CurrentAvMedPolicy N/A

Cinacalcet (Sensipar) prior authorization and step-therapy

Form and clinical criteria governing prior authorization and step-therapy for cinacalcet (Sensipar) for AvMed members; applies to prescribers seeking pharmacy coverage for cinacalcet.

Policy Summary

PayerAvMed

PolicyCinacalcet (Sensipar) prior authorization and step-therapy

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must sign the prior authorization form and fax it with required labs and documentation to AvMed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial authorization duration

12 moReauthorization duration

30/60/90 mgQuantity limits

>=18Minimum age

Coverage and Medical Necessity Criteria

Initial Therapy - Secondary Hyperparathyroidism

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Secondary Hyperparathyroidism initial: 1) Prescribed by or in consultation with a nephrologist or endocrinologist; 2) Member is >=18 years of age; 3) Diagnosis of chronic kidney disease (CKD); 4) Member is currently undergoing dialysis; 5) Baseline (pre-treatment) intact parathyroid hormone (iPTH) >300 pg/mL OR bio-intact parathyroid hormone (biPTH) >160 pg/mL (labs must be submitted); 6) Baseline serum calcium (Ca) >8.4 mg/dL (corrected for albumin) (labs must be submitted); 7) Documented failure, contraindication, or ineffective response at maximally tolerated doses to a minimum 3-month trial with a vitamin D agent (e.g., calcitriol, doxercalciferol, paricalcitol) verified by pharmacy paid claims; 8) Documented failure, contraindication, or ineffective response at maximally tolerated doses to a minimum 3-month trial with a phosphate binder (e.g., calcium carbonate, calcium acetate, sevelamer HCl, sevelamer carbonate, lanthanum carbonate) verified by pharmacy paid claims.

Initial authorization 6 months

Initial Therapy - Parathyroid Carcinoma

Covered when ALL of the following are met for Parathyroid Carcinoma (initial authorization):

Parathyroid Carcinoma initial: 1) Prescribed by or in consultation with an oncologist, nephrologist, or endocrinologist; 2) Member is >=18 years of age; 3) Diagnosis of parathyroid carcinoma; 4) Confirmation the patient has hypercalcemia defined by baseline serum calcium (Ca) >10 mg/dL (corrected for albumin) (labs must be submitted).

Initial authorization 6 months

Initial Therapy - Primary Hyperparathyroidism

Covered when ALL of the following are met for Primary Hyperparathyroidism (initial authorization):

Primary Hyperparathyroidism initial: 1) Prescribed by or in consultation with a nephrologist or endocrinologist; 2) Member is >=18 years of age; 3) Confirmation the patient has severe hypercalcemia defined by baseline (pre-treatment) serum calcium (Ca) >12 mg/dL (corrected for albumin) (labs must be submitted); 4) Confirmation that parathyroidectomy is indicated but patient is unable to undergo surgery (documentation/labs/notes must be submitted).

Initial authorization 6 months

Reauthorization - Secondary Hyperparathyroidism

Reauthorization criteria for Secondary Hyperparathyroidism (all must be met):

Secondary Hyperparathyroidism reauth: 1) Absence of unacceptable toxicity from the drug (e.g., hypocalcemia, upper gastrointestinal bleeding, seizures, hypotension, worsening heart failure, arrhythmia, adynamic bone disease); 2) Adequate documentation of disease response with improvement of intact parathyroid hormone (iPTH) from pretreatment baseline has been submitted; 3) Current iPTH >150 pg/mL (labs must be submitted); 4) Current serum calcium (Ca) >7.5 mg/dL AND the patient does not have symptoms of hypocalcemia (labs must be submitted).

Reauthorization 12 months

Reauthorization - Parathyroid Carcinoma

Reauthorization criteria for Parathyroid Carcinoma (all must be met):

Parathyroid Carcinoma reauth: 1) Absence of unacceptable toxicity from the drug (e.g., hypocalcemia, upper gastrointestinal bleeding, seizures, hypotension, worsening heart failure, arrhythmia, adynamic bone disease); 2) Adequate documentation of disease response as indicated by improvement of serum calcium (Ca) from pretreatment baseline has been submitted; 3) Current serum calcium (Ca) >8.4 mg/dL (labs must be submitted).

Reauthorization 12 months

Reauthorization - Primary Hyperparathyroidism

Reauthorization criteria for Primary Hyperparathyroidism (all must be met):

Primary Hyperparathyroidism reauth: 1) Absence of unacceptable toxicity from the drug (e.g., hypocalcemia, upper gastrointestinal bleeding, seizures, hypotension, worsening heart failure, arrhythmia, adynamic bone disease); 2) Adequate documentation of disease response as indicated by improvement of serum calcium (Ca) from pretreatment baseline has been submitted; 3) Current serum calcium (Ca) >8.4 mg/dL (labs must be submitted).

