ModifiedBlue Cross Blue Shield - MassachusettsPolicy 041

Step therapy and quantity limits for oral anti-diabetic medications

Defines step therapy, prior use, and quantity/coverage rules for formulary oral antidiabetic medications for BCBSMA commercial plans and describes prior authorization and documentation requirements for exceptions.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyStep therapy and quantity limits for oral anti-diabetic medications

Policy CodePolicy 041

Change TypeMaterial updates to Rx/step therapy application and formulary listings

Effective Date

Next Review Date

Key ActionSubmit prior authorization using the Formulary Exception/Prior Authorization form and include documentation of prior trials or clinical rationale.

SourceLink

POLICY UPDATE CHANGES

Policy updated to indicate Prior Authorization, Step Therapy, and Step Therapy applies to Pharmacy (Rx) benefit and to list managed plan applicability.

Added linagliptin/metformin as Step 3.

Added Brynovin as Step 3.

Added Cycloset as Step 3.

Clarified/updated examples of preferred insulins (e.g. Novolin/Novolog).

Added Zituvimet to the DPP-4 table as NFNC and added Metformin 750mg immediate release to Step 3 of the traditional table.

Mar 15, 2026policy last updated

130 daysprior-use lookback

Step 1/2/3formulary steps

Multiple

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24 moformulary review interval

Coverage and Medical Necessity Criteria

Initial coverage criteria for Traditional and DPP-4 inhibitor classes

Covered when ALL of the following are met:

General: Documented diagnosis of Type 2 Diabetes Mellitus.

Applies to traditional anti-diabetic medications and DPP-4 inhibitors.

Step therapy requirement: Meet the step therapy requirements described below.

Specific step assignments and prior use rules follow in the formulary tables.

Step 1 / Step 2 / Step 3 coverage logic

Step-based coverage logic (examples shown)

Step 1: Use of Step 1 formulary medications (generics such as metformin and other Step 1 classes) is required before advancing to higher steps.

Step 1 entries are covered with no requirements for many generics (e.g., metformin, sulfonylureas, meglitinides, alpha-glucosidase inhibitors).

Step 2 prior-use requirement: For Step 2 agents, requires prior use of ONE Step 1 medication OR history of prior use of any Step 2 medication in this table within the previous 130 days.1 of Step 1 or Step 2 within 130 days

Applies to listed Step 2 agents such as pioglitazone, Afrezza, rosiglitazone, Kerendia, Riomet ER, etc.

Step 3 prior-use requirement: For Step 3 agents, requires prior use of TWO Step 2 medications OR history of prior use of a Step 3 medication in this table within the previous 130 days.2 of Step 2 or Step 3 within 130 days

Applies to listed Step 3 agents such as Actoplus Met, Duetact, Fortamet, Glumetza, Glynase, metformin ER generics, Precose, Riomet, etc.

SGLT2 medical necessity

SGLT2 inhibitors may be considered medically necessary when ALL of the following are met:

SGLT2 initial criteria: Documented diagnosis of Type 2 Diabetes Mellitus.

Required for coverage of SGLT2 class agents per policy.

Step therapy requirement: Meet the step therapy requirements described below (class-specific Step 1/2/3 rules).

Refer to the SGLT2 formulary table for per-product prior-use rules (e.g., Step 2 requires one Step 1 med or prior Step 2 within 130 days; Step 3 requires two Step 2 meds or prior Step 3 within 130 days).

Class examples: Specific SGLT2 products have step assignments: some (e.g., Glyxambi, Jardiance, Synjardy, Trijardy XR) are Step 2 and require prior use of one Step 1 medication or history of a Step 2 med within 130 days; others (e.g., bexagliflozin, dapagliflozin, Invokamet) are Step 3/NFNC and require prior use of two Step 2 medications or history of a Step 3 med within 130 days.

See SGLT2 product lines and Step 2/Step 3 prior-use criteria in the formulary tables.

DPP-4 coverage and step therapy

DPP-4 and combination DPP-4 agents coverage/step requirements (per-product examples):

DPP-4 product rules: Many DPP-4 agents and DPP-4 combinations (e.g., sitagliptin, sitagliptin/metformin, saxagliptin combinations, alogliptin products, linagliptin combinations, ertugliflozin+sitagliptin combinations, and other branded DPP-4 agents) are designated NFNC for lower steps and require prior use of TWO Step 2 medications OR history of prior use of a Step 3 medication in this table within the previous 130 days for approval as specified per product.

Per-product listings in the DPP-4 tables show 1 = NFNC and 2 = Requires prior use of TWO step 2 medications OR history of prior use of a step 3 medication within the previous 130 days.

Examples include: sitagliptin and sitagliptin/metformin (listed NFNC; Step 2 requires two Step 2 meds or Step 3 history within 130 days); Tradjenta (linagliptin), Nesina (alogliptin), Onglyza (saxagliptin), Kombiglyze XR, Oseni, Qtern, Steglujan, Zituvimet, and Zituvio are each shown with NFNC designation and the two-step prior-use requirement in the formulary tables.

