ModifiedBlue Cross Blue Shield - MassachusettsPolicy 041

Step therapy and quantity limits for oral anti-diabetic medications

Defines step therapy, prior authorization, and quantity-limit rules for formulary anti-diabetic medications for BCBSMA commercial members; applies to prescribing providers and pharmacy operations for commercial lines listed. Individual consideration procedures are included for atypical patients.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyStep therapy and quantity limits for oral anti-diabetic medications

Policy CodePolicy 041

Change TypeAdded multiple Step 3 agents and DPP-4 entries

Effective Date1/15/2026

Next Review Date

Key ActionSubmit prior authorization using the Formulary Exception/Prior Authorization form by phone, fax, or mail to Pharmacy Operations with documentation of prior trials and supporting records.

SourceLink

POLICY UPDATE CHANGES

Added Brynovin as Step 3.

Added Cycloset as Step 3.

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

Added bexagliflozin to step 3 of SGLT2 table.

Added sitagliptin & sitagliptin/metformin to the policy.

RequiredStep Therapy

CommercialPlan population

130 daysLookback

PresentNFNC agents

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Coverage Criteria

Traditional Anti-diabetic Medications - Initial coverage

Covered when ALL of the following are met:

Traditional anti-diabetic coverage: Documented diagnosis of Type 2 Diabetes Mellitus.

Step therapy requirement: Meet the step therapy requirements described below (see step tables for class/drug-specific prior-use rules).

Step 1 agents are preferred; Step 2/3 require prior use of Step 1/2 agents or specific prior-use counts as detailed in policy tables.

DPP-4 Inhibitors - Initial coverage

Covered when ALL of the following are met:

DPP-4 coverage: Documented diagnosis of Type 2 Diabetes Mellitus.

Step therapy requirement for DPP-4: Meet the step therapy requirements described below; DPP-4 agents are assigned to Steps with prior-use and 130-day lookback rules as specified in the drug tables.

Examples: sitagliptin and saxagliptin require prior use of ONE Step 1 medication or history of any Step 2 within previous 130 days for Step 2 status; several DPP-4 agents are NFNC and require more prior use (see tables).

SGLT2 inhibitors - medical necessity

Covered when ALL of the following are met:

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

See step therapy requirements for medication-specific prior use.

SGLT2 step therapy: Meet the step therapy requirements described below: prior use of required lower-step medications within the previous 130 days or documented history of prior use of specified step medications as listed in the tables.

Many Step 2 SGLT2 agents require prior use of ONE Step 1 medication; many Step 3 agents require prior use of TWO Step 2 medications.

Step 2 and Step 3 prior-use logic

Coverage dependent on stepwise prior therapy:

Step 2 requirement: For Step 2 drugs (examples: Farxiga, Jardiance, Glyxambi, Synjardy), requires prior use of ONE Step 1 medication OR history of prior use of any Step 2 medication within the previous 130 days.within previous 130 days

Applies per drug as listed in tables.

Step 3 requirement: For Step 3 drugs (examples: Invokana, Brenzavvy, Steglatro, Steglujan, Segluromet, certain dapagliflozin products), requires prior use of TWO Step 2 medications OR history of prior use of a Step 3 medication within the previous 130 days.within previous 130 days

Many Step 3 agents are designated NFNC and subject to QCD; see tables for formulary status and exact prior-use requirements.

Coverage of medications that are FDA-approved for non-diabetic indications is not determined by this step therapy policy. Such uses are governed by the related medical policies listed in the Related Policies section; providers should consult those specific policies for coverage criteria when a drug is prescribed for a non-diabetic indication.

Several agents in the tables are designated NFNC (Non‑Formulary Non‑Covered). These NFNC designations are subject to the policy’s step therapy requirements and quantity‑limit (Quality Care Dosing) rules; an NFNC status indicates that the drug is not routinely covered under the formulary unless the member meets the step therapy prior‑use criteria or an approved exception is granted.

Per the policy, all requests must meet the step therapy requirement and for non‑covered medications the member generally must have prior treatment failure with, or a contraindication to, at least two covered formulary alternatives when available. NFNC agents shown with QCD are additionally subject to quantity limits defined by the Quality Care Dosing policy.

For NFNC‑designated agents, the policy requires documentation of prior use of lower‑step therapies before consideration. Specifically, many NFNC Step 3 agents require prior use of two Step 2 medications or documentation of prior use of a Step 3 medication within the previous 130 days to meet the step therapy requirement.

Examples in the drug tables (e.g., ertugliflozin/sitagliptin combinations, sitagliptin products, bexagliflozin, and several canagliflozin formulations) are listed as NFNC and state the explicit requirement of prior trials of two Step 2 agents or a recent Step 3 history as the condition for consideration.

Agents listed as NFNC are considered non‑covered unless the step therapy and prior‑use criteria are met or an approved exception/individual consideration is granted. Requests that do not demonstrate the required prior therapy or an approved exception may be denied, and member cost‑share consequences (e.g., higher non‑preferred copay) may apply if an exception is approved.

