CurrentPremera BluecrossPolicy N/A

Pharmacotherapy of Type 1 and Type 2 Diabetes Mellitus

Defines medical and pharmacy benefit coverage criteria, documentation, dosing limits, and coding for pharmacologic treatments for type 1 and type 2 diabetes including GLP‑1, GIP/GLP‑1, DPP‑4, SGLT2 combinations, and teplizumab (Tzield). Affects providers prescribing or requesting coverage for these agents.

Policy Summary

PayerPremera Bluecross

PolicyPharmacotherapy of Type 1 and Type 2 Diabetes Mellitus

Policy CodePolicy N/A

Change TypeAdministrative update (no material clinical changes)

Effective DateMay 1, 2026

Next Review DateApr 14, 2026

Key ActionSubmit clinical chart notes (diagnosis, history, physical exam, medication history, and supporting labs) to document medical necessity for nonpreferred agents and prior‑authorization requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9381Tzield HCPCS

Stage 2 → delay Stage 3Tzield coverage

A1C ≥ 6.5%Diagnostic A1C

AddedAge requirements

12 monthsAuth duration

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Coverage Criteria and Medical Necessity

Insulin and Injectable Noninsulin Combination Products — First Line

Insulin and GLP-1 combination — Initial therapy

ALL of the following

The individual is aged 18 years or older.
Has been diagnosed with type 2 diabetes mellitus (see Related Information).
Has had an adequate trial of or has a contraindication to metformin.
This drug will not be used in combination with another GLP-1 or GIP/GLP-1 receptor agonist.

Glucagon-like Peptide-1 (GLP-1) Receptor Agonists — First Line

GLP-1 receptor agonists — First-line / age-specific

ALL of the following

The individual is aged 18 years or older for adult-only products; for generic liraglutide and Trulicity (dulaglutide) the individual may be aged 10 years or older (pediatric indication).
Age requirement applies per product as listed.
Has been diagnosed with type 2 diabetes mellitus (see Related Information).
Has had an adequate trial of or has a contraindication to metformin.
This drug will not be used in combination with another GLP-1 or GIP/GLP-1 receptor agonist.
Does not exceed FDA labeled maximum daily dose (see Dosage and Quantity Limit Table).

Dipeptidyl Peptidase-4 (DPP-4) Inhibitors

DPP-4 inhibitors — First-line and Second-line

First Line

The individual is aged 18 years or older.
Has been diagnosed with type 2 diabetes mellitus (see Related Information).
Has had an adequate trial of or has a contraindication to metformin.
This drug will not be used in combination with another DPP-4 inhibitor.

Second Line

The individual is aged 18 years or older.

CD3-Directed Antibody (Tzield) — Medical Necessity

Tzield — Stage 2 T1D to delay Stage 3

ALL of the following

The individual is aged 8 years or older.
- ALL of the following
  - Presence of at least 2 autoantibodies (e.g., GAD65, IAA, IA-2A, ZnT8A, or ICA).
  - Evidence of dysglycemia on oral glucose tolerance testing.
Tzield (teplizumab-mzwv) is administered as a once daily infusion for 14 consecutive days.

Billing and Coding

Medical Benefit HCPCSHCPCSCovered

J9381

Injection, teplizumab-mzwv (Tzield), 5 mcg

Medical benefit HCPCSHCPCSCovered

J9381

Injection, teplizumab-mzwv (Tzield), 5 mcg

Policy-related HCPCS/Coding updatesHCPCS

J1813	HCPCS code added (policy history)
J1814	HCPCS code added (policy history)
J9381	HCPCS code added (policy history)
C9149	HCPC code termed (history)
J3590	Code noted historically to report Tzield

Age and prior metformin trial — age limits and metformin trial requirement

Age requirementMost agents require the individual to be aged 18 years or older; certain agents (generic liraglutide and Trulicity/dulaglutide) are allowed from age 10 years and older

Metformin trial requirementHas had an adequate trial of metformin or has a documented contraindication to metformin

Class-combination prohibitionDrug will not be used in combination with another GLP-1 or GIP/GLP-1 receptor agonist (when applicable)

A1C diagnostic threshold

A1C diagnostic thresholdA1C ≥ 6.5% (≥48 mmol/mol) measured by an NGSP‑certified method

Confirmatory testing

Provider Actions, Authorization, and Documentation

Prior Authorization

Drug-specific prior authorization requirements

Many nonpreferred injectable and oral noninsulin diabetes agents require prior authorization demonstrating the member meets age and prior‑trial (or contraindication to metformin) requirements; include chart documentation to support these criteria.

Member must meet the age requirement specified for the agent (e.g., most agents ≥18 years; some agents ≥10 years).
Document an adequate trial of or contraindication to metformin as required by the specific agent.

Billing Rule

Tzield medical benefit and billing

Tzield (teplizumab-mzwv) is managed through the medical benefit and has an associated HCPCS code for billing.

