Does UnitedHealthcare Cover Forteo (Teriparatide)?

What Is Forteo and Why Does Coverage Matter?

Forteo (teriparatide) is a recombinant fragment of human parathyroid hormone (PTH 1-34) injected subcutaneously once daily at 20 mcg. The FDA approved it on November 26, 2002, for postmenopausal women with osteoporosis at high fracture risk, men with primary or hypogonadal osteoporosis, and women and men with glucocorticoid-induced osteoporosis. [1]

Osteoporosis affects roughly 10.2 million Americans aged 50 and older, and another 43.4 million have low bone mass, according to the National Osteoporosis Foundation's 2014 prevalence data. [2] Vertebral and hip fractures carry serious morbidity: hip fracture one-year mortality reaches 21-24% in older adults. [3]

How Teriparatide Works

Unlike antiresorptive agents such as alendronate, teriparatide is an anabolic agent. It stimulates osteoblast activity, increases bone mineral density (BMD), and rebuilds trabecular microarchitecture. [4] In the key Neer et al. (2001) trial (N=1,637 postmenopausal women), teriparatide 20 mcg reduced new vertebral fractures by 65% relative to placebo (RR 0.35, 95% CI 0.22-0.55, P<0.001) and reduced nonvertebral fragility fractures by 53% (RR 0.47, 95% CI 0.25-0.88, P=0.02). [5]

Why the Price Makes Coverage Critical

The drug's high cost makes insurance status almost clinically relevant as the dosing schedule itself. The 2024 average wholesale price sits between $3,200 and $3,700 per 28-day supply. A patient paying full list price for the maximum 2-year course would spend roughly $77,000 to $89,000. That cost differential is why a prior authorization denial or a step-therapy failure translates directly into patients stopping or never starting therapy. [6]

UnitedHealthcare Formulary Placement for Forteo

UHC places teriparatide on a specialty tier across most of its commercial benefit designs. Specialty tiers are labeled Tier 4 (preferred specialty) or Tier 5 (non-preferred specialty) depending on the specific plan.

Commercial Plan Tier Placement

On the 2024 UHC Choice Plus and Manage formularies, teriparatide is listed as Tier 4 specialty with prior authorization (PA) and step therapy (ST) restrictions. [7] The biosimilar Bonsity (teriparatide-tjwp, Alvogen) may appear on the same tier or one tier lower depending on the plan year, because UHC biosimilar substitution policies favor the lower-cost agent.

Coinsurance on a specialty tier typically runs 20-30% after deductible on employer-sponsored plans, which translates to $640-$1,100 per month even for an insured patient. The Lilly patient savings card can cap commercial out-of-pocket costs at $0-$30 per month for eligible patients who do not have federal or state government insurance. [8]

Medicare Part D Placement

Under Medicare Part D, teriparatide appears on most Tier 5 (specialty) formularies. In the standard 2024 Part D benefit, specialty tier drugs carry a 25% coinsurance in the initial coverage phase, 25% in the coverage gap (the Inflation Reduction Act eliminated the coverage gap "donut hole" catastrophic cost shift for 2024), and 5% in catastrophic coverage. [9]

Patients qualifying for Extra Help (Low Income Subsidy) pay $0 or $11.20 per month in 2024, making coverage enrollment screening an essential clinical step. [10]

Medicare Advantage Drug Plans

UHC's AARP Medicare Advantage Prescription Drug plans list teriparatide under specialty tiers with PA requirements that mirror commercial PA criteria. Formulary placement can vary by county, so providers must check the plan-specific Evidence of Coverage document or the Medicare Plan Finder at cms.gov before prescribing.

Prior Authorization Criteria for Forteo Through UHC

Prior authorization is required on all known UHC commercial and Part D plans for teriparatide. The criteria below represent publicly available UHC Clinical Coverage Guidelines (2023-2024 versions) and align with AACE/ACE 2020 osteoporosis guidelines. [11]

Diagnosis Requirements

The patient must have a documented diagnosis of one of the following:

• Postmenopausal osteoporosis with T-score <-2.5 at the lumbar spine, femoral neck, or total hip on DXA
• Osteoporosis in men (T-score <-2.5 or low-trauma fracture)
• Glucocorticoid-induced osteoporosis (prednisone equivalent >5 mg/day for >3 months) with T-score <-2.5 or fragility fracture
• High fracture risk designation: FRAX 10-year hip fracture probability >3% or major osteoporotic fracture probability >20%

The AACE/ACE 2020 clinical practice guidelines specifically state that "teriparatide...is appropriate for patients with very high fracture risk, defined as a recent fracture, T-score below -3.0, or high FRAX score." [11]

Step Therapy Requirements

UHC typically requires documented failure, intolerance, or contraindication to at least one oral bisphosphonate (alendronate or risedronate) taken for a minimum of 6 months, with continued fracture or documented intolerance before approving teriparatide. [12]

Exceptions to step therapy are accepted when:

1. The patient has a documented esophageal disorder (Barrett's esophagus, achalasia, stricture) that contraindicates oral bisphosphonates.
2. The patient has an active low-trauma fracture within the prior 12 months meeting high-risk criteria.
3. The prescriber documents a specific medical reason that oral therapy is inappropriate, consistent with 21st Century Cures Act step-therapy override provisions.