Reauthorization 12 months

Initial Authorization Summary

Initial therapy

Initial authorization criteria summarized by diagnosis; initial approval duration 6 months.

Initial therapy per diagnosis: See criteria sets for Secondary Hyperparathyroidism, Parathyroid Carcinoma, and Primary Hyperparathyroidism including requirement for specialist involvement, member age >=18 years, diagnosis-specific baseline biochemical thresholds (iPTH/biPTH or serum calcium as applicable), and prior therapy requirements for secondary hyperparathyroidism (vitamin D agent and phosphate binder trials).

Initial authorization 6 months

Reauthorization / Continuation Criteria

Reauthorization / Continuation Therapy

Reauthorization requirements (continuation therapy):

Continuation general: 1) Absence of unacceptable toxicity from the drug; 2) Documentation of disease response (improvement in iPTH for secondary HPT or improvement in serum calcium for parathyroid carcinoma and primary HPT) with supporting labs/notes submitted; 3) Meet current biochemical thresholds per diagnosis (e.g., current iPTH >150 pg/mL for secondary HPT; current serum calcium thresholds per diagnosis as specified); 4) Reauthorization period 12 months.

Required Provider Actions and Submission Instructions

Prior Authorization

Prior Authorization Submission

Prior authorization is required. The prescribing physician must sign and clearly print their name (preprinted stamps are not valid) on the prior authorization request form. The completed form (including a legible prescriber signature, phone and fax numbers) must be faxed to AvMed at 1-305-671-0200. Incomplete, incorrect, or illegible information may delay processing or result in denial.

Fax prior authorization form to 1-305-671-0200
Prescriber signature required (hand-signed; stamps not valid)
Ensure phone and fax numbers on form are correct

Step Therapy

Step Therapy Requirements for Secondary Hyperparathyroidism

For secondary hyperparathyroidism, the member must have documentation of prior trials unless contraindicated or ineffective. Provide pharmacy paid-claims verification or chart notes to support prior therapy trials. All supporting labs must be submitted with the request.

Documented failure/contraindication/ineffective response to a ≥3 month trial of a vitamin D agent (e.g., calcitriol, doxercalciferol, paricalcitol)
Documented failure/contraindication/ineffective response to a ≥3 month trial of a phosphate binder (e.g., calcium carbonate, calcium acetate, sevelamer, lanthanum)
Provide pharmacy paid-claims or chart notes as verification

Documentation Required

Required Documentation

Submit supporting clinical documentation with the prior authorization request. Required documentation includes prescriber signature and clinical data (labs, diagnoses, and chart notes) as indicated below. Failure to submit required documentation (for example, baseline or current iPTH and serum calcium corrected for albumin, CKD/dialysis status, age, specialist consultation, and verification of prior therapy trials) may result in delay or denial.

Prescriber signature (hand-signed) on request form
Baseline (pre-treatment) intact PTH (iPTH) >300 pg/mL OR bio-intact PTH >160 pg/mL for secondary hyperparathyroidism (labs must be submitted)
Baseline serum calcium corrected for albumin (labs must be submitted)
Documentation of CKD and dialysis status when applicable
Verification of prior therapy trials via pharmacy paid claims or chart notes
For reauthorization: current iPTH and current serum calcium labs as specified in criteria

Denial Risk

Incomplete Information or Missing Documentation

Incomplete, illegible, or missing information (including missing labs, diagnoses, specialist consultation notes, or prescriber signature) may delay the authorization process or lead to denial. Use of sample medications to initiate therapy does not meet step-edit/prior authorization requirements.

Missing baseline or current labs (iPTH, serum calcium corrected for albumin) may result in denial
Illegible or unsigned forms may delay processing or result in denial

Clinical Thresholds and Lab Criteria

inv-08: Baseline iPTH / biPTH

Baseline thresholdIntact parathyroid hormone (iPTH) >300 pg/mL OR bio-intact parathyroid hormone (biPTH) >160 pg/mL (baseline, pre-treatment); labs must be submitted with request.

Required documentationBaseline iPTH or biPTH lab result must be provided with the prior authorization request.

Applicable diagnosisSecondary Hyperparathyroidism in patients with CKD on dialysis (see criteria).

inv-09: Serum calcium thresholds

Secondary Hyperparathyroidism (baseline)Serum calcium (Ca) >8.4 mg/dL (corrected for albumin); labs must be submitted with request.