Background and Scope

Diabetes mellitus is a metabolic disease characterized by impaired insulin production (type 1) or insulin resistance with relative insulin deficiency (type 2). Management ranges from lifestyle modification and oral agents to injectable noninsulin therapies and insulin. This policy covers pharmacologic treatments for type 1 and type 2 diabetes, including GLP‑1 and GIP/GLP‑1 receptor agonists, DPP‑4 inhibitors, SGLT2 combinations, insulin/GLP‑1 combination products, and Tzield (teplizumab‑mzwv) where specified; the policy also defines diagnostic thresholds, staging for type 1 diabetes, and documentation requirements to support medical necessity.

Definitions and Staging

T1D stages (policy stage definitions)

Stage 1 definitionPresence of multiple islet autoantibodies with normoglycemia; presymptomatic

Stage 2 definitionIslet autoantibodies with dysglycemia (IFG/IGT) — examples: FPG 100–125 mg/dL, 2‑h PG 140–199 mg/dL, A1C 5.7–6.4% or ≥10% increase in A1C

Stage 3 definitionOvert hyperglycemia meeting standard diagnostic criteria with symptomatic diabetes; autoantibodies may be absent

Stage 1 Type 1 Diabetes

Core featuresAutoimmunity present; normoglycemia; presymptomatic (no IFG/IGT)

Diagnostic criteria examplesMultiple islet autoantibodies and absence of impaired fasting glucose or impaired glucose tolerance

Policy Summary

PayerPremera Bluecross

PolicyPharmacotherapy of Type 1 and Type 2 Diabetes Mellitus

Policy CodePolicy N/A

Change TypeAdministrative update (no material clinical changes)

Effective DateMay 1, 2026

Next Review DateApr 14, 2026

SourceLink

On This Page

Has been diagnosed with type 2 diabetes mellitus (see Related Information).

Has had an adequate trial of or has a contraindication to metformin.

Has had an adequate trial of 2 of the following: Januvia (sitagliptin); Janumet (sitagliptin-metformin); Janumet XR (sitagliptin-metformin extended release); Jentadueto (linagliptin-metformin); Jentadueto XR (linagliptin-metformin extended-release); generic saxagliptin; generic saxagliptin-metformin; Tradjenta (linagliptin).

This drug will not be used in combination with another DPP-4 inhibitor.

Tzield (teplizumab-mzwv) is prescribed by or in consultation with an endocrinologist.

In the absence of unequivocal hyperglycemia, diagnosis requires two abnormal test results obtained concurrently or at separate times

ContextApplies to diagnosis in nonpregnant individuals as one option in the OR diagnostic list

Fasting plasma glucose diagnostic threshold

FPG diagnostic thresholdFasting plasma glucose (FPG) ≥ 126 mg/dL (≥7.0 mmol/L); fasting defined as no caloric intake for at least 8 hours

Stage 2 range (related)FPG 100–125 mg/dL used to define dysglycemia for Stage 2 Type 1 Diabetes (IFG)

Confirmatory testingIn absence of unequivocal hyperglycemia, two abnormal results are required for diagnosis

2-hour OGTT diagnostic threshold

2‑hour OGTT diagnostic threshold2‑hour plasma glucose ≥ 200 mg/dL (≥11.1 mmol/L) during a 75 g OGTT

Stage 2 related OGTT criteriaStage 2 dysglycemia includes 2‑hour PG 140–199 mg/dL (IGT); trials may use 30/60/90‑minute OGTT plasma glucose ≥200 mg/dL as alternative criteria

Testing procedureOGTT should follow WHO method using 75 g anhydrous glucose dissolved in water

Blood pressure screening threshold

BP screening threshold for T2DScreen asymptomatic adults for type 2 diabetes if they have sustained blood pressure (treated or untreated) greater than 135/80 mm Hg

Gestational screening noteScreen asymptomatic pregnant women for gestational diabetes after 24 weeks' gestation

ScopeRecommendations cited as published screening recommendations used by the policy

Benefit: medical benefit (Tzield); all other drugs in this policy are pharmacy benefit.
Billing code: J9381 (Injection, teplizumab-mzwv, 5 mcg).

Prior Authorization

Prior authorization and duration

Most drugs in the policy require prior authorization and approvals are time‑limited; initial and reauthorization durations were standardized to up to 12 months for most drugs.

HCPCS coding history includes additions such as J1813, J1814, and J9381.
Initial and re‑authorization durations updated from 3 years to 12 months for most drugs (Tzield excepted).

Step Therapy

Step therapy / trial requirements

Some second‑line agents require documented trials of specified first‑line agents before coverage (step therapy).

DPP‑4 second‑line agents require an adequate trial of 2 listed agents (e.g., sitagliptin, Janumet, Janumet XR, Jentadueto, generic saxagliptin, Tradjenta).
For certain DPP‑4+SGLT2 second‑line products (e.g., Steglujan), an adequate trial of 1 of Glyxambi or Trijardy XR is required.

