ModifiedHealth NetPolicy CP PMN.235

Emtricitabine/Tenofovir Alafenamide (Descovy)

Policy governing medical necessity and authorization criteria for Descovy for treatment of HIV-1 infection and for HIV pre-exposure prophylaxis (PrEP) across Health Net lines of business (Commercial, HIM, Medicaid). Affects prescribers and payers managing authorization requests.

Policy Summary

PayerHealth Net

PolicyEmtricitabine/Tenofovir Alafenamide (Descovy)

Policy CodePolicy CP PMN.235

Change TypeMaterial coverage edits (step therapy and redirection removed for PrEPNevada-specific management restrictions added)

Effective DateJun 1, 2020

Next Review Date

Key ActionSubmit prior authorization with documentation (chart notes, lab results) demonstrating member meets diagnosis, weight thresholds, and indication-specific criteria.

SourceLink

POLICY UPDATE CHANGES

Added disclaimer that medical management techniques, including quantity management beyond step therapy, is not allowed for members in Nevada per SB 439.

Removed redirection to generic Truvada per USPSTF PrEP recommendation.

2FDA-approved uses

12 monthsTypical approval duration

200/25 mgAdult dose

120/15 mgPediatric strength

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Coverage Criteria for Descovy (Emtricitabine/Tenofovir Alafenamide)

Initial Therapy

Covered when ALL of the following are met:

HIV-1 treatment initial: 1. Diagnosis of HIV-1 infection; 2. Descovy is prescribed in combination with other antiretroviral agents for the treatment of HIV-1 infection; 3. Member weighs >= 14 kg; 4. If treatment-naive and member weighs >= 17 kg, member must instead use emtricitabine/tenofovir disoproxil fumarate (generic Truvada) unless Truvada is contraindicated, clinically significant adverse effects occur, or the member has bone or renal comorbidities or risk factors; 5. Dose does not exceed weight-based maximums: for members 14 kg to <25 kg use 120 mg emtricitabine / 15 mg tenofovir alafenamide (1 tablet) once daily; for members >=25 kg use 200 mg emtricitabine / 25 mg tenofovir alafenamide (1 tablet) once daily.see weight thresholds

Approval duration: 12 months

Pre-exposure Prophylaxis

Covered when ALL of the following are met:

PrEP: 1. Member is HIV-negative and has no signs or symptoms of acute HIV infection; 2. Member is considered at risk for acquiring HIV and meets at least one risk criterion (examples include: engaging in sexual activity with an HIV-infected partner; inconsistent or no condom use; diagnosis of a sexually transmitted infection; exchange of sex for commodities; incarceration; not in a monogamous partnership; injection drug use; partner of unknown HIV status with risk factors); 3. Member weighs >= 35 kg; 4. Dose does not exceed 200 mg emtricitabine / 25 mg tenofovir alafenamide (1 tablet) per day.weight >=35 kg

PrEP indication excludes individuals at risk from receptive vaginal sex; Approval duration: 12 months

Continuation Therapy

Covered when ALL of the following are met:

Continuation: 1. Member is currently receiving Descovy via the Centene benefit or has documentation showing current therapy for at least 30 days; 2. Member is responding positively to therapy; 3. If the request is for a dose increase, the new dose does not exceed weight-based maxima: for members 14 kg to <25 kg use 120 mg/15 mg once daily; for all others use 200 mg/25 mg once daily.see weight thresholds

Approval duration: 12 months

Requests for use of Descovy for non‑FDA approved indications that are not specifically addressed within this policy must follow the organization’s off‑label use requirements. Such requests should include sufficient clinical documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies (for example, CP.CPA.09 for commercial lines or the corresponding program policy for Medicaid/marketplace). Without adequate supporting documentation consistent with those off‑label policies, coverage for non‑FDA indications will not be authorized.

When there is a conflict between this clinical policy and an applicable state Medicaid coverage provision, the state Medicaid coverage provision takes precedence. Providers and reviewers should consult the relevant state Medicaid manual for specific coverage rules that override this policy for Medicaid members.

Per the policy’s not‑authorized and off‑label guidance, requests for Descovy for indications that are not FDA‑approved and are not addressed in this policy will be considered not medically necessary unless there is sufficient supporting evidence of efficacy and safety supplied in accordance with the referenced off‑label use policies. Absence of such documentation may result in denial of the request.

Product Strengths, Dosing, and Coding

Product strengthsNDC

200/25 mg	Tablet: 200 mg emtricitabine / 25 mg tenofovir alafenamide
120/15 mg	Tablet: 120 mg emtricitabine / 15 mg tenofovir alafenamide

Weight thresholds

Pediatric weight thresholdMember must weigh ≥ 14 kg for HIV-1 treatment eligibility; dosing splits: 14 to <25 kg use 120/15 mg once daily; ≥ 25 kg use 200/25 mg once daily.

Treatment-naive pediatric considerationIf treatment-naive and member weighs ≥ 17 kg, prescribers are directed to use emtricitabine/tenofovir disoproxil fumarate (generic Truvada) unless contraindicated or clinically inappropriate.

PrEP weight thresholdFor PrEP, member must weigh ≥ 35 kg and dose must not exceed 200/25 mg (one tablet) per day.

Maximum daily dosesPrEP and adult/≥25 kg treatment maximum: 200 mg emtricitabine / 25 mg tenofovir alafenamide (one tablet) per day; pediatric 14 to <25 kg maximum: 120/15 mg QD.

