Does Security Health Plan Cover Prolia?

What Is Prolia and Why Is It Prescribed?

Prolia (denosumab) is a fully human monoclonal antibody that inhibits RANK Ligand, the protein that activates osteoclasts. By blocking osteoclast formation, Prolia slows bone resorption and increases bone mineral density (BMD) in patients at high fracture risk. The FDA approved Prolia on June 1, 2010, for postmenopausal women with osteoporosis at high fracture risk, and later expanded its label to include male osteoporosis, glucocorticoid-induced osteoporosis, and bone loss associated with hormone-ablation therapy in prostate and breast cancer patients [1].

The FREEDOM Trial: Core Evidence

The key FREEDOM trial (N=7,808) demonstrated that denosumab 60 mg every 6 months reduced new vertebral fractures by 68% and hip fractures by 40% compared to placebo over 36 months (P<0.001 for both endpoints) [2]. That level of fracture reduction is the clinical foundation most insurers, including Security Health Plan, use when evaluating whether to cover Prolia for a specific member.

Other FDA-Approved Indications

Beyond postmenopausal osteoporosis, the FDA label covers [1]:

• Osteoporosis in men at high fracture risk
• Glucocorticoid-induced osteoporosis in adults on systemic corticosteroids for at least 6 months
• Bone loss in women with breast cancer receiving aromatase inhibitors
• Bone loss in men with prostate cancer receiving androgen deprivation therapy

Security Health Plan's medical policies generally mirror FDA-labeled indications, though each requires supporting documentation at the time of prior authorization.

How Security Health Plan Structures Prolia Coverage

Security Health Plan is a regional, Wisconsin-based managed care organization offering commercial, Medicare Advantage, and Medicaid (BadgerCare) products. Prolia typically appears in one of two benefit categories depending on the plan type: the pharmacy benefit or the medical benefit.

Pharmacy Benefit vs. Medical Benefit

When Prolia is dispensed through a specialty pharmacy and self-administered (which is not standard, since it requires a provider injection), it falls under the pharmacy benefit. In practice, Prolia injections are almost always administered in a physician office or clinic, so Security Health Plan most commonly processes them under the medical benefit using HCPCS code J0897 (injection, denosumab, 1 mg). Each 60 mg injection therefore bills as 60 units of J0897.

Understanding which benefit applies matters because cost-sharing differs. Medical benefit claims count toward your medical deductible and out-of-pocket maximum, while specialty pharmacy claims count toward your pharmacy deductible. Confirm the correct pathway with Security Health Plan before scheduling your injection.

Formulary Placement

On commercial plans, denosumab is typically placed on a specialty tier (Tier 4 or Tier 5), which carries the highest cost-sharing. Medicare Advantage members enrolled through Security Health Plan should check the plan's Annual Notice of Change each October, because formulary tier placement and prior authorization requirements can change each plan year. The Centers for Medicare and Medicaid Services (CMS) publishes guidance on Medicare drug coverage that governs how Medicare Advantage plans must handle Part B biologics [3].

Prior Authorization Requirements for Prolia Under Security Health Plan

Prior authorization (PA) is a near-universal requirement for Prolia across all Security Health Plan product lines. The PA process exists to confirm that Prolia is medically necessary for the individual member before the plan agrees to pay.

What Your Prescriber Needs to Submit

A typical Security Health Plan PA submission for Prolia includes:

• Diagnosis codes: ICD-10-CM M81.0 (age-related osteoporosis without current pathological fracture) or the appropriate secondary codes for glucocorticoid-induced or cancer-related bone loss
• DEXA scan results: T-score at the lumbar spine or femoral neck, dated within 24 months
• Fracture history: Documentation of prior osteoporotic fractures, if any
• Previous therapy: Evidence that the member has tried or failed, or has a documented contraindication to, an oral bisphosphonate (e.g., alendronate 70 mg weekly or risedronate 35 mg weekly) for at least 6 to 12 months
• Prescriber attestation: A statement that the member is at high fracture risk based on FRAX score or clinical judgment

The National Osteoporosis Foundation (now part of the American Bone Health framework) and the Endocrine Society both recommend pharmacotherapy for postmenopausal women with a T-score of <-2.5 or a T-score between -1.0 and -2.5 with a 10-year FRAX hip fracture probability of 3% or greater [4]. Security Health Plan's criteria typically align with these thresholds.

