Normal current IGF-1
A supporting laboratory report must be available upon request.
The member's IGF-1 level has decreased or normalized since initiation of therapy.Decreased or normalized IGF-1
Supporting chart notes must be available upon request.

Continuation Therapy

Authorization of 12 months may be granted when all of the following criteria are met.

Required Prior Treatment

Step	Therapy requirement	Requirement for Sandostatin LAR Depot
1	For FDA-approved Sandostatin LAR indications, initial treatment with Sandostatin Injection must be completed first.	Sandostatin Injection must have been shown to be effective and tolerated before Sandostatin LAR Depot is initiated.

Policy Summary

PayerClover Health

PolicySandostatin LAR Depot (octreotide acetate) Coverage Criteria

Policy CodePolicy 2748-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing the applicable coverage criteria are met, including a high pretreatment IGF-1 level for initial acromegaly approval.

SourceLink

On This Page

Merkel cell carcinoma.

Hepatocellular carcinoma.

Bowel obstruction due to peritoneal carcinomatosis.

Postgastrectomy dumping syndrome.

Zollinger-Ellison syndrome.

Prior Authorization

Hormone-Related Syndrome Authorization

Authorization for 12 months may be granted for hormone-related syndromes and symptom management associated with covered tumors.

Carcinoid syndrome
Management of symptoms related to hormone hypersecretion of vasoactive intestinal peptide tumors (VIPomas)

Prior Authorization

Other Tumor Authorization

Authorization for 12 months may be granted for treatment of thymomas and for meningiomas when the member has surgically inaccessible recurrent or progressive disease.

Document the qualifying disease status for meningioma.
Treatment of thymomas is covered when the authorization criterion is met.

Prior Authorization

Indication-Based Authorization

Authorization for 12 months may be granted for the covered indications listed below. Select and document the applicable indication and supporting clinical information.

Thymomas
Meningiomas with surgically inaccessible recurrent or progressive disease
Hepatocellular carcinoma
Bowel obstruction due to peritoneal carcinomatosis
Postgastrectomy dumping syndrome
Zollinger-Ellison syndrome

Prior Authorization

Merkel Cell Carcinoma Authorization

Authorization for 12 months may be granted for Sandostatin LAR as a single agent for somatostatin receptor-positive Merkel cell carcinoma when the member has a contraindication to anti-PD-L1 or anti-PD-1 therapy and qualifying disease status.

Regional or metastatic disease, or
Disease progression while on anti-PD-L1 or anti-PD-1 therapy

Unsupported block type: prior_auth

Prior Authorization

Prior Sandostatin Injection Response

Sandostatin LAR is covered for FDA-approved indications only when initial treatment with Sandostatin Injection has been shown to be effective and tolerated.

Acromegaly
Severe diarrhea and flushing episodes associated with metastatic carcinoid tumors
Profuse watery diarrhea associated with VIPomas

Documentation Required

Initial Acromegaly Documentation

For initial acromegaly approval, retain documentation showing a high pretreatment IGF-1 level for the member’s age and/or gender.

Laboratory report indicating high pretreatment insulin-like growth factor-1 (IGF-1) level
Chart notes indicating an inadequate or partial response to surgery or radiotherapy, or that surgery or radiotherapy are not an option

Documentation Required

Continuation Acromegaly Documentation

For continuation of acromegaly therapy, retain documentation showing that IGF-1 has improved since treatment began.

Laboratory report indicating normal current IGF-1 levels, or
Chart notes indicating that the member’s IGF-1 level has decreased or normalized since initiation of therapy

Documentation Required

Meningioma Documentation

For meningioma authorization, document that the disease is surgically inaccessible and recurrent or progressive.

Chart notes or other clinical records must support both the surgical inaccessibility and recurrent or progressive disease requirements.

Documentation Required

Merkel Cell Carcinoma Documentation

For Merkel cell carcinoma authorization, document receptor status, the contraindication to anti-PD-L1 or anti-PD-1 therapy, and qualifying disease status.