Provider Requirements, Prior Authorization, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (e.g., chart notes, laboratory results, or other clinical information) supporting that the member meets all approval criteria for the requested indication (treatment of HIV-1 or PrEP). Requests for continuation, dose changes, or new starts must include evidence of diagnosis, weight where applicable, and prior therapy details when step therapy applies.

Affected therapies: Descovy (emtricitabine/tenofovir alafenamide) for HIV-1 treatment and HIV PrEP
Documentation required: diagnosis, weight, evidence of response to therapy for continuation, prior 30-day therapy documentation when applicable

Step Therapy

Step Therapy and Exceptions

Step therapy edits apply where specified: for treatment‑naive pediatric patients, members weighing ≥17 kg may be required to try emtricitabine/tenofovir disoproxil fumarate (generic Truvada) before Descovy unless contraindicated, clinically significant adverse effects occur, or member has bone/renal comorbidities or other documented risk factors. State-specific exceptions (for example, Illinois HIM per IL HB 5395) may bypass step therapy requirements.

Key Definitions

Pre-exposure prophylaxis (PrEP)

DefinitionPre-exposure prophylaxis (PrEP) is the use of antiretroviral medication by HIV-negative individuals to reduce the risk of acquiring HIV infection.

Eligibility clinical checksMember must be HIV-negative with no signs or symptoms of acute HIV infection prior to initiating PrEP.

Risk criteria examplesCovered when member is considered at risk (examples include sex with an HIV-infected partner, inconsistent condom use, STI diagnosis, exchange of sex for commodities, incarceration, non-monogamous partnership, injection drug use, or partner of unknown status with risk factors).

Limitations noted in policyPrEP indication in this policy excludes individuals at risk from receptive vaginal sex (effectiveness not evaluated).

Clinical policy / medical necessity guide

Purpose

Background on Descovy

Descovy is a fixed‑dose combination tablet of emtricitabine and tenofovir alafenamide (TAF). It is available as 200 mg/25 mg and a lower‑strength 120 mg/15 mg tablet for weight‑based pediatric dosing. The product is indicated for treatment of HIV‑1 infection in adults and pediatric patients with dosing determined by weight, and it is also indicated for HIV pre‑exposure prophylaxis (PrEP) in at‑risk adults and adolescents meeting the specified weight criteria.

Policy Summary

PayerHealth Net

PolicyEmtricitabine/Tenofovir Alafenamide (Descovy)

Policy CodePolicy CP PMN.235

Change TypeMaterial coverage edits (step therapy and redirection removed for PrEPNevada-specific management restrictions added)

Effective DateJun 1, 2020

Next Review Date

Key ActionSubmit prior authorization with documentation (chart notes, lab results) demonstrating member meets diagnosis, weight thresholds, and indication-specific criteria.

SourceLink

On This Page

Pediatric weight thresholds: alternative dosing and step requirements vary by weight band (see clinical criteria)
Exceptions to step therapy: documented contraindication to emtricitabine/tenofovir disoproxil fumarate, adverse effects, bone/renal comorbidity, or state-mandated bypass

Step Therapy

Prior Authorization and Step Therapy Edits / State Bypasses

Step therapy and prior authorization edits have been updated over time: historical guidance specified trying generic Truvada when available; redirection to generic Truvada was removed per USPSTF PrEP recommendation, and an IL HIM bypass was added per IL HB 5395. Check current policy/version for applicable state-specific edits.

Removed redirection to generic Truvada per USPSTF PrEP recommendation (effective 01.07.25)
Added step therapy bypass for Illinois HIM per IL HB 5395 (effective 02.14.25)
Review the policy effective date and state law for current applicability

Denial Risk

Triggers for Denial

Requests may be denied if criteria are not met. Non‑FDA indications lacking sufficient documentation of efficacy and safety, PrEP requests for individuals with unknown or positive HIV status, or missing required clinical information (diagnosis, weight, labs) are examples of denial triggers.

Non‑FDA uses: require supporting evidence per off‑label policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or may be denied
PrEP contraindication: requests for PrEP in persons with unknown or positive HIV status may be denied
Insufficient documentation: missing chart notes, labs, or other clinical information may result in denial

Note

Coverage Dependent on Plan Contract and Law

Coverage is subject to the member's plan contract, evidence of coverage, and applicable state and federal laws. This clinical policy is a guide to medical necessity and does not guarantee payment. The health plan may change, amend, or withdraw the policy; legal/regulatory requirements override policy when discrepancies exist.

Coverage depends on plan terms, exclusions, limitations, and applicable state/federal law
Clinical policy is not a guarantee of payment — verify benefits and prior authorization requirements with the member's plan

Documentation Required

Provider Responsibility and Documentation Alignment

Providers are expected to exercise professional medical judgment and must align submitted documentation with the clinical rationale for the request. When requesting exceptions to step therapy or continuation/quantity changes, include specific clinical justification (e.g., contraindications, adverse events, comorbidities, prior treatment history) to support the request.

Provider responsibility: supply clear clinical rationale and supporting records when requesting overrides or exceptions
Operational note: approval durations (typically 12 months) and pediatric dosing thresholds are specified in the clinical criteria

A clinical policy is a guide to medical necessity used to assist coverage decisions and administering benefits; it provides standards current at the time of approval.

Not a contract or payment guaranteeThis clinical policy does not constitute a contract or guarantee regarding payment or results and is not a directive for clinical practice.

Provider responsibilityProviders are expected to exercise professional medical judgment and are solely responsible for medical advice and treatment; the policy does not dictate how to practice medicine.

Coverage subject to plan and lawCoverage decisions and benefit administration are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and to applicable state and federal requirements.