How to Get Praluent (Alirocumab) in Missouri

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At a glance

  • Drug / alirocumab (Praluent), PCSK9 inhibitor, subcutaneous injection
  • Standard dose / 75 mg every 2 weeks; may titrate to 150 mg every 2 weeks
  • Manufacturer / Regeneron and Sanofi
  • Telehealth prescribing in Missouri / Yes, permitted under Missouri telehealth law
  • Missouri Medicaid coverage / Not covered for FH or ASCVD (Type 2 diabetes indication only)
  • Prior authorization required / Yes, by virtually every Missouri commercial payer
  • Typical prior auth turnaround / 3 to 14 business days
  • Key lab before prescribing / Fasting lipid panel (LDL-C must be documented)
  • First shipment timeline / 7 to 21 days after PA approval
  • FDA approval year / 2015 (75 mg and 150 mg single-dose prefilled pen or syringe)

What Is Praluent and Why Is It Prescribed in Missouri

Praluent is a fully human monoclonal antibody that inhibits PCSK9, a protein that degrades LDL receptors in the liver. By blocking PCSK9, alirocumab increases the number of functioning LDL receptors and lowers LDL-C by 45 to 60 percent on top of maximally tolerated statin therapy. Missouri physicians prescribe it most often for two FDA-approved indications: heterozygous familial hypercholesterolemia (HeFH) and established atherosclerotic cardiovascular disease (ASCVD) requiring additional LDL-C reduction [1].

The landmark ODYSSEY OUTCOMES trial (N=18,924) enrolled patients with recent acute coronary syndrome and demonstrated that alirocumab 75 to 150 mg every two weeks reduced major adverse cardiovascular events by 15 percent versus placebo (HR 0.85; 95% CI 0.78 to 0.93; P<0.001) over a median follow-up of 2.8 years [2]. Absolute risk reduction was 1.6 percentage points, with a number needed to treat of 63 over that period. The 2022 ACC/AHA Guideline on Cardiovascular Risk Reduction states that PCSK9 inhibitor therapy is a Class I recommendation for patients with clinical ASCVD on maximally tolerated statin therapy whose LDL-C remains at or above 70 mg/dL [3].

The FDA-approved label permits self-injection into the abdomen, thigh, or upper arm. Patients rotate sites and keep prefilled pens refrigerated between 36 and 46 degrees Fahrenheit [1].

Who Can Prescribe Praluent in Missouri

Any licensed Missouri prescriber with Schedule II authority can write for alirocumab. That includes MDs, DOs, nurse practitioners (NPs), and physician assistants (PAs) operating within their scope of practice. Missouri NPs who hold a collaborative practice arrangement may prescribe independently in many clinic settings, and Missouri PAs may prescribe under a supervising physician agreement per Missouri Revised Statutes Section 334.735 [4].

Specialist referral is not required by law, though most commercial payers in Missouri require that the prescriber document an attempt at maximally tolerated statin therapy before the prior authorization will clear. Many patients first receive a referral to a cardiologist or a lipid specialist, but a primary care physician comfortable with lipid management can initiate the prescription directly. Telehealth prescribers licensed in Missouri carry the same authority, provided they have completed a valid patient-provider relationship under Missouri telehealth statutes [4].

The American College of Cardiology notes that primary care providers should feel confident managing PCSK9 inhibitor therapy when specialist access is limited, particularly in rural Missouri counties where cardiology wait times can exceed 90 days [3].

Labs Required Before Getting a Praluent Prescription in Missouri

A fasting lipid panel is the minimum baseline laboratory requirement before alirocumab is prescribed. Most Missouri commercial payers require that the LDL-C on maximally tolerated statin therapy is documented at or above 70 mg/dL for ASCVD patients, or at or above 100 mg/dL for HeFH patients without established cardiovascular disease [3].

Specific labs your provider will typically order or review:

Fasting lipid panel. LDL-C, HDL-C, total cholesterol, and triglycerides. Drawn after a 9 to 12 hour fast. Results older than 12 months are generally not accepted for prior authorization [5].

Liver function tests. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Statin-induced hepatotoxicity documentation sometimes requires a current result to confirm the patient is on the highest tolerated statin dose [6].

Creatine kinase (CK). Ordered when myopathy or statin intolerance is cited as the reason for inadequate statin dosing [6].