Step Therapy: Bisphosphonates First

Most Security Health Plan commercial plans require documented failure of or contraindication to a generic oral bisphosphonate before approving Prolia. Alendronate (Fosamax generic) costs roughly $10 to $20 per month through most Wisconsin pharmacies, making it an accessible first-line agent. Documented contraindications that may allow skipping step therapy include [5]:

• Esophageal stricture or achalasia
• Inability to sit or stand upright for 30 minutes
• Creatinine clearance <35 mL/min (severe renal impairment)
• Documented intolerance with prior bisphosphonate use

If your prescriber documents one of these contraindications clearly in the PA request, Security Health Plan may waive the step-therapy requirement and approve Prolia as first-line therapy.

Approval Timeline

Federal regulations under the Affordable Care Act require non-urgent PA decisions within 15 calendar days for medical benefit requests, and 72 hours for urgent requests. Wisconsin state insurance regulations may impose shorter windows. Ask your prescriber's office to submit the PA request at least 3 to 4 weeks before your intended injection date to allow time for appeals if the initial request is denied.

Medicare Advantage Members: Part B vs. Part D Coverage

Security Health Plan offers Medicare Advantage plans in Wisconsin. For these members, Prolia administered in a physician's office is typically covered under Medicare Part B rather than Part D, because it meets the Part B definition of a drug administered incident to a physician service [3].

Part B Cost-Sharing

Under original Medicare (and most Medicare Advantage plans that follow Part B cost-sharing structures), the patient pays 20% of the Medicare-approved amount after the Part B deductible is met. For Prolia, the Medicare-allowed amount per injection is updated quarterly by CMS. In 2024, the average sales price (ASP)-based reimbursement for denosumab 60 mg was approximately $1,300 to $1,600 per injection, meaning a 20% coinsurance equals roughly $260 to $320 per dose without supplemental coverage.

Security Health Plan Medicare Advantage plans may apply different cost-sharing, potentially lower, for in-network providers. Review your Evidence of Coverage document annually.

Low-Income Subsidy and Extra Help

Medicare members with low income may qualify for the Part D Low-Income Subsidy (LIS), also called Extra Help, which can reduce cost-sharing significantly even for Part B biologics administered through Medicare Advantage. The Social Security Administration manages LIS enrollment; eligibility is tied to income at or below 150% of the federal poverty level [6].

What to Do If Security Health Plan Denies Prolia Coverage

A denial is not the end of the road. Federal law gives you the right to appeal any adverse coverage decision.

Level 1 Appeal

Submit a written Level 1 appeal within 180 days of the denial date. Include a letter from your prescriber explaining medical necessity, updated DEXA results if available, your FRAX score, and any peer-reviewed literature supporting Prolia for your specific indication. The FREEDOM trial data [2] and Endocrine Society Clinical Practice Guideline [4] are appropriate to attach.

External Review

If Security Health Plan upholds the denial at Level 1, you have the right to an external independent review under Wisconsin state law and federal ACA rules. An independent review organization (IRO) then evaluates the clinical evidence. IRO overturn rates for specialty medications with strong trial evidence tend to be meaningful; a 2019 analysis found that members who pursued external review won their appeal approximately 40% of the time across all plan types [7].

Physician Peer-to-Peer Review

Before filing a formal appeal, ask your prescriber to request a peer-to-peer (P2P) review call with the Security Health Plan medical director or their designee. P2P calls often resolve denials faster than the written appeal process, particularly when the prescriber can cite specific FRAX scores, prior fracture history, or documented bisphosphonate intolerance.

Cost-Saving Strategies for Prolia

Even with coverage, out-of-pocket costs can be significant. Several programs may help.

