Pharmacy Prior Authorization Criteria

Octreotide Products - PA, NF

Indications for Prior Authorization

Sandostatin (octreotide acetate)

• For diagnosis of Acromegaly
  Indicated to reduce blood levels of growth hormone and IGF-1 (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.

• For diagnosis of Carcinoid Tumors, for Symptomatic Treatment of Diarrhea or Flushing
  Indicated for the treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.

  Limitations of Use: Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Sandostatin Injection; these trials were not optimally designed to detect such effects.

• For diagnosis of Vasoactive Intestinal Peptide Tumors (VIPomas), for Symptomatic Treatment of Diarrhea
  Indicated for the treatment of the profuse watery diarrhea associated with VIP-secreting tumors.

  Limitations of Use: Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Sandostatin Injection; these trials were not optimally designed to detect such effects.

Sandostatin LAR Depot (octreotide acetate)

• For diagnosis of General
  Indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.

• For diagnosis of Acromegaly
  Indicated for long-term maintenance therapy in acromegalic patients who have had an 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.

• For diagnosis of Carcinoid Tumors, for Symptomatic Treatment of Diarrhea or Flushing
  Indicated for long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. Limitation of Use: The effect of Sandostatin LAR on tumor size, rate of growth and development of metastases, has not been determined.

• For diagnosis of Vasoactive Intestinal Peptide Tumors (VIPomas), for Symptomatic Treatment of Diarrhea
  Indicated for long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors. Limitation of Use: The effect of Sandostatin LAR on tumor size, rate of growth and development of metastases, has not been determined.

Mycapssa (octreotide capsule, delayed release)

• For diagnosis of Acromegaly
  Indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

Criteria

Brand Sandostatin, Generic octreotide, Brand Sandostatin LAR, Generic octreotide LAR

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Acromegaly

• Diagnosis of acromegaly
AND
• One of the following:
• Inadequate response to one of the following:
• Surgery
• Pituitary irradiation
OR
• Not a candidate for surgical resection or pituitary irradiation
AND
• Trial and failure, contraindication, or intolerance to a dopamine agonist (e.g., bromocriptine or cabergoline) at maximally tolerated doses
AND
• One of the following:
• Patient has had a trial of short-acting generic octreotide and responded to and tolerated therapy (applies to Sandostatin LAR and generic octreotide LAR only)
OR
• Trial and failure, or intolerance to generic octreotide (applies to Brand Sandostatin only)

Mycapssa

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Acromegaly

• Diagnosis of acromegaly
AND
• One of the following:
• Inadequate response to one of the following:
• Surgery
• Pituitary irradiation
OR
• Not a candidate for surgical resection or pituitary irradiation
AND
• Patient has responded to and tolerated treatment with generic octreotide or lanreotide
AND
• Patient requires long-term maintenance treatment

Brand Sandostatin, Generic octreotide, Brand Sandostatin LAR, Generic octreotide LAR, Mycapssa

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Acromegaly

• Patient demonstrates positive clinical response to therapy (e.g., reduction or normalization of IGF-1/GH level for same age and sex, reduction in tumor size)

Brand Sandostatin, Generic octreotide

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Acromegaly

• Submission of medical records (e.g., chart notes) confirming diagnosis of acromegaly
AND
• One of the following:
• Inadequate response to one of the following:
• Surgery
• Pituitary irradiation
OR
• Not a candidate for surgical resection or pituitary irradiation
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to a dopamine agonist (e.g., bromocriptine or cabergoline) at maximally tolerated doses
AND
• Both of the following (Applies to Brand Sandostatin only):
• Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) with generic octreotide
AND
• Submission of medical records confirming generic octreotide has not been effective AND valid clinical justification provided explaining how Brand Sandostatin is expected to provide benefit when generic octreotide has not been shown to be effective despite having the same active ingredient

Mycapssa

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Acromegaly

• Submission of medical records (e.g., chart notes) confirming diagnosis of acromegaly
AND
• Submission of medical records (e.g., chart notes) of one of the following to confirm diagnosis of acromegaly:
• Serum GH level greater than 1 ng/mL after a 2 hour oral glucose tolerance test (OGTT) at the time of diagnosis
OR
• Elevated serum IGF-1 levels (above the age and gender adjusted normal range as provided by the physician's lab) at the time of diagnosis
AND
• One of the following:
• Inadequate response to one of the following:
• Surgery
• Pituitary irradiation
OR
• Not a candidate for surgical resection or pituitary irradiation
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming patient has responded to and tolerated treatment with generic octreotide or lanreotide
AND
• Patient requires long-term maintenance treatment

Brand Sandostatin LAR, Generic octreotide LAR

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Acromegaly

• Submission of medical records (e.g., chart notes) confirming diagnosis of acromegaly
AND
• One of the following:
• Inadequate response to one of the following:
• Surgery
• Pituitary irradiation
OR
• Not a candidate for surgical resection or pituitary irradiation
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to a dopamine agonist (e.g., bromocriptine or cabergoline) at maximally tolerated doses
AND
• All of the following (Applies to Brand Sandostatin LAR only):
• Patient has had a trial of short-acting generic octreotide and responded to and tolerated therapy
AND
• Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) with generic octreotide LAR
AND
• Submission of medical records confirming generic octreotide LAR has not been effective AND valid clinical justification provided explaining how Brand Sandostatin is expected to provide benefit when generic octreotide LAR has not been shown to be effective despite having the same active ingredient

Brand Sandostatin, Generic octreotide,Brand Sandostatin LAR, Generic octreotide LAR

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Carcinoid Tumors, for Symptomatic Treatment of Diarrhea or Flushing

