Esperion Secures Additional Commercial and Medicare Formulary Coverage for NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe)
Esperion announced expanded coverage for NEXLETOL® and NEXLIZET®, their FDA-approved non-statin medications for lowering LDL cholesterol and reducing cardiovascular risk. The drugs now have access to over 92% of commercially insured lives and 65% of Medicare lives, totaling more than 170 million covered individuals. This increased coverage follows the FDA's approval of expanded indications for both primary and secondary prevention patients.
The improved formulary status and streamlined prior authorization processes make it easier for healthcare providers to prescribe these medications. NEXLETOL and NEXLIZET are unique in being the only non-statins FDA-approved for both LDL-C reduction and cardiovascular risk reduction in patients unable to take recommended statin therapy.
Esperion ha annunciato una copertura ampliata per NEXLETOL® e NEXLIZET®, i loro farmaci non statinici approvati dalla FDA per ridurre il colesterolo LDL e il rischio cardiovascolare. I farmaci ora hanno accesso a oltre il 92% delle persone assicurate commercialmente e il 65% delle persone con Medicare, per un totale di oltre 170 milioni di individui coperti. Questo aumento della copertura segue l'approvazione da parte della FDA di indicazioni ampliate per pazienti in prevenzione primaria e secondaria.
Il miglioramento dello stato del formulario e dei processi di autorizzazione anticipata semplificati rendono più facile per i fornitori di assistenza sanitaria prescrivere questi farmaci. NEXLETOL e NEXLIZET sono unici in quanto sono gli unici non statini approvati dalla FDA per la riduzione del LDL-C e la riduzione del rischio cardiovascolare in pazienti che non possono seguire la terapia con statine raccomandata.
Esperion anunció una cobertura ampliada para NEXLETOL® y NEXLIZET®, sus medicamentos no estatínicos aprobados por la FDA para reducir el colesterol LDL y el riesgo cardiovascular. Los medicamentos ahora tienen acceso a más del 92% de las vidas aseguradas comercialmente y 65% de las vidas de Medicare, alcanzando más de 170 millones de individuos cubiertos. Esta aumento en la cobertura sigue la aprobación de la FDA de indicaciones ampliadas para pacientes en prevención primaria y secundaria.
El mejor estado del formulario y los procesos de autorización previa simplificados hacen que sea más fácil para los proveedores de atención médica prescribir estos medicamentos. NEXLETOL y NEXLIZET son únicos como los únicos no estatínicos aprobados por la FDA tanto para la reducción del LDL-C como para la reducción del riesgo cardiovascular en pacientes que no pueden tomar la terapia con estatinas recomendada.
Esperion은 LDL 콜레스테롤을 낮추고 심혈관 위험을 줄이기 위한 FDA 승인 비스타틴 약물인 NEXLETOL® 및 NEXLIZET®의 확대된 접근성을 발표했습니다. 이 약물은 이제 상업적으로 보험가입된 92% 이상 및 메디케어 가입자의 65%에 접근할 수 있습니다, 총 1억 7천만 명 이상의 보장된 개인에 해당합니다. 이러한 확대된 접근성은 1차 및 2차 예방 환자에 대한 FDA의 승인 이후 이루어졌습니다.
개선된 약제 목록 상태와 간소화된 사전 승인 프로세스는 의료 제공자가 이 약물을 처방하는 것을 더 쉽게 만듭니다. NEXLETOL과 NEXLIZET은 권장되는 스타틴 요법을 복용할 수 없는 환자에 대해 LDL-C 감소와 심혈관 위험 감소를 위해 FDA에서 승인된 유일한 비스타틴입니다.
Esperion a annoncé une couverture élargie pour NEXLETOL® et NEXLIZET®, leurs médicaments non statiniques approuvés par la FDA pour abaisser le cholestérol LDL et réduire le risque cardiovasculaire. Les médicaments ont désormais accès à plus de 92 % des personnes assurées commercialement et 65 % des bénéficiaires de Medicare, totalisant plus de 170 millions d'individus couverts. Cette augmentation de la couverture fait suite à l'approbation par la FDA d'indications élargies pour les patients en prévention primaire et secondaire.
Le statut amélioré du formulaire et les processus d'autorisation anticipée simplifiés facilitent la prescription de ces médicaments par les professionnels de santé. NEXLETOL et NEXLIZET sont uniques en tant que seuls non statiniques approuvés par la FDA pour la réduction du LDL-C et la réduction du risque cardiovasculaire chez les patients incapables de suivre une thérapie par statines recommandée.
Esperion hat eine erweiterte Abdeckung für NEXLETOL® und NEXLIZET®, ihre von der FDA genehmigten nicht-statins zur Senkung des LDL-Cholesterins und zur Reduzierung des kardiovaskulären Risikos, angekündigt. Die Medikamente haben jetzt Zugang zu über 92 % der kommerziell versicherten Personen und 65 % der Medicare-Versicherten, insgesamt mehr als 170 Millionen abgedeckte Personen. Diese erweiterte Abdeckung folgt der Genehmigung der FDA für erweiterte Indikationen für Patienten zur Primär- und Sekundärprävention.
Der verbesserte Formularstatus und die optimierten Genehmigungsprozesse machen es einfacher für Gesundheitsdienstleister, diese Medikamente zu verschreiben. NEXLETOL und NEXLIZET sind einzigartig, da sie die einzigen von der FDA genehmigten nicht-statins zur Senkung von LDL-C und zur Reduzierung des kardiovaskulären Risikos bei Patienten sind, die empfohlenen Statintherapien nicht einnehmen können.
