CurrentAvMedPolicy N/A

Prior authorization criteria for parathyroid analogs (Forteo, Tymlos, teriparatide)

Form and clinical criteria that govern prior authorization and step-edit requests for teriparatide products (Forteo, Tymlos, teriparatide) for AvMed members; applies to prescribing providers requesting coverage through Pharmacy Prior Authorization. Affects members seeking these specialty injectable osteoporosis therapies.

Policy Summary

PayerAvMed

PolicyPrior authorization for parathyroid analogs (Forteo, Tymlos, teriparatide)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete and sign the prior authorization form and fax it to 1-305-671-0200 with supporting documentation (chart notes, BMD, FRAX, labs).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24Max lifetime approval (months)

2.4 mLForteo limit

1.56 mLTymlos limit

2.48 mLteriparatide limit

Coverage Criteria for Parathyroid Analogs

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Initial Authorization Criteria

Covered when ALL of the following groups of criteria are met:

Section A - Diagnosis

Diagnosis options: Post-menopausal osteoporosis; Male with primary or hypogonadal osteoporosis; Systemic glucocorticoid-induced osteoporosis
Confirmation of osteoporosis: History of vertebral or other low-trauma fragility fracture within past 5 years; OR T-score ≤ -2.5 at spine, femoral neck, total hip, or 1/3 radius; OR T-score between -1 and > -2.5 with pre-treatment FRAX major fracture risk ≥ 20% or hip fracture risk ≥ 3%; OR very high risk for fracture (T-score ≤ -3.0, T-score ≤ -2.5 with history of fragility fractures, or severe/multiple vertebral fractures).

Section B - Prerequisite therapy

Bisphosphonate trial: 12-month minimum trial of one bisphosphonate (alendronate, ibandronate, risedronate, or zoledronic acid) with documentation of failure (no BMD improvement at end of trial, decline in BMD, or fracture while on therapy).
Bisphosphonate intolerance/contraindication: Documented intolerance, FDA-labeled contraindication, or hypersensitivity to both an oral and IV bisphosphonate defined by two of: hypersensitivity to two bisphosphonates (one must be alendronate); inability to sit/stand upright ≥ 30 minutes; pre-existing GI disorders (e.g., Barrett's esophagus, hypersecretory disorders, delayed esophageal emptying, atrophic gastritis); uncorrected hypocalcemia; severe renal insufficiency (CrCl <35 mL/min for alendronate agents and zoledronic acid or CrCl <30 mL/min for risedronate and ibandronate).

Product-specific prior therapy for Forteo: For approval of Forteo, member must have had trial and failure of ONE of the following: Tymlos (abaloparatide) or teriparatide (recombinant).

Section C - Contraindications and concurrent therapy: Member must NOT be currently using and must NOT initiate bisphosphonate, SERM, calcitonin (Miacalcin or Fortical), denosumab (Prolia or Xgeva), or romosozumab (Evenity) while on the requested medication; member must NOT have contraindications including history of skeletal irradiation, history of osteosarcoma, open epiphyses, Paget's disease, hypercalcemia, or hyperparathyroidism.

When requesting a parathyroid hormone analog, the member must not be concurrently using — and must agree not to initiate — any of the following agents during therapy with the requested medication: bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin (Miacalcin or Fortical), denosumab (Prolia or Xgeva), or romosozumab (Evenity). Requests that indicate current use or planned initiation of these therapies while on the requested parathyroid analog will not meet coverage criteria.

The member also must not have any of the listed contraindications to anabolic parathyroid therapy. These include a history of skeletal irradiation, a history of osteosarcoma, open epiphyses, Paget’s disease, hypercalcemia, or hyperparathyroidism. Presence of any of these contraindications excludes the member from approval.

Initial Therapy Requirements

Initial therapy requirements

Initial authorization requires meeting diagnostic criteria and prerequisite therapy rules.

Diagnostic confirmation: See Section A criteria: fracture history within 5 years, or BMD T-score thresholds (≤ -2.5 at spine/femoral neck/total hip/1/3 radius), or T-score -1 to > -2.5 with FRAX 10-year major fracture risk ≥ 20% or hip fracture risk ≥ 3%; very high risk definitions apply.

Prerequisite therapy: Either a 12-month trial of one bisphosphonate with documented failure OR documented intolerance/contraindication to both oral and IV bisphosphonates as defined in the form.

Forteo-specific: For Forteo approval, member must have trial and failure of ONE of: Tymlos (abaloparatide) or teriparatide (recombinant).

Product-Specific Quantity Limits

Forteo — Quantity Limit

DrugForteo (teriparatide)

Quantity limitMaximum 2.4 mL per 28 days

Related limitMaximum 24-month cumulative lifetime therapy for all parathyroid analogs

Tymlos — Quantity Limit

DrugTymlos (abaloparatide)

Quantity limitMaximum 1.56 mL per 28 days

Related limitMaximum 24-month cumulative lifetime therapy for all parathyroid analogs

teriparatide (recombinant) — Quantity Limit

Drugteriparatide (recombinant)

Quantity limitMaximum 2.48 mL per 28 days

Related limitMaximum 24-month cumulative lifetime therapy for all parathyroid analogs

Prior Trial / Step Requirements

Submission requirements	Incomplete or illegible request	Required supporting documentation
No results

Step Therapy

Prior Trial / Step Requirements (Step therapy)

Members must meet ONE of the following prior trial and step requirements for consideration: a 12-month trial and failure of one (1) bisphosphonate OR documented intolerance/contraindication to both oral and IV bisphosphonates. For approval of Forteo (teriparatide) or Tymlos (abaloparatide), member must have trial and failure of ONE of the other anabolic agents as listed.

