CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cinacalcet (Sensipar) — Coverage Criteria

Defines covered indications, prior authorization duration, and continuation criteria for cinacalcet (Sensipar) for members of Neighborhood Health Plan of Rhode Island per the listed clinical conditions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCinacalcet (Sensipar) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization (up to 12 months) and provide laboratory documentation including corrected serum calcium and, for dialysis patients, baseline and subsequent iPTH to demonstrate benefit for continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

>= 8.4calcium threshold

↓ iPTHdialysis continuation evidence

normalized Caother continuation evidence

Coverage Criteria for cinacalcet (Sensipar)

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Initial authorization criteria

Covered when ALL of the following are met for the respective indication:

Covered indications: Member has one of the following indications: 1) Secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on dialysis; 2) Primary hyperparathyroidism in adults who are unable to undergo parathyroidectomy; 3) Hypercalcemia in adult patients with parathyroid carcinoma; 4) Tertiary hyperparathyroidism in post-kidney transplant patients not receiving dialysis (compendial).

Indication list from policy Sections A–D

Laboratory threshold: For any of the covered indications, member has corrected serum calcium greater than or equal to 8.4 mg/dL (total calcium corrected for albumin; see Appendix).>= 8.4 mg/dL

Applied to secondary HPT on dialysis, primary HPT when surgery not possible, tertiary HPT post-transplant not on dialysis, and parathyroid carcinoma

Continuation/Reauthorization criteria

Covered for continuation when ALL of the following are met:

Continuation evidence of benefit for dialysis patients: Member with secondary hyperparathyroidism on dialysis is experiencing benefit from therapy as evidenced by a decrease in intact parathyroid hormone (iPTH) levels from pretreatment baseline.decrease from baseline

Required for reauthorization

Continuation evidence of benefit for other indications: Member with other covered indications is experiencing benefit from therapy as evidenced by decreased or normalized corrected serum calcium levels since starting therapy.decreased or normalized corrected calcium

Required for reauthorization

Use of cinacalcet (Sensipar) for any indication other than the FDA‑approved indications and the single specified compendial use — tertiary hyperparathyroidism in post‑kidney transplant patients not receiving dialysis — is considered experimental/investigational and not medically necessary.

Treatment with cinacalcet for conditions outside the FDA‑approved indications and the stated compendial use is not covered. Specifically, therapies for indications other than those listed (including any indication not enumerated in the policy aside from the compendial tertiary post‑transplant use) will be denied as not medically necessary.

Coding and Clinical Thresholds

Corrected serum calcium threshold

Corrected serum calcium threshold>= 8.4 mg/dL

Applies to secondary HPT on dialysisCorrected serum calcium >= 8.4 mg/dL required for authorization

Applies to primary HPT when surgery not possibleCorrected serum calcium >= 8.4 mg/dL required for authorization

Applies to tertiary HPT post-transplant (compendial)Corrected serum calcium >= 8.4 mg/dL required for authorization

Applies to parathyroid carcinomaCorrected serum calcium >= 8.4 mg/dL required for authorization

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for covered indications. Authorization of up to 12 months may be granted for the following indications when documentation (including corrected serum calcium calculated as total calcium + 0.8(4.0 - serum albumin)) supports the request: secondary hyperparathyroidism in members with chronic kidney disease on dialysis; primary hyperparathyroidism for members unable to undergo parathyroidectomy; tertiary hyperparathyroidism in post-kidney transplant patients not receiving dialysis; and parathyroid carcinoma. For the dialysis, primary, tertiary, and parathyroid carcinoma indications, serum calcium (corrected for albumin) must be ≥ 8.4 mg/dL. Requests should include relevant laboratory results and clinical rationale.

Authorization duration: up to 12 months for covered indications
Corrected calcium formula: total calcium + 0.8(4.0 - serum albumin) — include value with request
Covered indications: secondary hyperparathyroidism with CKD on dialysis; primary hyperparathyroidism when surgery not possible; tertiary hyperparathyroidism post-kidney transplant not on dialysis; parathyroid carcinoma

Documentation Required

Reauthorization — Evidence of Benefit Required

Reauthorization for continued therapy (up to 12 months) requires evidence of clinical benefit. For secondary hyperparathyroidism with CKD on dialysis, provide documentation of a decrease in intact parathyroid hormone (iPTH) from pretreatment baseline. For all other approved indications, provide documentation of decreased or normalized corrected serum calcium since initiating therapy.

Reauthorization evidence for dialysis indication: decreased iPTH from pretreatment baseline
Reauthorization evidence for other indications: decreased or normalized corrected serum calcium values

Denial Risk

Experimental / Investigational — Not Covered

Experimental/investigational exclusions: All indications not listed as covered above (including any uses outside secondary, primary, tertiary post-transplant, and parathyroid carcinoma indications) are considered experimental/investigational and are not medically necessary. Requests for non-covered indications should be denied.

Explicit denial risk for non-covered indications — all other uses are investigational/not medically necessary

Documentation Required

Required Laboratory & Documentation

Required laboratory documentation must be provided with initial and reauthorization requests. Include corrected serum calcium (use formula: total calcium + 0.8(4.0 - serum albumin)), relevant intact PTH values (with pretreatment baseline for dialysis indication), and any other supporting labs or clinical notes demonstrating the indication and response to therapy.

Include corrected serum calcium value and supporting albumin and total calcium labs
Include pretreatment baseline iPTH and follow-up iPTH for secondary hyperparathyroidism on dialysis
Attach clinical rationale and prior treatment history (e.g., inability to undergo parathyroidectomy when claimed)

Background

Cinacalcet (Sensipar) is a calcimimetic agent used to lower parathyroid hormone and serum calcium in disorders of hyperparathyroidism and hypercalcemia. The policy recognizes its use in FDA‑approved indications and a single compendial indication (tertiary hyperparathyroidism after kidney transplant in patients not on dialysis); uses outside those recognized indications are considered experimental/investigational.

Definitions

Corrected serum calcium definition

Correction formulaCorrected calcium = total calcium + 0.8(4.0 - serum albumin)

Measurement referenced in policyPolicy applies corrected calcium (per formula) when assessing serum calcium for authorization

Use case in dialysis patientsCorrected calcium (per formula) used to determine eligibility for secondary HPT on dialysis (>= 8.4 mg/dL)

Use case in non-dialysis/other indicationsCorrected calcium (per formula) used to determine eligibility for primary HPT, tertiary HPT post-transplant, and parathyroid carcinoma (>= 8.4 mg/dL)