Providers seeking coverage for NFNC agents should follow the individual consideration/exception process and supply the required supporting documentation showing prior trials, contraindications, or clinical rationale per the policy’s documentation requirements.

Coding and Code Lists

SGLT2 and combination products listed in policymixed

Farxiga	dapagliflozin (ST, QCD) - requires prior use of ONE step 1 medication OR history of prior use of any step 2 medication within the previous 130 days
Jardiance	empagliflozin (ST, QCD) - requires prior use of ONE step 1 medication OR history of prior use of any step 2 medication within the previous 130 days
Glyxambi	empagliflozin / linagliptin (ST, QCD) - requires prior use of ONE step 1 medication OR history of prior use of any step 2 medication within the previous 130 days
Synjardy	empagliflozin / metformin (ST, QCD) - requires prior use of ONE step 1 medication OR history of prior use of any step 2 medication within the previous 130 days
Xigduo XR	dapagliflozin / metformin (ST, QCD) - requires prior use of ONE step 1 medication OR history of prior use of any step 2 medication within the previous 130 days
Invokana	canagliflozin (NFNC, QCD) - requires prior use of TWO step 2 medications OR history of prior use of a step 3 medication within the previous 130 days
Invokamet / XR	canagliflozin / metformin (NFNC, QCD) - requires prior use of TWO step 2 medications OR history of prior use of a step 3 medication within the previous 130 days
Steglatro	ertugliflozin (NFNC, QCD) - requires prior use of TWO step 2 medications OR history of prior use of a step 3 medication within the previous 130 days
Steglujan	ertugliflozin and sitagliptin (NFNC, QCD) - requires prior use of TWO step 2 medications OR history of prior use of a step 3 medication within the previous 130 days
Segluromet	ertugliflozin and metformin (NFNC, QCD) - requires prior use of TWO step 2 medications OR history of prior use of a step 3 medication within the previous 130 days

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DPP-4 agents and combinationsmixed

sitagliptin	DPP-4 agent; listed as NFNC and requires prior use of TWO step 2 medications OR history of prior use of a step 3 medication within the previous 130 days
sitagliptin / metformin (Zituvimet)	listed as NFNC with requirement of prior use of TWO step 2 medications OR history of prior use of a step 3 medication within the previous 130 days
saxagliptin (Onglyza)	listed as NFNC and requires prior use of TWO step 2 medications OR history of prior use of a step 3 medication within the previous 130 days
linagliptin (Tradjenta)	DPP-4 agent listed as NFNC and requires prior use of TWO step 2 medications OR history of prior use of a step 3 medication within the previous 130 days

Prior-use lookback window (inv-11)

Prior-use lookback windowPrevious 130 days — prescription claim records are used to establish prior use within the previous 130 days

Evidence sources acceptedPrescription claim records; if unavailable, provider must submit supporting documentation (chart notes, lab results) to demonstrate prior use

ApplicationApplies to step therapy prior-use checks for many Step 2 and Step 3 agents across classes

Prior use lookback (inv-12)

Required lookback intervalPrevious 130 days — prior use must be documented within the previous 130 days for step-therapy consideration

How prior use is verified

Provider Actions and Requirements

Prior Authorization

Prior Authorization and contact

Many medications in this policy require prior authorization. Providers may request coverage using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm) or the BCBSMA Formulary Exception/Prior Authorization form. To submit: call Pharmacy Operations at 1-800-366-7778 or fax 1-800-583-6289. Use the eForm link or print-and-fax form #434 when applicable.

Phone: 1-800-366-7778
Fax: 1-800-583-6289
Prior Authorization / Formulary Exception form (MA Standard eForm or #434)

Step Therapy

SGLT2 inhibitors require step-therapy prior authorization

SGLT2 inhibitors on the formulary are subject to step therapy and prior authorization. Approval typically requires a documented diagnosis of Type 2 Diabetes Mellitus and evidence of prior use of preferred agents as described in the step structure (see Step 1 and Step 2 prerequisites).

Documented Type 2 Diabetes diagnosis required

Background

This policy governs use of oral and selected injectable antihyperglycemic agents for the treatment of Type 2 Diabetes Mellitus. It organizes medications into a three‑tier Step Therapy structure (Step 1 / Step 2 / Step 3) and applies prior‑use and quantity‑limit rules to determine medical necessity for coverage under BCBSMA commercial plans.

Step assignments and prior‑use rules in the policy tables define when Step 1 agents (preferred) should be used first, when Step 2 agents require evidence of prior Step 1 use, and when Step 3 agents require evidence of prior Step 2 use. Many agents are also subject to Quality Care Dosing (QCD) quantity limits referenced to policy #621B.

Providers and pharmacy operations must follow the step therapy prior authorization process for covered and non‑covered agents; approvals typically require a documented diagnosis of Type 2 Diabetes and supporting evidence of prior trials or treatment failures as outlined in the tables and the policy’s prior‑use lookback rules.

