Chelating/Binding Agents

Auryxia^® (Ferric Citrate) Approval Criteria:

An FDA approved diagnosis of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis; AND
- Documented trials of inadequate response to at least two of the phosphate binders available without a prior authorization or a patient-specific, clinically significant reason why the member cannot use all phosphate binders available without a prior authorization; and
- A patient-specific, clinically significant reason why the member cannot use Velphoro^® (sucroferric oxyhydroxide) must be provided; or
An FDA approved diagnosis of iron deficiency anemia (IDA) in patients with CKD not on dialysis; AND
- Documented lab results verifying IDA; AND
- A documented intolerance or inadequate response to prior treatment with oral iron.
A quantity limit of 12 tablets per day will apply based on maximum recommended dose.

Lanthanum Carbonate (Generic Fosrenol^®) Approval Criteria:

An FDA diagnosis of hyperphosphatemia in patients with end stage renal disease (ESRD); AND
Documented trials of inadequate response to at least two of the phosphate binders available without a prior authorization or a patient-specific, clinically significant reason why the member cannot use all phosphate binders available without a prior authorization; AND
Fosrenol® is brand preferred. Authorization of the generic formulation requires a patient-specific, clinically significant reason why the member cannot use the brand formulation.

An FDA approved diagnosis; AND
A patient-specific, clinically significant reason other than convenience why member cannot use Exjade® (deferasirox) must be provided; AND
For Jadenu® Sprinkle (deferasirox oral granules), an age restriction of six years and younger will apply. Members older than six years of age will require a patient-specific, clinically significant reason why Jadenu® oral tablets cannot be used even when the tablets are crushed; AND
The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling.

An FDA approved diagnosis of hyperkalemia; AND
Medications known to cause hyperkalemia [e.g., aldosterone antagonists, nonsteroidal anti-inflammatory drugs (NSAIDs)] have been discontinued or reduced to the lowest effective dose where clinically appropriate; AND
A trial of a potassium-eliminating diuretic or documentation why a diuretic is not appropriate for the member; AND
Documentation of a low potassium diet; AND
A quantity limit of 30 packets per month will apply. Quantity limit overrides will be granted to allow for initial 3 times daily dosing.

Renagel^® (Sevelamer Hydrochloride) Approval Criteria:

An FDA approved indication for the control of serum phosphorus in members with chronic kidney disease (CKD) on dialysis; and
A patient-specific, clinically significant reason why the member cannot use Renvela^® (sevelamer carbonate) 800mg tablets or other phosphate binders available without prior authorization must be provided.

Velphoro^® (Sucroferric Oxyhydroxide) Approval Criteria:

An FDA approved diagnosis of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis; and
Documented trials of inadequate response to at least two of the phosphate binders available without a prior authorization or a patient-specific, clinically significant reason why the member cannot use all phosphate binders available without a prior authorization.

An FDA approved diagnosis of hyperkalemia; AND
Medications known to cause hyperkalemia [e.g., aldosterone antagonists, nonsteroidal anti-inflammatory drugs (NSAIDs)] have been discontinued or reduced to the lowest effective dose where clinically appropriate; AND
A trial of a potassium-eliminating diuretic or documentation why a diuretic is not appropriate for the member; AND
Documentation of a low potassium diet; AND
A quantity limit of 30 packets per month will apply.

Xphozah^® (Tenapanor) Approval Criteria:

An FDA approved indication to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis; and
Member must be 18 years of age or older; and
Documented trials of inadequate response to at least 2 of the phosphate binders available without prior authorization or a patient-specific, clinically significant reason why the member cannot use all phosphate binders available without prior authorization must be provided; and
Documented trial of inadequate response to at least 1 iron-based phosphate binder [e.g., Auryxia^® (ferric citrate), Velphoro^® (sucroferric oxyhydroxide)] or a patient-specific clinically significant reason why the member cannot use an iron-based phosphate binder must be provided.