Does WellCare Cover Forteo (Teriparatide)?

What Is Forteo and Why Does It Require Special Coverage Review?

Forteo is recombinant human parathyroid hormone (1-34), marketed by Eli Lilly. The FDA approved it in November 2002 for postmenopausal women and men with osteoporosis at high fracture risk, and later for glucocorticoid-induced osteoporosis. [1] Unlike antiresorptive drugs such as alendronate or denosumab, teriparatide actually builds new bone by stimulating osteoblast activity, making it one of the few anabolic options in osteoporosis pharmacotherapy.

Because Forteo carries a list price above $1,000 per month and the FDA originally included a boxed warning about osteosarcoma risk in rodents (which has since been substantially revised), insurers classify it as a specialty-tier drug requiring clinical justification before dispensing.

The Osteosarcoma Warning Update

The FDA removed the boxed warning about osteosarcoma from Forteo's labeling in January 2020 after post-marketing surveillance in approximately 2.7 million patient-years of exposure found no causal link to osteosarcoma in humans. [2] Despite that regulatory change, most payers retained their prior authorization requirements because of cost, not safety concerns.

Why Anabolic Therapy Costs More Than Antiresorptives

Bisphosphonates such as generic alendronate cost roughly $10 to $30 per month. Forteo costs more than 40 times that figure. The American Association of Clinical Endocrinology (AACE) 2020 guidelines recommend anabolic therapy for patients classified as "very high risk", meaning a recent fracture (<12 months), T-score below -3.0, or multiple fractures, precisely because the cost-benefit calculus favors it only in severe disease. [3] WellCare's PA criteria are written to mirror that clinical threshold.

How WellCare's Formulary Tiers Work

WellCare offers Medicare Advantage Prescription Drug (MA-PD) plans and standalone Part D Prescription Drug Plans (PDP) across dozens of states. Formulary details vary by plan name, plan year, and county, but the tier structure follows a common pattern.

Standard Tier Definitions

• Tier 1: Preferred generics (lowest copay, $0 to $10)
• Tier 2: Non-preferred generics ($10 to $25)
• Tier 3: Preferred brand-name drugs ($35 to $50)
• Tier 4: Non-preferred brands ($80 to $120)
• Tier 5: Specialty drugs (25% to 33% coinsurance, often $200 to $600+ per fill)

Forteo lands at Tier 4 or Tier 5 depending on the specific WellCare plan. The biosimilar Bonsity (teriparatide-tpwt, approved by the FDA in May 2021) [4] appears at a lower tier on some WellCare formularies and is frequently the preferred agent when teriparatide therapy is authorized.

The Coverage Gap (Donut Hole) and IRA Changes

Under the Inflation Reduction Act, the Part D coverage gap was eliminated for 2025. Enrollees now face a $2,000 annual out-of-pocket cap for Part D covered drugs. [5] For Forteo users who previously spent thousands cycling through the donut hole, this change is clinically meaningful: once you hit $2,000 in true out-of-pocket costs for the calendar year, WellCare pays 100% of covered drug costs for the remainder of the year.

WellCare Prior Authorization Criteria for Forteo

Prior authorization is the central obstacle most patients face. WellCare's criteria are not public in a single document, but they align closely with CMS coverage policy and AACE/NOF guidelines. Based on standard Part D PA criteria for teriparatide, WellCare typically requires the prescriber to document:

Clinical Eligibility Criteria

1. Diagnosis confirmation: Postmenopausal osteoporosis, male osteoporosis, or glucocorticoid-induced osteoporosis confirmed by DEXA scan.
2. Severity threshold: T-score at the lumbar spine or femoral neck of -2.5 or lower, OR a prior low-trauma (fragility) fracture, OR T-score between -1.0 and -2.5 with a 10-year FRAX hip fracture probability above 3% or major osteoporotic fracture probability above 20%. [6]
3. Step therapy completion or exemption: A documented trial of an oral bisphosphonate (typically alendronate 70 mg weekly or risedronate 35 mg weekly) for at least 6 to 12 months, unless contraindicated or the patient suffered a fracture on bisphosphonate therapy.
4. Contraindication documentation (if bypassing step therapy): Documented GI intolerance, esophageal disease, inability to remain upright 30 minutes post-dose, renal impairment with CrCl <35 mL/min, or IV bisphosphonate failure.
5. Prescriber specialty: Many WellCare plans require the prescribing physician to be an endocrinologist, rheumatologist, or orthopedic specialist, though primary care physicians can often submit with supporting specialist notes.

Quantity Limits and Duration

WellCare imposes a quantity limit matching the FDA-approved dosing: one 2.4 mL prefilled pen (28-day supply) per month. Authorization is typically granted for 12 months at initial approval, renewable once for a maximum of 24 cumulative months lifetime. After 24 months, the FDA label itself restricts further Forteo use. [1]

The HealthRX clinical team uses a three-gate framework when submitting Forteo PA requests to WellCare:

Gate 1 (Severity): Confirm DEXA T-score with report date and site. Attach the radiology report, not just the clinic note summary.

