CurrentAnthemPolicy N/A

Essential Direct Drugs List (closed formulary) — Coverage Criteria

Defines Anthem's closed 'Essential Direct Drugs List' (a prescription drug formulary) describing which FDA‑approved medications are covered, preferred alternatives, and the exception/prior authorization process for members and providers in California.

Policy Summary

PayerAnthem

PolicyEssential Direct Drugs List (closed formulary) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionProviders must call Member Services or sign in at anthem.com/ca to submit a prior authorization (exception) for medications not on the Essential Direct Drugs List.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

closedformulary type

20+drug categories

portalmember access

prior authexception available

Spanishlanguage

Coverage Rules & Formulary Scope

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Coverage rule (general)

Covered only when ALL of the following are met

Formulary coverage and exceptions: 1) The medication is included on the Essential Direct Drugs List; AND 2) If the medication is not on the Essential Direct Drugs List, coverage requires an approved prior authorization/exception.

Members and providers should review Prescription Benefits at anthem.com/ca for specific restrictions (quantity limits, step therapy, prior authorization) and contact Member Services as needed.

La Lista de medicamentos directos esenciales es un formulario cerrado de medicamentos recetados aprobados por la FDA; solo se cubren los medicamentos incluidos en esa lista a menos que se apruebe una excepción (autorización previa). Los medicamentos de marca que tienen un equivalente genérico disponible no están comprendidos en la Lista de medicamentos directos esenciales. Los miembros y proveedores deben revisar las restricciones específicas (por ejemplo, límites de cantidad, autorización previa o requisitos de terapia escalonada) iniciando sesión en anthem.com/ca en Prescription Benefits o llamando a Servicios para miembros al número en la tarjeta de identificación.

El documento identifica múltiples productos de marca que no están en la lista de medicamentos (no cubiertos salvo excepción). Ejemplos incluidos en la lista comprenden: Belsomra, Dayvigo, Zolpidem cápsulas (hipnóticos/sedantes); Renflexis, Inflectra, Zymfentra (infliximab no listados); y agentes de esclerosis múltiple como Bafiertam, Briumvi, Gilenya, Kesimpta, Ocrevus, Tysabri. También se listan numerosos productos oftálmicos, nasales, inmunoglobulinas y agentes para migraña y disfunción eréctil, entre otros, que están identificados como no incluidos en la Lista de medicamentos directos esenciales.

La sección titulada «Medicamentos excluidos comunes de un vistazo (en orden alfabético)» presenta múltiples entradas de productos excluidos con alternativas asociadas; el formato muestra pares de producto excluido = alternativa. Ejemplos parciales del listado alfabético incluyen: Azelex = Emflaza; Belsomra = Eprontia; Bepreve = Epsolay; Bimzelx = exenatide; Bivigam = Symbravo; Bomyntra = Zavzpret; Bafiertam = Onzetra; Basaglar = Yesintek; Cibinqo = Gammaked; Cimzia = Pyzchiva. El inventario alfabético continúa a lo largo de la sección y debe usarse como referencia cruzada cuando se considera sustitución o se solicita cobertura para un producto excluido.

Preferred alternatives

Preferred alternatives by therapeutic class

Hypnotics/sedatives: Preferred alternatives include eszopiclone, zaleplon, and zolpidem (tablet/ER formulations as noted) as alternatives to non‑formulary agents such as Belsomra, Dayvigo, and zolpidem capsules.

Immunoglobulins: Preferred immunoglobulin products include Cutaquig, Gamunex‑C, Hizentra, Octagam, and Xembify instead of the listed non‑formulary immune serum products (e.g., Alyglo, Asceniv, Bivigam, Cuvitru, Flebogamma, Gamastan, Gammagard/SD, Gammaked, Gammaplex, Hyqvia, Panzyga, Privigen, Qivigy, Yimmugo).

PDE5 inhibitors (impotence): Preferred alternatives are sildenafil citrate (generic Viagra) and tadalafil (generic Cialis) rather than Stendra, vardenafil tablets, or Vybrique.

Migraine - CGRP antagonists: Preferred CGRP antagonist options include Aimovig, Ajovy, Emgality, Nurtec, Qulipta, and Ubrelvy versus non‑formulary agents Vyepti and Zavzpret.

What Providers Must Do / Authorization & Substitution

Prior Authorization

Prior Authorization Required

Prior authorization (exception) is required for non‑formulary and non‑listed medications, including many specialty branded products. Prescribers must initiate a prior authorization request by calling the Member Services number on the member’s ID card or by signing in at anthem.com/ca and using Tools & Resources to download and submit the Prior Authorization form. Electronic prior authorization submissions are available and may process faster or in real time.

