Ambrisentan (Letairis and Opsumit)
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Endothelin System and Therapeutic Application of Endothelin Receptor
xperim ACCESS Freely available online & E en OPEN l ta a l ic P in h l a C r m f o a c l a o n l o r g u y o J Journal of ISSN: 2161-1459 Clinical & Experimental Pharmacology Research Article Endothelin System and Therapeutic Application of Endothelin Receptor Antagonists Abebe Basazn Mekuria, Zemene Demelash Kifle*, Mohammedbrhan Abdelwuhab Department of Pharmacology, School of Pharmacy, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia ABSTRACT Endothelin is a 21 amino acid molecule endogenous potent vasoconstrictor peptide. Endothelin is synthesized in vascular endothelial and smooth muscle cells, as well as in neural, renal, pulmonic, and inflammatory cells. It acts through a seven transmembrane endothelin receptor A (ETA) and endothelin receptor B (ETB) receptors belongs to G protein-coupled rhodopsin-type receptor superfamily. This peptide involved in pathogenesis of cardiovascular disorder like (heart failure, arterial hypertension, myocardial infraction and atherosclerosis), renal failure, pulmonary arterial hypertension and it also involved in pathogenesis of cancer. Potentially endothelin receptor antagonist helps the treatment of the above disorder. Currently, there are a lot of trails both per-clinical and clinical on endothelin antagonist for various cardiovascular, pulmonary and cancer disorder. Some are approved by FAD for the treatment. These agents are including both selective and non-selective endothelin receptor antagonist (ETA/B). Currently, Bosentan, Ambrisentan, and Macitentan approved -
Comparison of Pharmacological Activity of Macitentan and Bosentan in Preclinical Models of Systemic and Pulmonary Hypertension
LFS-13929; No of Pages 7 Life Sciences xxx (2014) xxx–xxx Contents lists available at ScienceDirect Life Sciences journal homepage: www.elsevier.com/locate/lifescie Comparison of pharmacological activity of macitentan and bosentan in preclinical models of systemic and pulmonary hypertension Marc Iglarz ⁎, Alexandre Bossu, Daniel Wanner, Céline Bortolamiol, Markus Rey, Patrick Hess, Martine Clozel Drug Discovery Department, Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, 4123 Allschwil, Switzerland article info abstract Article history: Aims: The endothelin (ET) system is a tissular system, as the production of ET isoforms is mostly autocrine or Received 29 October 2013 paracrine. Macitentan is a novel dual ETA/ETB receptor antagonist with enhanced tissue distribution and Accepted 12 February 2014 sustained receptor binding properties designed to achieve a more efficacious ET receptor blockade. To determine Available online xxxx if these features translate into improved efficacy in vivo, a study was designed in which rats with either systemic or pulmonary hypertension and equipped with telemetry were given macitentan on top of maximally effective Keywords: doses of another dual ET /ET receptor antagonist, bosentan, which does not display sustained receptor occupan- Endothelin A B Pharmacology cy and shows less tissue distribution. – Blood pressure Main methods: After establishing dose response curves of both compounds in conscious, hypertensive Dahl salt- Pulmonary hypertension sensitive and pulmonary hypertensive bleomycin-treated rats, macitentan was administered on top of the max- Rat imal effective dose of bosentan. Key findings: In hypertensive rats, macitentan 30 mg/kg further decreased mean arterial blood pressure (MAP) by 19 mm Hg when given on top of bosentan 100 mg/kg (n =9,p b 0.01 vs. -
Opsumit) Reference Number: CP.PHAR.194 Effective Date: 03.16 Last Review Date: 02.21 Line of Business: Medicaid Revision Log
