CurrentCignaPolicy N/A

Diabetes - Metformin Step Therapy Policy

Defines step therapy requirements for coverage of immediate- and extended-release metformin products for treatment of type 2 diabetes and who must meet step requirements before coverage of higher-step products.

Policy Summary

PayerCigna

PolicyDiabetes - Metformin Step Therapy Policy

Policy CodePolicy N/A

Change TypeMultiple material edits (additions, removals, reclassification)

Effective DateN/A

Next Review DateN/A

Key ActionDocument that required lower-step metformin product(s) were tried (or that the patient cannot use them per listed exceptions) before requesting coverage for a higher-step product.

SourceLink

POLICY UPDATE CHANGES

Metformin 750 mg tablets (branded generic) was added to the policy and to Step 2 of the immediate-release products step.

Metformin 750 mg tablets (generic) was added to the policy and to Step 2 of the immediate-release products step.

Riomet ER was removed from Step 2 of the extended-release products step and the related approval criterion for patients with swallowing difficulty was removed.

Metformin 625 mg tablet was reclassified from 'generic' to 'brand' in Step 2 immediate-release products.

3Immediate‑release step levels listed

3Extended‑release step levels

1 yrApproval duration (exceptions)

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Coverage Criteria for Metformin Step Therapy

Immediate-Release Initial Coverage Criteria

Immediate-Release Products are covered when meeting the following step progression rules:

Immediate-Release Step Progression: If the patient has tried one Step 1 immediate-release product, approve a Step 2 immediate-release product.trial of one Step 1 product

Step 1 = generic immediate-release metformin tablets (500, 850, 1000 mg); Step 2 = Riomet (brand and generic), metformin 625 mg, metformin 750 mg (branded generic and generic)

Swallowing exception: If the patient is unable to swallow or has difficulty swallowing tablets containing metformin, approve metformin oral solution (Riomet, generic).documented inability to swallow

This is an explicit exception for oral solution in immediate-release products.

Extended-Release Initial Coverage Criteria

Extended-Release Products are covered when meeting the following step progression rules:

Extended-Release Step 1 to 2: If the patient has tried one Step 1 extended-release product, approve a Step 2 extended-release product.trial of one Step 1 product

Step 1 = generic to Glucophage XR; Step 2 = generic to Fortamet

Extended-Release Step 2 to 3: If the patient has tried one Step 1 extended-release product AND one Step 2 extended-release product, approve a Step 3 extended-release product.trial of one Step 1 and one Step 2 product

Step 3 = Glumetza (brand and generic)

Metformin immediate- and extended-release products are covered only when the policy's step therapy criteria are met for the requested product. Any use not meeting the stated step therapy criteria is considered not medically necessary.

Exceptions to coverage are limited to those explicitly listed in the step therapy criteria. Any other exception beyond the listed step therapy criteria is considered not medically necessary.

Coding and Dose Information

References (no billing codes listed)mixed

No codes listed

Maximum daily metformin dose

Maximum daily metformin dose2,550 mg per day (given in divided doses)

Typical starting immediate‑release dose500 mg twice daily or 850 mg once daily (per prescribing information)

Titration guidanceIncrease by 500 mg weekly or 850 mg every 2 weeks based on glycemic control and tolerability

Provider Requirements and Prior Authorization

Prior Authorization

Step therapy prior authorization

Step therapy approvals are provided for 1 year in duration. This program requires use of the designated lower-step metformin products before coverage of Step 2 or Step 3 products is allowed.

Approvals valid for 12 months from approval date.
If the Step Therapy rule is not met at point of service, coverage will be determined by the step therapy criteria and may be denied.

Denial Risk

Denial risk for unmet step therapy

If the Step Therapy rule is not met for a Step 2 or Step 3 product at the point of service, the request may be denied. Coverage will be determined by the step therapy criteria; failure to document required prior-step trials or applicable exceptions increases denial risk.

Denials likely when required Step 1 (or Step 2, if applicable) products were not tried and no exception is documented.

Product Definitions

Immediate‑Release Metformin — definitions and strengths

Product formsImmediate‑release metformin tablets and Riomet oral solution (generic)

IndicationTreatment of type 2 diabetes mellitus in conjunction with diet and exercise in patients ≥ 10 years of age

Common tablet strengths500 mg, 850 mg, 1,000 mg

Other single‑dose tabletsMetformin 625 mg and 750 mg available as branded generics; metformin 750 mg available as generic

Extended‑Release Metformin — definitions

Product typesExtended‑release metformin tablets (generic to obsolete brand Glucophage XR and Fortamet XR) and Glumetza (brand and generic)

Clinical Background

Metformin (immediate- and extended-release) is indicated as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes. Prescribing information describes typical starting doses and titration up to a maximum recommended dose of 2,550 mg per day. Immediate-release formulations are also indicated for patients aged 10 years and older.

Policy Summary

PayerCigna

PolicyDiabetes - Metformin Step Therapy Policy

Policy CodePolicy N/A

Change TypeMultiple material edits (additions, removals, reclassification)

Effective DateN/A

Next Review DateN/A

Key ActionDocument that required lower-step metformin product(s) were tried (or that the patient cannot use them per listed exceptions) before requesting coverage for a higher-step product.

SourceLink

On This Page

Documentation Required

Documentation and coding

Submit prior authorization requests with the appropriate covered diagnosis and procedure codes and include supporting clinical information per the applicable benefit plan. Medical necessity documentation must be provided to demonstrate trials of required lower-step products or valid exceptions.

Include relevant diagnosis codes and procedure codes as of the date of service.
Attach clinical notes documenting medication trials, intolerances, or swallowing difficulty.
Failure to submit required documentation may result in denial or delay.

Step Therapy

Provider requirements for step progression

Providers must document that required lower-step metformin product(s) were tried and failed, were not tolerated, or are otherwise not appropriate. Specific acceptable progressions: for immediate-release products, trial of one Step 1 product is required before Step 2; for extended-release products, trial of one Step 1 product is required before Step 2, and trial of one Step 1 and one Step 2 product is required before Step 3. If the patient cannot swallow tablets, oral solution (Riomet) is an accepted alternative.

Immediate-release: trial of one Step 1 IR product required before Step 2 IR.
If unable to swallow tablets, metformin oral solution (Riomet) is acceptable.
Extended-release: trial of one Step 1 ER product required before Step 2 ER; trial of one Step 1 ER and one Step 2 ER required before Step 3 ER.

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Examples in policyGeneric ER metformin, Glucophage XR (obsolete brand), Fortamet XR (obsolete brand), and Glumetza