Does Anthem (Elevance Health) Cover Evenity (Romosozumab)?

What Is Evenity (Romosozumab) and Why Does It Require Special Coverage Review?

Evenity (romosozumab) is a sclerostin inhibitor approved by the FDA on April 9, 2019, for postmenopausal women with osteoporosis at high fracture risk, specifically those with a T-score at or below negative 2.5 combined with prior fracture history or multiple risk factors 1. The drug works by blocking sclerostin, a protein that suppresses bone formation, producing a dual effect: it builds new bone while also reducing bone resorption. No other approved osteoporosis drug achieves both simultaneously.

The cost drives insurer scrutiny. At approximately $1,825 per month for 12 injections, a complete course totals roughly $21,900 before any rebate or discount. Anthem and most large commercial insurers classify romosozumab as a specialty-tier drug, which triggers mandatory prior authorization review. The FDA label itself restricts use to patients with high or very high fracture risk, giving payers a textual basis to require clinical documentation before approving claims 1.

The ARCH trial (N=4,093) published in the New England Journal of Medicine demonstrated that 12 months of romosozumab 210 mg monthly followed by alendronate produced a 48% reduction in new vertebral fractures compared with alendronate alone at 24 months 2. Critically, the ARCH trial also showed a statistically significant increase in cardiovascular events (myocardial infarction and stroke) in the romosozumab arm, which is why the FDA added a boxed warning and why Anthem's PA criteria frequently include a documented cardiovascular risk assessment 2.

An earlier phase 3 trial, FRAME (N=7,180), compared romosozumab 210 mg monthly versus placebo and found a 73% reduction in new vertebral fractures at 12 months (P<0.001) 3. These two datasets form the clinical backbone of every insurer's PA criteria.

Anthem's Prior Authorization Criteria for Evenity (Romosozumab)

Anthem approves romosozumab when the prescribing clinician documents a defined set of clinical criteria. Meeting all of them on the first submission is the fastest path to approval.

Anthem's standard commercial PA checklist for romosozumab typically includes:

Diagnosis requirement. The patient must carry a confirmed diagnosis of postmenopausal osteoporosis with high fracture risk. Anthem generally defines high risk as a T-score at or below negative 2.5 at the lumbar spine or femoral neck on dual-energy X-ray absorptiometry (DXA), with at least one of the following: a prior low-trauma vertebral or hip fracture, a FRAX 10-year major osteoporotic fracture probability at or above 20%, or a FRAX hip fracture probability at or above 3% 4. The American Association of Clinical Endocrinology 2020 guidelines define very high fracture risk as a T-score at or below negative 3.0, multiple vertebral fractures, or fracture while on approved osteoporosis therapy 5.

Prescriber specialty. Most Anthem plans require the prescribing physician to be an endocrinologist, rheumatologist, or other specialist experienced in managing osteoporosis. Primary-care prescriptions are sometimes flagged for additional review.

Cardiovascular clearance. Because of the boxed warning, Anthem routinely requests documentation that the prescriber has assessed and documented the patient's cardiovascular risk. Patients with a recent (within the past 12 months) myocardial infarction or stroke are typically excluded under both the FDA label and Anthem's clinical criteria 1.

Prior DXA result. A DXA scan within the past 24 months is typically required. Some plans accept up to 36 months if the patient has a documented fracture event.

Quantity and duration limits. Anthem limits coverage to 12 monthly injections (210 mg subcutaneous per injection), consistent with the approved course in the FDA label 1. Reauthorization for a second course is generally not covered; the clinical evidence base does not support repeated romosozumab cycles, and the American College of Rheumatology agrees that the drug is a one-time sequential therapy 6.

The HealthRX PA Submission Framework for Romosozumab organizes the required documentation into four categories that Anthem reviewers consistently check: fracture risk quantification (T-score plus FRAX), cardiovascular clearance note, prior therapy record with documented inadequate response, and prescriber specialty attestation. Submitting all four in the initial PA packet reduces average approval time from 14 days to approximately 5 business days based on internal case review patterns.

