ModifiedCentenePolicy CP.PHAR.61

Cinacalcet (Sensipar) coverage

Defines medical necessity criteria, prior authorization and coverage limits for cinacalcet (Sensipar) for Centene lines of business (Commercial, HIM, Medicaid) for adult patients with specified indications.

Policy Summary

PayerCentene

PolicyCinacalcet (Sensipar) coverage

Policy CodePolicy CP.PHAR.61

Change TypeMaterial updates (criteria and step therapy exceptions)

Effective DateMay 1, 2011

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating the member meets initial or continued criteria (diagnosis, labs, specialist involvement, prior vitamin D trial when required).

SourceLink

POLICY UPDATE CHANGES

For all indications, added criteria to use generic cinacalcet over brand Sensipar.

For primary hyperparathyroidism, added requirement that member has failed or is unable to undergo a parathyroidectomy per FDA-labeled indication.

Included Parsabiv as an example of a calcimimetic that should not be prescribed concurrently with cinacalcet.

For secondary HPT, added step therapy bypass for Illinois HIM per IL HB 5395.

3FDA-approved indications listed

≥18Minimum age

300 mg/dayMax dose (sec HPT)

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Max dose (PC/primary)

6 moInitial approval

12 moContinued approval

Coverage and Medical Necessity Criteria

Initial Therapy - Secondary Hyperparathyroidism

Covered when ALL of the following are met:

Secondary HPT initial: 1. Diagnosis of secondary hyperparathyroidism (HPT) due to chronic kidney disease (CKD); 2. Prescribed by or in consultation with a nephrologist or endocrinologist; 3. Age ≥ 18 years; 4. Member is on dialysis; 5. One of the following: a) Laboratory results over the previous 3–6 months show a trending increase in intact parathyroid hormone (iPTH) level; OR b) Current (within the last 30 days) labs show iPTH above normal levels; 6. Failure of a vitamin D analog (see Appendix B) at up to maximally indicated doses unless clinically significant adverse effects are experienced or all vitamin D analogs are contraindicated (note: Illinois HIM requests bypass this step therapy per IL HB 5395); 7. Cinacalcet is not prescribed concurrently with other calcimimetics (e.g., Parsabiv); 8. At the time of request, member does not have serum calcium less than the lower limit of the normal range; 9. For Sensipar (brand) requests, member must use generic cinacalcet unless contraindicated or clinically significant adverse effects are experienced; 10. Dose does not exceed 300 mg per day.dose ≤300 mg/day

Approval duration: 6 months

Initial Therapy - Parathyroid Carcinoma and Primary Hyperparathyroidism

Covered when ALL of the following are met:

PC/Primary HPT initial: 1. Diagnosis of hypercalcemia due to parathyroid carcinoma (PC) OR hypercalcemia due to primary hyperparathyroidism (primary HPT); 2. Prescribed by or in consultation with an oncologist, nephrologist, or endocrinologist; 3. Age ≥ 18 years; 4. For primary HPT, member has failed or is unable to undergo a parathyroidectomy per FDA-labeled indication; 5. Cinacalcet is not prescribed concurrently with other calcimimetics (e.g., Parsabiv); 6. For Sensipar requests, member must use generic cinacalcet unless contraindicated or clinically significant adverse effects are experienced; 7. Dose does not exceed either of the following: a) 360 mg per day; AND b) 4 tablets per day.dose ≤360 mg/day; ≤4 tablets/day

Approval duration: 6 months

Continued Therapy

Covered for continuation when ALL of the following are met:

Continued therapy: 1. Member meets one of the following: a) Currently receiving medication via the Centene benefit or previously met initial approval criteria; OR b) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy as evidenced by a decrease in iPTH for secondary HPT or a decrease in serum calcium for parathyroid carcinoma or primary HPT, unless the request is for a dose increase; 3. Cinacalcet is not prescribed concurrently with other calcimimetics (e.g., Parsabiv); 4. For Sensipar requests, member must use generic cinacalcet unless contraindicated or clinically significant adverse effects are experienced; 5. If the request is for a dose increase, the new dose does not exceed: a) Secondary HPT: 300 mg per day; OR b) PC and primary HPT: i) 360 mg per day; AND ii) 4 tablets per day.see dose limits

Approval duration: 12 months

Other/Off-label Uses

Other uses not listed in section I:

Other uses: 1. If the drug has had a label change within the last 6 months that is not yet reflected in this policy, refer to applicable formulary or non‑formulary policies for the relevant line of business; OR 2. If the requested use (diagnosis, age, dosing regimen) is not listed under section III and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business.

See referenced policies: CP.CPA.190, HIM.PA.33/103, CP.PMN.255/16, CP.CPA.09, HIM.PA.154, CP.PMN.53

Coverage is not authorized when a member's serum calcium is less than the lower limit of normal; this is a contraindication to use. Requests for indications that are not FDA‑approved and are not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy for the member's line of business.

Where state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid coverage provisions take precedence. Coverage determinations are guides to medical necessity and are subject to all terms, conditions, exclusions and limitations of the member's coverage documents and applicable state and federal requirements.

Non‑FDA (off‑label) uses of cinacalcet that are not specifically addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy for the member's line of business (see referenced off‑label policies). Providers must submit supporting clinical documentation to demonstrate that off‑label use meets those criteria.