Trial requirement: Member has had a minimum 12-month trial of ONE of the following bisphosphonates with evidence of no BMD improvement, decline in BMD, or fracture while on therapy. Submit BMD assessments, radiographs and/or chart notes documenting failure: alendronate (Fosamax), ibandronate (Boniva), risedronate (Actonel), zoledronic acid (Reclast).
Intolerance/Contraindication alternative: Member has documented intolerance, FDA-labeled contraindication, or hypersensitivity to BOTH an oral and an IV bisphosphonate. Documentation must include two of the following: hypersensitivity to TWO bisphosphonates (one must be alendronate), inability to sit/stand upright ≥30 minutes, pre-existing GI disorders (e.g., Barrett's esophagus, hypersecretory disorders, delayed esophageal emptying, atrophic gastritis), uncorrected hypocalcemia, or severe renal insufficiency (CrCL <35 mL/min for alendronate agents and zoledronic acid OR CrCL <30 mL/min for risedronate and ibandronate).
Anabolic agents requirement: For approval of Forteo (teriparatide), member must have trial and failure of ONE of the following: Tymlos (abaloparatide) injection OR teriparatide (recombinant) injection. Chart notes documenting therapy failure must be submitted.

Provider Submission and Documentation

Prior Authorization

Submit signed prior authorization form via fax

Complete the Pharmacy Prior Authorization/Step-Edit Request form, ensure the prescribing physician signs and prints their name (pre-printed stamps not valid), and fax the completed form to 1-305-671-0200. Confirm plan coverage and specialty dispensing requirements before submission.

Fax the signed form to 1-305-671-0200.
Prescribing physician signature and legible printed name required on the request form.

Documentation Required

Provide required supporting documentation and prescriber signature

Provide supporting documentation with the request: signed prescriber form plus chart notes, radiographs, BMD assessments, FRAX assessment, and relevant lab results (e.g., calcium, renal function) to demonstrate diagnosis, prior therapy trials/failures, or documented intolerances.

Documentation confirming diagnosis (chart notes, radiographs, BMD or FRAX) as required in Section A.
BMD assessments and/or radiographs showing lack of improvement, decline, or fracture while on bisphosphonate therapy for prior trial evidence.
Laboratory results including calcium and renal function (CrCl) when applicable.
Prescriber signature on the authorization form (preprinted stamps not valid).

Denial Risk

Risk of delay or denial for incomplete/illegible requests or missing documentation

Incomplete, incorrect, or illegible information—or missing supporting documentation such as labs, diagnostics, or chart notes—may delay authorization or result in denial of the request.

Authorization may be delayed if the form is not complete, correct, or legible.
Requests may be denied if required documentation (labs, diagnostics, chart notes) supporting checked criteria is not provided.

Site of Care and Specialty Pharmacy

Billing Rule

Specialty pharmacy dispensing and plan-specific coverage rules (PropriumRx)

Medications are dispensed through the Specialty Pharmacy (PropriumRx); coverage may vary by plan and non-formulary drugs require documentation of medical necessity. Use of samples to initiate therapy does not satisfy step-edit/prior authorization requirements.

Medication being provided by Specialty Pharmacy - PropriumRx.
If a drug is non-formulary on a member’s plan, documentation of medical necessity will be required.
Sample use does not meet step-edit/prior authorization criteria; prior therapies may be verified through pharmacy paid claims or chart notes.

Background

Parathyroid hormone analogs (anabolic osteoporosis agents) are intended for use in patients at high or very high risk for fracture and require careful patient selection. These agents are prescribed only when diagnostic criteria and prerequisite therapy rules are met and when no contraindications exist.

Because these medications have specific safety concerns and interact with other osteoporosis therapies, the policy requires patients to avoid concurrent use of other major bone-active agents (see contraindications and concurrent therapy restrictions) and documents contraindications such as prior skeletal irradiation or history of osteosarcoma before approval will be granted.

Policy Summary

PayerAvMed

PolicyPrior authorization for parathyroid analogs (Forteo, Tymlos, teriparatide)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete and sign the prior authorization form and fax it to 1-305-671-0200 with supporting documentation (chart notes, BMD, FRAX, labs).

SourceLink

On This Page

OpenPayer

Prior authorization criteria for parathyroid analogs (Forteo, Tymlos, teriparatide)

Coverage Criteria for Parathyroid Analogs

Initial Therapy Requirements

Continuation and Duration Limits

Product-Specific Quantity Limits

Clinical Thresholds and Codes

Prior Trial / Step Requirements

Provider Submission and Documentation

Site of Care and Specialty Pharmacy

Definitions and Risk Categories

Background