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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsWashington HCA Calcitonin Prior Auth | OpenPayer
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    CurrentWashington State Health Care AuthorityPolicy 30.04.30-2

    Bone Density Regulators - Calcitonins

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    Washington Apple Health coverage and prior authorization for calcitonin-salmon products used for hypercalcemia, Paget's disease, and postmenopausal osteoporosis, including clinical criteria, preferred-drug trials, reauthorization, dosage, and quantity limits.

    Policy Summary
    PayerWashington State Health Care Authority
    PolicyBone Density Regulators - Calcitonins
    Policy CodePolicy 30.04.30-2
    Change TypeNo material change
    Effective DateJune 1, 2025
    Next Review DateNot specified
    Key ActionSubmit documentation showing that the applicable clinical criteria and required preferred-drug trial requirements are met.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    3Covered clinical indications
    1 monthHypercalcemia authorization
    12 monthsPaget's disease and osteoporosis authorization
    2 preferred agentsNon-preferred agent trial

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    12 months
    Bisphosphonate trial
    24 monthsPreferred SERM trial

    Indication-Specific Coverage Criteria

    Hypercalcemia — Initial Therapy

    Calcitonin-salmon (M iacalcin) may be approved when all the following documented criteria are met:

    ALL of the following

    • Patient is 18 years of age or older
    • Diagnosis of hypercalcemia

    Hypercalcemia — Reauthorization

    Calcitonin-salmon (M iacalcin) may be approved when all the following documented criteria are met:

    ALL of the following

    • Criteria 1–2 above continue to be met

    Paget's Disease — Initial Therapy

    Calcitonin-salmon (M iacalcin) may be approved when all the following documented criteria are met:

    ALL of the following

    • Patient is 18 years of age or older
    • Diagnosis of Paget's disease
    • Patient has symptomatic disease (e.g., bone pain, nerve compression, bone lesions, or fracture)

    • ONE of the following baseline assessments is included

      • Serum alkaline phosphatase (sAP)
      • Diagnostic radiograph, CT, or MRI
      • Biopsy results

    Paget's Disease — Reauthorization

    Calcitonin-salmon (M iacalcin) may be approved when all the following documented criteria are met:

    ALL of the following

    • Documentation is submitted demonstrating disease stability or a positive clinical response (e.g., improvement in sAP or bone pain)

    Postmenopausal Osteoporosis — Initial Therapy

    Calcitonin-salmon (M iacalcin) may be approved when all the following documented criteria are met:

    ALL of the following

    • Patient is 18 years of age or older
    • Diagnosis of osteoporosis
    • Patient is a postmenopausal female

    • AT LEAST ONE of the following fracture risk categories is met

      • T-score ≤ -2.5 in the lumbar spine, femoral neck, or total hip
      • T-score between -1 and -2.5 with a history of recent fragility fracture of the proximal humerus, pelvis, or distal forearm

    Postmenopausal Osteoporosis — Reauthorization

    Calcitonin-salmon (M iacalcin) may be approved when all the following documented criteria are met:

    ALL of the following

    • Documentation is submitted demonstrating disease stability or a positive clinical response (e.g., patient has not suffered a fragility fracture, and bone mineral density continues to improve or remain stable)

    Clinical Qualification Thresholds

    Bone mineral density
    Qualifying T-score≤ -2.5
    Anatomical siteLumbar spine
    Additional qualifying sitesFemoral neck or total hip
    Osteoporosis with recent fragility fracture
    Qualifying T-score rangeBetween -1 and -2.5
    Fracture requirementRecent fragility fracture
    Qualifying fracture sitesProximal humerus, pelvis, or distal forearm

    Prior Authorization and Documentation Requirements

    Prior Authorization

    Clinical Prior Authorization Required

    Prior authorization is required for calcitonin-salmon (M并iacalcin) under this clinical policy. The request must establish medical necessity under the applicable indication-specific criteria; if criteria are not met, a clinical reviewer may approve only when a medically necessary need is determined on a case-by-case basis.