Clinical Policy: Macitentan (Opsumit) Reference Number: CP.PHAR.194 Effective Date: 03.16 Last Review Date: 02.21 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Macitentan (Opsumit®) is an endothelin receptor antagonist. FDA Approved Indication(s) Opsumit is indicated for treatment of pulmonary arterial hypertension (PAH) (World Health Organization (WHO) Group I) to reduce the risks of disease progression and hospitalization for PAH. Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Opsumit is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Pulmonary Arterial Hypertension (must meet all): 1. Diagnosis of PAH; 2. Prescribed by or in consultation with a cardiologist or pulmonologist; 3. Failure of a calcium channel blocker (see Appendix B), unless member meets one of the following (a or b): a. Inadequate response or contraindication to acute vasodilator testing; b. Contraindication or clinically significant adverse effects to calcium channel blockers are experienced; 4. Failure of generic ambrisentan or bosentan, unless clinically significant adverse effects are experienced or both are contraindicated; 5. -
Summary of Appeals & Independent Review Organization
All Other Appeals All other appeals are for drugs not in an inpatient hospital setting that Molina was not able to approve. Sometimes, the clinical information sent to us for these drugs do not meet medical necessity on initial review. When drug preauthorization requests are denied, a member or provider has the right to appeal. Appeals allow time to provide more clinical information. With complete clinical information, we can usually approve the drug. These are considered an appeal overturn. When the denial decision is not overturned, it is considered upheld. Service Code/Drug Name Service Code Description Number of Appeals Number of Appeals Total Appeals Upheld Overturned A9274 EXTERNAL AMB INSULIN DEL SYSTEM DISPOSABLE EA 0 1 1 Abatacept 3 1 4 Abemaciclib 1 0 1 Acalabrutinib 0 1 1 Acne Combination - Two Ingredient 1 0 1 Acyclovir 0 1 1 Adalimumab 7 14 21 Adrenergic Combination - Two Ingredient 1 0 1 Aflibercept 0 2 2 Agalsidase 1 0 1 Alfuzosin 1 0 1 Amantadine 1 0 1 Ambrisentan 0 1 1 Amphetamine 0 1 1 Amphetamine Mixtures - Two Ingredient 1 8 9 Apixaban 7 21 28 Apremilast 12 13 25 Aprepitant 0 1 1 Aripiprazole 5 9 14 ARNI-Angiotensin II Recept Antag Comb - Two Ingredient 6 9 15 Asenapine 0 1 1 Atomoxetine 1 3 4 Atorvastatin 0 1 1 Atovaquone 1 0 1 Axitinib 0 1 1 Azathioprine 0 1 1 Azilsartan 1 0 1 Azithromycin 1 0 1 Baclofen 0 1 1 Baricitinib 1 1 2 Belimumab 0 1 1 Benralizumab 1 0 1 Beta-blockers - Ophthalmic Combination - Two Ingredient 0 2 2 Bimatoprost 0 1 1 Botulinum Toxin 1 4 5 Buprenorphine 4 3 7 Calcifediol 1 0 1 Calcipotriene -
Ambrisentan (Letairis®) Issued by PHA’S Scientific Leadership Council Information Is Based on the United States Food and Drug Administration Drug Labeling
Ambrisentan (Letairis®) Issued by PHA’s Scientific Leadership Council Information is based on the United States Food and Drug Administration drug labeling Last Updated November 2013 WHAT IS AMBRISENTAN? Ambrisentan is an oral medication classified as an endothelin receptor antagonist (ERA) which is approved for the treatment of pulmonary arterial hypertension (PAH) in World Health Organization (WHO) Group 1 patients. The goal of this therapy is to improve exercise ability and slow progression of the disease. Ambrisentan was approved for PAH by the United States Food and Drug Administration (FDA) in 2007. HOW DOES AMBRISENTAN WORK? Ambrisentan works by blocking endothelin, a substance made by the body. Endothelin causes blood vessels to narrow (constrict). It also causes abnormal growth of the muscle in the walls of the blood vessels in the lungs. This narrowing increases the pressure required to push the blood through the lungs to get oxygen. By blocking the action of endothelin, causing vessels to relax, ambrisentan decreases the pulmonary blood pressure to the heart and improves its function. This generally results in the ability to be more active. Research studies have verified this improvement. HOW IS AMBRISENTAN GIVEN? Ambrisentan is taken orally, with or without food. There are two FDA approved doses; 5 mg (pale pink and square) or 10 mg (dark pink and oval). Patients’ physicians will decide which strength is right for them. HOW IS AMBRISENTAN SUPPLIED? Ambrisentan comes in 5 and 10 mg, film-coated, unscored tablets. The 5 mg tablet is pale pink and square. The 10 mg tablet is deep pink and oval. -