- Expanded coverage to over 92% of commercially insured lives and 65% of Medicare lives
- Improved formulary status and streamlined prior authorization processes
- Unique FDA approval for both LDL-C reduction and cardiovascular risk reduction in non-statin patients
- Coverage by major insurers including Optum/United AARP, CVS/SilverScript, and Humana
- None.
Insights
The expanded coverage for NEXLETOL and NEXLIZET is a significant positive development for Esperion. With access to
The alignment of utilization management criteria with the FDA's expanded indications is also crucial, as it streamlines the prescription process for healthcare providers. This could lead to faster adoption and increased sales. However, investors should monitor how this translates into actual revenue growth in the coming quarters, as increased access doesn't always guarantee immediate sales uptick.
From a medical perspective, the expanded coverage for NEXLETOL and NEXLIZET is excellent news for patients with high cholesterol who can't tolerate statins. These drugs offer a novel approach to LDL-C reduction and cardiovascular risk management in both primary and secondary prevention settings. The CLEAR Outcomes trial data has clearly influenced payers' decisions, validating the drugs' efficacy and safety profile.
The ability to prescribe these medications more easily could lead to better patient outcomes, particularly for those at high risk of cardiovascular events. However, it's important to note that while access has improved, physicians will still need to carefully consider individual patient factors when prescribing these medications.
The improved formulary coverage and streamlined prior authorization processes represent a significant market access win for Esperion. Achieving
However, it's important to note that while coverage has improved, patient out-of-pocket costs will still play a role in actual utilization. Esperion should focus on ensuring affordable copays and implementing patient assistance programs to maximize the impact of this expanded coverage. Investors should watch for updates on prescription volume trends in the coming months to gauge the real-world impact of these access improvements.
– New Additions to Medicare Formularies at Optum/United AARP and CVS/SilverScript Coupled with Humana Provides Access to More Than
– Increased Coverage and Improved Prior Authorization Processes Make Prescribing NEXLETOL and NEXLIZET Easier for Healthcare Providers –
– NEXLETOL and NEXLIZET are the Only Non-Statins FDA Approved to Lower LDL Cholesterol and Reduce Risk of Myocardial Infarction and Coronary Revascularization in Both Primary and Secondary Prevention Patients –
ANN ARBOR, Mich., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Esperion today announced that NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) have achieved additional coverage on national and large regional formularies since the U.S. Food and Drug Administration’s (FDA) approval of the expanded indications, increasing total coverage to more than 136 million commercially insured lives (
“We are pleased with the response from insurance providers and large pharmacy benefit managers in embracing the CLEAR Outcomes trial data and aligning their utilization management criteria to the most recent FDA approved label indications for primary and secondary prevention,” said Sheldon Koenig, President and CEO. “Garnering optimal patient access with a breadth of coverage accounting for
NEXLETOL and NEXLIZET are the only non-statins FDA-approved to lower LDL cholesterol and reduce the risk of myocardial infarction and coronary revascularization in primary prevention and secondary prevention patients.
INDICATION
NEXLIZET and NEXLETOL are indicated:
- The bempedoic acid component of NEXLIZET and NEXLETOL is indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with:
- established cardiovascular disease (CVD), or
- at high risk for a CVD event but without established CVD.
- As an adjunct to diet:
- NEXLIZET, alone or in combination with other LDL-C lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
- NEXLETOL, in combination with other LDL-C lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
IMPORTANT SAFETY INFORMATION
NEXLIZET and NEXLETOL are contraindicated in patients with a prior hypersensitivity to bempedoic acid or ezetimibe or any of the excipients. Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported.
Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels, which may lead to gout. Hyperuricemia may occur early in treatment and persist throughout treatment, returning to baseline following discontinuation of treatment. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
Tendon Rupture: Bempedoic acid, a component of NEXLIZET and NEXLETOL, is associated with an increased risk of tendon rupture or injury. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture.
The most common adverse reactions in the primary hyperlipidemia trials of bempedoic acid, a component of NEXLIZET and NEXLETOL, in ≥
Adverse reactions reported in ≥
In the primary hyperlipidemia trials of NEXLIZET, the most commonly reported adverse reactions (incidence ≥
The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at an incidence of ≥
Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLIZET or NEXLETOL.
Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.
Please see full Prescribing Information for NEXLIZET and NEXLETOL.
Esperion Therapeutics
At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The status quo is not meeting the health needs of millions of people with high cholesterol – that is why our team of passionate industry leaders is breaking through the barriers that prevent patients from reaching their goals. Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there. Because when it comes to high cholesterol, getting to goal is not optional. It is our life’s work. For more information, visit esperion.com and esperionscience.com and follow us on X at twitter.com/EsperionInc.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, current and planned operational expenses, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion’s commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
Esperion Contact Information:
Investors:
investorrelations@esperion.com
Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438
FAQ
What new coverage did NEXLETOL and NEXLIZET secure for Esperion (ESPR)?
How does the expanded coverage affect prescribing NEXLETOL and NEXLIZET (ESPR)?
What makes NEXLETOL and NEXLIZET unique in the market for Esperion (ESPR)?
Which major insurers now cover NEXLETOL and NEXLIZET from Esperion (ESPR)?