Somatostatin receptor-positive disease
Contraindication to anti-PD-L1 or anti-PD-1 therapy
Regional or metastatic disease, or progression while on anti-PD-L1 or anti-PD-1 therapy

Documentation Required

Continuation Benefit Documentation

For continuation requests, document that the member is currently receiving the requested medication for a covered indication and is receiving clinical benefit from therapy.

For acromegaly: decreased or normalized IGF-1 since initiation of therapy
For all other indications: improvement or stabilization in clinical signs and symptoms since initiation of therapy

Prior Authorization

Unlisted Indication Requires Compendial Support

Indications not listed in the coverage criteria are assessed individually and must be supported by evidence from Medicare-approved compendia.

Include supporting Medicare-approved compendial evidence with the submission for an unlisted indication.

Denial Risk

Approval Criteria and Exclusions

The indication is a covered benefit only when all applicable approval criteria are met and the member has no exclusion to the prescribed therapy.

Verify that every criterion applicable to the requested indication is satisfied.
Confirm that no therapy exclusion applies.

Denial Risk

Meningioma Disease Status

Meningioma authorization requires surgically inaccessible recurrent or progressive disease.

Denial condition: Do not approve when the disease is not documented as surgically inaccessible, recurrent, and progressive as required.

Denial Risk

Merkel Cell Carcinoma Criteria

Merkel cell carcinoma treatment must be single-agent Sandostatin LAR for somatostatin receptor-positive disease, with a contraindication to anti-PD-L1 or anti-PD-1 therapy and qualifying disease status.

Qualifying disease status is regional or metastatic disease, or progression while on anti-PD-L1 or anti-PD-1 therapy.
Denial condition: Criteria are not met if treatment is not single-agent, disease is not somatostatin receptor-positive, no contraindication is present, or qualifying disease status is absent.

Denial Risk

Continuation Requirements

Continuation authorization requires current treatment with the requested medication, use for an indication in the coverage criteria, and documented benefit from therapy.

Denial condition: The member is not currently receiving the requested therapy.
Denial condition: The medication is not being used for a covered indication.
Denial condition: The member is not receiving benefit from therapy.

Authorization of 12 months may be granted for treatment of qualifying meningiomas.

Member has surgically inaccessible recurrent or progressive meningioma.Surgically inaccessible recurrent or progressive disease

Merkel Cell Carcinoma

Authorization of 12 months may be granted for qualifying Merkel cell carcinoma.

ALL of the following

Qualifying disease status
- Member has regional or metastatic disease.
- Member has disease progression while on anti-PD-L1 or anti-PD-1 therapy.

Additional Indications

Authorization of 12 months may be granted for treatment of one of the following indications.

Additional indications

Hepatocellular carcinoma.
Bowel obstruction due to peritoneal carcinomatosis.
Postgastrectomy dumping syndrome.
Zollinger-Ellison syndrome.

Initial Therapy Indications

FDA-approved indications are covered in addition to the specified additional indications.

Covered indication list

Treatment is for an FDA-approved indication.
Treatment is for one of the listed additional indications: neuroendocrine tumors of the gastrointestinal tract, lungs, or thymus; neuroendocrine tumors of the pancreas (islet cell tumors); gastroenteropancreatic neuroendocrine tumors; pheochromocytoma or paraganglioma; thymomas; meningiomas; Merkel cell carcinoma; hepatocellular carcinoma; bowel obstruction due to peritoneal carcinomatosis; postgastrectomy dumping syndrome; or Zollinger-Ellison syndrome.

Continuation therapy

Member is currently receiving therapy with the requested medication.
The requested medication is being used to treat an indication in the coverage criteria.
Member is receiving benefit from therapy.
For acromegaly, benefit is decreased or normalized IGF-1 since initiation of therapy. For all other indications, benefit is improvement or stabilization in clinical signs and symptoms since initiation of therapy.