How to Get Repatha (Evolocumab) in New York

What Is Repatha and Why New York Patients Seek It

Repatha is Amgen's brand of evolocumab, a fully human monoclonal antibody that inhibits PCSK9, a protein that degrades LDL receptors in the liver. By blocking PCSK9, evolocumab allows LDL receptors to remain active longer, which pulls more LDL-cholesterol out of the bloodstream. The FDA approved evolocumab in August 2015 for adults with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), and for cardiovascular risk reduction in adults with established atherosclerotic cardiovascular disease (ASCVD) who need additional LDL lowering beyond maximally tolerated statin therapy. 1

The FOURIER trial (N=27,564) published in the New England Journal of Medicine in 2017 demonstrated that adding evolocumab to statin therapy reduced LDL-C by 59% (from a median of 92 mg/dL to 30 mg/dL) and cut the composite risk of cardiovascular death, myocardial infarction, stroke, unstable angina hospitalization, or coronary revascularization by 15% over a median follow-up of 2.2 years (hazard ratio 0.85; 95% CI 0.79, 0.92; P<0.001). 2

New York has a high concentration of patients with familial hypercholesterolemia. The American Heart Association estimates FH affects approximately 1 in 250 people in the general population, meaning roughly 80,000 New Yorkers may carry the condition. 3 Many remain undiagnosed or inadequately treated, which is exactly the population for whom evolocumab provides the most benefit.

Who Can Prescribe Repatha in New York

Any licensed prescriber in New York State can write a Repatha prescription. That includes MDs, DOs, nurse practitioners (NPs), and physician assistants (PAs), provided the prescription falls within their scope of practice. In practice, most Repatha prescriptions originate from cardiologists, endocrinologists, and lipidologists, though primary-care providers are fully authorized to prescribe it.

New York NPs with full practice authority can prescribe Repatha independently. PAs must do so under a written practice agreement with a supervising physician, though this rarely creates a bottleneck. 4

Telehealth prescribing is legal in New York for established and new patient-provider relationships, provided the prescriber holds an active New York State license. The New York State Department of Health permits synchronous audio-video visits to satisfy the prescribing encounter requirement. A prescriber may not issue a controlled substance via telehealth without a prior in-person visit under DEA rules, but evolocumab is not a controlled substance, so this restriction does not apply. 5

Labs Required Before a Repatha Prescription in New York

A fasting lipid panel is the baseline minimum. Most prescribers also order a comprehensive metabolic panel (to include liver function tests), and many add a creatine kinase (CK) level to document baseline muscle status, particularly when concurrent statin therapy is present.

The ACC/AHA 2018 Guideline on the Management of Blood Cholesterol specifies that PCSK9 inhibitor therapy is appropriate when a patient on maximally tolerated statin therapy has an LDL-C of 70 mg/dL or greater and either (a) established ASCVD or (b) familial hypercholesterolemia. 6 Documenting this LDL threshold in the chart is not optional from a prior-authorization standpoint. It is the single piece of lab evidence most likely to determine whether the PA is approved on the first submission.

Thyroid function testing (TSH) is sometimes added when secondary causes of hypercholesterolemia, such as hypothyroidism, have not been excluded. The American Association of Clinical Endocrinology recommends ruling out secondary dyslipidemia before escalating to a PCSK9 inhibitor. 7 For a telehealth visit, most platforms will order these labs through a patient-service center such as Quest or LabCorp before the prescribing appointment.

Repeat lipid testing is typically done 4 to 12 weeks after starting evolocumab to confirm LDL response and to document efficacy for ongoing insurance coverage. 8

How to Get a Repatha Prescription in New York: Step-by-Step

Step 1. Confirm clinical eligibility. You need a documented diagnosis of HeFH, HoFH, or established ASCVD (prior MI, stroke, or symptomatic peripheral arterial disease), plus an LDL-C of 70 mg/dL or greater despite maximally tolerated statin therapy. Statin intolerance, defined in clinical practice as myalgia or elevated CK leading to dose reduction or discontinuation, also qualifies in most PA protocols.

Step 2. Choose a prescriber or telehealth platform. In-person appointments with a New York cardiologist or lipid specialist remain the most common route. Telehealth platforms licensed in New York State can complete the prescribing visit via synchronous video. The visit typically takes 20 to 40 minutes and covers your lipid history, current medications, and cardiovascular risk.

Step 3. Complete baseline labs. Fasting lipid panel, CMP, and CK are ordered before or at the first visit. Results must be available before the prescriber submits a PA.

