STEP THERAPY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: pramlintide
(Symlin)
PAGE: 1 of 7
REFERENCE NUMBER: CP.PST.13
EFFECTIVE DATE: 11/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED:
PRODUCT TYPE: All
REVISED: 11/09, 10/10, 11/11,
11/12, 11/13, 11/14
IMPORTANT REMINDER
This Clinical Policy has been developed by appropriately experienced and licensed health care
professionals based on a thorough review and consideration of generally accepted standards of
medical practice, peer-reviewed medical literature, government agency/program approval
status, and other indicia of medical necessity.
The purpose of this Clinical Policy is to provide a guide to medical necessity. Benefit
determinations should be based in all cases on the applicable contract provisions governing
plan benefits (“Benefit Plan Contract”) and applicable state and federal requirements, as well as
applicable plan-level administrative policies and procedures. To the extent there are any
conflicts between this Clinical Policy and the Benefit Plan Contract provisions, the Benefit Plan
Contract provisions will control.
Clinical policies are intended to be reflective of current scientific research and clinical thinking.
This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it
constitute a contract or guarantee regarding results. Providers are expected to exercise
professional medical judgment in providing the most appropriate care, and are solely
responsible for the medical advice and treatment of members.
Description:
Symlin is an injectable antihyperglycemic drug for use in
adult diabetic patients currently using insulin. It is a
synthetic form of human amylin, a hormone that is
secreted from pancreatic beta cells with insulin, and
reduces postprandial increases in glucose. Symlin
regulates postprandial glucose levels by slowing gastric
emptying, decreasing postprandial glucagon
concentrations, and promoting satiety.
Brand:
Pramlintide (Symlin): SymlinPen 60 mcg, 120 mcg
FDA Labeled
Indications:
1. Type 1 Diabetes Mellitus: as an adjunct treatment in
patients who use mealtime insulin therapy and who have
failed to achieve desired glucose control despite optimal
insulin therapy.
2. Type 2 Diabetes Mellitus: as an adjunct treatment in
Centene Medical Policy Statements represent technical documents developed by the Medical
Management Staff. Questions regarding interpretation of these policies for the purposes of
benefit coverage should be directed to a Medical Management Staff person.
STEP THERAPY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: pramlintide
(Symlin)
PAGE: 2 of 7
REFERENCE NUMBER: CP.PST.13
EFFECTIVE DATE: 11/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED:
PRODUCT TYPE: All
REVISED: 11/09, 10/10, 11/11,
11/12, 11/13, 11/14
patients who use mealtime insulin therapy and who have
failed to achieve desired glucose control despite optimal
insulin therapy, with or without a concurrent sulfonylurea
agent and/or metformin.
Criteria for
Approval:
Type 1 Diabetes Mellitus
A. Patient is ≥ 18 years old and diagnosed with Type 1
diabetes.
B. Patient is compliant with both basal (long-acting) insulin
and short-acting insulin as evidence by past claims for
both insulins. Step will look for 2 claims of each insulin in
the past 4 months. OR
C. Patient requires insulin pump as evidence by claims in a 6
month look back.
D. Patient checks blood glucose levels daily as evidence of at
least one claim for test strips in the past 3 months.
Type 2 Diabetes Mellitus
A. Patient is ≥ 18 years old and diagnosed with Type 2
diabetes.
B. Patient has had adequate trial of metformin as evidenced
by a one month trial of metformin in the past 90 days.
C. Patient checks blood glucose levels at least three times a
day as evidenced by claims for test strips in the past 90
days.
D. Patient had A1C measured in last 6 months.
Approval:
Initial Approval: Approve the 5ml vial for 6 months.
Continued Approval: 6 months if patient is adherent to
treatment regimen as evidence of 4 fills in the past 6 months.
Centene Medical Policy Statements represent technical documents developed by the Medical
Management Staff. Questions regarding interpretation of these policies for the purposes of
benefit coverage should be directed to a Medical Management Staff person.
