CurrentMass General Brigham Health PlanPolicy N/A

Parathyroid hormone analogs (teriparatide, abaloparatide)

Defines prior authorization requirements for pharmacy benefit coverage of parathyroid hormone analogs (Forteo/teriparatide, Tymlos/abaloparatide) for treatment of osteoporosis for Mass General Brigham Health Plan commercial/exchange members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyParathyroid hormone analogs (teriparatide, abaloparatide)

Policy CodePolicy N/A

Change TypeApproval duration revised

Effective DateSep 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and document prior treatment duration, fracture history, T-scores or FRAX score to support approval.

SourceLink

POLICY UPDATE CHANGES

Approval durations updated to a total of 24 months and the 'started and stabilized' statement now specifies members who have received less than 24 months of treatment.

24 monthsmaximum total approval duration

Commercial/Exchangeplan applicability

Prior Authprogram type required

Pharmacybenefit type

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Coverage Criteria for Parathyroid Hormone Analogs

Continuation of Therapy

Resubmission by the prescriber is required for continuation of therapy. Authorization for continued treatment may be granted when ONE of the following is met and documentation is provided:

ANY of the following

Member has experienced clinical benefit (e.g., no new fracture seen on radiography) and has not experienced clinically significant adverse events during therapy.
Member has experienced clinical benefit as evidenced by a bone mass measurement showing an improvement or stabilization in T-score compared with the previous bone mass measurement and member has not experienced any adverse effects.
Provide comparison bone density report showing change from prior study.

Covered Products and Coding Details

Covered productsNDC | mixedCovered

Forteo	teriparatide (brand)
Teriparatide	teriparatide (generic/alternate naming)
Tymlos	abaloparatide (brand)

High FRAX fracture probability — threshold

Definition10-year major osteoporotic fracture risk ≥ 20% OR 10-year hip fracture risk ≥ 3%.

Calculation toolUse the WHO FRAX® 10-year probability calculator (https://www.sheffield.ac.uk/FRAX/).

Policy threshold (actionable)High FRAX fracture probability is met when 10-year major osteoporotic fracture risk ≥ 20% OR hip fracture risk ≥ 3%.

Glucocorticoid exposure — threshold

Glucocorticoid exposure thresholdPrednisone equivalent ≥ 2.5 mg/day for ≥ 3 months.

Context in criteriaRequired as part of glucocorticoid-induced osteoporosis criteria where member is currently receiving or initiating glucocorticoid therapy at this dose/duration.

Related requirementAlso requires prior bisphosphonate trial ≥ 1 year or a clinical reason to avoid bisphosphonate, plus fragility fracture, T-score ≤ -2.5, or osteopenia with high FRAX.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for pharmacy benefit coverage of Forteo (teriparatide) and Tymlos (abaloparatide). This medication is specialty and must be filled at a contracted specialty pharmacy; contact the pharmacy benefit at Phone: 800-711-4555, Fax: 844-403-1029 for PA submission.

Pharmacy benefit prior authorization required
Specialty pharmacy dispensing only

Step Therapy

Therapy Trial Requirements

Document trials of or provide a clinical reason to avoid oral or injectable bisphosphonates when applicable. For postmenopausal osteoporosis, primary/hypogonadal osteoporosis in men, and glucocorticoid‑induced osteoporosis, the member must have either: a prior oral bisphosphonate trial of at least 1 year, a prior injectable bisphosphonate trial of at least 1 year, or a documented clinical reason to avoid bisphosphonates. Also document prior injectable osteoporosis therapies when relevant (e.g., zoledronic acid [Reclast], denosumab [Prolia], abaloparatide [Tymlos]).

Background

Parathyroid hormone-related protein analogs, including teriparatide and abaloparatide, are anabolic agents indicated for treatment of osteoporosis in the populations described in this policy. This document covers use for postmenopausal osteoporosis, primary or hypogonadal osteoporosis in men, and glucocorticoid-induced osteoporosis, and specifies the clinical criteria, required documentation (e.g., T-scores, FRAX, fracture history, prior therapy trials or reasons to avoid them), and program limits. Approvals are conditional on meeting the listed clinical criteria and are limited to a cumulative total treatment duration of 24 months.

Definitions

High FRAX definition and glucocorticoid adjustments

Base definitionHigh FRAX fracture probability: 10-year major osteoporotic fracture risk ≥ 20% OR 10-year hip fracture risk ≥ 3%.

Adjustment for higher-dose glucocorticoidsIf glucocorticoid treatment is > 7.5 mg prednisone equivalent per day, multiply the estimated FRAX major osteoporotic fracture risk by 1.15 and the hip fracture risk by 1.2.

Use in glucocorticoid-induced criteriaA member with osteopenia meets the FRAX component of glucocorticoid-induced osteoporosis criteria when pre-treatment FRAX meets the high-probability threshold (with adjustments applied for higher-dose glucocorticoids as specified).