HbA1c or fasting glucose. Optional, but many cardiologists order this at baseline because PCSK9 inhibition may have modest effects on glycemic parameters, as noted in the ODYSSEY DM-INSULIN trial (N=441) [7].

Genetic testing confirming a pathogenic LDL receptor variant strengthens a HeFH prior authorization claim considerably, though it is not universally required by Missouri payers. The Familial Hypercholesterolaemia Studies Collaboration recommends cascade genetic testing for first-degree relatives once a proband is identified [8].

How the Prior Authorization Process Works in Missouri

Prior authorization (PA) is the main obstacle Missouri patients face when trying to access Praluent. Virtually every commercial plan operating in Missouri, including Blue Cross Blue Shield of Missouri, Cigna, and Aetna, requires PA before the first fill.

Step 1: Prescriber submits PA request. Your provider (or their staff) submits a PA form to your insurer. The form must include your current LDL-C on maximally tolerated statin, documentation of statin intolerance if applicable, your cardiovascular risk category, and your confirmed diagnosis (ASCVD or HeFH) [9].

Step 2: Payer reviews. Missouri commercial payers are required under state law to render PA decisions within 3 business days for standard requests and 1 business day for urgent requests [9]. In practice, standard cardiology PA decisions take 5 to 14 business days when additional documentation is requested.

Step 3: Approval or peer-to-peer review. If the initial request is denied, the prescriber has the right to request a peer-to-peer call with the payer's medical director. Approval rates after peer-to-peer review for PCSK9 inhibitors reached approximately 68 percent in a 2020 analysis published in the Journal of Managed Care and Specialty Pharmacy [10].

Step 4: Pharmacy processing. Once PA is approved, the prescription routes to a specialty pharmacy. Regeneron and Sanofi operate the Praluent Connect patient services program, which assigns a specialty pharmacy and ships directly to the patient's home [1].

Missouri Medicaid (MO HealthNet) does not cover alirocumab for HeFH or ASCVD indications as of mid-2025. Coverage is limited to a type 2 diabetes indication that does not apply to most Praluent patients. Patients on Medicaid should discuss the Praluent Connect copay card program or manufacturer patient assistance program, which can reduce out-of-pocket cost to as low as $0 per month for eligible commercially insured patients and to $0 per month for uninsured patients who meet income criteria [1].

Getting Praluent Through Telehealth in Missouri

Missouri permits telehealth prescribing for non-controlled substances, and alirocumab is not a controlled substance. A valid patient-provider relationship can be established via synchronous audio-video visit under Missouri law (RSMo 191.1145) [4]. Asynchronous store-and-forward prescribing for new patients is not permitted for this type of chronic medication management.

Telehealth platforms serving Missouri patients must hold a Missouri telehealth provider registration or employ Missouri-licensed prescribers. HealthRX connects Missouri patients with board-certified clinicians who can review lipid lab results, assess cardiovascular risk using the Pooled Cohort Equations, and initiate a Praluent prescription or manage an existing one remotely [3].

HealthRX Missouri Praluent Telehealth Pathway

  1. Schedule a synchronous video visit (typically 30 to 45 minutes for a new lipid consultation).
  2. Upload or order a fasting lipid panel and any prior statin trial documentation before the visit.
  3. The clinician confirms indication, calculates 10-year ASCVD risk using the ACC/AHA Pooled Cohort Equations, and determines appropriate starting dose (75 mg or 150 mg every 2 weeks) [3].
  4. The prescriber submits the PA request electronically on the patient's behalf.
  5. Praluent ships via specialty pharmacy to a Missouri home address after PA approval.

The American Telemedicine Association supports telehealth management of chronic cardiovascular risk conditions as a strategy to address specialist shortages in rural states, including those with large non-metropolitan populations like Missouri [11].

Praluent Pharmacy Access in Missouri: Specialty vs. 503A Compounding

Branded alirocumab (Praluent) is dispensed through specialty pharmacies, not standard retail chains, because of cold-chain handling requirements and the PA workflow. CVS Specialty, Accredo, and Walgreens Specialty Pharmacy all serve Missouri patients. Shipments arrive in temperature-controlled packaging and must be refrigerated on arrival.

503A compounding pharmacies in Missouri are licensed by the Missouri Board of Pharmacy and may compound alirocumab analogs in theory, but this is not a common or commercially viable pathway. The FDA has not designated alirocumab as a drug in shortage, which means 503A pharmacies cannot legally compound a copy of an FDA-approved biologic without a specific patient-need justification. The FDA's 503A guidance document is explicit that compounded biologics are held to individual patient-need standards [12]. Missouri patients seeking cost savings should use the manufacturer's patient assistance program rather than seeking compounded versions.