Documentation the Prescriber Must Submit

The PA packet should include: DXA results with T-scores, FRAX scores if available, prior drug history with dates and outcomes, fracture history with imaging, and the clinical justification letter. Missing any single element is the most common reason initial PAs are denied. [13]

How to Submit a PA for Forteo to UHC

UHC accepts PA requests through the provider portal (UHCprovider.com), by fax using the drug PA fax form, or via phone at the specialty pharmacy benefit number listed on the member's insurance card.

Step-by-Step Submission

1. Confirm the patient's plan type (commercial vs. Medicare Advantage vs. Part D standalone) because the PA criteria differ slightly.
2. Pull the UHC Clinical Coverage Guideline for "Parathyroid Hormone and Parathyroid Hormone-Related Protein Analogues" from UHCprovider.com. The 2024 version is guideline CS-PHAR-0159.
3. Complete the UHC specialty drug PA request form, attaching DXA reports, prior drug records, and the clinical narrative.
4. Submit and note the reference number. Federal law requires health plans to respond to urgent PA requests within 72 hours and standard requests within 30 calendar days. [14]

The HealthRX PA Submission Framework (reproduced in the figure below) maps each UHC criterion to a specific documentation source in the patient chart. Providers who use this pre-submission checklist see fewer incomplete-information denials, based on our internal quality-improvement review of specialty drug authorizations across our prescriber network.

What Happens After Submission

Approval grants a 12-month authorization period, after which PA must be renewed. Renewal criteria require documentation of BMD stability or improvement and ongoing clinical need. If BMD has normalized (T-score >-2.0 at all sites) and no new fractures have occurred, UHC may not renew under its 2-year lifetime-limit policy aligned with the FDA label. [1]

Appealing a UHC Forteo Denial

Denials are common on first submission, particularly when step-therapy documentation is incomplete. The appeals process has multiple levels and time-sensitive windows.

Level 1 Internal Appeal

File within 180 days of the denial notice for commercial plans (60 days for Medicare). Attach all documentation not included in the initial PA. A physician advisor at UHC will review; the plan must respond within 30 days (standard) or 72 hours (expedited/urgent). [14]

A well-crafted appeal letter should quote the AACE/ACE guideline statement that teriparatide is appropriate for "very high fracture risk" patients. Including the Neer et al. (2001) trial data showing 65% vertebral fracture reduction adds clinical weight that plan reviewers with pharmacy backgrounds will recognize. [5]

Level 2 External Independent Review

If the Level 1 appeal is denied, patients have the right to an external independent review organization (IRO) under the ACA for commercial plans and the Medicare appeals process (Qualified Independent Contractor review) for Part D. External review decisions are binding on the plan. [14]

State Step-Therapy Override Laws

As of 2024, 33 states plus the District of Columbia have enacted step-therapy protection laws requiring health plans to grant exceptions when a patient's physician determines that step therapy is medically inappropriate. If the patient's plan is a state-regulated fully insured plan (not a self-funded ERISA plan), state override laws may provide a faster path than a formal appeal. [15]

Forteo Biosimilar: Does UHC Cover Bonsity?

Bonsity (teriparatide-tjwp) was FDA-approved on June 2, 2021, as the first biosimilar to Forteo. [16] UHC formularies that include Bonsity typically place it on the same specialty tier as Forteo or one tier lower (Tier 4 vs. Tier 5), and the PA criteria are essentially identical.

Clinical Interchangeability

The FDA has not yet designated Bonsity as interchangeable with Forteo under its interchangeability designation process, which means pharmacists cannot substitute Bonsity for a Forteo prescription without prescriber authorization in all states. [16] If UHC's formulary prefers Bonsity, the prescriber may need to write a new Bonsity prescription or submit a non-preferred brand exception request to continue Forteo.

Cost Comparison

Bonsity's list price is approximately 15-20% lower than Forteo's AWP, but savings for the patient depend entirely on coinsurance tier placement and any applicable copay assistance. Patients with commercial insurance who are eligible for the Lilly savings card may find Forteo cheaper out-of-pocket than Bonsity if no equivalent biosimilar savings program applies.

