How to Get Evenity (Romosozumab) in Florida

What Is Evenity (Romosozumab) and Why Florida Patients Seek It

Evenity is a sclerostin inhibitor that simultaneously builds new bone and reduces bone resorption. The FDA approved it on April 9, 2019, for postmenopausal women with osteoporosis at high fracture risk, defined as a prior osteoporotic fracture, a T-score at or below -2.5, or multiple clinical risk factors. 1

The Dual Mechanism That Sets It Apart

Most osteoporosis drugs work by slowing bone breakdown. Romosozumab blocks sclerostin, a protein produced by osteocytes that normally suppresses bone formation. By removing that brake, it drives osteoblast activity while simultaneously reducing RANK-ligand-mediated resorption. 2

This dual action produces bone mineral density (BMD) gains that antiresorptive drugs alone cannot match in a 12-month window.

The ARCH Trial: What the Evidence Shows

In the ARCH trial (N=4,093), romosozumab 210 mg monthly for 12 months followed by alendronate reduced new vertebral fracture risk by 48% compared with alendronate alone over 24 months (6.2% vs. 11.9%, P<0.001). 2 Non-vertebral fracture risk fell by 19% (P=0.04) and hip fracture risk by 38% (P=0.02). 2

The FRAME trial (N=7,180) compared romosozumab against placebo and showed a 73% reduction in new vertebral fractures at 12 months (0.5% vs. 1.8%, P<0.001). 3

The Cardiovascular Black-Box Warning

ARCH detected a higher rate of serious cardiovascular events in the romosozumab arm vs. The alendronate arm (2.5% vs. 1.9%). 2 The FDA responded with a black-box warning. Evenity is contraindicated in patients who have had a myocardial infarction or stroke within the preceding 12 months. 1 Every Florida prescriber must screen for this history before writing the first order.

Who Can Prescribe Evenity in Florida

Florida law allows multiple prescriber types to order romosozumab, provided they hold an active Florida license and operate within their defined scope of practice.

MD and DO Physicians

Board-certified endocrinologists, rheumatologists, and internists most commonly prescribe Evenity. Osteoporosis management falls within the scope of any licensed Florida physician. The Endocrine Society's 2019 clinical practice guideline recommends anabolic agents like romosozumab for patients with very high fracture risk, defined as a prior hip or vertebral fracture, T-score below -3.0, or a FRAX 10-year major osteoporotic fracture probability above 30%. 4

Nurse Practitioners and Physician Assistants

Florida Advanced Practice Registered Nurses (APRNs) with a supervising physician protocol may prescribe Schedule III-V controlled substances and most non-controlled specialty drugs including romosozumab. 5 Physician Assistants (PAs) operating under a supervising physician's written delegation agreement have the same prescribing authority for this drug class. Telehealth APRNs and PAs have been prescribing romosozumab in Florida since 2020.

Telehealth Prescribers

Florida Statute 456.47 explicitly permits telehealth prescribing of non-controlled medications when the prescriber can conduct a sufficient evaluation. 6 Romosozumab is not a controlled substance, so a synchronous audio-video visit that allows the prescriber to review labs, imaging, and cardiovascular history satisfies this requirement. The prescriber must hold an active Florida license or a Florida telehealth registration.

Required Labs and Imaging Before Your First Dose

No prescriber in Florida can safely write for romosozumab without confirming two things: the fracture risk justifies the drug, and the patient does not have uncorrected hypocalcemia or a recent cardiac event.

DEXA Scan Requirements

A dual-energy X-ray absorptiometry (DEXA) scan at the lumbar spine and femoral neck is mandatory. The American Association of Clinical Endocrinology (AACE) 2020 guidelines specify that a T-score at or below -2.5 at either site (or below -1.0 with a fragility fracture history) supports anabolic therapy. 7 Florida Medicare covers DEXA every 24 months for eligible beneficiaries. 8

Blood and Urine Labs

Before the first injection, prescribers order:

• Serum calcium and albumin (romosozumab is contraindicated with hypocalcemia; correct it first) 1
• Serum 25-hydroxyvitamin D (target above 30 ng/mL before starting; supplement if below) 4
• Comprehensive metabolic panel (renal function, liver enzymes)
• PTH (to rule out primary hyperparathyroidism as a reversible cause)
• CBC (baseline)
• Urine N-telopeptide or serum CTX (baseline bone resorption marker for monitoring) 7

Cardiovascular Screening

The prescriber must document absence of myocardial infarction or stroke in the prior 12 months. Many Florida clinicians also obtain a resting ECG and review statin and antiplatelet therapy before authorizing the first dose. 1

Dental Evaluation

Osteonecrosis of the jaw (ONJ) is rare with romosozumab (reported rate <0.1% in clinical trials) but the FDA label recommends completing necessary dental procedures before starting therapy. 1 Florida oral surgeons experienced with bone-modifying agents can provide a pre-treatment clearance letter.

