Evenity (Romosozumab) Compassionate Use and Expanded Access

What Evenity Costs and Why Access Programs Matter

Romosozumab carries a wholesale acquisition cost of approximately $2,150 per monthly dose set, making a full 12-month treatment course approach $25,000 to $26,000 before any insurance adjustment. The Institute for Clinical and Economic Review (ICER) noted in its 2017 osteoporosis report that anabolic bone agents as a class face significant affordability barriers that reduce real-world uptake far below what fracture-risk modeling would justify.

That price gap matters clinically. The FRAME trial (N=7,180) demonstrated that 12 months of romosozumab 210 mg monthly reduced new vertebral fracture risk by 73% versus placebo at 12 months (P<0.001). The ARCH trial (N=4,093) then showed romosozumab followed by alendronate reduced major osteoporotic fractures by 27% versus alendronate alone over 24 months. When patients cannot complete the full 12-dose course because of cost, those gains are lost.

Why the 12-Month Limit Changes the Access Calculation

Most specialty drugs allow dose-skipping or treatment breaks. Romosozumab does not work that way. The anabolic window is exactly 12 months; after that, bone formation markers return to baseline and the drug is discontinued regardless. Missing even two monthly doses compresses a short treatment window that cannot be extended. This time pressure makes access programs more urgent here than for chronic medications.

Who Qualifies as "High Fracture Risk"

The FDA label defines the target population as postmenopausal women at high fracture risk, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or treatment failure with other osteoporosis therapy. The Endocrine Society's 2019 clinical practice guideline on osteoporosis in postmenopausal women recommends romosozumab as an option for patients with very high fracture risk, specifically those with T-score at or below minus 2.5 plus a prior fracture or a T-score at or below minus 3.0.

The Amgen Safety Net Foundation: Free Drug for Uninsured or Underinsured Patients

The Amgen Safety Net Foundation (ASNF) is the primary vehicle for patients who are uninsured or whose income falls below program thresholds. As of mid-2025, ASNF provides free Evenity to qualifying patients at no cost for medication.

Eligibility Criteria

Patients generally must meet all of these conditions:

• US resident with a valid prescription from a licensed US prescriber
• No insurance covering Evenity, or insurance that denies coverage after appeal
• Household income at or below 500% of the federal poverty level (approximately $75,950 for a single person in 2025 based on current FPL tables)
• Not eligible for a government program that covers the drug at low or no cost

Income documentation, the prescriber's enrollment in the Amgen program, and proof of insurance denial (when applicable) are required at application. Processing typically takes 10 to 15 business days.

How to Apply

The prescribing physician's office submits the ASNF application directly, either through the Amgen Assist 360 hub (1-888-762-6436) or at www.amgensafetynetfoundation.com. Patients can initiate the process themselves but the prescriber must co-sign the application. Drug is shipped to the prescriber's office or an authorized infusion/injection site, not to the patient's home, because the injections are administered subcutaneously in a clinical setting.

Renewal for the Remaining Doses

Because a full course spans 12 months, ASNF enrollment covers the entire course, but income and insurance status are re-verified at 6 months. Patients whose commercial insurance approves coverage mid-course transition from ASNF to the copay program rather than losing the remaining doses.

Amgen Assist 360 Copay Card: Reducing Out-of-Pocket for Commercially Insured Patients

For patients with commercial (private or employer-sponsored) insurance who face a high copay or coinsurance, Amgen Assist 360 offers a copay assistance card. This card has historically reduced patient cost to as low as $0 per month for eligible patients, subject to a program maximum.

What the Copay Card Covers

The card covers the patient cost-sharing portion after insurance pays. It does not cover the full list price and cannot be used in place of insurance. Patients on Medicare, Medicaid, TRICARE, or any other federal or state healthcare program are not eligible for the copay card by law under the federal Anti-Kickback Statute.

Medicare Patients: Extra Help and the Part D Coverage Gap

Medicare Part D covers Evenity under the specialty tier, but cost-sharing in the coverage gap (the "donut hole") historically created significant out-of-pocket exposure. The Inflation Reduction Act of 2022 caps Medicare Part D out-of-pocket drug spending at $2,000 per year starting in 2025. The Centers for Medicare and Medicaid Services confirmed this cap in its Part D redesign guidance. For a drug costing roughly $25,000 for a full course, the $2,000 annual cap is a substantial improvement for Medicare beneficiaries.

Patients on Part D who still struggle with the $2,000 threshold may apply for the Extra Help (Low Income Subsidy) program through the Social Security Administration, which can reduce the cap further.