    • Non-preferred brand products with an A-rated generic, biosimilar, or interchangeable biosimilar must also meet Non-Clinical Policy No. 0001 (NC-001).
    • A new FDA-approved indication not addressed in this policy will be evaluated case by case using FDA labeling.
    Step Therapy

    Preferred-Agent Requirement

    Because new-to-market and other non-preferred agents on the Apple Health Preferred Drug List (AHPDL) are subject to prior authorization, document an inadequate response, severe adverse reaction, intolerance, or contraindication to the required preferred agents before requesting calcitonin-salmon.

    • If at least two preferred agents are available in the class, document inadequate response or documented intolerance due to severe adverse reaction or contraindication to at least two preferred agents.

    Clinical Background

    Osteoporosis is characterized by decreased bone mass and increased fracture risk, most commonly affecting the spine, hip, and wrist. The policy recognizes high fracture risk through low bone mineral density, a history of hip or vertebral fracture, selected recent fragility fractures, elevated 10-year FRAX fracture probability, or long-term glucocorticoid exposure at a prednisone-equivalent dose of ≥7.5 mg per day.

    Risk Definitions

    High fracture risk
    Bone mineral density criterionT-score below -2.5 in the spine, femoral neck, and/or total hip without fracture
    Prior fracture criterionHistory of hip or vertebral fracture regardless of bone mineral density
    Recent fragility fracture criterionT-score at or below -1 with a recent fracture of the proximal humerus, pelvis, or distal forearm
    FRAX criterionT-score between -1.0 and -2.5 with a 10-year FRAX risk of at least 20% for any major fracture or at least 3% for hip fracture
    Glucocorticoid criterionLong-term glucocorticoid treatment at a prednisone-equivalent dose of at least 7.5 mg per day

    Initial Therapy by Indication

    Hypercalcemia

    Covered when ALL criteria are met:

    • Age: Patient is 18 years of age or older.≥18 years
    • Diagnosis of hypercalcemia.

    Paget's Disease

    Covered when ALL criteria are met:

    Paget's disease

    • Age: Patient is 18 years of age or older.

    Reauthorization Criteria

    Reauthorization

    Reauthorization is available when ALL of the following are met:

    Indication-specific continuation: For hypercalcemia, criteria 1–2 continue to be met. For Paget's disease, documentation demonstrates disease stability or a positive clinical response, such as improvement in serum alkaline phosphatase or bone pain. For postmenopausal osteoporosis, documentation demonstrates disease stability or a positive clinical response, including no fragility fracture and bone mineral density that continues to improve or remains stable.

    Authorization is for 1 month for hypercalcemia and 12 months for Paget's disease or postmenopausal osteoporosis.

    Preferred Drug Trials

    CoverageApplies toRequired trialException
    RequiredNon-preferred agents in the classTrial at least two preferred agentsIf only one preferred agent is available, trial that one agent; document inadequate response or intolerance due to severe adverse reaction or contraindication.
    CoverageApplies toRequired trialDuration / exception
    RequiredPaget's disease or postmenopausal osteoporosisAt least one preferred Apple Health PDL oral or intravenous bisphosphonateMinimum trial of 12 months; the requirement does not apply when all preferred agents are contraindicated or not tolerated.
    CoverageApplies toRequired trialDuration / exception
    RequiredPostmenopausal osteoporosisAt least one preferred Apple Health PDL selective estrogen receptor modulator (SERM)Minimum trial of 24 months; the requirement does not apply when all preferred agents are contraindicated or not tolerated.

    Product Dosage and Quantity Limits

    Miacalcin (brand)
    IndicationHypercalcemia
    Dosage form400 IU/2 mL vial
    Dosing limitationDosing is weight dependent
    Miacalcin (brand)
    IndicationsPaget's disease and postmenopausal osteoporosis
    Dosage form400 IU/2 mL vial
    Quantity limit14 mL per 28 days
    Policy Summary
    PayerWashington State Health Care Authority
    PolicyBone Density Regulators - Calcitonins
    Policy CodePolicy 30.04.30-2
    Change TypeNo material change
    Effective DateJune 1, 2025
    Next Review DateNot specified
    Key ActionSubmit documentation showing that the applicable clinical criteria and required preferred-drug trial requirements are met.
    SourceLink
    On This Page
    Indication-Specific Coverage CriteriaClinical Qualification ThresholdsPrior Authorization and Documentation RequirementsClinical BackgroundRisk DefinitionsInitial Therapy by IndicationReauthorization CriteriaPreferred Drug TrialsProduct Dosage and Quantity Limits
    Treatment with at least one Preferred Apple Health Preferred Drug List (PDL) oral or intravenous bisphosphonate medication has been ineffective, unless all are contraindicated or not toleratedminimum trial of 12 months
  1. T-score between -1 and -2.5 with a FRAX 10-year probability for major fracture ≥20% or hip fracture ≥3%