STEP THERAPY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: pramlintide
(Symlin)
PAGE: 3 of 7
REFERENCE NUMBER: CP.PST.13
EFFECTIVE DATE: 11/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED:
PRODUCT TYPE: All
REVISED: 11/09, 10/10, 11/11,
11/12, 11/13, 11/14
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Special Instructions
Symlin is only approved for use in patients also taking prandial
insulin.
Symlin is used with insulin and has been associated with an
increased risk of insulin-induced severe hypoglycemia, particularly
in those with type 1 diabetes. When this occurs it is seen within 3
hours following a pramlintide injection. Appropriate patient
selection, careful patient education, dose titration, and insulin
dose adjustments are critical elements for reducing this serious
risk.
Symlin has not been evaluated in pediatric patients.
Symlin should not be used in patients who require the use of drugs
that stimulate gastrointestinal motility.
Symlin should not be used in patients with a diagnosis of
gastroparesis, diabetes with neurologic manifestations, or those
with history of noncompliance with insulin therapy or blood
glucose monitoring.
Symlin should not be used in patients who have poor compliance
with their current insulin regimen, poor compliance with
prescribed self monitoring of blood glucose (SMBG), or poorly
controlled diabetes mellitus as evidenced by a glycosylated
hemoglobin > 9%.
Concurrent use of Symlin with exenatide or other GLP-1 based
therapies has not been studied and cannot be recommended.
Please see prescribing information for dosing, warnings,
precautions.
Pregnancy Category C risk.
Centene Medical Policy Statements represent technical documents developed by the Medical
Management Staff. Questions regarding interpretation of these policies for the purposes of
benefit coverage should be directed to a Medical Management Staff person.
STEP THERAPY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: pramlintide
(Symlin)
PAGE: 4 of 7
REFERENCE NUMBER: CP.PST.13
EFFECTIVE DATE: 11/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED:
PRODUCT TYPE: All
REVISED: 11/09, 10/10, 11/11,
11/12, 11/13, 11/14
References: 1. Symlin® prescribing information. Accessed October 2014.
http://packageinserts.bms.com/pi/pi_symlin.pdf
2. Symlin® monograph, Clinical Pharmacology. Accessed
October 2014, http://www.clinicalpharmacology.com.
3. Diabetes Mellitus, Type 2: Treatment & Medication,
monograph from eMedicine. Accessed September, 2014.
http://emedicine.medscape.com/article/117853-overview
4. Diabetes Mellitus, Type 1: Treatment & Medication,
monograph from eMedicine. Accessed October 2014.
http://emedicine.medscape.com/article/117739-overview
5. Amylin analogs for the treatment of diabetes mellitus Up-todate. \Accessed October 2014. http://www.uptodate.com
Revision Log
Revision
Added “SymlinPen 60 mcg, 120 mcg (subject to pen device approval
protocols)” to the “Brand” section.
Omitted the following at the beginning of the “Criteria for Approval”
section: “Note: This drug should be prescribed by or in consultation
with a specialist in endocrinology”.
Added the following items to the “Criteria for Approval” “Type 1
Diabetes” section:
 Prescribed by or in consultation with a specialist in
endocrinology
 Age ≥ 18 years
Added the following items to the “Criteria for Approval” “Type 2
Diabetes” section:
 Prescribed by or in consultation with a specialist in
endocrinology
 Age ≥ 18 years
 Patient has tried and failed combination metformin with
sulfonylurea and metformin with thiazolidinedione (TZD)
Date
11/09
11/09
11/09
11/09
Centene Medical Policy Statements represent technical documents developed by the Medical
Management Staff. Questions regarding interpretation of these policies for the purposes of
benefit coverage should be directed to a Medical Management Staff person.
