CurrentNeighborhood Health Plan of Rhode IslandPolicy 2048-D

sucroferric oxyhydroxide (Velphoro) coverage for dialysis-dependent CKD

Policy governs coverage and prior authorization requirements for Velphoro (sucroferric oxyhydroxide) to control serum phosphorus in patients aged ≥9 years with chronic kidney disease on dialysis under Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policysucroferric oxyhydroxide (Velphoro) coverage for dialysis-dependent CKD

Policy CodePolicy 2048-D

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization when the initial step therapy criterion (≥30-day calcium acetate fill within past 120 days) is not met and document one qualifying clinical rationale.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥9minimum patient age for indication

12 moduration of approval

30d/120dinitial step therapy lookback

Coverage Criteria for Velphoro (sucroferric oxyhydroxide)

Chronic Kidney Disease (dialysis-dependent) — Initial or Ongoing Therapy

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Covered when ALL of the following are met:

Population and indication: Patient is receiving dialysis and is aged 9 years or older with chronic kidney disease for control of serum phosphorusage >= 9 years; on dialysis

Supported by FDA indication

Calcium acetate requirement: ONE of the following clinical conditions is met regarding calcium acetate: the patient has experienced an inadequate treatment response to calcium acetate; the patient has experienced an intolerance to calcium acetate; the patient has a contraindication that would prohibit a trial of calcium acetate; OR it has been determined that calcium acetate is NOT appropriate for the patient (examples: hypercalcemia, arterial calcification, adynamic bone disease, low PTH levels, or age)1 of several clinical conditions

Authorization may be granted if any single listed condition applies

Use of this policy is limited to the FDA-approved indication: control of serum phosphorus in adults and pediatric patients aged ≥9 years with chronic kidney disease who are receiving dialysis. Use for indications outside this population is not within the scope of this policy and will be treated as off‑label.

Drug and Step-Therapy Coding

Referenced drugNDC|Mixed

Velphoro / sucroferric oxyhydroxide

Product referenced — brand and generic name

Initial step therapy fill — lookback

Lookback requirementMember must have filled ≥30-day supply of calcium acetate within the past 120 days under a CVS Caremark-administered prescription benefit

Action if metRequested drug will be paid under the prescription benefit (no medical PA applied)

Action if not metClaim will reject with message that prior authorization is required; PA criteria will then be applied

Prior Authorization, Step-Therapy, and Documentation Requirements

Prior Authorization

Claim will reject and require prior authorization

Claims for the requested drug will reject if initial step therapy criteria are not met; a prior authorization (PA) is then required and must be submitted to the PA unit for review.

Claim reject triggers when no prior 30-day calcium acetate (e.g., PhosLo) fill under CVS Caremark in past 120 days
After reject, submit PA request to PA unit for evaluation

Step Therapy

Initial step therapy rules

If the patient has filled a prescription for at least a 30-day supply of calcium acetate (e.g., PhosLo) within the past 120 days under a prescription benefit administered by CVS Caremark, the requested drug will be paid under that prescription benefit. If the patient does not meet these initial step therapy criteria, the claim will reject and a PA is required.

Step-therapy lookback period: 120 days
Required prior fill: >= 30-day supply of calcium acetate (e.g., PhosLo)
Prescription benefit administrator referenced: CVS Caremark

Documentation Required

Required clinical rationale

Authorization may be granted when the requested drug is being prescribed to control serum phosphorus levels in adult and pediatric patients ≥9 years of age with chronic kidney disease on dialysis when documentation supports ONE of the following clinical rationales.

Inadequate treatment response to calcium acetate (e.g., PhosLo)
Intolerance to calcium acetate (e.g., PhosLo)
Contraindication to calcium acetate that would prohibit a trial (e.g., severe hypercalcemia)
Clinical determination that calcium acetate is not appropriate (examples: hypercalcemia, arterial calcification, adynamic bone disease, low PTH levels, or age)

Denial Risk

PROVIDER ACTIONS

Provider actions: ensure PA is submitted if the initial step therapy requirement is not met and include documentation of the clinical rationale (inadequate response, intolerance, contraindication, or reason calcium acetate is inappropriate). Claims will reject at point of sale/processing if step therapy criteria are not satisfied.

Include clinical documentation supporting ONE of the required rationales with the PA submission
If PA is not obtained when required, expect claim denial/rejection message directing to obtain PA
PA unit will apply the full authorization criteria upon receipt of a PA request

Definitions

Dialysis-dependent CKD — definition and age limitation

DefinitionChronic kidney disease in patients receiving dialysis therapy (dialysis-dependent CKD)

Indication age limitVelphoro indication limited to patients aged ≥9 years

Authorization contextAuthorization may be granted when prescribed to control serum phosphorus in adults and pediatric patients ≥9 years on dialysis if one qualifying clinical condition regarding calcium acetate is met

Background

Velphoro (sucroferric oxyhydroxide) is an oral phosphate binder indicated to control serum phosphorus levels in adults and pediatric patients 9 years of age and older with chronic kidney disease on dialysis. This policy governs coverage and prior authorization requirements for Velphoro when used for that indication.