  2. AT LEAST ONE of the following treatment histories is documented

    • Treatment with at least one Preferred Apple Health Preferred Drug List (PDL) oral or intravenous bisphosphonate medication has been ineffective, unless all are contraindicated or not toleratedminimum trial of 12 months
    • Treatment with at least one Preferred Apple Health Preferred Drug List (PDL) selective estrogen receptor modulator (SERM) medication has been ineffective, unless all are contraindicated or not toleratedminimum trial of 24 months
    3. FRAX major fracture risk
    Risk measureFRAX 10-year probability
    Fracture typeMajor fracture
    Qualifying threshold≥20%
    FRAX hip fracture risk
    Risk measureFRAX 10-year probability
    Fracture typeHip fracture
    Qualifying threshold≥3%
    Glucocorticoid exposure
    ExposureLong-term glucocorticoid treatment
    Dose basisPrednisone-equivalent dose
    Qualifying dose≥7.5 mg per day
  3. If only one preferred agent is available, document inadequate response or documented intolerance due to severe adverse reaction or contraindication to that one agent.
  4. Use the current Apple Health Preferred Drug List to identify preferred agents.
    5. Step Therapy

    Preferred Bisphosphonate Trial

    For Paget’s disease and postmenopausal osteoporosis, document an ineffective trial of at least one preferred Apple Health PDL oral or intravenous bisphosphonate before requesting calcitonin-salmon.

    • Minimum required trial: 12 months.
    • The trial is not required when all preferred bisphosphonates are contraindicated or not tolerated; document the applicable contraindication or intolerance.
    • For Paget’s disease, authorization is for 12 months when all criteria are met.
    Step Therapy

    Preferred SERM Trial

    For postmenopausal osteoporosis, document an ineffective trial of at least one preferred Apple Health PDL selective estrogen receptor modulator (SERM) before requesting calcitonin-salmon.

    • Minimum required trial: 24 months.
    • The trial is not required when all preferred SERMs are contraindicated or not tolerated; document the applicable contraindication or intolerance.
    Documentation Required

    Initial Clinical Documentation

    Submit initial clinical documentation supporting the requested indication and all applicable baseline requirements. Documentation must establish the patient’s age, diagnosis, symptoms when required, and baseline disease assessment.

    • Hypercalcemia: patient is at least 18 years old and has a diagnosis of hypercalcemia.
    • Paget’s disease: patient is at least 18 years old, has Paget’s disease, and has symptomatic disease such as bone pain, nerve compression, bone lesions, or fracture.
    • For Paget’s disease, include at least one baseline assessment: serum alkaline phosphatase (sAP), diagnostic radiograph/CT/MRI, or biopsy results.
    Documentation Required

    Osteoporosis Risk and Prior-Treatment Documentation

    For postmenopausal osteoporosis, document the patient’s postmenopausal status, osteoporosis diagnosis, fracture-risk findings, and prior treatment history.

    • Patient must be at least 18 years old and a postmenopausal female with a diagnosis of osteoporosis.
    • Document at least one qualifying risk finding: T-score ≤ -2.5 at the lumbar spine, femoral neck, or total hip; T-score between -1 and -2.5 with a recent fragility fracture of the proximal humerus, pelvis, or distal forearm; or T-score between -1 and -2.5 with a FRAX 10-year probability of major fracture ≥20% or hip fracture ≥3%.
    • Document the required preferred bisphosphonate and/or SERM treatment history, including duration, response, and any contraindication or intolerance.
    Documentation Required

    Reauthorization Response Documentation

    For reauthorization, submit documentation demonstrating that the patient’s disease remains stable or that the patient has had a positive clinical response to calcitonin-salmon.