STEP THERAPY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: pramlintide
(Symlin)
PAGE: 5 of 7
REFERENCE NUMBER: CP.PST.13
EFFECTIVE DATE: 11/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED:
PRODUCT TYPE: All
REVISED: 11/09, 10/10, 11/11,
11/12, 11/13, 11/14
therapy, unless contraindicated. Contraindications include
intolerance to or adverse reactions to any of the combination
components or comorbidities, other than obesity, precluding
their use and
 Patient is compliant with oral therapy or
 Patient is compliant with insulin therapy
Added “Symlin® should not be administered to patients taking
Metoclopramide due to possible antagonism to effects of
Pramlintide” to the “Special Instructions” section.
Updated Reference section to reflect current literature search and
reference documents.
Added combination metformin and DPP-IV inhibitors (along with
other combos) as an oral therapy precondition, with an “or”
statement.
Specified the approval of Symlin is for use of the vials.
Updated Reference section to reflect current literature search and
reference documents.
Added “from pancreatic beta cells, and reduces postprandial
increases in glucose” to the “Description” section.
Removed the requirement for combination oral and insulin therapy
and three or more daily insulin injections.
Changed oral therapy options from “OR” statements to “AND”
statements.
Updated Reference section to reflect current literature search and
reference documents
Revised Symlin’s Description and included its mechanism of action.
Combined age and diagnosis requirement in criteria for approval
Revised HbA1c requirement in criteria for approval
Inserted maximized dose requirement for Type 2 DM oral therapy in
criteria for approval.
Removed compliance with Type 2 DM oral therapy requirement in
criteria for approval
11/09
11/09
10/10
10/10
10/10
11/11
11/11
11/11
11/11
11/12
11/12
11/12
11/12
11/12
Centene Medical Policy Statements represent technical documents developed by the Medical
Management Staff. Questions regarding interpretation of these policies for the purposes of
benefit coverage should be directed to a Medical Management Staff person.
STEP THERAPY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: pramlintide
(Symlin)
PAGE: 6 of 7
REFERENCE NUMBER: CP.PST.13
EFFECTIVE DATE: 11/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED:
PRODUCT TYPE: All
REVISED: 11/09, 10/10, 11/11,
11/12, 11/13, 11/14
Edited Type 2 DM insulin requirement criteria for approval to
match Type 1 DM criteria.
Reiterated insulin requirement in Special Instructions.
Added dose titration recommendation for hypoglycemia precaution
in Special Instructions.
Added drug interaction warning with medications that stimulate GI
motility in Special Instructions.
Added recommendation against off-label use of Symlin with GLP-1
based therapies in Special Instructions.
Added Amylin Analogs UptoDate reference.
Removed Metoclopramide drug interaction warning in Special
Instructions.
Updated references.
Added eMedicine Type 1 DM web link.
Updated Reference section to reflect current literature search and
reference documents.
Removed the following requirement in the criteria for approval for
both Type 1 and Type 2 Diabetes Mellitus for “Prescribed by or in
consultation with a specialist in endocrinology.”
Modified to become step therapy. Removed Sulfonylurea
requirement from step. Updated criteria to allow for claims
evaluation vs manual review.
11/12
11/12
11/12
11/12
11/12
11/12
11/12
11/12
11/12
11/13
11/13
11/14
Centene Medical Policy Statements represent technical documents developed by the Medical
Management Staff. Questions regarding interpretation of these policies for the purposes of
benefit coverage should be directed to a Medical Management Staff person.
STEP THERAPY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: pramlintide
(Symlin)
PAGE: 7 of 7
REFERENCE NUMBER: CP.PST.13
EFFECTIVE DATE: 11/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED:
PRODUCT TYPE: All
REVISED: 11/09, 10/10, 11/11,
11/12, 11/13, 11/14
POLICY AND PROCEDURE APPROVAL
Pharmacy & Therapeutics Committee:
Approval on file
V.P., Pharmacy Operations:
Approval on file
Sr. V.P., Chief Medical Officer:
Approval on file
Centene Medical Policy Statements represent technical documents developed by the Medical
Management Staff. Questions regarding interpretation of these policies for the purposes of
benefit coverage should be directed to a Medical Management Staff person.