Download sandostatin lar ® depot

Prior Authorization Protocol
SANDOSTATIN®, SANDOSTATIN LAR® DEPOT (octreotide)
NATL
Coverage of drugs is first determined by the member’s pharmacy benefit. Please consult with or refer to
the Evidence of Coverage document.
I.
FDA Approved Indications:
Immediate-release Sandostatin
•
•
•
To reduce blood levels of growth hormone and insulin-like growth factor (IGF-I)
(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 the symptomatic treatment of patients with metastatic carcinoid tumors where it
suppresses or inhibits the severe diarrhea and flushing episodes associated with the
disease.
For treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide
(VIP) secreting tumors.
Sandostatin LAR
For patients in whom initial treatment with Sandostatin Injection has been shown to be effective
and tolerated.
• 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.
• 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.
II.
Health Net Approved Indications and Usage Guidelines:
•
Treatment of acromegaly
OR
•
For management of gastrointestinal neuroendocrine tumors (NETs), such as any of the
following:
o
Treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid
tumors
o
Prophylactic treatment to prevent carcinoid crises prior to surgery for carcinoid tumor
o
To reverse life-threatening hypotension due to carcinoid crisis during induction of
anesthesia
o
For the treatment of the profuse watery diarrhea associated with vasoactive intestinal
polypeptide-secreting tumors (VIPomas)
o
Prophylactic treatment prior to surgery for functioning gastrinoma (Zollinger Ellison
syndrome)
o
Prophylactic treatment prior to hepatic artery embolization for nonresectable multiple and
hormone-secreting neuroendocrine tumors
Confidential and Proprietary
Page - 1
Draft Prepared: 08.03.05JK
Approved by Health Net Pharmacy & Therapeutics Committee: 11.16.05, 11.18.09, 11.17.10, 11.9.11, 11.20.13, 11.19.14, 11.18.15
Updated: 08.09.05 MG, 09.09.05 RJL, 09.12.05 JK, 02.13.06 AG, 04.02.07 LR, 02.08.08 M McClusky, 07.10.08 MJMcClusky,
07.29.09 MJMcClusky, 06.28.10 MJMcClusky, 06.03.11 A Myong, 07.25.12 R. Gedey, 06.24.13 MJMcClusky, 11.19.13 S Redline,
09.09.14 A Myong, 07.03.15 M Vien, 01.11.16 L Borichevskiy, 12.15.16 A Sahota
Prior Authorization Protocol
SANDOSTATIN®, SANDOSTATIN LAR® DEPOT (octreotide)
NATL
o Stabilization of blood glucose levels in persons with functioning islet cell tumors
(insulinomas or glucagonomas);
OR
•
To reduce the incidence and severity of the postoperative complications of high-risk
pancreatic surgery
OR
•
Treatment of chemotherapy and/or radiation therapy-induced diarrhea
OR
•
Treatment of severe secretory diarrhea associated with acquired immunodeficiency
syndrome (AIDS)
OR
•
Treatment of acute bleeding and early rebleeding of gastroesophageal varices associated
with cirrhosis when used in conjunction with endoscopic band ligation or sclerotherapy or
alone, if ligation/sclerotherapy is not immediately available
OR
•
Treatment of unresectable malignant thymoma that is refractory to standard chemotherapy
OR
•
To reduce output from gastrointestinal (GI) or pancreatic fistulas
OR
•
Management of gastrointestinal symptoms (e.g. nausea, vomiting, and pain) of inoperable
bowel obstruction in persons with far advanced cancer
OR
•
Thyroid stimulating hormone (TSH) hypersecretion due to TSH secreting adenoma
OR
•
III.
Coverage is Not Authorized For:
•
IV.
Dumping syndrome following gastric resection
Non-FDA approved indications, which are not listed in the Health Net Approved Indications
and Usage Guidelines section unless there is sufficient documentation of efficacy and safety
in the published literature.
General Information:
•
•
Sandostatin LAR Depot is used for long-term maintenance therapy after the patient has
successfully been titrated on Sandostatin for a minimum of 2 weeks.
Two open label clinical studies investigated a 48-week treatment with Sandostatin LAR®
Depot in 143 untreated (de novo) acromegalic patients. The median reduction in tumor
Confidential and Proprietary
Page - 2
Draft Prepared: 08.03.05JK
Approved by Health Net Pharmacy & Therapeutics Committee: 11.16.05, 11.18.09, 11.17.10, 11.9.11, 11.20.13, 11.19.14, 11.18.15
Updated: 08.09.05 MG, 09.09.05 RJL, 09.12.05 JK, 02.13.06 AG, 04.02.07 LR, 02.08.08 M McClusky, 07.10.08 MJMcClusky,
07.29.09 MJMcClusky, 06.28.10 MJMcClusky, 06.03.11 A Myong, 07.25.12 R. Gedey, 06.24.13 MJMcClusky, 11.19.13 S Redline,
09.09.14 A Myong, 07.03.15 M Vien, 01.11.16 L Borichevskiy, 12.15.16 A Sahota
Prior Authorization Protocol
SANDOSTATIN®, SANDOSTATIN LAR® DEPOT (octreotide)
NATL
•
•
•
•
V.
volume was 20.6 % in Study 1 (49 patients) at 24 weeks and 24.5% in Study 2 (94 patients)
at 24 weeks and 36.2% at 48 weeks.
