ModifiedCentenePolicy CP.PMN.129

Pramlintide (Symlin)

Criteria and administrative requirements for medical necessity determination and authorization of pramlintide (Symlin) for members with type 1 or type 2 diabetes who use mealtime insulin. Applies to Centene-affiliated health plans and affected lines of business.

Policy Summary

PayerCentene

PolicyPramlintide (Symlin)

Policy CodePolicy CP.PMN.129

Change TypeMaterial coverage and administrative updates (approval durationsstep therapy)

Effective DateJun 1, 2018

Next Review Date

Key ActionSubmit prior authorization with supporting documentation (office notes, lab results) demonstrating the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Modified Commercial line of business approval duration to '6 months or to member's renewal period, whichever is longer.'

For Medicaid/HIM, extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition.

Revised step therapy in line with FDA label for IL HIM per IL HB 5395.

Age ≥ 18minimum age for coverage

Type 1 or Type 2covered diagnoses

Commercial: 6mapproval duration (commercial)

Medicaid/HIM: 12mapproval duration (Medicaid/HIM)

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met

Initial Approval - Diabetes Mellitus: 1. Diagnosis of type 1 or type 2 diabetes mellitus; 2. Prescribed by or in consultation with an endocrinologist; 3. Age ≥ 18 years; 4. One of the following (a or b): (a) For Illinois HIM requests only: member meets BOTH of the following: (i) currently receiving mealtime insulin (e.g., Apidra, Humalog, Humulin N, Humulin R, Novolog); AND (ii) failure to achieve desired glycemic control despite optimal insulin therapy; OR (b) For all other requests: member meets ONE of the following: (i) failure of three or more daily mealtime insulin injections (e.g., Apidra, Humalog, Humulin N, Humulin R, Novolog), each used for ≥ 3 months unless clinically significant adverse effects or contraindications; OR (ii) currently using an insulin pump; 5. Dose does not exceed: (a) for type 1 diabetes: 60 mcg prior to each major meal; (b) for type 2 diabetes: 120 mcg prior to each major meal.

State-specific branch for Illinois HIM under node 4a

Continuation Therapy

Continued therapy is covered when ALL of the following are met

Continued Therapy - Diabetes Mellitus: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy as evidenced by reduction in HbA1c at the end of the initial authorization period; 3. If request is for a dose increase, the new dose does not exceed: (a) for type 1 diabetes: 60 mcg prior to each major meal; (b) for type 2 diabetes: 120 mcg prior to each major meal.reduction in HbA1c (unspecified magnitude)

Continuation requires objective evidence of response (HbA1c reduction)

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or unless coverage is supported by the member’s evidence of coverage documents.

Coverage decisions under this clinical policy are a guide to medical necessity and do not guarantee payment. Determinations are subject to all terms, conditions, exclusions, and limitations of the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract of insurance), as well as applicable state and federal requirements and Health Plan administrative policies and procedures.

Uses for indications that are not FDA‑approved and are not supported by sufficient evidence per the referenced off‑label use policies are considered not authorized (not medically necessary) under this policy unless adequate supporting documentation is provided or applicable evidence of coverage allows otherwise.

Coding

HCPCS Codes referencedHCPCS

J3490

Unclassified drugs

Meal caloric/carbohydrate threshold for dosing

Dosing timingDose given prior to each major meal (≥ 250 kcal or containing ≥ 30 g of carbohydrate)

Definition of major mealMeal ≥ 250 kilocalories

Alternative carbohydrate criterionMajor meal may be defined as any meal containing ≥ 30 g of carbohydrate

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for pramlintide (Symlin). Approval durations vary by line of business: Medicaid/HIM — 12 months; Commercial — 6 months or to member's renewal period, whichever is longer.

Approval duration — Medicaid/HIM: 12 months
Approval duration — Commercial: 6 months or to member's renewal period, whichever is longer

Step Therapy

Step Therapy Requirements

Prior authorization requests must demonstrate that the member meets the policy's step therapy and initial approval criteria. For non‑Illinois HIM requests, members must have failed three or more daily mealtime insulin injections (each used ≥ 3 months) or be using an insulin pump as specified in the Initial Approval Criteria. For Illinois HIM requests, the member must be currently receiving mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy.

Non‑Illinois HIM: Failure of ≥3 different daily mealtime insulin injections, each used ≥ 3 months, unless contraindicated or intolerant; OR currently using an insulin pump

Background

Pramlintide (Symlin) is an amylin analog indicated as adjunctive therapy for adults with type 1 or type 2 diabetes who use mealtime insulin and have not achieved desired glycemic control despite optimal insulin therapy. Initiation, dosing, and safety considerations differ by diabetes type; notable safety concerns include the risk of severe hypoglycemia and contraindications such as prior serious hypersensitivity and confirmed gastroparesis.

Definitions & Safety

amylin analog indicated for adults with type 1 or type 2 diabetes using mealtime insulin

DrugPramlintide (Symlin)

Drug classAmylin analog

Indication (FDA)Adjunctive therapy for adults with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy

Safety contraindications/boxed warning

Contraindication: hypersensitivityPrior serious hypersensitivity reaction to Symlin or its ingredients

Contraindication: hypoglycemia unawarenessHypoglycemia unawareness

Contraindication: gastroparesis