The Prior Authorization Process for Florida Insurers

Prior authorization (PA) is nearly universal for Evenity in Florida. Skipping this step is the single most common cause of delay.

What Commercial Plans Require

Florida Blue, Aetna, Cigna, and UnitedHealthcare all require documentation of:

1. DEXA T-score at or below -2.5, or prior fragility fracture confirmed by imaging 9
2. Trial and failure or contraindication to a bisphosphonate (typically alendronate 70 mg weekly for at least 12 months) 4
3. Absence of contraindications listed in the FDA label 1
4. Prescriber attestation that fracture risk is "very high" per AACE or Endocrine Society criteria 7

Most Florida commercial PA decisions arrive in 3 to 10 business days. Appeals for initial denials succeed roughly 40% of the time when the prescriber submits peer-reviewed literature alongside the clinical chart. 10

Medicare Part B vs. Part D

Romosozumab administered in a physician office is billed under Medicare Part B (HCPCS code J3111). Coverage requires an ICD-10 code for osteoporosis with current pathological fracture (M80.xx) or osteoporosis without fracture (M81.xx) plus supporting DEXA documentation. 8 Medicare Part D covers self-administered injections at home, though most patients receive the injections in-office.

Florida Medicaid

Florida Medicaid does not cover romosozumab for osteoporosis under the current preferred drug list. Patients on Medicaid must pursue Amgen's EVENITY patient assistance program (EVENITY ONE Source) directly, which can provide the drug at no cost to qualifying patients earning below 500% of the federal poverty level.

Step-by-Step: Getting Romosozumab in Florida

The pathway below reflects the standard workflow across Florida endocrinology, rheumatology, and telehealth practices as of mid-2025.

Step 1. Schedule an Initial Evaluation

Book an appointment with a Florida-licensed prescriber, either in person or via a HIPAA-compliant telehealth platform. Bring or upload:

• Prior DEXA scan results (within 24 months)
• Any fracture history (radiology reports, surgical records)
• Current medication list, including supplements
• Cardiovascular history (MI, stroke, stents)

If you have no recent DEXA, most Florida imaging centers offer self-pay scans for $75 to $150. Results are typically available within 48 hours.

Step 2. Complete Baseline Labs

Order the panel described above. LabCorp and Quest both have over 200 Florida patient service centers. Results return in 24 to 72 hours for standard panels.

Step 3. Prescriber Sends PA Request

The prescriber or their staff submits the PA packet to your insurer. Ask for a copy of everything submitted so you can track the request.

Step 4. PA Approval and Specialty Pharmacy Assignment

Once approved, the plan routes the prescription to a contracted specialty pharmacy. In Florida, common options include CVS Specialty, Accredo, and Walgreens Specialty. The pharmacy contacts you to schedule delivery of the pre-filled syringes (two 105 mg injections per monthly dose) and coordinates with your prescriber's office or infusion suite.

Step 5. First Injection

The first injection is almost always given in-office or at an infusion center. A nurse or medical assistant administers both 105 mg injections subcutaneously (one into each thigh, or abdomen, or upper arm) within the same appointment. Subsequent monthly doses may be self-administered if the prescriber provides training and deems it appropriate.

Step 6. Monitoring During the 12-Month Course

Serum calcium is rechecked at month 1 in patients who started with borderline levels. A follow-up DEXA is typically ordered at month 12, immediately before transitioning to an antiresorptive agent. 4 Stopping romosozumab without transitioning to bisphosphonate or denosumab leads to rapid BMD loss; this is not optional. 7

Telehealth Options for Florida Patients

Florida's telehealth statute permits full prescribing authority for non-controlled drugs after a synchronous audio-video evaluation. For romosozumab, this means:

What a Telehealth Visit Can Cover

A telehealth prescriber can review uploaded DEXA results and lab reports, take a complete fracture and cardiovascular history, confirm contraindication screening, and write the PA request electronically. The visit cannot replace the physical injection, which requires an in-person clinical setting.

