Patiromer and Sodium Zirconium Cyclosilicate

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Patiromer and Sodium Zirconium Cyclosilicate Goals: Restrict use of patiromer and sodium zirconium cyclosilicate (SZC) to patients with persistent or recurrent hyperkalemia not requiring urgent treatment. Prevent use in the emergent setting or in scenarios not supported by the medical literature. Length of Authorization: 3 months Requires PA: Patiromer and Sodium Zirconium Cyclosilicate Covered Alternatives: Current PMPDP preferred drug list per OAR 410-121-0030 at www.orpdl.org Searchable site for Oregon FFS Drug Class listed at www.orpdl.org/drugs/ Approval Criteria 1. Is this a request for continuation of therapy Yes: Go to Renewal No: Go to #2 previously approved by the FFS program Criteria (patient already on patiromer or Sodium Zirconium Cyclosilicate (SZC))? 2. What diagnosis is being treated? Record ICD10 code. Go to #3 3. Does the patient have persistent or Yes: Go to #4 No: Pass to RPh. recurrent serum potassium of ≥5.5 mEq/L Deny; medical despite a review for discontinuation of appropriateness medications that may contribute to hyperkalemia (e.g., potassium supplements, potassium-sparing diuretics, nonsteroidal anti-inflammatory drugs)? 4. Does the patient have hyperkalemia Yes: Pass to RPh. No: Go to #5 requiring emergency intervention (serum Deny; medical potassium ≥6.5 mEq/L)? appropriateness 5. Is the request for patiromer? Yes: Go to #6 No: Go to #7 6. Does the patient have hypomagnesemia Yes: Pass to RPh. No: Go to #7 (serum magnesium < 1.4 mg/dL)? Deny; medical appropriateness 7. Does the patient have a severe GI disorder Yes: Pass to RPh. No: Approve up to 3 (i.e., major GI surgery (e.g., large bowel Deny; medical months resection), bowel obstruction/impaction, appropriateness swallowing disorders, gastroparesis, or severe constipation)? Renewal Criteria 1. Is the patient’s potassium level < 5.1 Yes: Approve for up to No: Pass to RPh. mEq/L and has this decreased by at least 3 months Deny; medical 0.35 mEq/L from baseline? appropriateness P&T Review: 05/19 (DM), 05/16 Implementation: 7/1/2019, 8/16, 7/1/16 .

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ACC.Org/Infographics ©2020 American College of Cardiology W20006
Potassium Binders in the Management of Chronic Hyperkalemia ✖ Development of hyperkalemia can be either acute or chronic depending on the time of onset, the presence or absence of symptoms, and underlying etiology. ✖ Chronic hyperkalemia is a potentially life-threatening condition commonly seen in older patients with heart failure (HF), chronic kidney disease (CKD), and renin-angiotensin- aldosterone system (RAAS) inhibitor therapy. PROBLEM ✖ Although sodium polystyrene sulfonate (Kayexalate®) is widely used for hyperkalemia management, its use has many limitations including: - A lack of robust randomized clinical trials showing evidence for efficacy and safety2 - An association with serious gastrointestinal (GI) injury (e.g. intestinal necrosis)2,5 - Limited use in patients with sodium intake restrictions3 ✔ Prior to initiating potassium binders, patients should be on a low potassium diet and treated with a potassium-wasting diuretic if appropriate. A dose adjustment of RAAS inhibitor therapies should be attempted in patients with CKD. ✔ Newer potassium binders, patiromer and sodium zirconium cyclosilicate, have more robust clinical trials documenting improved safety profile by reducing serum potassium and SOLUTION maintaining normokalemia in patients with HF and CKD.1,6,8,9 - RAAS inhibitors were able to be continued in patients with HF and CKD when receiving concurrent patiromer1,6,9 - Normokalemia was maintained in CKD patients with and without RAAS inhibitors therapy while receiving concurrent sodium zirconium cyclosilicate8 TREATMENT TABLE: Drug Name Patiromer Sodium zirconium cyclosilicate Binds potassium in lumen of GI and increases its fecal excretion Mechanism of Action Colon Small and large intestine Initial dose: 10 grams 3x daily for up to 48hrs 8.4 grams daily Maintenance dose: 10 grams daily Dosing Up-titrate at weekly intervals to reach Up-titrate at weekly intervals by 5 grams desired serum potassium concentration daily to reach desired serum potassium (max.
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