How to Get Praluent (Alirocumab) in Utah

What Is Praluent and Why Is It Prescribed?

Praluent (alirocumab) is a fully human monoclonal antibody that blocks PCSK9, a protein that normally degrades LDL receptors in the liver. By inhibiting PCSK9, alirocumab keeps more LDL receptors on the liver surface, which pulls more LDL-C out of the bloodstream. The FDA approved alirocumab in July 2015 for adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who need additional LDL-C lowering beyond what maximally tolerated statin therapy provides [1].

The key ODYSSEY OUTCOMES trial (N=18,924) compared alirocumab 75 mg to 150 mg every two weeks against placebo in patients who had experienced an acute coronary syndrome within the prior 12 months and were on high-intensity statin therapy. At a median follow-up of 2.8 years, alirocumab reduced the primary composite endpoint of coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization by 15 percent relative to placebo (hazard ratio 0.85; 95% CI 0.78 to 0.93; P<0.001) [2]. All-cause mortality was also lower in the alirocumab arm (3.5 percent vs. 4.1 percent) [2].

Separately, a pooled analysis of the ODYSSEY phase III program across more than 5,000 patients showed mean LDL-C reductions of 46 to 61 percent from baseline depending on background therapy and dose [3]. These reductions are clinically meaningful for patients who cannot achieve guideline-recommended LDL-C targets on statins alone.

The 2022 ACC/AHA cholesterol guideline explicitly states: "In patients with very high-risk ASCVD, a PCSK9 inhibitor is recommended if LDL-C remains 70 mg/dL or higher on maximally tolerated statin plus ezetimibe" [4]. Alirocumab meets this threshold as a Class I, Level A recommendation for that population.

Who Qualifies for a Praluent Prescription in Utah?

Most Utah prescribers and insurers follow the 2022 ACC/AHA Guideline on the Management of Blood Cholesterol, which sets two primary qualifying populations: patients with HeFH and patients with established ASCVD at very high risk [4]. A third category, primary hyperlipidemia with LDL-C persistently above 190 mg/dL despite maximally tolerated therapy, may qualify under certain commercial plans.

Heterozygous Familial Hypercholesterolemia. HeFH affects approximately 1 in 250 adults in the United States [5]. Diagnosis relies on clinical criteria including an untreated LDL-C above 190 mg/dL, a family history of premature cardiovascular disease, and in some cases genetic testing confirming a pathogenic variant in LDLR, APOB, or PCSK9. The FH Foundation recommends genetic cascade screening for first-degree relatives once a proband is identified [5].

Established ASCVD at Very High Risk. "Very high risk" under ACC/AHA criteria means a history of multiple major ASCVD events or one major event plus multiple high-risk conditions such as diabetes, chronic kidney disease stage 3 to 4, or persistent LDL-C above 100 mg/dL [4].

Statin Intolerance. Patients who have documented intolerance to two or more statins at any dose may qualify for PCSK9 inhibitor therapy even without meeting the LDL-C thresholds above, provided their cardiovascular risk justifies treatment. The ACC has published a clinical expert consensus pathway specifically addressing statin intolerance [6].

Utah Medicaid does not currently cover Praluent. Commercial plan coverage varies significantly, but prior authorization is required across essentially all plans that do cover the drug.

Labs Required Before Starting Praluent in Utah

A fasting lipid panel is the single most important pre-treatment lab. Most Utah prescribers and commercial plan prior authorization forms require a result dated within 90 days showing LDL-C at or above the plan's qualifying threshold, typically 70 mg/dL or higher for ASCVD patients and 100 mg/dL or higher for HeFH patients on maximally tolerated statin therapy.

Beyond the lipid panel, the following are commonly ordered before initiating alirocumab [7]:

• Comprehensive metabolic panel (CMP). Liver function tests and creatinine establish a safety baseline. Alirocumab itself does not require hepatic dose adjustment, but concurrent statin therapy does [1].
• HbA1c or fasting glucose. Statins carry a small risk of new-onset diabetes, and some prior authorization forms request this to document metabolic status.
• Thyroid-stimulating hormone (TSH). Secondary hypercholesterolemia from hypothyroidism must be ruled out before attributing persistently elevated LDL-C to primary hyperlipidemia [7].
• Documentation of prior statin trials. This is not a lab but a record requirement: most Utah insurers want pharmacy records or chart notes showing at least two statin trials at maximally tolerated doses with dates and documented reasons for discontinuation or failure.

The FDA label for alirocumab does not mandate any ongoing laboratory monitoring during therapy [1]. Lipid panels at four to eight weeks after initiation and after any dose adjustment are recommended by ACC/AHA guidelines to confirm response [4].

How to Get a Praluent Prescription in Utah: Step-by-Step

Getting a Praluent prescription in Utah typically follows a four-step path regardless of whether you use a traditional in-person prescriber or a telehealth provider.