Finding a Telehealth Prescriber

HealthRX connects Florida patients with board-certified endocrinologists and internists who manage osteoporosis via telehealth. After the visit, the prescriber coordinates directly with a Florida specialty pharmacy and your insurer's PA team.

A 2021 study in the Journal of Bone and Mineral Research (N=312) found that telehealth-initiated osteoporosis treatment achieved equivalent 12-month medication adherence (78% vs. 74%, P=0.38) compared with in-person initiation, with no significant difference in adverse events. 11

Documentation You Must Upload Before the Visit

Upload your most recent DEXA report, a list of prior osteoporosis medications with dates, any imaging confirming prior fractures, your cardiovascular history summary, and your insurance card (both sides). A complete upload cuts the average telehealth visit to approximately 20 minutes and accelerates the PA submission.

Pharmacy and Cost Considerations in Florida

Specialty Pharmacy Delivery

Evenity ships cold (2 to 8 degrees Celsius) in a pre-filled dual-syringe carton. Florida specialty pharmacies ship overnight with temperature-controlled packaging. Most patients coordinate delivery to their prescriber's office rather than their home to ensure proper storage and administration.

503A Compounding in Florida

Florida Board of Pharmacy licensed 503A compounding pharmacies may prepare romosozumab-based preparations only for patient-specific prescriptions, not for office stock. Compounded versions are not FDA-approved and lack the clinical trial data supporting the branded product. The American College of Rheumatology advises using FDA-approved biologics whenever commercially available. 12 No compounded romosozumab has equivalent bioavailability data, so prescribers at HealthRX write exclusively for branded Evenity.

Cost Without Insurance

Evenity's list price is approximately $2,100 per monthly carton (two syringes). Twelve doses cost roughly $25,200 without insurance or assistance programs. Amgen's EVENITY ONE Source program (1-833-EVENITY) provides co-pay support for commercially insured patients and free drug for uninsured or underinsured patients who qualify. 13

Cost With Insurance

After prior authorization, commercially insured patients typically pay $0 to $30 per month using Amgen's co-pay card. Medicare beneficiaries have co-pays under Part B that vary by plan but are generally 20% of the Medicare-approved amount after the Part B deductible.

Transitioning Off Romosozumab: What Happens After 12 Doses

The 12-dose course is fixed. Romosozumab is not re-initiated after completion. 1 After month 12, the standard of care is immediate transition to:

• Alendronate 70 mg weekly (oral bisphosphonate, first-line post-romosozumab per ARCH protocol) 2
• Denosumab 60 mg every 6 months (subcutaneous, preferred when bisphosphonate is contraindicated due to renal impairment or GI intolerance) 4
• Zoledronic acid 5 mg IV annually (for patients with adherence concerns or severe GI disease) 14

The Endocrine Society's 2019 guideline states: "After completing romosozumab therapy, patients should receive antiresorptive therapy to maintain the gains in BMD." 4 A DEXA at month 12 establishes the new baseline and guides antiresorptive dosing decisions.

Special Populations and Contraindications Specific to Florida Prescribers

Hypocalcemia Correction First

Romosozumab transiently suppresses serum calcium. Any patient with a serum calcium below 8.5 mg/dL must be repleted with calcium carbonate 1,000 to 1,200 mg daily and vitamin D 2,000 to 4,000 IU daily for at least 4 weeks before the first injection. Recheck calcium before proceeding. 1

Renal Impairment

Patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2 may be at higher risk for hypocalcemia. Romosozumab is not renally cleared but calcium monitoring must be more frequent in this group. 1

Men with Osteoporosis

The FDA approval covers postmenopausal women. Use in men is off-label. A phase 3 trial (N=245, published in JBMR 2019) showed lumbar spine BMD gains of 12.1% at 12 months in men receiving romosozumab vs. 1.7% for placebo (P<0.001), supporting off-label use in high-risk men under appropriate clinical judgment. 15

Glucocorticoid-Induced Osteoporosis

Patients on chronic prednisone at doses above 7.5 mg daily for more than 3 months have accelerated fracture risk. The American College of Rheumatology 2022 guideline on glucocorticoid-induced osteoporosis conditionally recommends romosozumab for very-high-risk patients who cannot tolerate or have failed oral bisphosphonates. 16