Parathyroid Carcinoma (baseline)Serum calcium (Ca) >10 mg/dL (corrected for albumin); labs must be submitted with request.

Primary Hyperparathyroidism — severe (baseline)Serum calcium (Ca) >12 mg/dL (corrected for albumin); labs must be submitted with request.

inv-10: Reauthorization calcium and iPTH

Current iPTH for reauthorization (secondary HPT)Current intact parathyroid hormone (iPTH) >150 pg/mL; labs must be submitted with request.

Current serum calcium for reauthorization (secondary HPT)Current serum calcium (Ca) >7.5 mg/dL AND patient does not have symptoms of hypocalcemia; labs must be submitted with request.

Clinical response requirementAdequate documentation of disease response with improvement of iPTH from pretreatment baseline must be submitted.

Definitions and Thresholds

inv-16: Baseline iPTH/biPTH threshold for Secondary Hyperparathyroidism

Threshold definitionPre-treatment intact parathyroid hormone (iPTH) >300 pg/mL OR bio-intact parathyroid hormone (biPTH) >160 pg/mL.

Use with documentationBaseline lab values must be submitted with the authorization request.

Indication contextApplies to Secondary Hyperparathyroidism in CKD patients on dialysis per initial authorization criteria.

inv-17: Hypercalcemia threshold for Parathyroid Carcinoma

Hypercalcemia thresholdBaseline serum calcium (Ca) >10 mg/dL (corrected for albumin).

DocumentationBaseline serum calcium lab (albumin-corrected) must be submitted with the request to confirm parathyroid carcinoma–related hypercalcemia.

Prescriber requirementPrescribed by or in consultation with an oncologist, nephrologist, or endocrinologist per initial criteria.

inv-18: Severe hypercalcemia threshold for Primary Hyperparathyroidism

Severe hypercalcemia thresholdBaseline (pre-treatment) serum calcium (Ca) >12 mg/dL (corrected for albumin).

DocumentationAlbumin-corrected baseline serum calcium must be submitted with the request and confirmation that parathyroidectomy is indicated but patient is unable to undergo surgery, when applicable.

Prescriber requirementMust be prescribed by or in consultation with a nephrologist or endocrinologist per initial criteria.

Step Therapy Requirements

Step	Requirement	Duration / Notes
1
Member has documented failure, contraindication, or ineffective response to a vitamin D agent (e.g., calcitriol, doxercalciferol, paricalcitol)
Minimum 3-month trial; verified by pharmacy paid claims

Step	Requirement	Duration / Notes
2
Member has documented failure, contraindication, or ineffective response to a phosphate binder (e.g., calcium carbonate, calcium acetate, sevelamer HCl, sevelamer carbonate, lanthanum carbonate)
Minimum 3-month trial; verified by pharmacy paid claims

Quantity Limits by Strength

inv-23: cinacalcet 30 mg tablet

Daily quantity limitcinacalcet 30 mg tablet: 2 tablets per day.

UnitLimit expressed as tablets per day; quantity verification via pharmacy claims when applicable.

Initial authorization durationInitial authorization duration is 6 months (see clinical criteria).

inv-24: cinacalcet 60 mg tablet

Daily quantity limitcinacalcet 60 mg tablet: 2 tablets per day.

UnitLimit expressed as tablets per day; quantity verification via pharmacy claims when applicable.

Related limitsSee separate limits for 30 mg and 90 mg tablet strengths.

inv-25: cinacalcet 90 mg tablet

Daily quantity limitcinacalcet 90 mg tablet: 4 tablets per day.

UnitLimit expressed as tablets per day; apply when prescribing highest-strength formulations.

Pharmacy verificationPharmacy paid claims may be used to verify prior therapy trials and quantity use for step therapy requirements.

Background

Cinacalcet (Sensipar) is a calcimimetic indicated for disorders of parathyroid hormone regulation, including secondary hyperparathyroidism in chronic kidney disease patients on dialysis, treatment of hypercalcemia in parathyroid carcinoma, and management of primary hyperparathyroidism when surgery is not an option. Approval for therapy requires biochemical evidence (baseline and follow-up labs) and, for many indications, specialist involvement (nephrology, endocrinology, or oncology as appropriate).

Cinacalcet acts by modulating the calcium-sensing receptor on parathyroid cells to lower parathyroid hormone and serum calcium; coverage decisions are based on diagnosis-specific laboratory thresholds and documented response to prior therapies where required (see coverage criteria for exact iPTH and serum calcium thresholds).

Policy Summary

PayerAvMed

PolicyCinacalcet (Sensipar) prior authorization and step-therapy

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must sign the prior authorization form and fax it with required labs and documentation to AvMed.

SourceLink

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