Angiotensin receptor blockers (ARBs) and ARB combination prior authorization
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Defines prior authorization (PA) requirements and approval criteria for ARB products and ARB combination therapies for Georgia Medicaid fee-for-service members.
No material clinical or coverage changes in this revision.
Coverage Criteria for ARBs and Combinations
Edarbi (azilsartan)
Approvals for Edarbi require meeting one of the following conditions:
Excludes Entresto
Valsartan oral solution (generic)
Approvals for valsartan oral solution require:
Either condition suffices
Amlodipine/valsartan generic
Approvals for amlodipine/valsartan require:
Specifically references losartan-containing product
Edarbyclor (azilsartan/chlorthalidone)
Approvals for Edarbyclor require meeting one of the following:
Two alternative pathways provided
Entresto (sacubitril/valsartan tablets)
Approvals for Entresto require:
Both conditions required
Other non-preferred combinations (Amlodipine/Olmesartan, Exforge HCT, Telmisartan/Amlodipine, Tribenzor)
Approvals for these combinations require:
Specifies required prior trials or intolerances
Exceptions to the policy’s coverage conditions are handled on a case-by-case basis through the prior authorization process. Providers seeking an exception should initiate a prior authorization request with OptumRx at 1-866-525-5827. The PA process will evaluate clinical rationale and supporting documentation to determine whether an exception to the stated criteria is warranted.
This policy does not include blanket statements listing agents as ‘‘not medically necessary.’’ Instead, coverage is managed via specified criteria and the prior authorization process. Note that certain products listed as preferred (for example, amlodipine/valsartan and Entresto) nonetheless require prior authorization per the policy notes.
Provider Actions and Prior Authorization Process
Prior authorization required — contact OptumRx
Prior authorization is required for specified non-preferred ARBs and ARB combination products and for some preferred products (e.g., amlodipine/valsartan and Entresto). Initiate PA requests by calling OptumRx at 1-866-525-5827.
- Applies to non-preferred agents listed (e.g., Edarbi, valsartan oral solution, Edarbyclor, certain combination products).
- Preferred products that still require PA include amlodipine/valsartan and Entresto.
Step therapy: required trials of preferred ARB(s)
Approval of non-preferred ARBs or combination products requires prior trials or documented contraindications to specified preferred ARB or ARB combination products; many pathways explicitly require a trial of a losartan-containing product or losartan/hydrochlorothiazide first.
- Edarbi: inadequate response or intolerance to at least two preferred ARB/ARB Combination products, one must be a losartan-containing product.
- Edarbyclor: inadequate response to at least two preferred ARB/Diuretic combinations, one must be losartan/HCTZ (or intolerance to two preferred combinations, one losartan-containing).
- Other non-preferred combinations: inadequate response to losartan/HCTZ and amlodipine/valsartan or intolerance to losartan and valsartan.
- Amlodipine/valsartan: trial or intolerance to a losartan-containing product.
Required clinical documentation to support PA
Submit clinical rationale and supporting documentation with the PA to demonstrate inadequate response, allergy, contraindication, drug‑drug interaction, or intolerable side effects to required prior agents; include documentation of inability to use tablets for valsartan oral solution and, for Entresto, diagnosis of heart failure and patient age.
- Clinical rationale describing prior treatment failures or intolerances.
- Relevant lab results or clinical measures supporting inadequate response when applicable.
- History of prior trials (agent, dose, dates, and outcome).
- Allergy or contraindication documentation.
- Description of relevant drug–drug interactions.
- For valsartan oral solution: documentation member cannot swallow solid oral dosage forms or requires a dose not available in tablets.
- For Entresto: documentation of heart failure diagnosis and that member is ≥1 year old.
Denial risk if trials or contraindications are not documented
Requests that do not document the required prior trials, intolerance, allergy, contraindication, or drug–drug interaction as specified for each non‑preferred agent or combination may be denied.
- Denial risk exists if required trials (e.g., losartan-containing product or losartan/HCTZ) or documented contraindications/intolerances are not provided.
Step Therapy Requirements
| Agent | Step requirement |
|---|---|
| Edarbi (azilsartan) | Member must have inadequate response, allergy, contraindication, drug-drug interaction, or intolerable side effects to at least two preferred ARB or ARB combination products (Excludes Entresto), one of which must be a losartan-containing product. |
| Amlodipine/valsartan (generic) | Member must have inadequate response, allergy, contraindication, drug-drug interaction, or intolerable side effects to a losartan-containing product. |
| Edarbyclor (azilsartan/chlorthalidone) | Member must have inadequate response to at least two preferred ARB/diuretic combination products, one of which must be losartan/hydrochlorothiazide, OR have allergies, contraindications, drug-drug interactions, or intolerable side effects to at least two preferred ARB/diuretic combination products, one of which must be a losartan-containing product. |
| Other non-preferred combinations (Amlodipine/Olmesartan, Exforge HCT, Telmisartan/Amlodipine, Tribenzor) | Member must have inadequate response to losartan/hydrochlorothiazide and amlodipine/valsartan, OR have allergies, contraindications, drug-drug interactions, or intolerable side effects to losartan and valsartan. |
Definitions and Key Terms
Quantity Limits
Background
Angiotensin receptor blockers (ARBs) and ARB combination products are primarily used to treat hypertension and select heart failure indications. Combination formulations commonly pair an ARB with a diuretic or a calcium channel blocker to address resistant or difficult-to-control blood pressure. Entresto (sacubitril/valsartan) is a neprilysin inhibitor plus ARB indicated for heart failure and is specifically included in this policy with age-related coverage considerations.
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