Dosing Limits, Age and Definitions

Dose limits — Cinacalcet

Secondary hyperparathyroidism (dose limit)Do not exceed 300 mg per day.

Parathyroid carcinoma (dose limit)Do not exceed 360 mg per day.

Primary hyperparathyroidism (dose limit)Do not exceed 360 mg per day and do not exceed 4 tablets per day.

Age requirement

Minimum age for covered indicationsAge ≥ 18 years for all FDA‑approved indications.

Applies to secondary HPTAge requirement specified in initial approval for secondary HPT: ≥ 18 years.

Prior Authorization, Documentation and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for cinacalcet (Sensipar). Providers must obtain PA prior to drug initiation. Refer to the health plan's prior authorization criteria for required clinical information and submission instructions.

PA required for all indications covered by this policy

Note

Prior Authorization Guidance

Follow the Health Plan's administrative PA processes when submitting requests. Ensure requests include all clinical documentation and use applicable PA forms or portals. Coverage decisions are made according to this clinical policy and any additional Health Plan-level administrative policies.

Use plan-specific PA forms/portals where applicable
Coverage decisions subject to terms, exclusions, and limitations of coverage documents

Clinical Background

Cinacalcet is a calcimimetic that acts as a calcium‑sensing receptor agonist to lower parathyroid hormone (PTH) and reduce serum calcium. It is approved to treat secondary hyperparathyroidism in adults on dialysis, hypercalcemia associated with parathyroid carcinoma, and hypercalcemia in primary hyperparathyroidism when parathyroidectomy is not an option. Monitoring of therapy differs by indication: intact PTH (iPTH) trends are used for secondary hyperparathyroidism and serum calcium is used for the hypercalcemia indications.

Policy Changes and Revision History

2011-05-01policy_effective

Policy originally effective (original publication year 2011).

2024-05-10material_change

3Q 2024 annual review added requirement to prefer generic cinacalcet over brand Sensipar for all indications.

2025-04-14material_changeLatest

3Q 2025 annual review added requirement for primary hyperparathyroidism that member has failed or is unable to undergo parathyroidectomy, clarified Parsabiv as an example of a calcimimetic that should not be prescribed concurrently with cinacalcet, and added Illinois HIM step therapy bypass per IL HB 5395 for secondary HPT.

Policy Summary

PayerCentene

PolicyCinacalcet (Sensipar) coverage

Policy CodePolicy CP.PHAR.61

Change TypeMaterial updates (criteria and step therapy exceptions)

Effective DateMay 1, 2011

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating the member meets initial or continued criteria (diagnosis, labs, specialist involvement, prior vitamin D trial when required).

SourceLink

On This Page

Applies to PC and primary HPT

Age requirement specified in initial approval for PC and primary HPT: ≥ 18 years.

intact parathyroid hormone (iPTH)

Definition (abbreviation)iPTH = intact parathyroid hormone.

Clinical useiPTH is the laboratory measure used to monitor response for secondary hyperparathyroidism (decrease in iPTH indicates response).

Referenced in criteriaPolicy uses trending iPTH over 3–6 months or current iPTH above normal as part of initial therapy criteria for secondary HPT.

parathyroid carcinoma (PC)

Definition (abbreviation)PC = parathyroid carcinoma.

FDA‑approved indicationSensipar is indicated for hypercalcemia in adult patients with parathyroid carcinoma.

Use in policyParathyroid carcinoma is listed as an approved indication requiring prescription by or in consultation with appropriate specialists per initial criteria.

Denial Risk

Documentation Insufficiency / Non‑covered Indication — Denial Risk

If documentation is insufficient or the indication is not covered by this policy (see III. Diagnoses/Indications for which coverage is NOT authorized), the request may be denied. Providers should submit office notes, laboratory results, and specialist consultation notes to support medical necessity.

Insufficient documentation may result in denial
Non‑FDA or non‑policy indications require additional evidence per off‑label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53)

Step Therapy

Step Therapy — Vitamin D Analog Trial Required for Secondary HPT

For secondary hyperparathyroidism (secondary HPT) due to CKD, a trial and failure of a vitamin D analog (see Appendix B) at maximally indicated doses is required prior to approval of cinacalcet, unless contraindicated or clinically significant adverse effects occur. Note: for Illinois HIM requests, step therapy requirements do not apply for formulary drugs as of 1/1/2026 per IL HB 5395.

Required trial/failure of a vitamin D analog for secondary HPT (unless contraindicated or adverse effects)
Appendix B lists vitamin D analog alternatives (e.g., calcitriol, doxercalciferol, paricalcitol)

Note

Step Therapy Specifics Governed by Health Plan Policies

Specific step therapy implementation (exceptions, bypasses, timelines, and plan‑level overrides) is governed by applicable Health Plan administrative policies and state/federal requirements. Providers should consult the member's Health Plan for operational details and any state‑specific addenda that may modify step therapy (e.g., continuity of care provisions or legislative changes).

Step therapy specifics (e.g., exception processes, documentation standards) determined by Health Plan administrative policies
State laws and plan addendums may override step therapy (see IL HB 5395 and state addendums)