Applies to non‑formulary specialty drugs and medications not on the Essential Direct Drug List.
Electronic prior authorizations may be approved in real time; fax or phone options remain available.
Members and prescribers can view current formulary status, quantity limits, step‑therapy and PA details at anthem.com/ca > Prescription Benefits.

Prior Authorization

Non‑Formulary Specialty Drugs Require Evaluation

Non‑formulary specialty and branded medications that are not on the Essential Direct Drug List typically require a full evaluation and prior authorization. If a covered preferred alternative exists, coverage for a non‑formulary specialty drug may be denied unless a clinical exception is granted.

Prescribers should include clinical rationale and supporting documentation when requesting an exception for non‑formulary specialty drugs.
If a preferred alternative is clinically appropriate, the plan may require trial of that alternative (step therapy) before approving the requested non‑formulary specialty medication.

Denial Risk

Riesgo de denegación por medicamento excluido

Algunos medicamentos que están excluidos de la lista pueden conllevar un riesgo de denegación si se solicita cobertura sin una autorización previa aprobada. Para medicamentos excluidos, el proveedor debe presentar documentación clínica que justifique la excepción antes de la dispensación.

Los prescriptores y farmacias deben usar la guía alfabética de medicamentos excluidos y sus alternativas cuando consideren sustituciones o presenten solicitudes de excepción.
Los miembros pueden iniciar sesión en anthem.com/ca para ver alternativas preferidas, límites de cantidad y requisitos de PA.

Note

Formulary Restrictions & Non‑Covered Medications

Formulary restrictions such as quantity limits, prior authorization, and step therapy may apply. If a requested medication is not on the formulary, it is not covered unless an exception is approved.

Members and prescribers should check anthem.com/ca for the most up‑to‑date restriction details.
Non‑covered medications may have preferred alternatives listed by therapeutic class—step therapy may be required.

Step Therapy

Preferred‑Alternative Step (Step Therapy)

If the preferred alternatives listed by class are clinically appropriate, plan policy may require trial of those agents before approving the non‑formulary medication (step therapy). Providers should document prior treatment trials and clinical justification when requesting an exception.

List of preferred alternatives is organized by therapeutic class—refer to the formulary for specific alternatives.
Document prior therapeutic failures or contraindications to preferred alternatives to support an exception request.

Prior Authorization

How to Request an Exception / Prior Authorization

How to request an exception/prior authorization: call Member Services using the number on the member’s ID card or sign in at anthem.com/ca to download and submit the prior authorization form. Electronic submission is available and may result in faster processing.

Include all relevant clinical notes, prior treatment history, and supporting documentation with the PA request.
Pharmacies and prescribers should reference the alphabetized excluded‑common mapping when proposing substitutions or completing the PA form.

Documentation Required

Listado de exclusiones y alternativas (documentación requerida)

Listado de exclusiones y alternativas: se proporcionan pares medicamento excluido ↔ alternativa preferida y se espera documentación clínica cuando se solicita una excepción. Consulte la guía alfabética para opciones de sustitución y la documentación requerida.

Los prescriptores deben adjuntar evidencia de intentos con alternativas preferidas o razón clínica clara de por qué no son adecuadas.
Las farmacias deben usar el mapeo alfabético para sugerir alternativas cuando corresponda y ayudar al proveedor con la documentación.

Denial Risk

No cubierto salvo excepción

Los medicamentos que no aparecen en la Lista de medicamentos directos esenciales no están cubiertos a menos que se apruebe una excepción (autorización previa). Si no se presenta o aprueba la excepción, la reclamación será denegada.

Asegúrese de que la solicitud de excepción incluya toda la documentación clínica necesaria para evitar demoras o denegaciones.
Revise el Certificado/Evidencia de Cobertura o el SPD para detalles del plan respecto a coberturas excepcionales.

Step Therapy Notes & Tables

Policy note	Action / Where to check
Some medications on the formulary may require step therapy (therapy prior to covering a requested agent).
Members and providers should sign in to Prescription Benefits at anthem.com/ca or call Member Services (number on member ID card) to view specific step therapy, prior authorization, and quantity-limit requirements for a medication.

