CurrentCignaPolicy IP0090

HIV antiretroviral products (darunavir propylene glycolate; Truvada) coverage criteria

Defines medical necessity criteria and coverage parameters for specific HIV products (darunavir propylene glycolate and Truvada) for Cigna-administered Individual and Family Plans; affects providers requesting coverage for these products.

Policy Summary

PayerCigna

PolicyHIV antiretroviral products (darunavir propylene glycolate; Truvada) coverage criteria

Policy CodePolicy IP0090

Change TypeRemoval — Descovy

Effective DateJan 1, 2025

Next Review Date

Key ActionObtain and document a trial of the bioequivalent generic product and justification if the member cannot tolerate the generic due to an inactive-ingredient allergy or serious adverse reaction.

SourceLink

POLICY UPDATE CHANGES

Removed Descovy from the policy.

2products listed for review

12 moapproval duration

IFPplan type governed

1explicit exclusions

Coverage and Medical Necessity Criteria

Policy Summary

PayerCigna

PolicyHIV antiretroviral products (darunavir propylene glycolate; Truvada) coverage criteria

Policy CodePolicy IP0090

Change TypeRemoval — Descovy

Effective DateJan 1, 2025

Next Review Date

SourceLink

On This Page

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.

Darunavir propylene glycolate (600 mg, 800 mg): Darunavir propylene glycolate is considered medically necessary when there is documented trial of darunavir ethanolate (generic for Prezista) AND the member cannot take darunavir ethanolate due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction.

Applies to Individual and Family Plans

Truvada (emtricitabine/tenofovir disoproxil fumarate): Truvada is considered medically necessary when the individual meets BOTH of the following: (1) Documentation of ONE of the following indications: A. Treatment of HIV; B. HIV Preexposure Prophylaxis (PrEP); C. HIV Postexposure Prophylaxis (PEP); D. Treatment of Hepatitis B. AND (2) Documented trial of emtricitabine/tenofovir disoproxil fumarate (the bioequivalent generic product) AND cannot take it due to a formulation difference in the inactive ingredient(s) resulting in a significant allergy or serious adverse reaction.

Applies to Individual and Family Plans

Provider Requirements and Authorization Procedures

Prior Authorization

Prior authorization and approval duration

Coverage requires meeting the listed medical necessity criteria and, when approved, initial and reauthorization approvals are for 12 months.

Step Therapy

Step therapy / trial of generic required

A documented trial of the reference generic or bioequivalent product is required before coverage of the brand formulation will be approved. Examples include a trial of darunavir ethanolate for darunavir propylene glycolate products, or emtricitabine/tenofovir disoproxil fumarate for Truvada.

Step therapy applies to affected products: trial of the generic/bioequivalent is required prior to brand coverage.
If the generic trial is not documented, prior authorization will be denied.

Documentation Required

Required documentation for formulation-difference justification

When a member cannot use the generic or bioequivalent product due to a formulation-related safety concern, the provider must document the trial of the referenced generic/bioequivalent and provide clinical justification that the member cannot take the generic because of a formulation difference in inactive ingredient(s) that would result in a significant allergy or serious adverse reaction.

Documentation must include evidence of the trial (dates, dose, duration) and clinical rationale for intolerance or allergy to the generic's inactive ingredients.
Notes such as patient-reported intolerance without supporting clinical detail may be insufficient for approval.

Note

Sample product note

Receipt of sample product does not satisfy any criteria requirements for coverage.

Denial Risk

Denial for non-specified uses

Uses of the listed products for indications other than those specified in the coverage criteria are considered experimental, investigational or unproven and are not covered.

Any other use is considered experimental, investigational or unproven and may be denied.

Product-specific Definitions and Formulation Notes

Darunavir propylene glycolate — key facts

TermDarunavir propylene glycolate (600 mg, 800 mg)

Medical necessity conditionConsidered medically necessary only when there is a documented trial of darunavir ethanolate (generic for Prezista)

Inability to take genericMember cannot take darunavir ethanolate due to a formulation difference in inactive ingredient(s) that would result in a significant allergy or serious adverse reaction

Plan applicabilityApplies to Individual and Family Plans

Supporting requirementDosage, frequency, duration, and site of care must be reasonable, clinically appropriate, and supported by evidence-based literature

Truvada — key facts

TermTruvada (emtricitabine/tenofovir disoproxil fumarate)

Indications (one required)Treatment of HIV; HIV Preexposure Prophylaxis (PrEP); HIV Postexposure Prophylaxis (PEP); Treatment of Hepatitis B

Medical necessity conditionDocumented trial of emtricitabine/tenofovir disoproxil fumarate (the bioequivalent generic) and inability to take it due to a formulation difference in inactive ingredient(s) causing a significant allergy or serious adverse reaction

Logic for coverageBoth: (1) documentation of one indicated use AND (2) documented trial of the bioequivalent generic with documented inability to use it

Plan applicabilityApplies to Individual and Family Plans

Clinical and Policy Background

Antiretroviral agents are used both to treat HIV infection and for prevention strategies, including pre‑exposure prophylaxis (PrEP) and post‑exposure prophylaxis (PEP). Truvada (emtricitabine/tenofovir disoproxil fumarate) is addressed in this policy and may be medically necessary for treatment of HIV, for PrEP or PEP, and for treatment of hepatitis B when the medical necessity criteria are met, including documentation of a trial of the bioequivalent generic and inability to tolerate that product due to a formulation‑related significant allergy or serious adverse reaction. For the most current clinical recommendations, refer to NIH HIV treatment and prevention guidelines.