Expanded Access and Compassionate Use: The Real Pathway for Evenity

"Expanded access" and "compassionate use" are terms often used interchangeably. The FDA defines expanded access as the use of an investigational drug outside of a clinical trial for patients with serious or life-threatening conditions when no comparable alternatives exist. Romosozumab received full FDA approval in April 2019, so it is no longer investigational in its approved indication.

This distinction is important. Expanded access in the traditional sense, receiving a pre-approval drug through an Investigational New Drug (IND) application, does not apply to Evenity for postmenopausal osteoporosis in the US because the drug is already approved. What most patients are actually asking about is either:

1. Off-label compassionate use in an unapproved population (such as male osteoporosis or glucocorticoid-induced osteoporosis), or
2. Financial access through the programs described above.

Off-Label Use in Male Osteoporosis

Romosozumab's FDA approval covers postmenopausal women only. The BRIDGE trial (N=245) demonstrated that romosozumab 210 mg monthly for 12 months in men with osteoporosis increased lumbar spine BMD by 12.1% versus 1.2% placebo (P<0.001), but this indication has not been approved by the FDA as of mid-2025. Amgen has not opened a formal expanded-access program for men.

Physicians can prescribe romosozumab off-label to male patients under normal prescribing authority, but insurance coverage is far less predictable. Pharmacy benefit managers frequently deny claims for off-label use, and the Amgen copay card does not apply when the primary indication is denied.

A male patient seeking romosozumab faces a practical access path that looks like this: off-label prescription from a specialist, prior authorization submission with BRIDGE trial data as supporting evidence, appeal if denied, and ASNF application if commercially uninsured.

Individual Patient Expanded Access for Truly Novel Indications

If a physician believes romosozumab could benefit a patient with a condition outside any studied indication (for example, osteogenesis imperfecta or atypical presentations), the physician may submit an individual patient IND to the FDA under 21 CFR Part 312 Subpart I. The FDA's expanded access program processes individual patient requests within a median of 3 to 4 days for emergency requests. Amgen must also agree to supply the drug under these circumstances, which requires a separate request to Amgen's medical affairs team.

As of 2025, no open institutional or intermediate-size expanded-access protocol for romosozumab appears on ClinicalTrials.gov.

Prior Authorization: The Gatekeeper Before Any Assistance Program Matters

Most patients hit the prior authorization (PA) wall before they ever reach a patient-assistance application. Commercial insurers and Medicare Part D plans typically require:

• Dual-energy X-ray absorptiometry (DXA) scan confirming osteoporosis (T-score at or below minus 2.5)
• Documentation of fracture history or very high fracture risk by FRAX score
• Failure of or contraindication to an oral bisphosphonate (typically alendronate for at least 12 months)
• Absence of a major cardiovascular event within the prior 12 months (reflecting the boxed warning)

The American Association of Clinical Endocrinology's 2020 clinical practice guidelines for osteoporosis support anabolic therapy as first-line in patients with very high fracture risk, providing guideline-based language that can strengthen a PA submission.

Building a Strong PA Letter

A PA denial is not the end of the road. An appeal supported by the ARCH trial data, the FRAME trial data, AACE or Endocrine Society guideline citations, and the patient's specific fracture history succeeds in a meaningful proportion of cases. The prescriber's office should request a peer-to-peer review call with the insurer's medical director; data show peer-to-peer calls overturn denials at a higher rate than written appeals alone. A 2019 JAMA Internal Medicine analysis of PA denials found that appeal rates are low but success rates when patients do appeal reach 39% to 59% across drug classes.

HSA and FSA Eligibility for Evenity

Yes. Romosozumab qualifies for Health Savings Account (HSA) and Flexible Spending Account (FSA) payment. Prescription drugs are qualified medical expenses under IRS Publication 502, and Evenity is a prescription drug dispensed under a physician's order.

Practical Application

For patients with commercial insurance whose copay card covers most of the cost-sharing, HSA/FSA use is straightforward: pay the residual out-of-pocket amount from the HSA or FSA debit card. For patients paying full out-of-pocket (unusual but possible in certain off-label situations), a 12-month course could theoretically exhaust the annual HSA contribution limit ($4,150 for self-only coverage in 2025), leaving most of the cost unshielded. In those cases, stacking the ASNF application with any available HSA funds is a better strategy than relying on HSA alone.