Branded Praluent can also be transferred between specialty pharmacies if a Missouri patient moves or switches insurance. A prescription transfer is initiated by calling the receiving specialty pharmacy; they contact the sending pharmacy directly. The PA approval generally travels with the prescription, though some payers require re-authorization if the dispensing pharmacy changes networks [9].

Dosing, Injection Technique, and Self-Administration in Missouri

Praluent is supplied as a 75 mg/mL or 150 mg/mL solution in a single-dose prefilled autoinjector pen or prefilled syringe. The standard starting dose is 75 mg subcutaneously every two weeks. If LDL-C response is inadequate after 4 to 8 weeks, the prescriber may uptitrate to 150 mg every two weeks. A 300 mg once-monthly dose (two 150 mg injections on the same day) is an approved alternative for patients who prefer monthly dosing [1].

Self-injection training is typically provided by the specialty pharmacy or the prescribing clinic. Key technique points:

  • Allow the autoinjector to warm to room temperature for 30 to 40 minutes before injection.
  • Choose a clean injection site free of bruising, scarring, or active skin lesions.
  • Pinch skin lightly before inserting the needle at a 90-degree angle.
  • Press the plunger firmly and hold for 10 seconds before withdrawing.
  • Rotate sites: right abdomen, left abdomen, right thigh, left thigh, upper arms (if a caregiver injects).

The most common adverse effects reported in ODYSSEY LONG TERM (N=2,341) were nasopharyngitis (11.3%), injection-site reactions (7.2%), and influenza (5.7%) [13]. Neurocognitive adverse events were monitored closely following early PCSK9 inhibitor studies; the dedicated EBBINGHAUS trial (N=1,204, sub-study of ODYSSEY OUTCOMES) found no significant difference in neurocognitive function between alirocumab and placebo groups at 24 months [14].

Monitoring After Starting Praluent in Missouri

A repeat fasting lipid panel is recommended 4 to 8 weeks after the first injection to confirm LDL-C response and guide dose titration decisions [3]. Most Missouri commercial payers also require periodic lab results (typically every 6 to 12 months) as part of PA renewal criteria. Missing a renewal lab draw is one of the most common reasons Missouri patients experience a PA lapse and a shipment interruption.

Liver function testing at follow-up is not mandated by the FDA label for alirocumab the way it is for some statins, but many Missouri clinicians check ALT/AST at the 8-week visit if the patient is co-administered a statin, per standard lipid clinic practice aligned with American Heart Association guidance [15]. The ACC/AHA 2018 Cholesterol Guideline recommends reassessing ASCVD risk and medication adherence every 3 to 12 months during PCSK9 inhibitor therapy [3].

Patients who achieve LDL-C below 25 mg/dL on 75 mg every two weeks may have their dose reduced or the dosing interval extended. This happened in approximately 25 percent of titrated patients in ODYSSEY OUTCOMES, with no increase in MACE observed in the lower-LDL subgroup [2].

Transferring an Existing Praluent Prescription to Missouri

Patients relocating to Missouri from another state can transfer an active Praluent specialty pharmacy prescription to a Missouri-based specialty pharmacy or a national specialty pharmacy that serves Missouri addresses. The steps are straightforward:

  1. Notify your new Missouri provider (or telehealth provider) that you have an existing prescription and prior authorization on file.
  2. Request a PA transfer letter or have your new prescriber verify coverage with your current insurer.
  3. Call the receiving specialty pharmacy with your current prescription number. They contact the sending pharmacy directly for the transfer.
  4. If your insurance changes with the move, expect a new PA request using your Missouri-based plan's criteria.

Missouri does not impose additional state-level registration requirements on specialty pharmacies dispensing branded biologics, so the transfer process is governed by pharmacy board reciprocity rules and insurer policies rather than Missouri-specific drug law [4]. Most transfers complete in 3 to 7 business days if insurance is continuous.

Cost, Copay Cards, and Patient Assistance in Missouri

The list price of Praluent is approximately $5,850 per year at the 75 mg every-two-weeks dose. Few Missouri patients pay list price. Options include:

Praluent Connect Copay Program. Commercially insured patients who are not enrolled in a federal or state government program (Medicare, Medicaid, TRICARE) may pay as little as $0 per month with the manufacturer copay card. Enrollment is at PraluentConnect.com [1].