Gate 2 (Step therapy): Pull pharmacy fill history as objective evidence of bisphosphonate trial. A prescriber note alone is often insufficient; WellCare reviewers want dispensing records.

Gate 3 (Fracture or failure): If the patient fractured on bisphosphonate therapy, include imaging reports with dates. If GI intolerance is the exemption, include endoscopy reports or documented gastroenterology consultation. Subjective patient reports of intolerance without corroborating records are the single most common reason for initial PA denial.

Step Therapy Requirements: What WellCare Expects First

Step therapy, also called "fail-first", requires patients to try less expensive drugs before a plan will cover a higher-cost option. For Forteo, WellCare's step therapy protocol typically requires:

First-Line Agents (Required Trial)

• Alendronate (generic Fosamax) 70 mg orally once weekly: The most common required first step. Generic cost is under $15 per month. [7]
• Risedronate (generic Actonel) 35 mg weekly or 150 mg monthly: An alternative first step, especially when GI side effects limit alendronate.

Second-Line Agents (Sometimes Required Before Forteo)

• Zoledronic acid (generic Reclast) 5 mg IV annually: Some WellCare plans require documented failure of or contraindication to IV bisphosphonate before approving teriparatide. This step is more common in plans with stricter specialty-drug protocols.
• Denosumab (Prolia) 60 mg subcutaneous every 6 months: Less commonly a required step, but some MA-PD plans list it as a preferred second-line option before anabolic therapy.

The American College of Rheumatology 2022 guidelines for osteoporosis management acknowledge that step therapy is clinically appropriate for most patients, but specifically note that patients with "imminent fracture risk" (very high risk category) should have access to anabolic therapy without mandatory antiresorptive failure. [8] Including ACR guideline language in the PA request can strengthen the case for bypassing step therapy.

How to Submit a WellCare Prior Authorization Request

Step-by-Step Process

1. Obtain the correct form. WellCare's prior authorization forms are plan-specific. Download the current year's PA form from WellCare's provider portal or call WellCare Provider Services at the number on the patient's insurance card.
2. Complete the clinical section fully. Incomplete submissions are the leading cause of delays. Include: diagnosis code (M81.0 for postmenopausal osteoporosis without current pathological fracture; M80.08XA for wedge fracture), DEXA T-score with date, prescribing specialty, step therapy history, and the specific Forteo NDC.
3. Submit with supporting documentation. Attach DEXA report, pharmacy fill history for prior bisphosphonate, fracture imaging if applicable, and any specialist consultation notes.
4. Track the timeline. CMS requires Medicare Part D plans to respond to standard PA requests within 72 hours and urgent requests within 24 hours. [9]
5. Request peer-to-peer review if denied. The prescriber can call WellCare's medical director for a peer-to-peer review within 24 to 48 hours of a denial. This single step reverses roughly 30% to 50% of initial denials in specialty-drug categories, based on published payer data.

What to Do If WellCare Denies Forteo Coverage

Denial is not the final word. Medicare Part D enrollees have a structured appeal chain.

The Medicare Part D Appeal Process

1. Coverage Determination (Initial Decision): The starting point. If denied, request a formal denial notice with the reason code.
2. Redetermination (Level 1 Appeal): Submitted to WellCare within 60 days of denial. WellCare must respond within 7 days (standard) or 72 hours (expedited). [9]
3. Reconsideration (Level 2 Appeal): If WellCare upholds the denial, the case goes to an Independent Review Entity (IRE) contracted by CMS. The IRE issues a decision within 7 days standard or 72 hours expedited.
4. ALJ Hearing (Level 3): If the IRE denies and the amount in controversy exceeds $180 (2024 threshold), an Administrative Law Judge hearing is available.
5. Medicare Appeals Council (Level 4) and Federal District Court (Level 5) follow for escalation.

CMS data from 2022 show that approximately 76% of Part D redeterminations that reached Level 2 (the IRE) were decided in favor of the enrollee at some point in the appeals chain. [9] Submitting a strong clinical letter citing AACE or ACR guidelines substantially improves outcomes at Level 1 and Level 2.

Expedited Appeals for Urgent Cases

If a patient has sustained a fragility fracture and is awaiting discharge from a skilled nursing facility or hospital, the appeal qualifies as expedited. The prescribing physician must attest in writing that the standard timeline would seriously jeopardize the patient's health. WellCare must respond within 24 hours.

Forteo Alternatives WellCare Is More Likely to Cover

When Forteo faces repeated denial or step therapy requirements are genuinely burdensome, three alternatives deserve attention.

Bonsity (Teriparatide Biosimilar)

Bonsity (teriparatide-tpwt), manufactured by Alvogen and FDA-approved in May 2021 [4], delivers the same 20 mcg/day dose via a similar prefilled pen. The mechanism, efficacy, and safety profile are equivalent by regulatory definition. WellCare formularies in several states list Bonsity at a lower tier than brand Forteo, making it the path-of-least-resistance teriparatide option for many enrollees. Always ask WellCare specifically whether the PA approved for Forteo transfers automatically to Bonsity, as some plans process them under different NDCs.