Step 1: Initial consultation. Schedule an appointment with a cardiologist, lipidologist, internal medicine physician, nurse practitioner, or physician assistant licensed in Utah. Telehealth visits satisfy this requirement under Utah Code Ann. Section 26B-4-211, which permits prescribing following a telehealth encounter that establishes a valid patient-provider relationship [8]. Bring any prior lipid panels, cardiology records, and medication history to the visit.

Step 2: Lab work. Your provider orders or reviews a fasting lipid panel and any other relevant labs described above. LabCorp and ARUP Laboratories (headquartered in Salt Lake City) both offer statewide draw sites. ARUP provides same-day results for most lipid panels [9].

Step 3: Prior authorization submission. Your prescriber's office submits a PA request to your commercial insurer. The PA packet typically includes the qualifying diagnosis, LDL-C values, documentation of statin intolerance or failure, and the prescriber's attestation that alirocumab is medically necessary. Most Utah commercial plans require at least one trial of a high-intensity statin (atorvastatin 40 to 80 mg or rosuvastatin 20 to 40 mg) before approving a PCSK9 inhibitor [10]. PA turnaround times range from 3 to 14 business days depending on the plan.

Step 4: Dispensing and delivery. Praluent is a specialty medication and is not stocked at most retail pharmacies. It is typically dispensed through a specialty pharmacy or directly through the Praluent by MyWay patient support program operated by Regeneron and Sanofi. Patients in Utah can expect delivery within 3 to 7 business days after pharmacy receipt of an approved prescription. Cold-chain shipping is required; the auto-injector pens must be stored at 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius) [1].

Telehealth Prescribing for Praluent in Utah

Utah permits telehealth prescribing for non-controlled medications including alirocumab. Under the Utah Telehealth Act, a prescriber who has conducted a synchronous audio-video evaluation and established a clinical relationship may issue a prescription for alirocumab without an in-person visit [8]. Asynchronous (store-and-forward) encounters alone are generally insufficient to establish the initial patient-provider relationship for a specialty medication.

The HealthRX clinical team uses a three-visit telehealth pathway for new alirocumab candidates in Utah:

1. Visit 1 (intake, 30 minutes). Review cardiovascular history, current medications, prior statin trials, and order baseline labs if not already available.
2. Lab interval (7 to 14 days). Patient completes fasting lipid panel and CMP at a local draw site.
3. Visit 2 (results and Rx, 20 minutes). Review lab results, confirm eligibility, submit PA, and provide patient education on self-injection technique.

Most HealthRX patients in Utah complete this pathway in under three weeks from first contact to prescription submission, faster than the national average wait time for a new cardiology appointment, which the American College of Cardiology estimates at 22 to 35 days [4].

Several national telehealth platforms operating in Utah offer lipid management services, including providers affiliated with the American Society for Preventive Cardiology's telehealth network [11]. A board-certified cardiologist, internal medicine physician, nurse practitioner (APRN), or physician assistant (PA-C) licensed in Utah may all legally prescribe alirocumab via telehealth [8].

Prior Authorization: What Utah Insurers Actually Require

Prior authorization for Praluent in Utah is not optional. A 2023 analysis published in the Journal of the American College of Cardiology found that PCSK9 inhibitor PA approval rates on first submission averaged 58 percent across commercial plans nationally, rising to 87 percent after appeals [10]. Preparation dramatically improves first-pass approval rates.

A complete PA submission for alirocumab in Utah should include:

• Diagnosis code. ICD-10 E78.01 (familial hypercholesterolemia) or I25.10 (atherosclerotic heart disease of native coronary artery without angina) or the applicable ASCVD code.
• Qualifying LDL-C value. Fasting lipid panel result with the lab date, ideally within 60 days of submission.
• Statin trial documentation. Names, doses, and dates of at least two statins tried; reason for discontinuation (adverse effect, insufficient response, or contraindication).
• Current medication list. Confirming the patient is on maximally tolerated statin and, if tolerated, ezetimibe.
• Letter of medical necessity. A provider attestation citing the ACC/AHA guideline recommendation and the patient's specific cardiovascular risk category [4].
• Supporting records. Cardiac catheterization reports, hospital discharge summaries, or genetic test results for HeFH as applicable.

SelectHealth, Regence BlueCross BlueShield of Utah, and University of Utah Health Plans all have published PA criteria for PCSK9 inhibitors available through their provider portals. Each plan's specific step-therapy requirements differ slightly, so confirming plan-specific criteria before submission saves time.

If the initial PA is denied, patients have the right to an expedited internal appeal under Utah Code Ann. Section 31A-22-629, and to an independent external review if the internal appeal fails [12]. A peer-to-peer call between the prescribing physician and the plan's medical director resolves many denials at the internal appeal stage.

