CurrentUnitedHealthcarePolicy 2025D0112D

Provider Administered Drugs - Preferred Products

Defines UnitedHealthcare's preferred and non-preferred provider-administered treprostinil products under the medical benefit and the criteria for covering non-preferred alternatives; applies to providers submitting medical benefit drug claims.

Policy Summary

PayerUnitedHealthcare

PolicyProvider Administered Drugs - Preferred Products

Policy CodePolicy 2025D0112D

Change TypeRevised non-preferred product list

Effective DateJul 1, 2025

Next Review Date

Key ActionStart members new to therapy on the UnitedHealthcare preferred treprostinil product unless Preferred Product Criteria are met and physician attestation is provided.

SourceLink

POLICY UPDATE CHANGES

Revised list of non-preferred medical drug products and removed specific inactive Par Sterile Products NDCs.

Updated Benefit Considerations section to reflect the most current information.

1HCPCS code listed

6Preferred presentations

5+Non-preferred listings

Coverage Criteria

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Preferred product coverage: Coverage provided for UnitedHealthcare preferred treprostinil products when applicable Diagnosis-Specific Criteria are met.

Preferred products listed in policy.

Non-preferred product coverage: Treatment with a listed non-preferred product is medically necessary for proven indications when BOTH of the following are met: history of intolerance or contraindication to one of UnitedHealthcare's preferred products; and physician attests that the same intolerance/contraindication/adverse event would not be expected to occur with the respective non-preferred product.

Members new to therapy must use preferred product unless Preferred Product Criteria are met.

Use of a non-preferred treprostinil product for a member who is new to therapy is not routinely covered unless the member meets the Preferred Product Criteria. Members new to therapy are required to start on the UnitedHealthcare preferred product; coverage of a listed non-preferred product requires BOTH: a documented history of intolerance or contraindication to a UnitedHealthcare preferred product, and a physician attestation that the same intolerance/contraindication or adverse event would not be expected with the requested non-preferred product.

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage of non-preferred treprostinil products. Coverage of any listed non-preferred product requires meeting the Preferred Product Criteria and Diagnosis-Specific Criteria.

Non-preferred products: coverage contingent on meeting Preferred Product Criteria and Diagnosis-Specific Criteria
Prior authorization required for non-preferred treprostinil products

Step Therapy

Step Therapy Requirement for New-to-Therapy Members

New-to-therapy members must use the UnitedHealthcare preferred product. Coverage may be denied if the member is new to therapy and has not tried the preferred product unless an exception in the Preferred Product Criteria is met.

Members new to therapy are required to trial the preferred product before a non-preferred product will be covered
Denial risk if preferred product not tried and no exception documented

Documentation Required

Physician Attestation and Documentation Required

To obtain coverage for a non-preferred product, the prescribing physician must document a history of intolerance or contraindication to the UnitedHealthcare preferred product and provide an attestation that the same intolerance, contraindication, or adverse event would not be expected with the non-preferred product.

Physician attestation must state the specific intolerance or contraindication to the preferred product
Attestation must confirm in the physician's clinical opinion the adverse event would not be expected with the non-preferred product

Step Therapy

Step Therapy Enforcement and Exceptions

Step therapy requires that members new to therapy trial the designated UnitedHealthcare preferred product before a non-preferred product will be approved, unless the Preferred Product Criteria (history of intolerance/contraindication plus physician attestation) are met.

Exceptions to step therapy allowed only when Preferred Product Criteria are satisfied
Ensure documentation of prior trial of the preferred product or applicable intolerance/contraindication and attestation

Background

Treprostinil is a prostacyclin analog administered by injection for pulmonary arterial hypertension and is available in multiple concentrations and manufacturer presentations. UnitedHealthcare designates certain manufacturer/labeler presentations as preferred; other brand or generic presentations are listed as non-preferred and are subject to the Preferred Product Criteria for coverage.

Definitions

Preferred product

DefinitionA UnitedHealthcare-designated manufacturer/labeler presentation of treprostinil that is the first-line product for members new to therapy.

Listed preferred presentationsTreprostinil 20mg/20mL; 50mg/20mL; 100mg/20mL; 200mg/20mL (Sandoz Inc./Novartis) — specific NDCs listed in policy.

Role in initial therapyMembers new to therapy must be started on a UnitedHealthcare preferred treprostinil product unless Preferred Product Criteria are met.

Coverage conditionCovered when applicable diagnosis-specific criteria are met and the preferred product is used as first-line.

Examples of preferred manufacturersSandoz Inc. (a Novartis Company) listings shown in policy.

Non-preferred product

DefinitionBrand or generic presentations of treprostinil not designated as UnitedHealthcare preferred; coverage requires meeting Preferred Product Criteria and any diagnosis-specific criteria.

Listed non-preferred presentationsRemodulin (treprostinil) 1 mg/mL, 2.5 mg/mL, 5 mg/mL, 10 mg/mL (United Therapeutics) and specified Teva/Dr. Reddy's treprostinil presentations (NDCs listed in policy).

Coverage requirementsTreatment with a listed non-preferred product is medically necessary only when BOTH: history of intolerance or contraindication to a UnitedHealthcare preferred product; AND physician attests the same adverse event would not be expected with the non-preferred product.

Prior authorization/step therapyMembers new to therapy are required to use the preferred product; coverage of non-preferred products requires meeting Preferred Product Criteria including physician attestation.

Denial riskUse of a non-preferred product for a member new to therapy without meeting Preferred Product Criteria would not meet the policy's conditions for medical necessity and may be denied.

Initial Therapy Criteria

Preferred product required for new-to-therapy members

Initial therapy rule for members new to therapy

Initial therapy preference: Members new to therapy must be started on UnitedHealthcare preferred treprostinil products unless Preferred Product Criteria are met.

Physician attestation required for exceptions.

Step Therapy

Requirement	Detail
Physician attestation is required	Physician attests that, in their clinical opinion, the same intolerance, contraindication, or adverse event would not be expected to occur with the respective non-preferred product.
Documented history required	History of intolerance or contraindication to one of UnitedHealthcare's preferred products must be documented.
Applicability to new-to-therapy members	Members new to therapy must use the UnitedHealthcare preferred product unless the Preferred Product Criteria (including physician attestation) are met.

Policy Summary

PayerUnitedHealthcare

PolicyProvider Administered Drugs - Preferred Products

Policy CodePolicy 2025D0112D

Change TypeRevised non-preferred product list

Effective DateJul 1, 2025

Next Review Date

Key ActionStart members new to therapy on the UnitedHealthcare preferred treprostinil product unless Preferred Product Criteria are met and physician attestation is provided.

SourceLink

On This Page

OpenPayer

Provider Administered Drugs - Preferred Products

Coverage Criteria

Coding

Provider Actions

Background

Definitions

Initial Therapy Criteria

Step Therapy