Therapeutic class	Preferred alternatives (step therapy preference)
Hypnotics / sedatives
Preferred alternatives: eszopiclone, zaleplon, zolpidem (tablet/ER formulations) — preferred before non‑listed agents such as Belsomra, Dayvigo, zolpidem capsules.
Immunoglobulins (immune serum products)
Preferred alternatives: Cutaquig, Gamunex‑C, Hizentra, Octagam, Xembify — preferred before numerous non‑listed immune serum products (e.g., Alyglo, Asceniv, Bivigam, etc.).
PDE5 inhibitors (impotence agents)
Preferred alternatives: sildenafil citrate (generic Viagra), tadalafil (generic Cialis) — preferred before non‑listed agents such as Stendra, vardenafil tablets, Vybrique.
Infliximab products
Preferred alternatives: Avsola, Infliximab, Remicade — preferred before non‑listed infliximab products Renflexis, Inflectra, Zymfentra.
Migraine agents — CGRP antagonists / other migraine products
Preferred alternatives: triptans (almotriptan, eletriptan, naratriptan, rizatriptan tablet/ODT, sumatriptan [tablet/nasal/injection], zolmitriptan) and CGRP agents Aimovig, Ajovy, Emgality, Nurtec, Qulipta, Ubrelvy — preferred before non‑listed agents such as Vyepti, Zavzpret, Onzetra, Reyvow, Symbravo, Tosymra, Treximet, Zembrace.
Multiple sclerosis agents
Preferred alternatives include products listed (e.g., Avonex, Betaseron, glatiramer formulations, dimethyl fumarate, fingolimod alternatives) — preferred before several non‑listed MS agents (e.g., Bafiertam, Briumvi, Gilenya, Kesimpta, Ocrevus, Ponvory, Tysabri).

Key Terms & Definitions

Essential Direct Drugs List — definition of the closed formulary and coverage-exception principle

DefinitionThe Essential Direct Drugs List is a closed formulary of FDA‑approved prescription medications covered by the plan; only drugs on this list are covered unless an approved exception (prior authorization) is obtained.

Basis for inclusionMedications on the list were reviewed by the Pharmacy & Therapeutics (P&T) process considering efficacy, safety, similarity within class, and affordability.

Brand/generic ruleBrand products that have a generic equivalent available are not included on the Essential Direct Drugs List.

Where to viewMembers can view and search the Essential Direct Drugs List by signing in to anthem.com/ca and selecting Prescription Benefits.

Common limitationsThe formulary may impose restrictions such as quantity limits, prior authorization, or step‑therapy requirements; check the member's Certificate/Evidence of Coverage or plan SPD for details.

Prior authorization / exception — definition of the process to request coverage for non-formulary meds

PurposePrior authorization (exception) is the process by which a prescriber requests coverage for a medication not on the Essential Direct Drugs List.

How to requestProviders must call the Member Services number on the member ID card or sign in at anthem.com/ca to download and submit a prior authorization form (electronic submission may be available).

When requiredMedications not included on the Essential Direct Drugs List — including many specialty and branded agents — require prior authorization/exception before they will be covered.

DocumentationWhen requesting coverage for an excluded product, prescribers should reference the excluded‑to‑preferred mapping and document clinical justification comparing the requested drug to the preferred alternative.

Medicamentos que no están en la lista de medicamentos — definition of excluded/non-preferred products (Spanish)

EjemplosEl documento nombra múltiples marcas y productos (p. ej., Belsomra, Dayvigo, Renflexis, Inflectra, Vyepti, Zavzpret) clasificados como no incluidos en la lista.

Implicación de coberturaLos medicamentos que no están en la lista no están cubiertos a menos que se apruebe una excepción (autorización previa).

Uso del cruce alfabéticoLos prescritores/farmacias deben consultar el mapeo alfabético de 'Medicamentos excluidos comunes de un vistazo' para identificar alternativas preferidas al solicitar cobertura o sustituciones.

Medicamentos alternativos preferidos — definition of preferred alternative medications for substitution

Propósito clínicoLas alternativas preferidas incluyen genéricos, marcas preferidas o opciones OTC que ofrecen eficacia y costo razonable como sustitutos del producto excluido.

Ejemplos por claseHipnóticos/sedantes: eszopiclone, zaleplon, zolpidem (tabletas/ER); Inmunoglobulinas: Cutaquig, Gamunex‑C, Hizentra, Octagam, Xembify; Inhibidores PDE5: sildenafil, tadalafil; Antagonistas CGRP: Aimovig, Ajovy, Emgality, Nurtec, Qulipta, Ubrelvy.

Implicación de autorizaciónLa existencia de una alternativa preferida puede implicar que la cobertura de un producto no preferido requiera documentación adicional y/o falla de la alternativa preferida (step therapy) para aprobar una excepción.

OpenPayer

Essential Direct Drugs List (closed formulary) — Coverage Criteria

Coverage Rules & Formulary Scope

What Providers Must Do / Authorization & Substitution

Step Therapy Notes & Tables

Biosimilar Preferences

Key Terms & Definitions

Policy Background