CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

GLP-1 and GIP/GLP-1 agonist coverage (Ozempic, Rybelsus, Trulicity, Mounjaro)

Policy governing prior authorization and coverage criteria for GLP-1 receptor agonists and the GIP/GLP-1 agonist (Mounjaro) for Medicaid members, primarily for treatment of type 2 diabetes and type 2 diabetes with cardiovascular disease or chronic kidney disease.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGLP-1 and GIP/GLP-1 agonist coverage (Ozempic, Rybelsus, Trulicity, Mounjaro)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2018

Next Review DateN/A

Key ActionObtain prior authorization for a 12-month period when all specified criteria (diagnosis, age, prior‑therapy trials or intolerance, and agent-specific conditions) are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

4drugs listed

≥18min age (most)

≥10min age (Trulicity)

product-specificquantity limits

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Coverage and Medical Necessity Criteria

Initial Therapy (Type 2 Diabetes)

Covered when ALL of the following are met:

Initial Type 2 Diabetes Criteria: 1) Patient has a documented diagnosis of type 2 diabetes mellitus confirmed by accepted laboratory methodologies per treatment guidelines (e.g., A1C ≥ 6.5% or fasting plasma glucose ≥ 126 mg/dL, 2‑hour plasma glucose ≥ 200 mg/dL, or random plasma glucose ≥ 200 mg/dL); AND 2) Patient has not achieved target glucose control on metformin at maximum tolerated dose (2 g/day) for 3 months unless metformin is not clinically appropriate (e.g., A1C ≥ 9% or metformin contraindicated); AND 3) Age and agent-specific requirements: for Ozempic, Rybelsus, and Mounjaro patient is ≥18 years; for Trulicity patient is ≥10 years; AND 4) For Mounjaro requests the patient has experienced an inadequate treatment response, intolerance, or contraindication to Ozempic or Rybelsus; AND 5) These agents are not to be used in conjunction with DPP‑4 inhibitors (e.g., alogliptin and combinations).

Based on Criteria for Approval and Diabetes subsection.

Initial Therapy (Type 2 Diabetes with CVD/CKD)

Covered when ALL of the following are met:

Type 2 Diabetes with CVD/CKD Criteria: 1) Patient has a documented diagnosis of type 2 diabetes mellitus confirmed by accepted laboratory methodologies per treatment guidelines (e.g., A1C ≥ 6.5% or diagnostic glucose values); AND 2) Patient is 18 years of age or older; AND 3) One of the following agent-specific cardiovascular or renal conditions is present: a) established cardiovascular disease (history of prior myocardial infarction or prior stroke); OR b) symptomatic peripheral arterial disease demonstrated by intermittent claudication with ankle‑brachial index < 0.85 at rest, peripheral arterial revascularization, or amputation due to atherosclerotic disease; OR c) prior history of coronary or peripheral revascularization (e.g., CABG, PCI, angioplasty); OR d) request is for Ozempic and the patient has chronic kidney disease; OR e) request is for Trulicity and the patient has advanced CKD with eGFR < 30 mL/min/1.73 m2; OR f) request is for Trulicity and the patient has multiple cardiovascular risk factors; AND 4) For Trulicity requests in adults, the patient has experienced an inadequate treatment response, intolerance, or contraindication to Ozempic when specified.

Based on Type 2 diabetes with cardiovascular disease, cardiovascular risk factors or chronic kidney disease section.

Continuation Therapy

Covered for 12 months for continuation when ALL of the following are met:

Continuation Criteria: 1) Documentation that the patient continues to meet all initial criteria for the requested indication (type 2 diabetes or type 2 diabetes with CVD/CKD); AND 2) For type 2 diabetes patients, documentation demonstrating a reduction in A1C since starting therapy; AND 3) For patients treated for CVD/CKD indications, documentation that they continue to meet the indication‑specific conditions (as required at initiation).

Continuation authorization sections for Type 2 Diabetes and Type 2 Diabetes with CVD/CKD.

Requests for Ozempic, Rybelsus, Trulicity, and Mounjaro must not be prescribed or dispensed concurrently with Dipeptidyl Peptidase-4 (DPP-4) inhibitors such as alogliptin or combination products containing alogliptin. Concurrent use with these agents is a coverage exclusion.