Providers must follow the per-product criteria and supply documentation of prior trials or claim history within 130 days when requesting coverage.

Certain branded agents and branded combination products are designated NFNC (Non-Formulary Non-Covered) on the formulary tables unless the member meets the policy’s step/ prior-use requirements. Examples in the DPP‑4 and combination listings include alogliptin products and multiple sitagliptin/branded combinations that are shown as NFNC and require fulfillment of the step criteria prior to coverage.

The formulary tables list several specific agents as NFNC. Examples include Invokana (canagliflozin) and multiple dapagliflozin-containing products, as well as branded metformin ER products such as Fortamet and Glumetza, which are shown in the tables with an NFNC designation.

Medications listed as NFNC on the formulary are considered not covered unless the explicit prior-use (step therapy) criteria in the policy are satisfied. For many DPP‑4 agents and combination products the table entries require prior failure or documented use of lower-step alternatives before approval can be granted.

An NFNC designation indicates that the drug is not covered under the formulary unless the member meets an exception or the step-therapy criteria (for example, documented failure or contraindication to the required number of lower-step agents). The policy requires prior-use documentation per the step rules and notes that exceptions may be considered only with appropriate clinical documentation.

Formulary Listings, Codes, and Prior-Use Lookback

Formulary drug listings by stepmixed

Actos	pioglitazone (listed Step 2; requires prior use of one Step 1 medication or history of prior use of any Step 2 medication in this table within the previous 130 days)
Afrezza	inhaled insulin (listed Step 2; requires prior use of one Step 1 medication or history of prior use of any Step 2 medication in this table within the previous 130 days)
Avandia	rosiglitazone (listed Step 2; requires prior use of one Step 1 medication or history of prior use of any Step 2 medication in this table within the previous 130 days)
Kerendia	finerenone (listed Step 2; requires prior use of one Step 1 medication or history of prior use of any Step 2 medication in this table within the previous 130 days)
pioglitazone	pioglitazone (Step 2; requires prior use of one Step 1 medication or history of prior use of any Step 2 medication in this table within the previous 130 days)
Riomet ER	metformin solution ER (listed Step 2; requires prior use of one Step 1 medication or history of prior use of any Step 2 medication in this table within the previous 130 days)
Actoplus Met	pioglitazone/metformin (Step 3; requires prior use of two Step 2 medications OR history of prior use of a Step 3 medication in this table within the previous 130 days)
Duetact	pioglitazone and glimepiride (Step 3; requires prior use of two Step 2 medications OR history of prior use of a Step 3 medication in this table within the previous 130 days)
Fortamet	metformin ER (Step 3; requires prior use of two Step 2 medications OR history of prior use of a Step 3 medication in this table within the previous 130 days)
Glumetza	metformin ER (Step 3; requires prior use of two Step 2 medications OR history of prior use of a Step 3 medication in this table within the previous 130 days)

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Formulary status abbreviationsmixed

QCD	Quality Care Dosing (quantity limits policy #621B)
ST	Step Therapy
NFNC	Non-Formulary Non-Covered

Prior use lookback — 130-day history of prior step medication use

Lookback windowHistory of prior use of any medication in the relevant step within the previous 130 days

Evidence source for prior usePrescription claim records are used to establish prior use within the previous 130 days

When claims insufficientAdditional provider documentation (chart notes, labs or other clinical information) required when claim history does not establish prior use

Applies toStep 2 agents requiring one Step 1 or Step 2 history and Step 3 agents requiring two Step 2 or Step 3 history, per product tables

Prior use look-back — alternate reference

Prior-use claim method

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for pharmacy (Rx) benefit medications under this policy. To request coverage, providers may call Pharmacy Operations or submit the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm) or fax the printed form.

Applies to Rx benefit (not MED)
Applies to commercial members with BCBSMA formulary: Managed Care (HMO/POS), PPO/EPO, Indemnity, MEDEX with Rx plans, Managed Blue for Seniors

Note

Contact and Benefit Applicability

Step Therapy and Prior Authorization apply to the Rx benefit. Pharmacy Operations handles requests and can be reached at the phone and fax above. Prior authorization/step therapy requirements may result in alternative cost-share for non-preferred or non-formulary drugs if an exception is approved.