Definitions

Definitions: QCD / ST / NFNC (inv-22)

QCDQuality Care Dosing (quantity limits policy #621B)

STStep Therapy

NFNCNon-Formulary Non-Covered

QCD — Quality Care Dosing (inv-23)

Policy referenceQuality Care Dosing = quantity limits policy #621B

Where appliedQCD quantity limits are applied to many SGLT2 agents and other formulary products as noted in drug tables

Interaction with step therapyDrugs subject to QCD may still require Step Therapy prior-use requirements in addition to quantity limits

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyStep therapy and quantity limits for oral anti-diabetic medications

Policy CodePolicy 041

Change TypeAdded multiple Step 3 agents and DPP-4 entries

Effective Date1/15/2026

Next Review Date

Key ActionSubmit prior authorization using the Formulary Exception/Prior Authorization form by phone, fax, or mail to Pharmacy Operations with documentation of prior trials and supporting records.

SourceLink

On This Page

Prescription claim records are used to support prior use; when claims do not establish prior use, provider must supply supporting documentation

Classes referencedApplies to DPP-4 and SGLT2 prior-use rules where history within 130 days affects Step 1/2/3 determinations

Many SGLT2 products flagged as ST (step therapy) and QCD (quality care dosing)

Prior use of ONE Step 1 medication or history of prior use of any Step 2 medication within the previous 130 days is frequently required

Documentation Required

Provider documentation requirements

Provider must document the name and strength of formulary alternative(s) tried and failed (include dates when available) and provide specifics regarding treatment failure or contraindication. If clinical reasons prevent trial of formulary agent(s), include detailed clinical justification.

Include name and strength of alternatives tried and failed
Provide dates of use when available and specifics of treatment failure
Supply clinical rationale for contraindications or inability to trial alternatives

Step Therapy

Step therapy general rule

All requests must meet the Step Therapy general rule: members must trial and fail required lower-step or covered formulary alternatives first. For non-covered medications, the member must have had prior failure with or contraindication to at least two covered formulary alternatives when available. A higher non-preferred cost share may be applied if an exception is approved for a non-preferred or non-formulary drug.

All requests must meet step therapy requirement
Non-covered drugs require failure of (or contraindication to) at least two covered alternatives when available
Exception approvals may result in higher member cost share

Step Therapy

Step therapy structure and prerequisites

The policy organizes medications into Step 1, Step 2 and Step 3 with specific formulary status and prerequisites. Many Step 2 agents require prior use of one Step 1 agent (or prior use of any Step 2 agent within the previous 130 days). Many Step 3 agents require prior use of two Step 2 agents (or prior use of a Step 3 agent within the previous 130 days). See the drug tables for agent-specific prior use windows and required number of prior agents.

Step 1: covered agents with no prior requirements (generics like metformin, acarbose, sulfonylureas, etc.)
Step 2: typically requires prior use of ONE Step 1 agent or history of any Step 2 use within prior 130 days
Step 3: typically requires prior use of TWO Step 2 agents or history of Step 3 use within prior 130 days
Agent-specific exceptions and QCD (quality care dosing) flags shown in tables

Documentation Required

Supporting documentation for prior use

When prescription claims history is unavailable or does not establish required prior use or trial and failure of formulary alternatives, providers must submit supporting documentation (e.g., chart notes, lab results, or other clinical information). Requests based solely on free samples will not satisfy prior use criteria.

Submit chart notes, lab results or other clinical evidence when claims data is missing
Claims records may be used to establish prior use within previous 130 days
Requests based only on samples are insufficient and risk denial

Denial Risk

Documentation and sample-based denials

Requests that do not meet the clinical criteria or step therapy requirements may be denied. Lack of adequate supporting documentation (including reliance solely on samples) increases risk of denial and may result in higher member cost share if an exception is not approved.

Insufficient documentation or unmet step criteria may result in denial
Sample-only evidence will not meet coverage criteria
Higher member cost share may apply if exception denied

NFNC — Non-Formulary Non-Covered (inv-24)

DefinitionNon-Formulary Non-Covered (NFNC) — formulary designation indicating the agent is non-covered unless step therapy/prior-use criteria or an approved exception are met

Common consequenceNFNC agents typically require prior use of TWO Step 2 medications or history of a Step 3 within the previous 130 days for consideration

Denial riskAgents listed as NFNC are considered non-covered unless criteria or an individual exception are approved

ST — Step Therapy (inv-25)

DefinitionStep Therapy (ST) — a tiered prior-therapy program organizing medications into Step 1, Step 2, and Step 3 with specified prior-use requirements

General ruleNon-covered medications require prior failure or contraindication to at least two covered formulary alternatives when available; step-specific prior-use counts are defined in drug tables

Prior-use examplesMany Step 2 agents require prior use of ONE Step 1 medication (or history of any Step 2 within 130 days); many Step 3 agents require prior use of TWO Step 2 medications (or history of a Step 3 within 130 days)