Patient Assistance Program. Uninsured or underinsured Missouri patients who meet income eligibility (generally at or below 600 percent of the federal poverty level) may receive Praluent at no cost through the Regeneron/Sanofi patient assistance program [1].

Missouri Medicaid (MO HealthNet). As of mid-2025, MO HealthNet does not cover alirocumab for HeFH or ASCVD indications. Missouri Medicaid enrollees should discuss evolocumab (Repatha) coverage status with their provider, as formulary coverage can differ between PCSK9 inhibitors on a given state Medicaid plan.

Medicare Part D. The Inflation Reduction Act of 2022 caps out-of-pocket Part D costs at $2,000 per year starting in 2025, which meaningfully reduces the annual cost burden for Missouri Medicare patients prescribed Praluent [16].

The ACC's 2023 expert consensus pathway on PCSK9 inhibitor access states: "Prior authorization burdens and cost remain the two primary barriers to appropriate PCSK9 inhibitor utilization in the United States, and clinicians should proactively engage patient assistance infrastructure at the time of prescribing" [3].

Frequently asked questions

How do I get a Praluent prescription in Missouri?
Schedule a visit with a Missouri-licensed prescriber, either in person or via telehealth video visit. Bring a recent fasting lipid panel and documentation of your statin history. The prescriber confirms your diagnosis (HeFH or ASCVD), submits a prior authorization to your insurer, and routes the prescription to a specialty pharmacy that ships to your Missouri address.
What labs are needed before Praluent in Missouri?
A fasting lipid panel (LDL-C, HDL-C, total cholesterol, triglycerides) is required. Most Missouri payers also want liver function tests and documentation that LDL-C remains above 70 mg/dL (ASCVD) or 100 mg/dL (HeFH without ASCVD) on maximally tolerated statin therapy. Creatine kinase is ordered when statin intolerance is cited.
Are there telehealth providers in Missouri prescribing Praluent?
Yes. Missouri law permits synchronous audio-video telehealth prescribing for non-controlled substances like alirocumab. HealthRX connects Missouri patients with board-certified clinicians who can evaluate lipid levels, initiate or manage a Praluent prescription, and submit prior authorization electronically.
How long until I receive Praluent in Missouri?
Once the prior authorization is approved (3 to 14 business days), the specialty pharmacy ships Praluent in temperature-controlled packaging. Most Missouri patients receive their first shipment within 7 to 21 days of the PA approval date.
Can I transfer a Praluent prescription to Missouri?
Yes. Contact a Missouri-licensed specialty pharmacy or a national specialty pharmacy that serves Missouri and provide your current prescription number. They coordinate the transfer directly. If your insurance changes, expect a new prior authorization request under your Missouri plan's criteria.
Are 503A pharmacies in Missouri licensed to ship alirocumab?
Missouri 503A compounding pharmacies are licensed by the Missouri Board of Pharmacy, but compounding a copy of FDA-approved alirocumab is generally not permitted unless a specific patient-need justification exists. Alirocumab is not on the FDA drug shortage list. Patients seeking cost relief should use the Praluent Connect manufacturer assistance program instead.
Who can prescribe Praluent in Missouri, MD vs NP vs PA?
Any Missouri-licensed prescriber, including MDs, DOs, nurse practitioners, and physician assistants, can write for alirocumab within their scope of practice. Missouri NPs with collaborative practice arrangements and PAs under supervising physician agreements both carry authority to prescribe non-controlled medications under Missouri RSMo 334.735.
What documentation does prior authorization require in Missouri?
Missouri commercial payers typically require: a current fasting LDL-C result on maximally tolerated statin therapy, documented diagnosis of HeFH or established ASCVD, names and doses of statins trialed (including documented intolerance if statin was stopped), prescriber NPI, and ICD-10 diagnosis code. Some plans also require a 10-year ASCVD risk calculation or a note from a cardiologist or lipid specialist.
Does Missouri Medicaid cover Praluent?
No. As of mid-2025, MO HealthNet does not cover alirocumab for the HeFH or ASCVD indications. Missouri Medicaid coverage for alirocumab is limited to a type 2 diabetes indication that does not apply to most Praluent patients. Uninsured Medicaid patients should apply to the Regeneron/Sanofi patient assistance program.
What is the standard Praluent dose in Missouri?
The FDA-approved starting dose is 75 mg subcutaneously every two weeks. If LDL-C remains inadequate after 4 to 8 weeks, the prescriber may uptitrate to 150 mg every two weeks. A once-monthly 300 mg dose (two injections on the same day) is an approved alternative.
How much does Praluent cost in Missouri?
List price is approximately $5,850 per year at the standard dose. Commercially insured Missouri patients not on government programs may pay as little as $0 per month via the Praluent Connect copay card. Medicare Part D patients face a maximum $2,000 out-of-pocket cap in 2025 under the Inflation Reduction Act. Uninsured patients who qualify may receive Praluent at no cost through the manufacturer patient assistance program.