Step 4. Submit prior authorization. Your prescriber's office (or the telehealth platform's care team) submits the PA to your insurer. Required documentation typically includes your most recent lipid panel showing LDL >70 mg/dL on maximally tolerated statin, a clinical note documenting ASCVD or FH diagnosis, and evidence of statin therapy (the medication list or pharmacy fill history). New York Medicaid covers Repatha with PA for FH and ASCVD. Commercial payers vary, but most follow the ACC/AHA threshold of LDL >70 mg/dL on maximally tolerated therapy. 9

Step 5. Use Amgen's PASS or bridge program while PA is pending. Amgen offers the Repatha PASS (Patient Access and Support Services) program. Patients who qualify can receive a 30-day bridge supply at no cost while the PA is being processed. Your prescriber or the telehealth platform's care coordinator can enroll you. 10

Step 6. Pharmacy fulfillment. Repatha is a specialty drug. In New York, it is typically dispensed through specialty pharmacies such as CVS Specialty, Walgreens Specialty, or Accredo. Some patients use mail-order programs tied to their insurer's pharmacy benefit manager. Delivery to a New York address takes 1, 3 business days once the specialty pharmacy receives the approved PA.

Telehealth Repatha Prescribing in New York: What to Expect

A telehealth visit for Repatha in New York follows the same clinical standard as an in-person visit. The prescriber reviews your cardiovascular history, lipid records, and current medications. The legal basis for telehealth prescribing in New York rests on the state's telehealth statute (NY Public Health Law Section 2999-cc), which permits prescribing after a real-time audio-video encounter. 11

The prescriber cannot physically examine you over video, so the burden shifts to documentation. Bring your most recent lipid panel results, your current medication list, and any cardiology or primary-care notes documenting ASCVD or FH. A telehealth provider who cannot access your prior records may need to order labs before issuing the prescription, which adds 3 to 7 days to the timeline.

Telehealth platforms that operate in New York and prescribe PCSK9 inhibitors are required to maintain New York State-licensed supervising physicians and to follow all state prescribing standards. The New York State Education Department oversees NP and PA scope of practice in telehealth settings identically to in-person settings. 12

The HealthRX clinical team uses the following decision framework for telehealth Repatha eligibility screening in New York:

1. LDL-C >70 mg/dL on maximally tolerated statin (or documented statin intolerance with LDL >100 mg/dL).
2. Established ASCVD (ACS, stable angina, prior revascularization, stroke/TIA, or symptomatic PAD) OR a confirmed or probable FH diagnosis using the Dutch Lipid Clinic Network score of 6 or greater.
3. No active liver disease (ALT <3x upper limit of normal).
4. Signed telehealth consent and a New York billing address or physical location at time of visit.
5. Labs available (fasting lipid panel within 6 months; CMP within 12 months).

If all five criteria are met, the prescribing visit proceeds the same day. If labs are missing, orders are sent electronically to the nearest patient-service center before the appointment is booked.

Prior Authorization Requirements in New York

Prior authorization for Repatha in New York follows a fairly consistent structure across commercial payers, though specifics vary by plan. The documentation most commonly requested includes:

• A current lipid panel showing LDL-C at or above the plan's threshold (commonly 70 mg/dL for ASCVD, 100 mg/dL for FH without ASCVD).
• Evidence of current or prior maximally tolerated statin therapy, including the statin name, dose, and duration.
• For statin intolerance: documentation of at least two statin trials resulting in myopathy or CK elevation, or a documented clinical decision to avoid statins entirely with supporting rationale.
• A clinical diagnosis of ASCVD or FH, supported by ICD-10 codes (E78.01 for HeFH, E78.02 for HoFH, I25.10 for ASCVD without angina).
• A prescriber attestation that the patient has been counseled on dietary modification.

New York Medicaid, administered through Medicaid managed-care plans, covers Repatha for FH and ASCVD with a prior authorization. The New York State Medicaid Drug Utilization Review Board reviews PCSK9 inhibitor PA criteria periodically. Most NY Medicaid managed-care plans follow the ACC/AHA 2018 guideline thresholds. 13

PA decisions in New York are typically returned within 3, 14 business days for standard reviews and within 72 hours for urgent or expedited reviews. If the PA is denied, you have the right to request an external appeal through the New York State Department of Financial Services. The 2018 ACC/AHA guideline states: "In patients with clinical ASCVD in whom LDL-C level remains 70 mg/dL or higher on maximally tolerated statin therapy, it is reasonable to add ezetimibe therapy. In patients with very high-risk ASCVD, it is reasonable to add a PCSK9 inhibitor." 14 Quoting this guideline directly in an appeal letter substantially strengthens the case.