Amgen Prolia SupportPlus Program

Amgen, the manufacturer of Prolia, operates a patient support and cost-assistance program called Prolia SupportPlus. Commercially insured patients with financial need may qualify for co-pay assistance that reduces their cost to as low as $0 per injection. Medicare and Medicaid members are not eligible for manufacturer co-pay cards under federal anti-kickback rules, but may qualify for Amgen's free drug program if income criteria are met. Contact Amgen at 1-800-772-6436 or visit Amgen's patient assistance page to screen for eligibility.

Biosimilar Alternatives

Two FDA-approved biosimilars to Prolia, Jubbonti and Wyost (both denosumab-bbdz, manufactured by Sandoz), received FDA approval in June 2023 [8]. Biosimilars are required by law to have no clinically meaningful differences from the reference product in safety, purity, and potency. If Security Health Plan preferentially covers a denosumab biosimilar, switching to it rather than brand Prolia may reduce your cost-sharing substantially. Ask your prescriber whether a biosimilar substitution is appropriate for your clinical situation.

Wisconsin Pharmaceutical Assistance Program

Wisconsin does not currently operate a state pharmaceutical assistance program specifically for biologics, but low-income members may qualify for SeniorCare (Wisconsin's prescription drug program for seniors) or for full BadgerCare Plus coverage, which covers Prolia under Medicaid managed care with minimal cost-sharing for eligible members. The Wisconsin Department of Health Services maintains updated eligibility tables [9].

DEXA Scanning and Monitoring Requirements

Security Health Plan typically requires a baseline DEXA scan before approving Prolia and may require follow-up scans to continue coverage. The U.S. Preventive Services Task Force (USPSTF) recommends osteoporosis screening with DEXA for women aged 65 and older, and for younger postmenopausal women whose 10-year fracture risk equals or exceeds that of a 65-year-old white woman with no additional risk factors [10].

Frequency of DEXA Under Coverage

Most Security Health Plan plans cover DEXA scans every 2 years for monitoring established osteoporosis. The International Society for Clinical Densitometry recommends repeat BMD testing no more frequently than every 1 to 2 years when monitoring treatment response, and less frequently (every 3 to 5 years) in stable patients [11]. Ordering DEXA scans more frequently than the plan allows without a documented clinical rationale may result in a claim denial for the scan itself, which could then delay the PA renewal for Prolia.

T-Score Targets During Treatment

The Endocrine Society Clinical Practice Guideline states that a T-score above -2.5 at the hip or spine after 3 to 5 years of antiresorptive therapy may support a drug holiday for bisphosphonates, but Prolia requires a different management strategy [4]. Stopping denosumab abruptly is associated with rapid bone loss and an increased risk of multiple vertebral fractures, as documented in the FREEDOM Extension and subsequent case series [12]. Security Health Plan coverage decisions should account for this risk; if coverage lapses, your prescriber should transition you to a bisphosphonate to maintain the BMD gains.

Clinical Criteria Summary: Who Qualifies for Coverage

Security Health Plan's medical necessity criteria for Prolia generally require at least one of the following, supported by documentation:

1. Postmenopausal osteoporosis with T-score <-2.5 at lumbar spine, total hip, or femoral neck
2. Postmenopausal osteoporosis with T-score between -1.0 and -2.5 plus a prior low-trauma fracture
3. Osteoporosis in men with T-score <-2.5 confirmed on DEXA
4. Glucocorticoid-induced osteoporosis in patients on prednisone 5 mg/day or equivalent for 3 or more months
5. Hormone-ablation-related bone loss in prostate or breast cancer patients meeting BMD thresholds
6. Documented failure of, or contraindication to, at least one oral bisphosphonate (except where the indication itself bypasses step therapy)

The American Association of Clinical Endocrinology (AACE) 2020 Clinical Practice Guidelines classify denosumab as a first-line agent for patients at "very high" fracture risk, defined as a T-score <-3.0, multiple prior fractures, or a FRAX 10-year major osteoporotic fracture probability of 30% or greater [13]. Citing the AACE very-high-risk classification in your PA request may allow your prescriber to bypass step therapy in documented high-risk cases.