CurrentNeighborhood Health Plan of Rhode IslandPolicy 2048-D

Coverage criteria for Velphoro (sucroferric oxyhydroxide) — dialysis-dependent CKD

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

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCoverage criteria for Velphoro (sucroferric oxyhydroxide) — dialysis-dependent CKD

Policy CodePolicy 2048-D

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization when step therapy with calcium acetate is not met and document inadequate response, contraindication, or intolerance to calcium acetate.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

9+minimum patient age in indication

12 moduration of approval (DOA)

calcium acetateinitial step therapy prerequisite

Coverage Criteria for Velphoro (sucroferric oxyhydroxide)

Coverage for Velphoro in dialysis-dependent CKD

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Population: Patient is age >=9 years and has chronic kidney disease and is receiving dialysis (FDA indication)age >= 9

supported by Velphoro FDA indication

Clinical prerequisites to authorize Velphoro instead of calcium acetate: At least one of: inadequate response to calcium acetate (e.g., PhosLo); contraindication to calcium acetate; intolerance to calcium acetate; calcium acetate determined not appropriate (e.g., hypercalcemia, arterial calcification, adynamic bone disease, low PTH levels, or age)N/A

Step therapy with calcium acetate applies unless clinical exception is met

Step therapy pathway: If patient has filled >=30-day supply of calcium acetate within past 120 days under the CVS Caremark prescription benefit, the request will be processed under that prescription benefit; if not, the claim will reject and prior authorization is required>=30 days within 120 days

Initial step therapy requirement

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required if the patient does not meet the initial step therapy requirement. If the patient has not met the initial step therapy criteria, the claim will reject with a message indicating that a prior authorization (PA) is required; the PA unit will then apply the prior authorization criteria to submitted requests.

Operational consequence: claim rejection and requirement to submit PA when initial step therapy not met

Step Therapy

Initial Step Therapy Requirement

Initial step therapy requires documentation that the patient filled at least a 30-day supply of calcium acetate (e.g., PhosLo) within the past 120 days under the prescription benefit administered by CVS Caremark.

Required: 30-day fill of calcium acetate within 120 days
Applies to prescriptions filled under the CVS Caremark-administered prescription benefit

Documentation Required

Documentation Requirements

Documentation submitted with a PA request must support one of the following clinical rationales when calcium acetate was tried or is not appropriate: inadequate response, contraindication, intolerance, or clinical rationale explaining why calcium acetate is not appropriate (for example: hypercalcemia, arterial calcification, adynamic bone disease, low PTH levels, or age-related concerns).

One of the following must be documented: inadequate response, contraindication, intolerance, or other clinical rationale for not using calcium acetate
Examples of clinical rationale: hypercalcemia, arterial calcification, adynamic bone disease, low parathyroid hormone (PTH), or age-related risks

Indication and Clinical Definitions

inv-08: Indication — control of serum phosphorus in patients 9 years and older with CKD on dialysis

IndicationControl of serum phosphorus in adults and pediatric patients 9 years of age and older with chronic kidney disease (CKD) who are receiving dialysis (FDA‑approved)

Age thresholdPatients aged 9 years and older

Clinical contextUsed to control serum phosphorus levels in CKD patients on dialysis when one of the specified clinical criteria is met

Authorization conditionAuthorization may be granted when the drug is prescribed for the above indication and ONE of the listed clinical criteria is met

Duration/coverage noteApplies to adult and pediatric patients meeting criteria; follow prior authorization and step therapy requirements as specified elsewhere in the policy

inv-09: Clinical reasons calcium acetate may be inappropriate (e.g., hypercalcemia, arterial calcification, adynamic bone disease, low PTH, intolerance)

HypercalcemiaPresence of elevated serum calcium making calcium acetate inappropriate

Arterial calcificationVascular calcification that would contraindicate calcium‑based phosphate binders

Adynamic bone diseaseLow bone turnover condition where calcium acetate may be inappropriate

Low parathyroid hormone (PTH) levelsSuppressed PTH levels that may contraindicate calcium acetate use

Intolerance or contraindicationHistory of intolerance or contraindication to calcium acetate (e.g., adverse effects) making an alternative necessary