• Diagnosis of metastatic carcinoid tumor requiring symptomatic treatment of severe diarrhea or flushing episodes
AND
• One of the following:
• Patient has had a trial of short-acting generic octreotide and responded to and tolerated therapy (applies to Sandostatin LAR and generic octreotide LAR only)
OR
• Trial and failure, or intolerance to generic octreotide (applies to Brand Sandostatin only)

Brand Sandostatin, Generic octreotide, Brand Sandostatin LAR, Generic octreotide LAR

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Carcinoid Tumors, for Symptomatic Treatment of Diarrhea or Flushing

• Documentation of an improvement in the number of diarrhea or flushing episodes

Brand Sandostatin

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Carcinoid Tumors, for Symptomatic Treatment of Diarrhea or Flushing

• Submission of medical records (e.g., chart notes) confirming diagnosis of metastatic carcinoid tumor requiring symptomatic treatment of severe diarrhea or flushing episodes
AND
• Both of the following:
• Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) with generic octreotide
AND
• Submission of medical records confirming generic octreotide has not been effective AND valid clinical justification provided explaining how Brand Sandostatin is expected to provide benefit when generic octreotide has not been shown to be effective despite having the same active ingredient

Brand Sandostatin LAR, Generic octreotide LAR

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Carcinoid Tumors, for Symptomatic Treatment of Diarrhea or Flushing

• Submission of medical records (e.g., chart notes) confirming diagnosis of metastatic carcinoid tumor requiring symptomatic treatment of severe diarrhea or flushing episodes
AND
• Submission of medical records (e.g., chart notes) confirming patient has had a trial of short-acting generic octreotide and responded to and tolerated therapy

Brand Sandostatin, Generic octreotide, Brand Sandostatin LAR, Generic octreotide LAR

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Vasoactive Intestinal Peptide Tumors, for Symptomatic Treatment of Diarrhea

• Diagnosis of vasoactive intestinal peptide tumor requiring treatment of profuse watery diarrhea
AND
• One of the following:
• Patient has had a trial of short-acting generic octreotide and responded to and tolerated therapy (Applies to Sandostatin LAR only)
OR
• Trial and failure, or intolerance to generic octreotide (Applies to Brand Sandostatin)

Brand Sandostatin, Generic octreotide, Brand Sandostatin LAR, Generic Sandostatin LAR

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Vasoactive Intestinal Peptide Tumors, for Symptomatic Treatment of Diarrhea

• Patient demonstrates positive clinical response as evidenced by an improvement in the number of diarrhea episodes

Brand Sandostatin, generic octreotide

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Vasoactive Intestinal Peptide Tumors, for Symptomatic Treatment of Diarrhea

• Submission of medical records (e.g., chart notes) confirming diagnosis of vasoactive intestinal peptide tumor requiring treatment of profuse watery diarrhea
AND
• Both of the following (Applies to Brand Sandostatin only):
• Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) with generic octreotide
AND
• Submission of medical records confirming generic octreotide has not been effective AND valid clinical justification provided explaining how Brand Sandostatin is expected to provide benefit when generic octreotide has not been shown to be effective despite having the same active ingredient

Brand Sandostatin LAR, Generic octreotide LAR

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Vasoactive Intestinal Peptide Tumors, for Symptomatic Treatment of Diarrhea

• Submission of medical records (e.g., chart notes) confirming diagnosis of vasoactive intestinal peptide tumor requiring treatment of profuse watery diarrhea
AND
• Submission of medical records (e.g., chart notes) confirming patient has had a trial of short-acting generic octreotide and responded to and tolerated therapy

P & T Revisions

2024-12-19, 2024-10-29, 2023-12-01, 2022-11-22, 2021-12-30, 2021-10-27, 2021-10-05, 2021-09-27, 2021-05-21, 2020-11-25, 2020-08-28, 2020-06-29, 2019-10-04

References

1. Sandostatin Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. November 2023.
2. Sandostatin LAR Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. July 2023.
3. Octreotide Prescribing Information. Mylan Institutional LLC. Morgantown, WV. November 2022.
4. Mycapssa Prescribing Information. MW Encap Ltd. Scotland, UK. September 2023.

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Revision History

• 2024-12-19: Drug-specific NF criteria will apply for Sandostatin LAR and generic. Criteria will align with ORx Commercial criteria except submission of medical records will apply to confirm diagnosis check. Paid claims or submission of medical records will apply to confirm trial requirements. Submission of medical records will also be required for justification of how Brand Sandostatin is expected to provide benefit when generic octreotide has not been effective.
• 2024-10-29: Annual Review 2024: 1) Updated NF criteria to make more rigorous. 2) Updated verbiage to standard, e.g. reauth criteria. 3) Added criterion that patient requires long term maintenance treatment for mycappsa 4) Added new 20mg, 30mg generics for Sandostatin LAR IM injection.
• 2023-12-01: Annual review: Removed Bynfezia pen as target, obsolete date 5/14/2023; updated indications in line with prescribing guidelines; updated references. Updated standard reauth criteria to say "Patient demonstrates positive clinical response to therapy".
• 2022-11-22: Annual review: no criteria changes.
• 2021-12-30: Updated to add NF criteria sections for Mycapssa, Brand Sandostatin, and Bynfezia.
• 2021-10-27: Annual Review
• 2021-10-05: Add new GPI, 3017007010E505
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2020-11-25: Program Update: now requiring trial of generic octreotide before brand products are approved
• 2020-08-28: Program Update to add new product: Mycapssa DR capsules for acromegaly
• 2020-06-29: Program Update: Added new product Bynfezia Pen as target to step through generic octreotide, renamed GL Octreotide Products
• 2019-10-04: 2019 Annual Review with no changes.

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