Contact: Pharmacy Operations — Tel: 1-800-366-7778; Fax: 1-800-583-6289
Use Massachusetts Standard Form for Medication Prior Authorization Requests (eForm) or fax form #434

Terminology and Abbreviations

QCD — Quality Care Dosing

DefinitionQCD = Quality Care Dosing (quantity limits policy #621B)

Policy linkQuantity limits governed by policy #621B

Formulary notationQCD appears in product tables to indicate quantity limit application

ST — Step Therapy

DefinitionST = Step Therapy

StructureThree-step structure: Step 1 (formulary/generics), Step 2 (requires prior use of one Step 1 or history of Step 2 within 130 days), Step 3 (requires prior use of two Step 2 or history of Step 3 within 130 days)

Application

Policy Scope and Context

This policy governs use of oral anti‑diabetic medications for treatment of Type 2 Diabetes Mellitus and enforces a three-step formulary structure with associated step-therapy and quantity‑limit rules. It applies to pharmacy (Rx) benefit medications, requires prior authorization where specified, and references Quality Care Dosing (QCD) quantity limits (policy #621B). Providers must document prior therapies and meet the step/prior‑use lookback (typically 130 days) to establish eligibility for higher-step or NFNC agents.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyStep therapy and quantity limits for oral anti-diabetic medications

Policy CodePolicy 041

Change TypeMaterial updates to Rx/step therapy application and formulary listings

Effective Date

Next Review Date

Key ActionSubmit prior authorization using the Formulary Exception/Prior Authorization form and include documentation of prior trials or clinical rationale.

SourceLink

On This Page

The plan uses prescription claim records to support prior use within the previous 130 days

Provider backup documentationWhen historic prescription claim data are not available or do not establish prior use, additional documentation is required from the provider

Documentation examplesChart notes, lab results, or other clinical information may be submitted to support prior use or reasons alternatives were not tried

Step Therapy

Step Therapy Structure

The policy uses a three-step step-therapy structure. Step 1 includes preferred generics and formulary agents with no requirements. Step 2 includes agents that require prior use of ONE Step 1 medication or a history of prior use of any Step 2 medication within the previous 130 days. Step 3 includes non-formulary/non-covered (NFNC) agents that generally require prior use of TWO Step 2 medications or history of prior use of a Step 3 medication within the previous 130 days.

Step 1: Covered with no requirements — preferred generics (e.g., metformin, sulfonylureas)
Step 2: Requires prior use of ONE Step 1 medication or prior Step 2 use within previous 130 days (many branded SGLT2/DPP-4 products)
Step 3: Requires prior use of TWO Step 2 medications or prior Step 3 use within previous 130 days (many NFNC agents)

Step Therapy

Step Therapy Rules Overview

All requests must meet the step therapy requirements. For non-covered medications, the member must have had prior treatment failure with, or contraindication to, at least two covered formulary alternatives when available. The plan uses prescription claims within the previous 130 days to establish prior use; when claims data are unavailable or incomplete, providers must supply clinical documentation.

Requests for non-covered drugs require prior failure or contraindication to at least two covered formulary alternatives when available
Prescription claim records within previous 130 days will be used to verify prior use; additional provider documentation may be required if claim data are insufficient

Documentation Required

Provider Documentation Requirements

Provider must document the name and strength of formulary alternatives tried and failed (including dates if available) and specifics about the treatment failure. If clinical reasons prevent trial of formulary alternatives, provide specific clinical rationale.

Include medication name, strength, dates of use (if available), and description of treatment failure
If not trialing formulary alternatives, provide clinical justification preventing switch to formulary agent

Denial Risk

Denial Risk for Failing Criteria

Requests that do not meet clinical criteria may be denied. Requests based exclusively on sample use or with no prior-use claim history will not meet coverage criteria unless sufficient clinical documentation is submitted. Providers may request Individual Consideration for atypical patients when policy criteria are unlikely to be clinically effective.

Denial triggers include reliance solely on medication samples and lack of supporting prescription claim history without adequate clinical documentation
Providers may submit an Individual Consideration/exception request for atypical patients with supporting clinical evidence

Documentation Required

Required Documentation

Provider must submit supporting documentation (e.g., chart notes, lab results, prescription history) to show that the member met all approval criteria. Additional documentation will be required when prescription claim data are not available or fail to establish prior use or trial and failure of formulary alternatives.

Supporting documents may include chart notes, lab results, and prescription fill history
If claims data do not establish prior trials, include documentation showing clinical reasons and dates of prior therapies

Per-product tables list step assignment and specific prior-use requirements that must be met for authorization

NFNC — Non-Formulary Non-Covered

DefinitionNFNC = Non-Formulary Non-Covered

Coverage implicationMedications listed as NFNC are considered non-covered unless specified prior use criteria are met

Common examplesMultiple branded agents and certain metformin ER products are labeled NFNC in the product tables

Type 2 Diabetes Mellitus — Requirement for SGLT2 medical necessity

Required diagnosisDocumented diagnosis of Type 2 Diabetes Mellitus is required for medical necessity of SGLT2 inhibitors

Step therapy must be metSGLT2 agents must meet class-specific step therapy requirements listed in the step tables (prior-use rules and 130-day lookback apply)

DocumentationProvider must submit supporting documentation when prescription claim history does not establish prior use

Abbreviations — QCD / ST / NFNC

QCDQuality Care Dosing (quantity limits policy #621B)

STStep Therapy

NFNCNon-Formulary Non-Covered