CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Miacalcin (calcitonin salmon) (subcutaneous or intramuscular)

Defines prior-authorization medical benefit coverage criteria, dosing limits, and continuation requirements for Miacalcin (calcitonin salmon) injection for Medicaid, Commercial, and Medicare-Medicaid Plan (MMP) members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMiacalcin (calcitonin salmon) (subcutaneous or intramuscular)

Policy CodePolicy N/A

Change TypeAdministrative review

Effective DateApr 1, 2021

Next Review Date

Key ActionCoverage will be reviewed prospectively via the prior authorization process; requests must meet the specified clinical criteria and dosing limits.

SourceLink

POLICY UPDATE CHANGES

Review date updated to 04/09/2025 (policy reviewed 3/18/2021, 2/17/2022, 3/2/2023, 12/14/2023, 01/04/2024, 4/09/2025).

3Covered Indications

6Initial duration (months)

6Renewal duration (months)

Coverage Summary & Criteria

Coverage stance: Covered with criteria. Scope: Defines prior-authorization medical benefit coverage criteria, dosing limits, and continuation requirements for Miacalcin (calcitonin salmon) injection for Medicaid, Commercial, and Medicare-Medicaid Plan (MMP) members of Neighborhood Health Plan of Rhode Island. Coverage requires meeting the specified clinical criteria (including indication-specific step therapy and dosing limits) and is reviewed prospectively via prior authorization.

General requirements for coverage

Covered when ALL of the following are met:

Dose limit: Dose does not exceed FDA approved guidelines

MMP step therapy exception: MMP members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements

Hypercalcemic emergency

Covered when ALL of the following are met:

Hypercalcemic emergency: Requested drug is prescribed for the early treatment of hypercalcemic emergency not related to a malignancy

Prior therapy requirement: Member has tried and failed or has a contraindication or intolerance to cinacalcet

Paget's disease

Covered when ALL of the following are met:

Paget's disease indication: Requested drug is prescribed for treatment of symptomatic Paget's disease of bone in a member with moderate to severe disease

Prior therapy requirement: Member has tried and failed or has a contraindication or intolerance to both alendronate and pamidronate

Postmenopausal osteoporosis

Covered when ALL of the following are met:

Postmenopausal osteoporosis indication: Requested drug is prescribed for treatment of postmenopausal osteoporosis in a member greater than 5 years post menopausePostmenopausal status duration: > 5 years post menopause

Prior therapy requirement: Member has tried and failed, or has a contraindication or intolerance to two of the following agents: zoledronic acid, alendronate, teriparatide, Prolia (denosumab), Xgeva (denosumab)

MMP exception to Step Therapy

For Medicare-Medicaid Plan (MMP) members:

MMP prior receipt exception: MMP members who have previously received this medication within the past 365 days are not subject to Step Therapy RequirementsMMP prior receipt exception window: received within the past 365 days

Continuation / Renewal Criteria

Continuation of therapy (renewal)

Covered when ALL of the following are met:

Continuation of therapy - diagnosis: Patient meets all initial criteria for diagnosis requested

Continuation of therapy - tolerability: Patient is tolerating treatment and is not experiencing any unacceptable toxicity from the drug

Continuation of therapy - benefit: Patient has disease stabilization or improvement in disease (as defined by established clinical practice guidelines)Renewal coverage duration: 6 months

Applicable Codes

Covered HCPCSHCPCSCovered

J0630

Injection, calcitonin (salmon), up to 400 units

Definitions & billing

Billable unit1 billable unit = 400 IU

Dose/unit billing limits (summary)Paget's disease & postmenopausal osteoporosis: 100 units/day; maximum 7.5 billable units (1 unit = 400 IU) every 30 days. Hypercalcemia: weight‑based dosing with maximum up to 192 billable units every 30 days.

Dose does not exceed FDA approved guidelinesRequired for all indications per policy

Authorization, Documentation & Billing

Prior Authorization

Prior authorization required

Coverage will be reviewed prospectively via the prior authorization process. Requests must meet the specified clinical criteria and dosing limits to be approved.

J0630

Documentation Required

Document prior treatments or contraindications

For Paget's disease and postmenopausal osteoporosis, the request must include documentation of trials and failures or documented contraindications/intolerances to the specified alternative agents listed in the criteria.

Billing Rule

Dose / unit billing limits

Billing must follow the stated dose and billable unit limits. For Paget's disease and postmenopausal osteoporosis the dose is 100 units per day with a maximum of 7.5 billable units every 30 days (1 billable unit = 400 IU). For hypercalcemia dosing is weight‑based (4 units/kg every 12 hours, with possible escalation up to 8 units/kg and increased frequency) with a maximum of 192 billable units every 30 days. Providers must bill using HCPCS code J0630.

100 units/day
Max 7.5 billable units every 30 days (1 billable unit = 400 IU)
Hypercalcemia dosing per kg; max 192 billable units every 30 days

Evidence & References

Background/evidence summary: Miacalcin (calcitonin salmon) is indicated for Paget’s disease, hypercalcemia, and postmenopausal osteoporosis and the policy aligns use with FDA labeling and comparator step requirements. Randomized controlled trials in postmenopausal women showed significant improvements in lumbar spine BMD compared to placebo (with greater increases in those with lower baseline BMD) and an associated reduction in the incidence of vertebral fractures, especially in patients with prior fracture or low baseline BMD.

- Miacalcin package insert: Mylan Institutional LLC; August 2021; accessed March 2025 - Endocrine Society guideline: Singer FR et al., Paget's Disease of Bone: An Endocrine Society Clinical Practice Guideline, JCEM 2014

Background & Scope

Scope and background: This policy defines prior-authorization medical benefit coverage criteria, dosing limits, and continuation requirements for Miacalcin (calcitonin salmon) injection for Medicaid, Commercial, and MMP members. It specifies covered indications (hypercalcemic emergency, Paget’s disease, postmenopausal osteoporosis) and requires trials of or contraindications/intolerances to specified comparator therapies (e.g., cinacalcet for hypercalcemia; alendronate and pamidronate for Paget’s disease; two of zoledronic acid, alendronate, teriparatide, denosumab products for postmenopausal osteoporosis). MMP members who received the medication within the prior 365 days are exempt from step therapy. Dosing limits and billing guidance (J0630) are specified per indication.

Coverage thresholds

Postmenopausal status duration> 5 years post menopause

MMP prior receipt exception windowMember received medication within the past 365 days (exempt from step therapy)

Initial coverage duration6 months

Renewal coverage duration6 months

Initial vs Renewal mappingBoth initial and renewal coverage durations are 6 months per policy statistics and coverage durations section.

Policy Revision Timeline

2025-04-09revisedLatest

Review date updated to 04/09/2025 (administrative update; no clinical policy statement changes).

2024-01-04review

Policy reviewed on 01/04/2024.

2023-12-14review

Policy reviewed on 12/14/2023.

2023-03-02review

Policy reviewed on 03/02/2023.

2022-02-17review

Policy reviewed on 02/17/2022.

2021-03-18review

Policy reviewed on 03/18/2021.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMiacalcin (calcitonin salmon) (subcutaneous or intramuscular)

Policy CodePolicy N/A

Change TypeAdministrative review

Effective DateApr 1, 2021

Next Review Date

Key ActionCoverage will be reviewed prospectively via the prior authorization process; requests must meet the specified clinical criteria and dosing limits.

SourceLink

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