Requests that do not meet the documented diagnostic criteria for type 2 diabetes (confirmed by accepted laboratory methodologies), the policy age requirements, required prior-therapy or step-therapy trials, or that propose concurrent use of a DPP-4 inhibitor may be considered not medically necessary and subject to denial or requests for additional documentation. Providers should supply laboratory confirmation of diagnosis, evidence of prior metformin trial or contraindication, and documentation of required step-therapy trials when applicable.

Product Formulations, Diagnostic Thresholds, and Clinical Parameters

Ozempic (semaglutide) prefilled pensNDC

Ozempic 2/1.5ml	Semaglutide 2 mg per 1.5 mL pen
Ozempic 4/3ml	Semaglutide 4 mg per 3 mL pen
Ozempic 8/3ml	Semaglutide 8 mg per 3 mL pen

Trulicity (dulaglutide) prefilled pensNDC

Trulicity 0.75/0.5ml	Dulaglutide 0.75 mg per 0.5 mL pen
Trulicity 1.5/0.5ml	Dulaglutide 1.5 mg per 0.5 mL pen
Trulicity 3/0.5ml	Dulaglutide 3 mg per 0.5 mL pen
Trulicity 4.5/0.5ml	Dulaglutide 4.5 mg per 0.5 mL pen

Rybelsus (semaglutide) oral tabletsNDC

Rybelsus 1.5 mg	Semaglutide 1.5 mg tablet (formulation R2)
Rybelsus 3 mg	Semaglutide 3 mg tablet (formulation R1)
Rybelsus 4 mg	Semaglutide 4 mg tablet
Rybelsus 7 mg	Semaglutide 7 mg tablet (formulation R1)
Rybelsus 9 mg	Semaglutide 9 mg tablet
Rybelsus 14 mg	Semaglutide 14 mg tablet

Diagnostic glucose / A1C thresholds and metformin trial

A1C (diagnostic)A1C ≥ 6.5%

Fasting plasma glucose (diagnostic)FPG ≥ 126 mg/dL

2-hour plasma glucose (diagnostic)2-hour PG ≥ 200 mg/dL

Random plasma glucose (diagnostic)Random PG ≥ 200 mg/dL

Metformin trialMaximum tolerated dose of metformin (2 g/day) trial for 3 months unless not clinically appropriate

Peripheral arterial disease and CKD thresholds

Ankle-brachial index (PAD)ABI < 0.85 (at rest)

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for these agents. An authorization may be granted for a 12-month period when all specified criteria for the requested agent and indication are met.

Authorization duration: up to 12 months when criteria met
Applicable agents/indications: Ozempic, Rybelsus, Trulicity, Mounjaro (per policy criteria)

Step Therapy

Step Therapy / Step Requirement

For some agents, a trial and inadequate response, intolerance, or contraindication to specific preferred therapies is required before approval of the requested agent.

Mounjaro: requires prior trial and inadequate response, intolerance, or contraindication to Ozempic OR Rybelsus
Trulicity: requires prior trial and inadequate response, intolerance, or contraindication to Ozempic OR Rybelsus for eligible age groups

Clinical Background

Glucagon-like peptide-1 receptor agonists and the combined GIP/GLP-1 agonist are indicated to improve glycemic control in patients with type 2 diabetes mellitus. Some agents in this class have demonstrated additional benefits for cardiovascular or renal outcomes; when a cardiovascular disease or chronic kidney disease indication is claimed, the policy includes separate, agent-specific criteria addressing established cardiovascular disease, cardiovascular risk factors, or chronic kidney disease.

Patient Group Definitions

Type 2 diabetes with cardiovascular disease or CKD — definition examples (inv-16)

Established atherosclerotic cardiovascular disease examplesPrior myocardial infarction (MI) or prior stroke

Peripheral arterial disease (PAD)Symptomatic PAD (intermittent claudication) with ABI < 0.85, prior peripheral arterial revascularization, or amputation due to atherosclerotic disease

Prior coronary revascularizationPrior CABG, PCI, or angioplasty

Chronic kidney diseaseCKD diagnosis for Ozempic requests or advanced CKD with eGFR < 30 mL/min/1.73 m2 for Trulicity requests

Multiple cardiovascular risk factorsQualifies specifically as an indication for Trulicity when present