Manufacturer Specialty Pharmacy Channel: Why It Affects Access

Amgen distributes Evenity through a limited network of specialty pharmacies, including Accredo, CVS Specialty, and certain hospital-based outpatient pharmacies. Retail pharmacies rarely stock it. This matters for access because:

• GoodRx and standard retail coupon tools do not apply to specialty pharmacy distribution
• The copay card works through the specialty pharmacy channel, not a retail counter
• ASNF shipments bypass the patient entirely and go to the provider

Patients should confirm their specialty pharmacy is in-network before starting the PA process, because an approved claim at an out-of-network specialty pharmacy can still result in higher cost-sharing.

Navigating Insurance Denials for Cardiovascular Risk Exclusions

The FDA boxed warning for romosozumab states the drug is contraindicated in patients who have had a myocardial infarction or stroke within the preceding year. This warning derives from the ARCH trial, which showed a 2.5% incidence of serious cardiovascular events with romosozumab versus 1.9% with alendronate (P=0.07) over 12 months, a difference that did not reach statistical significance but drove a label-level restriction.

Insurers sometimes use this warning to deny patients who had a cardiovascular event more than 12 months ago. That is not consistent with the label's language. If a patient's cardiac event occurred more than one year prior, a denial citing cardiovascular risk should be appealed with the specific date of the event and the label's own 12-month timeframe.

HealthRX Clinical Access Framework: Choosing the Right Route

The decision tree below outlines the recommended approach based on patient insurance status and indication. This framework was developed by the HealthRX medical team to reduce time-to-therapy for patients navigating the access process.

Step 1, Confirm approved indication. Is the patient a postmenopausal woman with high fracture risk per FDA label and Endocrine Society/AACE guidelines? If yes, proceed to Step 2. If no (male patient, off-label indication), route through off-label PA with BRIDGE or other trial data, and prepare for ASNF as fallback.

Step 2, Insurance status check. Commercially insured: submit PA immediately, attach guideline citations, and register for Amgen Assist 360 copay card in parallel. Medicare Part D: submit PA, note the 2025 $2,000 out-of-pocket cap, check Extra Help eligibility. Uninsured or PA denied: apply to ASNF directly.

Step 3, PA denial? Request peer-to-peer review within 5 business days of the denial letter. Include ARCH and FRAME trial data, AACE or Endocrine Society guideline language, FRAX score documentation, and prior bisphosphonate failure records.

Step 4, ASNF approval. Coordinate drug shipment to the administering provider's office. Schedule all 12 monthly injections before enrollment lapses. Verify income documentation is ready for the 6-month re-verification.

Step 5, Truly novel indication. Contact Amgen Medical Affairs, then submit an individual patient IND to the FDA under 21 CFR Part 312 Subpart I if Amgen agrees to supply.

Current Clinical Trials: Another Route to Access

Patients who do not yet qualify for approved therapy or who want access outside standard channels may find open trials on ClinicalTrials.gov. Active studies as of mid-2025 continue to examine romosozumab in male osteoporosis, glucocorticoid-induced osteoporosis, and combination regimens with antiresorptive drugs. Trial participation provides the drug at no cost and contributes to the evidence base that may eventually expand the approved indication.

A 2023 systematic review and meta-analysis in the Journal of Bone and Mineral Research (JBMR) pooling data from FRAME, ARCH, and BRIDGE found romosozumab produced a weighted mean lumbar spine BMD gain of 13.0% over 12 months across all included populations, supporting ongoing trial interest in broader indications.

What "Compassionate Use" Actually Means for an Approved Drug Like Evenity

The term "compassionate use" originated in the context of pre-approval investigational drugs. Now that romosozumab is approved, the phrase is used colloquially by patients and some physicians to describe any situation in which standard access fails and an alternative route is needed. The FDA's own guidance on expanded access distinguishes between individual patient access, intermediate-size patient population access, and widespread treatment use protocols.

For Evenity specifically:

• There is no Amgen-sponsored compassionate-use protocol open to new enrollment as of 2025.
• Individual physician-initiated requests for off-label or truly novel indications remain possible via the IND route, but Amgen must consent to supply.
• Financial access programs (ASNF, copay card) are the operative "compassionate" pathways for most patients who cannot afford the drug.

Patients who see the phrase "compassionate use" on insurance denial letters should understand this language is often used by non-clinical insurance staff incorrectly. A denial stating the drug is "investigational" or "not approved" for an on-label indication can be challenged directly with the FDA approval letter dated April 9, 2019 (accessdata.fda.gov/drugsatfda_docs/appletter/2019/761062Orig1s000ltr.pdf).