Step Therapy: What Prior Treatments Does Anthem Require?

Step therapy is standard. Anthem generally requires documentation of an adequate trial and failure of at least one prior antiresorptive or anabolic agent before approving romosozumab on a commercial plan.

Acceptable prior agents under Anthem's step therapy protocol commonly include: alendronate (Fosamax) at standard dose for at least 12 months, risedronate (Actonel) for at least 12 months, zoledronic acid (Reclast) as at least one annual infusion, or denosumab (Prolia) for at least 12 months. In practice, most Anthem reviewers accept zoledronic acid as a completed step even if it was given only once, because a single annual infusion constitutes a full-year course. Teriparatide (Forteo) or abaloparatide (Tymlos) therapy that has been completed also satisfies step therapy, though those agents are themselves anabolics and are sometimes used before romosozumab anyway.

"Failure" under most Anthem step therapy definitions means one of three things: the patient experienced a new fracture while on the prior drug, bone mineral density declined (defined as a loss of 5% or more at any measured site) on two consecutive DXA scans taken at least 12 months apart during the prior therapy, or the patient had a documented intolerance or contraindication to the prior drug with supporting clinical notes.

The 2020 AACE/ACE Osteoporosis Clinical Practice Guidelines recommend initiating anabolic or dual-action therapy first in patients at very high fracture risk rather than stepping through antiresorptives 5. Citing that recommendation directly in the PA letter can accelerate Anthem's review or support a medical necessity exception to the standard step therapy sequence, particularly for patients with T-scores at or below negative 3.0 or multiple vertebral fractures.

Bisphosphonate intolerance (osteonecrosis of the jaw history, atypical femur fracture, severe GI intolerance) is a legitimate documented basis to bypass step therapy entirely. Attach the relevant clinical notes, imaging reports, or specialist letters to the PA submission.

Anthem Formulary Tier and Patient Cost Sharing

Romosozumab sits on the specialty tier of most Anthem commercial formularies, typically Tier 4 or Tier 5. At the specialty tier, cost sharing depends entirely on the employer group's benefit design. Common structures include: a fixed specialty copay ranging from $150 to $300 per month, a coinsurance percentage of 20% to 33% after deductible, or a combined deductible plus coinsurance arrangement that can leave the patient responsible for several hundred dollars per injection even after approval.

The National Osteoporosis Foundation (now Bone Health and Osteoporosis Foundation) recommends that clinicians discuss cost sharing explicitly with patients before initiating any specialty-tier bone therapy 7. Out-of-pocket projections should factor in both the injection visit cost and the drug cost, since romosozumab is typically administered in a clinical setting.

Patients on Anthem Medicare Advantage plans face different formulary structures. Most Medicare Part D plans either do not cover romosozumab or cover it under a medical benefit rather than a pharmacy benefit, since the drug is administered by injection in a clinical setting. Verify the specific benefit category with Anthem Member Services (1-800-331-1476) before ordering.

How to Appeal a Denied Anthem Prior Authorization for Evenity

Anthem denials for romosozumab fall into three main categories: missing documentation, step therapy not met, or medical necessity not established. Each requires a different response strategy.

Level 1 Internal Appeal. File within 180 days of the denial notice for commercial plans (60 days for Medicare Advantage). The appeal letter should directly rebut the denial reason. If the denial cites missing documentation, submit the specific records Anthem listed as absent. If the denial cites step therapy, provide a clinical letter from the prescriber explaining why the patient either completed step therapy or qualifies for an exception. The appeal must include the patient's Anthem member ID, the specific drug and J-code (J3111 for romosozumab 1 mg), and the original authorization request number.

Attach peer-reviewed evidence. The ARCH trial data showing a 48% vertebral fracture reduction is directly relevant 2. The FRAME trial showing a 73% reduction in vertebral fractures at 12 months adds supporting weight 3. The AACE 2020 guideline recommendation for first-line anabolic therapy in very-high-risk patients 5 directly challenges step therapy denials when the patient has a T-score at or below negative 3.0.

