Prior Auth Protocol

FDA Approved Indications:

For the treatment of hyperkalemia

Health Net Approved Indications and Usage Guidelines:

Diagnosis of hyperkalemia

AND

Failure or clinically significant adverse effects to generic Kayexalate

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature
Emergency treatment for life-threatening hyperkalemia because of its delayed onset of action

General Information:

Veltassa binds to many orally administered medications, which could decrease their absorption and reduce their effectiveness. Oral medications should be administered at least 6 hours before or 6 hours after Veltassa.
Hyperkalemia can occur from impaired urinary potassium excretion due to kidney disease and/or drugs that inhibit the renin-angiotensin-aldosterone system (RAAS).
A two-part, single-blind phase 3 study evaluated the efficacy and safety of Veltassa in 243 patients with CKD receiving RAAS inhibitors. Results demonstrated a mean change in serum potassium of -1.01 1 0.03 mEq/L (95% CI: -1.07, -0.95; P<0.001) following an onset of action of 7 hours; 76% (95% CI: 70, 81) of patients reached the target potassium level (3.8 mEq/L to <5.1 mEq/L) by week 4 of treatment.
The efficacy and safety of Veltassa administered for up to 52 weeks was evaluated in a study of 306 patients (AMETHYST-DN). The treatment effect on serum potassium was maintained with daily use of Veltassa.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
sodium polystyrene sulfonate (Kayexalate)	15 gm PO QD to QID 30-50 gm PR Q6H	Individualize dosage and duration of therapy according to assessment of potassium levels

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Veltassa	Initial dose is 8.4 gms PO QD Adjust dose by 8.4 gms as needed at weekly intervals	Length of Benefit

Product Availability:

Powder for oral suspension: 8.4, 16.8 and 25.2 gram packets

References:

1. Veltassa [Prescribing Information]. Redwood City, CA: Relypsa, Inc; October 2015.

2. Bakris GL, Pitt B, Weir MR, et al. Effect of patiromer on serum potassium levels in patients with hyperkalemia and diabetic kidney disease: The AMETHYST-DN randomized clinical trial. JAMA. 2015;314(2):151-161.

3. Weir MR, Bakris GL, Bushinsky DA, et al; for the OPAL-HK Investigators. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. N Engl J Med. 2015;372(3):211-221.

4. Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed November 3, 2015.

5. Sodium polystyrene sulfonate. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed November 3, 2015.