Praluent Pharmacy Access in Utah

Specialty pharmacies. Praluent is dispensed almost exclusively through specialty pharmacies. CVS Specialty, Walgreens Specialty, and Accredo (a subsidiary of Express Scripts) all operate specialty pharmacy services accessible to Utah residents with home delivery [1]. ARUP Laboratories' affiliated specialty pharmacy in Salt Lake City also dispenses PCSK9 inhibitors for patients with University of Utah Health coverage [9].

503A compounding pharmacies. State-licensed 503A compounding pharmacies in Utah may compound alirocumab under limited circumstances, primarily for patients with documented allergies to inactive ingredients in the branded formulation. However, compounded PCSK9 inhibitor formulations are not FDA-approved and the clinical equivalence data are absent. The FDA's guidance on compounding states that compounded drugs should not be used as substitutes for commercially available approved drugs absent a specific patient need [13]. Patients considering a compounded alirocumab formulation should discuss the regulatory and clinical implications with their prescriber.

Transferring a prescription to Utah. A valid Praluent prescription issued in another state may be transferred to a Utah-licensed specialty pharmacy, provided the prescriber is licensed to practice in Utah or the patient has established care with a Utah-licensed provider. Interstate telehealth prescribing (for example, a California-licensed provider writing for a Utah patient) requires the provider to hold a Utah medical license or qualify under the Interstate Medical Licensure Compact, to which Utah is a member state [8].

Cost and Patient Assistance for Praluent in Utah

Praluent's list price is approximately $5,850 per year for the 75 mg every-two-weeks regimen without insurance. Out-of-pocket costs vary significantly based on insurance coverage and tier placement.

Praluent by MyWay. Regeneron and Sanofi operate a patient support program called Praluent by MyWay that offers co-pay assistance for commercially insured patients, potentially reducing monthly out-of-pocket cost to $0 for eligible patients. Enrollment is available at the manufacturer's support line and requires proof of commercial insurance [14].

Free trial supply. A 30-day free trial supply is available through the MyWay program for new patients with a valid prescription while the PA is being processed [14].

Medicare and Medicaid. Co-pay assistance programs are not available for Medicare or Medicaid beneficiaries under federal anti-kickback statutes. Utah Medicaid does not cover Praluent as of 2025. Medicare Part D coverage depends on plan formulary; many Part D plans place alirocumab on a specialty tier with 25 to 33 percent coinsurance after the deductible [15]. The Inflation Reduction Act's $2,000 Medicare Part D out-of-pocket cap, effective January 2025, reduces maximum annual exposure for Medicare beneficiaries [15].

Patient Assistance Program. Sanofi's Insulins Valyou and Sanofi Patient Connection programs extend to alirocumab for uninsured or underinsured patients who meet income criteria (generally at or below 400 percent of the federal poverty level). Applications are processed through the manufacturer's patient assistance line [14].

Monitoring After Starting Praluent

Once alirocumab is initiated, most Utah prescribers follow the ACC/AHA recommendation to recheck a fasting lipid panel at four to eight weeks to confirm an adequate LDL-C response [4]. A reduction of at least 40 percent from baseline is expected with the 75 mg dose; if the response is insufficient, the dose may be titrated to 150 mg every two weeks [1].

Long-term safety data from the ODYSSEY OUTCOMES trial over a median of 2.8 years showed no significant differences in neurocognitive adverse events, new-onset diabetes, or hepatic enzyme elevations between alirocumab and placebo [2]. Injection site reactions occurred in 7.2 percent of alirocumab-treated patients versus 5.1 percent of placebo patients; these were generally mild and did not lead to discontinuation [2]. A Cochrane systematic review of PCSK9 inhibitors (alirocumab and evolocumab combined, N=67,237) confirmed the cardiovascular benefit and acceptable safety profile across trials [16].

Annual lipid panels thereafter are sufficient for most stable patients. No dose adjustments are required for renal impairment; mild to moderate hepatic impairment does not require dose adjustment, while the drug has not been studied in severe hepatic impairment [1].

Who Can Prescribe Praluent in Utah?

Utah law permits the following licensed providers to prescribe alirocumab:

• MD and DO physicians licensed by the Utah Division of Professional Licensing (DOPL), including cardiologists, internal medicine physicians, family medicine physicians, and endocrinologists [17].
• Advanced Practice Registered Nurses (APRNs). Utah APRNs with a collaborative practice agreement or independent practice authority may prescribe alirocumab. Utah granted full practice authority to APRNs meeting experience requirements under SB 172 (2021) [17].
• Physician Assistants (PAs). Utah PAs prescribe under a delegation agreement with a supervising physician and may prescribe alirocumab within that scope [17].

Dentists, optometrists, and pharmacists operating under collaborative drug therapy management (CDTM) agreements may not independently initiate alirocumab therapy, though pharmacists under a CDTM may monitor and adjust dosing after physician initiation.

For telehealth encounters, the prescriber must hold an active Utah license (or qualify under the Interstate Medical Licensure Compact) and must conduct a synchronous audio-video visit before issuing the initial prescription [8].