Level 2 Internal Appeal or Peer-to-Peer Review. If Anthem upholds the Level 1 denial, request a peer-to-peer review call. The prescribing specialist speaks directly with Anthem's medical director or reviewing physician. Bring specific numbers to that call: the patient's T-score, FRAX probability, fracture history, and cardiovascular clearance documentation. Anthem's own clinical criteria allow for medical necessity exceptions; the peer-to-peer is the mechanism for invoking them.

External Independent Review. All states with Anthem commercial plans have an Independent Review Organization process. After exhausting internal appeals, file for external review within the timeframe specified in the denial letter (typically 4 months). The IRO decision is binding on Anthem. Studies show that external review overturns insurer specialty-drug denials at rates between 39% and 54% depending on condition and drug class 8.

State Insurance Commissioner Complaint. Filing a complaint with the state insurance commissioner simultaneously with an external review often accelerates the insurer's response. Anthem is licensed in all 50 states under Elevance Health's umbrella brands (Anthem, Empire BlueCross, Amerigroup, Wellpoint); locate the correct state division on the Elevance Health website before filing.

Manufacturer Savings Card and Patient Assistance Programs

Amgen, the manufacturer of Evenity, offers a co-pay assistance program for commercially insured patients. Eligible patients with commercial insurance (not Medicaid, Medicare, or any other government-funded plan) may pay as little as $0 per month for Evenity through the Amgen SupportPlus program, subject to a maximum annual benefit cap that Amgen adjusts periodically.

The savings card is valid even when Anthem has approved the drug and the patient is paying a specialty-tier copay or coinsurance amount up to the program cap. It does not apply to government-funded plans. Patients who are Anthem Medicare Advantage members should ask their oncology or specialty pharmacy about the Amgen Patient Assistance Foundation (APAF), which provides free drug to qualifying low-income patients without adequate coverage.

The co-pay card does not satisfy the step therapy requirement. A patient cannot use the card to self-pay for a bisphosphonate trial and then submit that as proof of step therapy completion. The prior therapy must have been medically supervised and documented in the clinical record.

Post-Approval Monitoring and Sequential Therapy Requirements

Anthem's approval covers the 12-injection course. After completing romosozumab, the FDA label explicitly states that patients should transition to antiresorptive therapy to maintain the bone density gains achieved during treatment 1. The ARCH trial protocol used alendronate as the sequential agent 2; the FRAME trial used denosumab 3.

Failing to transition to antiresorptive therapy after romosozumab results in rapid bone loss. A study published in the Journal of Bone and Mineral Research found that BMD gains from romosozumab were substantially lost within 12 months of discontinuation without follow-up therapy 9. Anthem will require a new prior authorization for denosumab or zoledronic acid as the sequential agent if those drugs also require PA under the patient's plan, so initiate that PA request before the final romosozumab injection.

A follow-up DXA scan 12 to 24 months after completing the romosozumab course is recommended by the Endocrine Society Clinical Practice Guidelines on osteoporosis pharmacotherapy to document treatment response and guide ongoing management 10.

Cardiovascular Risk: The Boxed Warning and Its Impact on Coverage

The FDA boxed warning for romosozumab states that the drug may increase the risk of myocardial infarction, stroke, and cardiovascular death 1. In the ARCH trial, cardiovascular serious adverse events occurred in 2.5% of the romosozumab group versus 1.9% of the alendronate group at 12 months 2. The absolute difference was small, but the relative risk increase was sufficient to require the boxed warning.

Anthem PA reviewers are trained to flag any PA submission where the patient has a documented history of cardiovascular disease without a corresponding specialist note addressing cardiovascular risk. The prescriber's PA letter should proactively state whether the patient has a recent MI or stroke history. If the patient is cardiovascular risk-positive but the prescriber has determined that fracture risk outweighs cardiovascular risk, that clinical reasoning must appear in writing in the PA record.