Step Therapy

Combination insulin/GLP-1 therapy sequencing

Combination insulin + GLP‑1 products have narrow indications and are covered after inadequate control or trial on component therapies per clinical indications.

Xultophy approved for individuals inadequately controlled on liraglutide (≤1.8 mg daily) or basal insulin (<50 units daily).
Soliqua studied and used for individuals uncontrolled on basal insulin or on multiple oral agents; consider after inadequate control on component therapies.

Note

Formulary-preference and trial history

Policy history reflects preferred vs non‑preferred designations and required prior trials for nonpreferred combination products; providers should follow formulary preference and document prior agent use.

Historical moves of specific products between preferred and nonpreferred lists (examples: Soliqua moved to preferred; multiple DPP‑4 and SGLT2 combos moved between preferred/nonpreferred).
Nonpreferred agents have updated coverage criteria and may require prior trials of preferred alternatives.

Documentation Required

Required medical record documentation

Submit clinical chart notes that include diagnosis, relevant history, physical exam, and medication history to demonstrate that medical necessity criteria are met for drugs in this policy.

Include office visit notes documenting the diagnosis, relevant history, physical evaluation, and medication history.
Clinical documentation must substantiate age and prior‑trial or contraindication criteria required by the agent.

Documentation Required

Diagnostic and staging documentation

Diagnosis of diabetes and staging for type 1 diabetes must be supported by laboratory and autoantibody documentation as applicable when requesting coverage.

Diagnostic criteria: A1C ≥6.5% OR FPG ≥126 mg/dL OR 2‑h OGTT ≥200 mg/dL OR random plasma glucose ≥200 mg/dL with symptoms; confirmatory testing required when hyperglycemia is not unequivocal.
T1D staging: document presence/number of islet autoantibodies and dysglycemia criteria for Stage 2 when requesting Tzield.

Note

Documentation and approval tables

The policy contains tables for investigational/not medically necessary drugs, approved lengths of authorization, and documentation requirements introduced in prior updates; reference these tables when preparing requests.

A table identifying investigational or not medically necessary drugs and a length‑of‑approval table were added 09/01/21.
Documentation requirements table was added to clarify materials needed for approvals and reauthorizations.

Denial Risk

Documentation required for nonpreferred agents

Failure to provide clinical chart notes documenting medical necessity for nonpreferred agents may result in denial.

Ensure submitted records clearly demonstrate required age, diagnosis, prior‑trial or contraindication to metformin, and prior therapy trials where applicable.

Denial Risk

Benefit management for Tzield

Tzield benefit management is via the medical benefit; submitting requests to the pharmacy benefit or using incorrect benefit routing may trigger administrative denial.

Route requests and billing through the medical benefit to avoid administrative denials.

Denial Risk

Concurrent same-class use restriction

Concurrent use of another drug in the same class is prohibited; GLP‑1/GIP‑1 receptor agonists should not be used with another GLP‑1 or GIP/GLP‑1 agent, and DPP‑4 inhibitors should not be used with another DPP‑4 inhibitor.

Policy updated to require that use will not be in combination with another GLP‑1 or GIP/GLP‑1 receptor agonist.
Policy updated to require that DPP‑4 agents will not be used in combination with another DPP‑4 inhibitor.

Clinical implicationIndividuals are at risk but do not yet have dysglycemia or symptoms

Stage 2 Type 1 Diabetes

Core featuresIslet autoantibodies present with dysglycemia (IFG and/or IGT); presymptomatic

Numeric dysglycemia thresholdsFPG 100–125 mg/dL; 2‑h PG 140–199 mg/dL; A1C 5.7–6.4% or ≥10% increase in A1C

Relevance to Tzield eligibilityStage 2 individuals are the population for whom Tzield may be considered to delay Stage 3

Stage 3 Type 1 Diabetes

Core featuresAutoimmunity may be absent; diabetes by standard diagnostic criteria with overt hyperglycemia and symptoms

Diagnostic standardMeets diabetes diagnostic thresholds (A1C ≥6.5% OR FPG ≥126 mg/dL OR 2‑h OGTT ≥200 mg/dL or random glucose ≥200 mg/dL with symptoms)

Clinical implicationTypically requires insulin treatment

Screening recommendations

Adult screening thresholdScreen asymptomatic adults for type 2 diabetes when sustained BP >135/80 mm Hg

Pregnancy screening timingScreen asymptomatic pregnant women for gestational diabetes after 24 weeks' gestation

Source of recommendationPolicy cites published screening recommendations as rationale

Tzield (teplizumab-mzwv) definition

Drug identityTzield (teplizumab-mzwv) — an anti‑CD3 monoclonal antibody used to delay onset of Stage 3 T1D in Stage 2 individuals

Administration regimenAdministered as a once‑daily infusion for 14 consecutive days

Benefit and codingManaged via the medical benefit; HCPCS code J9381 (Injection, teplizumab‑mzwv, 5 mcg) is used for billing