    • Examples include improved serum alkaline phosphatase or bone pain in Paget’s disease, no new fragility fracture, and bone mineral density that continues to improve or remains stable.
    • For hypercalcemia, document that the initial age and diagnosis criteria continue to be met.
    • When all reauthorization criteria are met, authorization is generally for 12 months; hypercalcemia reauthorization is authorized for 1 month.
    Denial Risk

    Failure to Meet Indication-Specific Criteria

    A request may be denied when the indication-specific clinical requirements are not fully documented or met. The applicable criteria must be satisfied for hypercalcemia, Paget’s disease, or postmenopausal osteoporosis before authorization can be issued.

    • Hypercalcemia: denial risk applies when the patient is under 18 or hypercalcemia is not documented.
    • Paget’s disease: denial risk applies when age, diagnosis, symptomatic disease, baseline assessment, or the required preferred bisphosphonate history is missing or unmet.
    • Postmenopausal osteoporosis: denial risk applies when osteoporosis, postmenopausal status, a qualifying fracture-risk category, or required preferred-agent history is not documented.
    • Reauthorization may be denied when disease stability or positive clinical response is not demonstrated.
    Denial Risk

    Insufficient Preferred-Agent History

    Requests are at risk for denial when the required preferred-agent history is absent. Clearly identify the preferred Apple Health PDL agents tried, the trial duration, treatment outcome, and the reason a preferred agent cannot be used when applicable.

    • For bisphosphonates, document at least a 12-month trial unless all preferred agents were contraindicated or not tolerated.
    • For SERMs, document at least a 24-month trial unless all preferred agents were contraindicated or not tolerated.
    • For the general non-preferred-agent requirement, document trials of at least two preferred agents when two or more are available, or one preferred agent when only one is available.
    ≥18 years
  5. Diagnosis of Paget's disease.
  6. Symptoms: Patient has symptomatic disease, such as bone pain, nerve compression, bone lesions, or fracture.

  7. ONE of — baseline assessment

    • Serum alkaline phosphatase (sAP) is provided.
    • Diagnostic radiograph, CT, or MRI is provided.
    • Biopsy results are provided.
  8. Preferred bisphosphonate trial: Treatment with at least one preferred Apple Health PDL oral or intravenous bisphosphonate medication has been ineffective, unless all are contraindicated or not tolerated.Minimum trial: 12 months

    9. Postmenopausal Osteoporosis

    Covered when ALL criteria are met:

    Postmenopausal osteoporosis

    • Age: Patient is 18 years of age or older.≥18 years
    • Diagnosis of osteoporosis.
    • Population: Patient is a postmenopausal female.

    • ONE of — qualifying fracture-risk categories

      • T-score is ≤ -2.5 in the lumbar spine, femoral neck, or total hip.T-score ≤ -2.5
      • T-score is between -1 and -2.5 with a history of a recent fragility fracture of the proximal humerus, pelvis, or distal forearm.T-score -1 to -2.5
      • T-score is between -1 and -2.5 with a FRAX 10-year probability for major fracture of at least 20%.FRAX major fracture risk ≥20%
      • T-score is between -1 and -2.5 with a FRAX 10-year probability for hip fracture of at least 3%.FRAX hip fracture risk ≥3%

    • ONE of — preferred therapy history

      • Treatment with at least one preferred Apple Health PDL oral or intravenous bisphosphonate medication has been ineffective, unless all are contraindicated or not tolerated.Minimum trial: 12 months
      • Treatment with at least one preferred Apple Health PDL selective estrogen receptor modulator (SERM) medication has been ineffective, unless all are contraindicated or not tolerated.Minimum trial: 24 months
    Calcitonin-salmon (generic)
    IndicationHypercalcemia
    Dosage form400 IU/2 mL vial
    Dosing limitationDosing is weight dependent
    Calcitonin-salmon (generic)
    IndicationPaget's disease
    Dosage form400 IU/2 mL vial
    Quantity limit14 mL per 28 days
    Calcitonin-salmon (generic)
    IndicationPostmenopausal osteoporosis
    Dosage form200 IU nasal spray, 1 actuation; 3.7 mL bottle
    Quantity limit1 bottle per 28 days