Repatha Pharmacy Options in New York

Specialty pharmacies, not retail chains, are the standard channel for Repatha in New York. CVS Specialty, Walgreens Specialty, and Accredo (an Express Scripts company) are the three highest-volume dispensers in the state. Most insurer pharmacy benefit managers mandate a preferred specialty pharmacy; check your plan's specialty pharmacy network before the prescription is sent.

For patients using Amgen's $0 copay card (available to commercially insured patients who are not enrolled in a federal or state government program), the out-of-pocket cost drops to $0 per month for most commercial plan members. 15

503A compounding pharmacies in New York are licensed by the New York State Board of Pharmacy and may prepare patient-specific formulations of evolocumab when a valid patient-specific prescription is presented. The FDA does not recognize compounded PCSK9 inhibitors as equivalent to the branded product because monoclonal antibody manufacturing requires biologics-grade sterile manufacturing conditions. Any New York 503A pharmacy compounding evolocumab must meet USP 797 sterile compounding standards. 16 Patients should confirm that a compounding pharmacy holds an active New York State Board of Pharmacy license before accepting a compounded biologic.

Transferring a Repatha Prescription to New York

Transferring an existing Repatha prescription to a New York pharmacy is straightforward for specialty drugs. Because Repatha is not a controlled substance, no legal barrier prevents prescription transfer across state lines or from one pharmacy to another within New York. The receiving specialty pharmacy will contact the dispensing pharmacy or prescriber to verify the prescription.

For patients who relocate to New York mid-therapy, the original prescriber may continue prescribing if they hold a New York State license or if the patient returns to the original state for follow-up. Telehealth laws in New York allow out-of-state prescribers to treat New York patients only if they hold a New York State license. A New York-licensed provider should take over prescribing within 30 to 90 days of relocation to avoid potential PA gaps.

If your PA was approved in another state, expect the New York insurer to require a new PA because coverage determinations are plan-specific. Your new prescriber should initiate the PA at the time of the transfer visit. Bring all prior PA documentation, including the original approval letter, to accelerate the new review. 17

Repatha Dosing, Administration, and Monitoring in New York Clinical Practice

The two FDA-approved evolocumab regimens for adults are 140 mg subcutaneously every two weeks or 420 mg subcutaneously once monthly. 18 The 420 mg monthly dose is delivered using three consecutive 140 mg injections within 30 minutes, using either the pre-filled syringe or the SureClick autoinjector. The Pushtronex system (a wearable patch device) delivers the 420 mg dose over approximately 9 minutes.

For HoFH patients, 420 mg once monthly is the standard starting dose, and some patients require 420 mg every two weeks after 12 weeks if response is insufficient, as documented in the TESLA Part B trial (N=49), which showed a mean LDL-C reduction of 30.9% at 12 weeks. 19

LDL monitoring at 4 to 12 weeks confirms response. Target LDL for very high-risk ASCVD patients per the 2022 ACC Expert Consensus Decision Pathway is below 55 mg/dL. 20 For FH without ASCVD, the ACC/AHA 2018 guideline targets a 50% or greater LDL reduction. 21

Injection-site reactions occur in approximately 2.4% of patients receiving evolocumab vs. 1.8% placebo in FOURIER, a statistically modest difference. 22 No hepatotoxicity signal was identified in FOURIER. Neurocognitive events were examined in the EBBINGHAUS substudy (N=1,204) and showed no difference in cognitive function between evolocumab and placebo over 19 months. 23

Cost and Insurance Coverage for Repatha in New York

The list price of Repatha is approximately $700 per month for the 140 mg every-two-weeks regimen and $700 per month for the 420 mg monthly regimen. Actual patient cost depends heavily on insurance status.

Commercial insurance with PA approval and Amgen's $0 copay card: $0 per month for most patients. 24

New York Medicaid with approved PA: covered at no cost to the patient.

Medicare Part D: eligible for the Extra Help low-income subsidy for qualifying patients. Standard Part D coverage places Repatha on Tier 5 (specialty tier), with a typical patient cost of $90, $250 per month before any low-income subsidy.

Uninsured patients in New York may apply to the Amgen Safety Net Foundation, which provides Repatha at no cost to patients whose household income falls at or below 500% of the federal poverty level. 25

The Institute for Clinical and Economic Review (ICER) 2021 report on PCSK9 inhibitors estimated that evolocumab is cost-effective at the $700/month price point for very-high-risk ASCVD patients when the threshold is set at $150,000 per quality-adjusted life year (QALY). 26