CurrentCignaPolicy N/A

Phosphate Binders Preferred Step Therapy Policy

Defines Cigna's preferred step therapy requirements for phosphate binder medications used to control serum phosphorus in CKD/ESRD patients; applies to health benefit plans administered by Cigna companies. Affects prescribers and patients seeking coverage for listed phosphate binder products.

Policy Summary

PayerCigna

PolicyPhosphate Binders Preferred Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateOct 23, 2024

Key ActionDocument prior use of one Step 1 product to meet the step therapy requirement before approval of a Step 2 product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2therapy steps

1approval duration (yrs)

6Step 1 products

5Step 2 products

Coverage Criteria — Phosphate Binders Step Therapy

Initial Step Therapy

Covered when ALL of the following are met

ALL of the following

Step therapy requirement: Patient has tried one Step 1 product prior to use of a Step 2 producttrial of one Step 1 product
If met, approve Step 2 product for 1 year

Step 1 products include: generic lanthanum carbonate chewable tablets; Phoslyra oral solution; generic sevelamer carbonate powder for oral suspension; generic sevelamer carbonate tablets; generic sevelamer hydrochloride tablets; Velphoro chewable tablets.

Step 2 products include: Fosrenol chewable tablets; Fosrenol oral powder; Renagel tablets; Renvela powder for oral suspension; Renvela tablets.

Policy Summary

PayerCigna

PolicyPhosphate Binders Preferred Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateOct 23, 2024

Key ActionDocument prior use of one Step 1 product to meet the step therapy requirement before approval of a Step 2 product.

SourceLink

On This Page

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Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Approval for a Step 2 phosphate binder requires documentation that the patient has tried one Step 1 product. All approvals are provided for 1 year in duration.

Step 1 products: generic lanthanum carbonate chewable tablets; Phoslyra oral solution; generic sevelamer carbonate powder for oral suspension; generic sevelamer carbonate tablets; generic sevelamer hydrochloride tablets; Velphoro chewable tablets
Step 2 products: Fosrenol chewable tablets; Fosrenol oral powder; Renagel tablets; Renvela powder for oral suspension; Renvela tablets
Approval duration: 1 year

Step Therapy

Step Therapy Rule

Step Therapy Rule: This program encourages use of a Step 1 product prior to a Step 2 product. If the patient has tried one Step 1 product, a Step 2 product may be approved per the criteria.

Documentation Required

Documentation of Prior Step 1 Trial

Documentation Requirement: Document prior use of one Step 1 product to meet the step therapy requirement prior to approval of a Step 2 product.

Record which Step 1 product was tried and dates of therapy
Provide clinical rationale if Step 1 product was discontinued (e.g., intolerance, allergy, lack of efficacy)

Denial Risk

Denial Risk for Failing Step Therapy

Denial Risk: If the Preferred Step Therapy rule is not met for a Step 2 product at the point of service, coverage will be determined by the Preferred Step Therapy criteria and the request may be denied as not medically necessary.

Background and Clinical Context

Phosphate binders are medications used to reduce or control serum phosphorus in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD) on dialysis. This policy groups commonly used binders into a two-step preferred therapy approach: Step 1 products (including generic lanthanum carbonate chewable tablets, Phoslyra oral solution, generic sevelamer formulations, and Velphoro) are preferred initial agents, while Step 2 products (including Fosrenol, Renagel, and Renvela formulations) require prior trial of a Step 1 product before being approved. All approvals provided under this program are for 1 year in duration.

Definitions and Guideline References

Phosphate binders (examples)

Non-calcium bindersSevelamer (Renagel, Renvela) and lanthanum (Fosrenol)

Calcium-based binderCalcium acetate (Phoslyra)

Iron-based binderFerric-based binder (Velphoro / sucroferric oxyhydroxide)

Indication summaryMedications indicated to reduce or control serum phosphorus in patients with CKD/ESRD on dialysis

Notes on efficacy and formulationsAgents have generally similar efficacy; age indications and dosage forms vary across the class

KDIGO guidance (CKD‑MBD, 2017)

KDIGO recommendationRecommend lowering elevated phosphate toward the normal range in CKD Stage 3 through 5D

Treatment triggersBase phosphate‑lowering treatment decisions on persistently or progressively elevated serum phosphate levels

Laboratory contextDecisions should consider phosphate, calcium, and parathyroid hormone together due to complex interactions

Safety noteAim to avoid overt hyperphosphatemia; data supporting benefit of strictly normal phosphate are limited

Binder preferenceKDIGO provides no preference for a specific non‑calcium binder