Table 18: Renin Angiotensin System Antagonists

A  B   C   D   E   F   G   H I   J K   L   M   N   O   P   Q   R   S   T   U   V   W   X   Y   Z

Drug Category: Cardiovascular

Medication Class/Individual Agent: Renin Angiotensin System Antagonists

I. Prior Authorization Requirements

# This is a brand-name drug with FDA “A”-rated generic equivalents.  Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.

II. Therapeutic Uses

• FDA-approved

III. Evaluation Criteria for Approval

• ACE inhibitors – single agents
• ARBs – Single agents
• Direct renin inhibitors
• Concurrent therapy – ACE inhibitor, ARB, and/or direct renin inhibitor
• ACE inhibitors and ARB – Combination agents with HCTZ
• Azor, Exforge, Lexxel, Lotrel, Tarka
• Exforge HCT

II. Therepeutic Uses

FDA-approved, for example:

• hypertension
• congestive heart failure (captopril, candesartan,enalapril, fosinopril, lisinopril, quinapril,
  ramipril, trandolapril, valsartan)
• left ventricular dysfunction (captopril, enalapril, trandolapril)
• myocardial infarction (lisinopril, valsartan)
• diabetic nephropathy (captopril, irbesartan, losartan)
• cardiovascular events risk reduction (perindopril, ramipril)
• reduction of stroke risk with left ventricular hypertrophy (losartan)

Note: The above list may not include all FDA-approved indications.

Back | Table 18

III. Evaluation Criteria for Approval

• All prior-authorization requests must include clinical diagnosis, drug name, dose, and frequency.
• Additional criteria may apply, depending upon requested medication (see below)

Back | Table 18

ACE inhibitors – single agents

• Documentation of an inadequate response or adverse reaction to one generic ACE inhibitor is required.

SmartPA: Claims will usually process at the pharmacy without a prior authorization request if the member has pharmacy claims for a generic ACE inhibitor. ^†

Back | Table 1

ARBs – Single agents

• Documentation of one of the following is required:
  • an inadequate response, adverse reaction, or contraindication to an ACE inhibitor; or
  • diabetes with renal insufficiency.

SmartPA: Claims will usually process at the pharmacy without a prior authorization request if the member has pharmacy claims for a generic ACE inhibitor, or, the member has a history of MassHealth medical claims for diabetes with renal manifestations.^†

Back | Table 18

Direct renin inhibitors – Single agents

• Documentation of the following is required:
  • an inadequate response or adverse reaction to an ACE inhibitor and an ARB.

Back | Table 18

Concurrent therapy – ACE inhibitor, ARB, and/or direct renin inhibitor

• Requests for concurrent therapy with two or more renin angiotensin system agents are evaluated on a case-by-case basis.

Back | Table 18

ACE inhibitors and ARB – Combination agents with HCTZ

• Documentation of one of the following is required:
  • stable therapy on the separate agents for ≥ 3 months;
  • stable therapy on the combination agent for ≥ 3 months; or
  • medical necessity for one agent in patients with complex, multiple, comorbid conditions.

SmartPA: Claims will usually process at the pharmacy without a prior authorization request if the member has pharmacy claims for 90 days (on separate agents or combination agents) in the past 120 days.^†

Back | Table 18

Azor, Exforge, Lexxel, Lotrel, Tarka, Twynsta, Valturna

• Documentation of one of the following is required:
  • treatment with stable doses of the separate agents for a minimum of three months
  • stabilized for at least three months on the combination product; or 
  • medical necessity for one agent in patients with complex, multiple, comorbid conditions.

Back | Table 18

Exforge HCT

• Documentation of one of the following is required:
  • stable therapy on the separate agents for > 3 months;
  • stable therapy on the combination agent for > 3 months; or
  • medical necessity for one agent in patients with complex, multiple, comorbid conditions.

Back | Table 18

^†Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.