Use of Sandostatin to manage persons with short bowel syndrome if daily intravenous fluid
requirements are greater than 3 liters is not supported by literature. Sandostatin reduces fluid
losses but also diminishes splanchnic protein synthesis, which can interfere with the process
of adaptation. Sandostatin increases small bowel transit time but tachyphylaxis often
develops. In addition, Sandostatin predisposes patients to the development of gallstones for
which they are already at high risk.
AHFS states Sandostatin is effective for the acute management of potentially life threatening
hypotension associated with carcinoid crisis or to prevent carcinoid crisis that might be
precipitated by anesthesia, surgery, initiation of chemotherapy, or infection.
NCCN practice compendium guidelines recommend Sandostatin and Sandostatin LAR with a
category 2A for unresectable malignant thymoma that is refractory to standard chemotherapy
NCCN practice compendium guidelines recommend Sandostatin and Sandostatin LAR with a
category 2A for recurrent of progressive meningiomas when further radiation is not possible.
i. Gastrinoma and Zollinger-Ellison syndrome
ii. Insulinoma
Therapeutic Alternatives:
Drug
diphenoxylate/ atropine
(Lomotil)
loperamide
(Imodium)**
Morphine, Anhydrous
Oral solution (Opium
Tincture 1%)
Morphine, Anhydrous
Oral solution
(Paregoric)
Dosing Regimen
2 tabs (5 mg) PO QID
Dose Limit/Maximum Dose
8 tabs (20 mg) /day
4 mg PO initially, then 2 mg after
each loose stool
[50 mg/5 mL]:
6 mg (0.6 mL) PO QID
16 mg/day
[2 mg/5 mL]:
2 to 4 mg (5 to 10 mL) PO QID
PRN
5—10 ml) PO QD to QID
40 mL/day
6 mL/day
* Requires prior authorization
** Coverage of agents available without prescription (OTC) may vary with plan formulary and
benefit design
VI.
Recommended Dosing Regimen and Authorization Limit:
Drug
Sandostatin
Dosing Regimen
Acromegaly:
Initial: 50 mcg SC/IV TID
Maintenance: 100-500 mcg SC/IV TID (Max 1500
mcg/day)
Carcinoid tumor symptoms:
Initial: 100-600 mcg/day SC/IV in 2-4 divided doses
for 2 weeks
Authorization Limit
NATL: 6 months or
to member's renewal
period, whichever is
longer
HNMC: 6 months
Maintenance: 450 mcg/day SC/IV (Range 50-1500
Confidential and Proprietary
Page - 3
Draft Prepared: 08.03.05JK
Approved by Health Net Pharmacy & Therapeutics Committee: 11.16.05, 11.18.09, 11.17.10, 11.9.11, 11.20.13, 11.19.14, 11.18.15
Updated: 08.09.05 MG, 09.09.05 RJL, 09.12.05 JK, 02.13.06 AG, 04.02.07 LR, 02.08.08 M McClusky, 07.10.08 MJMcClusky,
07.29.09 MJMcClusky, 06.28.10 MJMcClusky, 06.03.11 A Myong, 07.25.12 R. Gedey, 06.24.13 MJMcClusky, 11.19.13 S Redline,
09.09.14 A Myong, 07.03.15 M Vien, 01.11.16 L Borichevskiy, 12.15.16 A Sahota
Prior Authorization Protocol
SANDOSTATIN®, SANDOSTATIN LAR® DEPOT (octreotide)
NATL
Drug
Dosing Regimen
Authorization Limit
mcg/day)
VIPomas:
Initial: 200-300 mcg SC/IV in 2-4 divided doses for 2
weeks
Maintenance: Not more than 450 mcg/day SC/IV
Sandostatin
LAR
All Other Indications
Doses vary based on indication
Acromegaly:
20-40 mg IM q 4 weeks for 3 months (Max 40 mg Q
4 weeks)
Carcinoid tumor symptoms:
20-30 mg IM q 4 weeks for 2 months (Max 30 mg Q
4 weeks); may decrease to 10 mg q 4 weeks after a
period of 2 months on 20 mg q 4 weeks
NATL: 6 months or
to member's renewal
period, whichever is
longer
HNMC: 6 months
VIPomas:
20-30 mg IM q 4 weeks for 2 months (Max 30 mg Q
4 weeks); may decrease to 10 mg q 4 weeks after a
period of 2 months on 20 mg q 4 weeks
All Other Indication
Doses vary based on indication
Sandostatin LAR® Depot should never be
administered intravenously or subcutaneously.