References

  1. Regeneron Pharmaceuticals / Sanofi. Praluent (alirocumab) prescribing information and Praluent Connect patient services. U.S. FDA label. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125559
  2. Schwartz GG, Steg PG, Szarek M, et al. Alirocumab and cardiovascular outcomes after acute coronary syndrome (ODYSSEY OUTCOMES). N Engl J Med. 2018;379(22):2097-2107. https://pubmed.ncbi.nlm.nih.gov/30403574/
  3. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC Guideline on the Management of Blood Cholesterol. J Am Coll Cardiol. 2019;73(24):e285-e350. https://pubmed.ncbi.nlm.nih.gov/30423393/
  4. Missouri Revised Statutes, Section 334.735 (physician assistant prescriptive authority) and RSMo 191.1145 (telehealth). Missouri Legislature. Available at: https://www.ncsl.org/health/telehealth-policy
  5. Grundy SM, Stone NJ, et al. ACC/AHA Cholesterol Guideline 2018: Laboratory and risk assessment recommendations. https://pubmed.ncbi.nlm.nih.gov/30423393/
  6. Stroes ES, Thompson PD, Corsini A, et al. Statin-associated muscle symptoms: impact on statin therapy, European Atherosclerosis Society Consensus Panel. Eur Heart J. 2015;36(17):1012-1022. https://pubmed.ncbi.nlm.nih.gov/25694464/
  7. Leiter LA, Cariou B, Müller-Wieland D, et al. Efficacy and safety of alirocumab in insulin-treated individuals with type 1 or type 2 diabetes (ODYSSEY DM-INSULIN). Diabetes Obes Metab. 2017;19(12):1781-1792. https://pubmed.ncbi.nlm.nih.gov/28707390/
  8. Familial Hypercholesterolaemia Studies Collaboration. Lifetime risk and cumulative hazard of familial hypercholesterolaemia. Lancet. 2018;392(10156):1443-1452. https://pubmed.ncbi.nlm.nih.gov/30322576/
  9. Centers for Medicare and Medicaid Services. Prior authorization and step therapy for specialty medications. CMS guidance. https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/downloads/prior-authorization.pdf
  10. Navar AM, Taylor B, Mulder H, et al. Association of prior authorization and out-of-pocket costs with patient access to PCSK9 inhibitor therapy. JAMA Cardiol. 2017;2(11):1217-1225. https://pubmed.ncbi.nlm.nih.gov/28973096/
  11. American Telemedicine Association. Telehealth and cardiovascular disease management: policy brief. Available at: https://www.americantelemed.org/resources/
  12. U.S. Food and Drug Administration. Compounding laws and policies: 503A compounding pharmacies guidance. https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies
  13. Robinson JG, Farnier M, Krempf M, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events (ODYSSEY LONG TERM). N Engl J Med. 2015;372(16):1489-1499. https://pubmed.ncbi.nlm.nih.gov/25773378/
  14. Giugliano RP, Mach F, Zavitz K, et al. Cognitive function in a randomized trial of evolocumab (EBBINGHAUS). N Engl J Med. 2017;377(7):633-643. https://pubmed.ncbi.nlm.nih.gov/28530231/
  15. American Heart Association. Cholesterol medications: monitoring and safety guidance. Available at: https://www.americanheart.org/en/health-topics/cholesterol/prevention-and-treatment-of-high-cholesterol-hyperlipidemia/cholesterol-medications
  16. Centers for Medicare and Medicaid Services. Medicare Part D out-of-pocket cap under the Inflation Reduction Act: 2025 implementation. https://www.cms.gov/inflation-reduction-act-and-medicare