Abaloparatide (Tymlos)

Abaloparatide 80 mcg/day subcutaneous was FDA-approved in April 2017 for postmenopausal women with osteoporosis at high fracture risk. [10] The ACTIVE trial (N=2,463) showed abaloparatide reduced new vertebral fractures by 86% vs. Placebo over 18 months (P<0.001). [11] Some WellCare plans tier Tymlos differently from Forteo, so it is worth requesting a formulary comparison if Forteo is denied.

Romosozumab (Evenity)

Romosozumab (Evenity) 210 mg monthly subcutaneous (two 105 mg injections) is a sclerostin inhibitor with both anabolic and antiresorptive effects, FDA-approved March 2019. [12] The ARCH trial (N=4,093) demonstrated romosozumab followed by alendronate reduced hip fracture risk by 38% vs. Alendronate alone at 24 months. [13] Romosozumab carries a boxed warning for cardiovascular risk and is contraindicated within 12 months of MI or stroke. WellCare's PA criteria for Evenity are similar in structure to those for Forteo but may differ in tier placement.

Cost-Reduction Strategies for Forteo

Eli Lilly Lilly Cares Foundation

Eli Lilly operates the Lilly Cares Foundation patient assistance program. Patients with household income at or below 400% of the federal poverty level who lack adequate coverage may qualify for free or reduced-cost Forteo. Applications are available at Lilly's official patient assistance site.

Medicare Extra Help (Low Income Subsidy)

Medicare's Extra Help program reduces Part D premiums, deductibles, and copays for qualifying low-income enrollees. In 2024, full Extra Help beneficiaries paid no more than $4.50 for generic drugs and $11.20 for brand-name drugs per fill. [5] Qualifying income is at or below 150% of the federal poverty level. Apply through Social Security Administration at ssa.gov.

340B Program Dispensing

Patients treated at 340B-covered health centers (Federally Qualified Health Centers, disproportionate-share hospitals) may access Forteo at substantially reduced acquisition cost. Ask your prescriber whether their institution participates in the 340B Drug Pricing Program.

What the Clinical Evidence Says About Forteo's Effectiveness

WellCare's coverage restrictions exist in a context where Forteo's efficacy is well-established. The key fracture prevention trial enrolled 1,637 postmenopausal women with prior vertebral fractures and randomized them to teriparatide 20 mcg/day or placebo for a median 21 months. New vertebral fractures occurred in 5% of teriparatide patients vs. 14% of placebo patients, representing a 65% relative risk reduction (P<0.001). [14] Nonvertebral fragility fractures were reduced by 53% (P<0.01). [14]

Bone mineral density (BMD) at the lumbar spine increased by 9.7% in the teriparatide group vs. A 2.4% increase with placebo at 18 months (P<0.001). [14] Those numbers provide the quantitative backbone for a clinical letter supporting PA approval: document the patient's baseline T-score, project BMD response against trial benchmarks, and frame the cost of an untreated hip fracture (estimated at $40,000 to $60,000 in acute and post-acute care) against the annual drug cost.

Glucocorticoid-Induced Osteoporosis

In patients taking prednisone or equivalent at 5 mg/day or greater for 3 months or longer, teriparatide 20 mcg/day increased lumbar spine BMD by 7.2% at 18 months vs. 3.4% with alendronate in a head-to-head randomized trial (P<0.001). [15] WellCare's PA criteria for glucocorticoid-induced osteoporosis typically require documentation of steroid dose, duration, and a DEXA T-score below -2.5 or fragility fracture history. Including the 7.2% BMD advantage over alendronate in the PA letter can tip borderline cases.

Post-Forteo Sequencing Matters

AACE guidelines explicitly recommend transitioning to an antiresorptive agent immediately after completing 24 months of teriparatide to preserve the BMD gains. [3] Without a following antiresorptive, BMD reverts toward baseline within 12 to 18 months. WellCare will cover that transition drug (typically denosumab or zoledronic acid) under a separate authorization; the prescriber should plan for that follow-up prescription before the Forteo course ends.

Documentation Checklist for Prescribers Submitting to WellCare

A complete submission package reduces the chance of denial on administrative grounds.

• DEXA report with T-score at lumbar spine AND femoral neck, dated within 24 months
• Fracture history with imaging reports if applicable (include fracture date)
• Pharmacy fill records for prior bisphosphonate (minimum 6 months' dispensing history)
• If bypassing step therapy: gastroenterology or nephrology note documenting contraindication
• ICD-10 diagnosis code (M81.0, M81.6, or M81.8 depending on etiology)
• Prescriber NPI and specialty designation
• FRAX 10-year fracture probability score if T-score is between -1.0 and -2.5
• Letter of medical necessity citing AACE 2020 or ACR 2022 guidelines with patient-specific clinical data