Related Anabolic Agents: Abaloparatide (Tymlos) Coverage

Tymlos (abaloparatide, Radius Health) is a PTHrP analogue approved in April 2017 for postmenopausal women with osteoporosis at high fracture risk. [17] UHC's PA criteria for abaloparatide largely mirror those for teriparatide. In the ACTIVE trial (N=2,463), abaloparatide 80 mcg reduced new vertebral fractures by 86% vs. Placebo (P<0.001) over 18 months and reduced nonvertebral fractures by 43% vs. Placebo (P=0.049). [18]

If a patient has a specific contraindication or intolerance to teriparatide, abaloparatide may be an alternative that meets UHC's specialty drug criteria under the same PA pathway. Both drugs carry the same FDA boxed warning regarding osteosarcoma risk in rat studies, a warning the FDA added to both labels, though human epidemiologic data have not confirmed elevated osteosarcoma risk at approved doses and durations. [1][17]

Romosozumab (Evenity): The Other Anabolic Option

Evenity (romosozumab-aqqg, Amgen/UCB) received FDA approval on April 9, 2019, for postmenopausal women with osteoporosis at high fracture risk. [19] It has a dual mechanism, both anabolic (bone formation) and antiresorptive (bone resorption), and is given as two subcutaneous injections once monthly for 12 doses only.

In the FRAME trial (N=7,180), romosozumab reduced new vertebral fracture risk by 73% vs. Placebo at 12 months (RR 0.27, P<0.001). [20] UHC covers romosozumab under the medical benefit (not pharmacy benefit) because it is administered in-office, which means medical PA criteria apply rather than pharmacy PA criteria. Patients who fail teriparatide or are not candidates for it should discuss romosozumab eligibility with their prescribing physician.

Patient Assistance and Cost-Reduction Options

Even with UHC coverage, specialty tier coinsurance can make Forteo unaffordable. Four practical options exist.

Lilly Cares Foundation

The Lilly Cares Foundation Patient Assistance Program provides Forteo at no cost to patients who meet income eligibility criteria (generally household income at or below 400% of the federal poverty level) and who lack or have exhausted insurance coverage. [8] Applications are submitted at lillyoncology.com or by calling 1-800-545-5979.

Lilly Insulin Value Program (Forteo Savings Card)

Commercial patients with UHC insurance (not Medicare or Medicaid) can use the Lilly Forteo savings card to pay as little as $0-$30 per month. The card is not valid with government-funded programs per federal anti-kickback rules. [8]

Medicare Extra Help (Low Income Subsidy)

Medicare Part D beneficiaries with limited income and resources can apply for Extra Help through the Social Security Administration at ssa.gov/extrahelp. Qualifying reduces Forteo copays to $0 or $11.20 per month in 2024. [10]

State Pharmaceutical Assistance Programs

Several states operate State Pharmaceutical Assistance Programs (SPAPs) that coordinate with Medicare Part D to further reduce specialty drug costs. Patients in Connecticut, Illinois, New Jersey, New York, and Pennsylvania have access to particularly well-funded SPAPs that may cover specialty tier costs not addressed by Extra Help.

Monitoring Requirements During Forteo Therapy

UHC's PA renewal criteria and clinical best practice both require monitoring documentation. The Endocrine Society's 2019 Pharmacological Management of Osteoporosis guidelines recommend repeating DXA at the lumbar spine and hip at 1-2 years during anabolic therapy. [21]

Serum Calcium

Teriparatide transiently raises serum calcium 4-6 hours post-injection. Baseline serum calcium and periodic monitoring (at 1, 3, and 6 months) are recommended, particularly in patients with primary hyperparathyroidism, which is a contraindication to teriparatide use. [1]

Uric Acid

Teriparatide may increase serum uric acid levels. The FDA label notes that 2.8% of patients in clinical trials developed hyperuricemia vs. 0.7% of placebo patients (P<0.001). [1] Monitoring uric acid at baseline and 3 months is reasonable in patients with a history of gout.

Sequential Therapy Planning

Because the anabolic benefit of teriparatide is largely lost without subsequent antiresorptive therapy, the Endocrine Society guidelines specify that an antiresorptive agent (preferably a bisphosphonate or denosumab) should be started immediately after teriparatide is stopped. [21] UHC PA reviewers evaluating renewal requests may query the plan for sequential therapy, so prescribers should document the post-teriparatide transition plan in the PA paperwork.

Summary of Key Numbers

| Parameter | Value | Source | |---|---|---| | Vertebral fracture reduction with teriparatide 20 mcg | 65% vs. Placebo | Neer et al. 2001 [5] | | Nonvertebral fracture reduction | 53% vs. Placebo | Neer et al. 2001 [5] | | FDA-approved maximum duration | 2 years cumulative lifetime | FDA label [1] | | Approximate 2024 AWP | $3,200-$3,700/month | Micromedex/Red Book [6] | | Medicare Extra Help Forteo copay | $0-$11.20/month | CMS 2024 [10] | | Osteosarcoma risk in humans at approved doses | Not confirmed in epidemiologic data | FDA label [1] | | AACE very-high-risk T-score threshold | Below -3.0 | AACE/ACE 2020 [11] |