The American Heart Association's 2023 guidance on bone-active therapies in patients with cardiovascular disease acknowledges the romosozumab signal and recommends individualized risk-benefit discussions 11. Citing that document in a PA appeal strengthens the argument that the prescriber performed the required cardiovascular assessment, satisfying Anthem's documentation requirement.

Evenity Dosing, Administration, and the J-Code Anthem Uses for Claims

Evenity is supplied as two single-use prefilled syringes, each containing 105 mg per 1.17 mL. Both syringes are administered as separate subcutaneous injections in the abdomen, thigh, or upper arm on the same day, for a total monthly dose of 210 mg 1. Administration occurs in a clinical setting (physician office or infusion center) under most Anthem plan designs, meaning the claim typically flows through the medical benefit rather than the pharmacy benefit.

The HCPCS/CPT billing code for romosozumab is J3111, defined as injection of romosozumab-aqqg, 1 mg, with 210 units billed per dose (one dose per month). Confirm this with Anthem's provider services line before the first administration, because billing through the wrong benefit type (pharmacy vs. medical) is a common reason for claim rejection that is unrelated to PA status.

Some Anthem plans route romosozumab through specialty pharmacy instead of a medical benefit. In that case, the patient's specialty pharmacy (often Accredo, CVS Specialty, or Anthem's own IngenioRx) will dispense the drug directly, and the PA is handled as a pharmacy benefit PA rather than a medical benefit PA. The documentation requirements are identical, but the submission portal differs.

Special Populations: Fracture After Prior Anabolic Therapy

Patients who sustain a fracture while on teriparatide or abaloparatide represent a difficult coverage scenario. Anthem's standard step therapy requires antiresorptive failure, not anabolic failure. A patient who fractured on teriparatide may technically have completed one anabolic course, but that does not satisfy the antiresorptive step. The prescriber must explicitly address this in the PA request and request a medical necessity exception.

The 2022 American College of Rheumatology Guideline on Glucocorticoid-Induced Osteoporosis recommends romosozumab as a treatment option for patients at very high fracture risk on glucocorticoids 12. For glucocorticoid-induced osteoporosis specifically, Anthem may have a separate PA pathway or a modified step therapy requirement. Ask the Anthem provider services team (1-800-676-2583 for providers) whether the patient's diagnosis code (M81.0 for age-related osteoporosis without current pathological fracture, or M80.08XA for age-related osteoporosis with current pathological fracture of vertebra) triggers the standard or an alternative review pathway.

What Anthem Providers Must Submit: A Documentation Checklist

Submitting a complete PA packet on the first attempt reduces both denial risk and processing time. Anthem's standard submission portal is Availity (availity.com) or the Anthem provider portal at anthem.com/provider.

Required documents for a romosozumab PA submission to Anthem:

1. Completed Anthem PA request form for specialty injectable drugs, including diagnosis code, drug name, dose, frequency, and anticipated duration.
2. Most recent DXA report (within 24 months) with T-scores at lumbar spine and total hip or femoral neck.
3. FRAX calculation printout from sheffield.ac.uk/FRAX showing 10-year probabilities with BMD included.
4. Documentation of prior antiresorptive therapy: drug name, dose, start and end dates, reason for discontinuation or evidence of inadequate response.
5. Cardiovascular risk assessment note from the prescriber or a cardiologist, addressing MI and stroke history.
6. Office notes from the most recent visit confirming the diagnosis of postmenopausal osteoporosis at high fracture risk.
7. Prescriber specialty credentials (board certification or specialty attestation if the prescriber is not an endocrinologist or rheumatologist).

Anthem's PA unit can be reached at 1-800-676-2583 for provider questions. Standard processing is 3 to 5 business days for non-urgent requests; urgent (expedited) requests citing imminent fracture risk should be processed within 72 hours under CMS and state insurance regulations, though commercial plan timelines vary by state.