VII.
Product Availability:
Sandostatin Ampule: 50 mcg, 100 mcg, or 500 mcg in 1 mL ampules
and 200 mcg/mL or 1000 mcg/mL in 5 mL multi-dose vials
Sandostatin LAR Depot Kit: 10 mg, 20 mg, 30 mg in 6 mL vials (requires reconstitution)
VIII.
References:
1. Sandostatin [package insert], East Hanover, NJ; Novartis: March 2012.
2. Sandostatin LAR Depot [package insert]. East Hanover, NJ; Novartis: June 2014.
3. American Gastroenterological Association. American Gastroenterological Association
medical position statement: Short bowel syndrome and intestinal transplantation.
Gastroenterology. 2003;124(4):1105-1110.
4. Ripamonti C, Mercadante S, Groff L, et.al. Role of octreotide, scopolamine, butylbromide,
and hydration in symptom control of patients with inoperable bowel obstruction and
nasogastric tubes: A prospective randomized trial. J Pain Symptom Manage. 2000;19(1):2334.
5. Mystakidou K, Tsilika E, Kalaidopoulou O, et al. Comparison of octreotide administration
versus conservative treatment in the management of inoperable bowel obstruction in patients
Confidential and Proprietary
Page - 4
Draft Prepared: 08.03.05JK
Approved by Health Net Pharmacy & Therapeutics Committee: 11.16.05, 11.18.09, 11.17.10, 11.9.11, 11.20.13, 11.19.14, 11.18.15
Updated: 08.09.05 MG, 09.09.05 RJL, 09.12.05 JK, 02.13.06 AG, 04.02.07 LR, 02.08.08 M McClusky, 07.10.08 MJMcClusky,
07.29.09 MJMcClusky, 06.28.10 MJMcClusky, 06.03.11 A Myong, 07.25.12 R. Gedey, 06.24.13 MJMcClusky, 11.19.13 S Redline,
09.09.14 A Myong, 07.03.15 M Vien, 01.11.16 L Borichevskiy, 12.15.16 A Sahota
Prior Authorization Protocol
SANDOSTATIN®, SANDOSTATIN LAR® DEPOT (octreotide)
NATL
6.
7.
8.
9.
10.
11.
with far advanced cancer: A randomized, double-blind, controlled clinical trial. Anticancer
Res. 2002;22(2B):1187-1192.
Erem C, Hacihasanoglu A, Sari A, et.al. A rare case and a rapid tumor response to therapy:
Dramatic reduction in tumor size during octreotide treatment in a patient with TSH-secreting
pituitary macroadenoma. Endocrine. 2004, 25(2):141-5.
Caron P, Arlot S, Bauters C, et.al. Efficacy of the long-acting octreotide formulation
(octreotide-LAR) in patients with thyrotropin-secreting pituitary adenomas. J Clin
Endocrinology & Metabolism. 2001, 86(6):2849-53.
Shimatsu A, Murabe H, Kamoi K, et.al. Treatment of thyrotropin-secreting pituitary adenomas
with octreotide. Endocrine Journal. 1999, 46(1):113-23.
Sandostatin. American Hospital Formulary Service Drug Information. Available at:
http://www.medicinescomplete.com/mc/ahfs/current/. Accessed January 11, 2016.
Micromedex® Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson
Healthcare. Updated periodically. Accessed January 11, 2016.
National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at:
http://www.nccn.org/professionals/drug_compendium. Accessed: January 11, 2016.
The materials provided to you are guidelines used by this health plan to authorize, modify, or determine
coverage for persons with similar illnesses or conditions. Specific care and treatment may vary
depending on individual needs and the benefits covered under your contract.
Confidential and Proprietary
Page - 5
Draft Prepared: 08.03.05JK
Approved by Health Net Pharmacy & Therapeutics Committee: 11.16.05, 11.18.09, 11.17.10, 11.9.11, 11.20.13, 11.19.14, 11.18.15
Updated: 08.09.05 MG, 09.09.05 RJL, 09.12.05 JK, 02.13.06 AG, 04.02.07 LR, 02.08.08 M McClusky, 07.10.08 MJMcClusky,
07.29.09 MJMcClusky, 06.28.10 MJMcClusky, 06.03.11 A Myong, 07.25.12 R. Gedey, 06.24.13 MJMcClusky, 11.19.13 S Redline,
09.09.14 A Myong, 07.03.15 M Vien, 01.11.16 L Borichevskiy, 12.15.16 A Sahota