CurrentMass General Brigham Health PlanPolicy N/A

Thiazolidinedione (TZD) Containing Products

Pharmacy benefit policy describing prior authorization and step therapy requirements for TZD-containing antidiabetic medications for Commercial/Exchange Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyThiazolidinedione (TZD) Containing Products

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 17, 2019

Next Review DateApr 17, 2019

Key ActionSubmit a prior authorization when initial step therapy requirements are not met for second-line TZD medications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Commercial/ExchangeApplicable plan

180Lookback (days)

12 monthsMax approval

PA + Step TherapyProgram types

Coverage and Approval Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

General pathways to approval

Pathway A: Stabilized on requested medication: Member has a diagnosis of Type II Diabetes mellitus AND the patient has been started and stabilized on the requested medication.
Pathway B: Metformin trial and inadequate response: Member has a diagnosis of Type II Diabetes mellitus AND patient has tried metformin or a metformin-containing product AND had a documented inadequate response.
Pathway C: Metformin contraindication: Member has a diagnosis of Type II Diabetes mellitus AND patient has a documented side effect, allergy or contraindication to metformin (examples: renal insufficiency, liver disease, heart failure, history of lactic acidosis).

ref

title

ref_orig_missing_fields_note

title_missing_fields_note

ref_orig_missing_fields_note_removed_for_validity

ref_missing_placeholder

ref_error_cleanup

ref_placeholder_removed

ref_error_final

ref

ref_invalid_removed

ref

Alogliptin/pioglitazone criteria

For alogliptin/pioglitazone combination product specifically:

Alogliptin/pioglitazone specific: A diagnosis of Type II Diabetes mellitus AND patient has tried either an alogliptin or a pioglitazone product AND had a documented inadequate response AND (the patient has been started and stabilized on the requested medication OR patient has tried metformin or a metformin-containing product with documented inadequate response).

There are no explicit exclusions listed in this policy beyond the program’s standard step-therapy and prior authorization (PA) requirements. The policy’s coverage guidelines enumerate the second-line thiazolidinedione (TZD) products and the approval pathways, but do not add other product-specific or population-wide exclusions outside the step-therapy/PA framework.

Use of second-line TZD-containing products will be denied at the point of sale when the prescription does not meet the initial step-therapy requirements and no prior authorization has been obtained. Prescriptions that fail the step-therapy criteria will adjudicate as a denial with an instruction that a PA is required; coverage for the second-line agent is only available after meeting the step-therapy pathway or receiving an approved prior authorization.

Medications and Coding

Covered medication products (by name)mixedCovered

pioglitazone	pioglitazone
pioglitazone/metformin	pioglitazone/metformin
pioglitazone/glimepiride	pioglitazone/glimepiride
Avandia	Avandia
Actoplus Met XR	Actoplus Met XR
alogliptin/pioglitazone	alogliptin/pioglitazone
NDCs not specified	Policy refers to named products but does not list specific NDC codes.

Step therapy lookback

Lookback periodMember must have filled a first-line medication or a second-line medication within the past 180 days to meet the step-therapy requirement for automatic payment of second-line agents.

PurposeEstablishes eligibility for second-line TZD-containing product to adjudicate at point of sale without prior authorization.

Applies toAll second-line TZD-containing products listed in this policy (e.g., pioglitazone and combinations).

Provider Actions, Prior Authorization, and Point-of-Sale

Prior Authorization

Prior Authorization Required for Second-Line TZD Products

Prior authorization is required for second-line thiazolidinedione (TZD) products when the member does not meet the initial step-therapy requirements at the point of sale. If the POS claim does not meet step-therapy rules it will deny with a message to submit a PA request.

Second-line TZD products include: pioglitazone, pioglitazone/metformin, pioglitazone/glimepiride, Actoplus Met XR, alogliptin/pioglitazone, and similar combinations.

Step Therapy

Initial Step-Therapy Rules

First-line agents are covered without prior authorization and will adjudicate automatically at the point of sale when initial step-therapy requirements are met. Second-line agents will pay at POS only if the member has filled a first-line medication or a second-line medication within the past 180 days.

First-line coverage: metformin or a metformin-containing product (no PA required).
Second-line coverage at POS: member must have a pharmacy claim for a first-line or second-line agent within the past 180 days; otherwise the claim will deny and require PA.

Documentation Required

Required Clinical Documentation for Prior Authorization

When requesting prior authorization for a second-line medication, include documentation that supports medical necessity. Approval will be granted only when required clinical evidence is provided.

Documentation of a diagnosis of Type II Diabetes Mellitus.
Evidence the patient has been started and stabilized on the requested second-line medication OR documentation that the patient tried a first-line agent (metformin or metformin-containing product) with an inadequate response.
If applicable, documentation of a trial and inadequate response to either component for combination products (e.g., alogliptin or pioglitazone for alogliptin/pioglitazone).
If metformin was not used or was stopped, documentation of a contraindication, allergy, or intolerance to metformin (examples: renal insufficiency, liver disease, heart failure, history of lactic acidosis).

Denial Risk

Point-of-Sale Denial Triggers

Prescriptions that fail to meet the initial step-therapy rules will deny at point of sale and require submission of a prior authorization with the clinical documentation listed above.

POS denial triggers: any second-line TZD or combination product when there is no eligible first-line or second-line fill in the past 180 days.
To avoid POS denial, ensure the member has an eligible claim history or submit PA with complete supporting documentation.

Definitions and Medication Categories

Second-line medications (TZD-containing)

Included TZD agentsPioglitazone (single-agent, e.g., Actos) and rosiglitazone (Avandia).

Pioglitazone combinationsPioglitazone/metformin; pioglitazone/glimepiride; Actoplus Met XR (pioglitazone + metformin).

Alogliptin combinationAlogliptin/pioglitazone combination product (specific criteria apply).

Policy scope noteSecond-line = pioglitazone, pioglitazone/metformin, pioglitazone/glimepiride, Actoplus Met XR, alogliptin/pioglitazone (rosiglitazone/Avandia also listed).

First-line medications

First-line agentMetformin (single-agent).

Metformin-containing productsMetformin combinations are considered first-line and are covered without prior authorization per step-therapy rules.

Coverage behaviorFirst-line medications listed on first-line are covered without prior authorization and satisfy step-therapy requirements for second-line agents when filled within the lookback period.

Background

Thiazolidinediones (TZDs) such as pioglitazone and rosiglitazone, and TZD-containing combination products, are categorized as second-line oral agents for the treatment of Type II Diabetes Mellitus in this policy. First-line therapy is metformin (or metformin-containing products), which are covered without prior authorization; second-line TZD agents are intended for use when metformin is inadequate, not tolerated, or when a patient has been stabilized on the requested TZD medication. For payment to process automatically, the member must have a relevant fill of a first-line or second-line agent within the past 180 days, otherwise PA documentation demonstrating one of the policy’s approval pathways (stabilized on the requested medication, documented inadequate response to metformin, or contraindication/intolerance to metformin) is required.