Doctors Healthcare Plans, Inc. Is an HMO with a Medicare Contract
ACTEMRA IV (S) MEDICATION(S) ACTEMRA 200 MG/10 ML VIAL, ACTEMRA 400 MG/20 ML VIAL, ACTEMRA 80 MG/4 ML VIAL COVERED USES All medically accepted indications not otherwise excluded from Part D. EXCLUSION CRITERIA N/A REQUIRED MEDICAL INFORMATION Rheumatoid Arthritis (RA) (Initial): Diagnosis of moderately to severely active RA. One of the following: Failure, contraindication, or intolerance to both Enbrel (etanercept) and Humira (adalimumab), OR for continuation of prior Actemra therapy. Systemic Juvenile Idiopathic arthritis (SJIA) (Initial): Diagnosis of active SJIA. Failure, contraindication, or intolerance to one NSAID or systemic glucocorticoid. Polyarticular Juvenile Idiopathic Arthritis (PJIA) (Initial): Diagnosis of active PJIA. One of the following: Failure, contraindication, or intolerance to both Enbrel (etanercept) and Humira (adalimumab), OR for continuation of prior Actemra therapy. All indications (Initial, reauth): Patient is not receiving Actemra in combination with a biologic DMARD [eg, Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]. AGE RESTRICTION N/A PRESCRIBER RESTRICTION All uses (Initial): Prescribed by or in consultation with a rheumatologist. COVERAGE DURATION All uses (Initial, reauth): 12 months OTHER CRITERIA All uses (Reauth): Documentation of positive clinical response to Actemra therapy. PAGE 1 LAST UPDATED 12/2019 ACTEMRA SC MEDICATION(S) ACTEMRA 162 MG/0.9 ML SYRINGE, ACTEMRA ACTPEN COVERED USES All medically accepted indications not otherwise excluded from Part D. EXCLUSION CRITERIA N/A REQUIRED MEDICAL INFORMATION Rheumatoid Arthritis (RA) (Initial): Diagnosis of moderately to severely active RA. One of the following: Trial and failure, contraindication, or intolerance to both Enbrel (etanercept) and Humira (adalimumab), OR for continuation of prior Actemra therapy. -
Opsumit, INN-Macitentan
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Opsumit 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg macitentan. Excipients with known effect Each film-coated tablet contains approximately 37 mg of lactose (as monohydrate) and approximately 0.06 mg of soya bean lecithin (E322). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). 5.5 mm, round, biconvex, white to off-white film-coated tablets, debossed with “10” on both sides. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease (see section 5.1). 4.2 Posology and method of administration Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. Posology The recommended dose is 10 mg once daily. Special populations Elderly No dose adjustment is required in patients over the age of 65 years (see section 5.2). There is limited clinical experience in patients over the age of 75 years.Therefore, Opsumit should be used with caution in this population (see section 4.4). Hepatic impairment Based on pharmacokinetic (PK) data, no dose adjustment is required in patients with mild, moderate or severe hepatic impairment (see sections 4.4 and 5.2). -
Ambrisentan (Letairis) Reference Number: ERX.SPMN.84 Effective Date: 07/16 Last Review Date: 06/16 Revision Log
Clinical Policy: Ambrisentan (Letairis) Reference Number: ERX.SPMN.84 Effective Date: 07/16 Last Review Date: 06/16 Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Policy/Criteria It is the policy of health plans affiliated with Envolve Pharmacy Solutions® that ambrisentan (Letairis®) is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Pulmonary Arterial Hypertension (PAH) (must meet all): 1. Prescribed by or in consultation with a cardiologist or pulmonologist experienced in the diagnosis and treatment of pulmonary hypertension; 2. Diagnosis of PAH World Health Organization (WHO) Group 1 (appendix B) confirmed by right heart catheterization and with one of the following: a. Inadequate response or contraindication to acute vasodilator testing; b. Trial and failure of, or contraindication to, calcium channel blockers; 3. WHO/New York Heart Association (NYHA) functional class II, III, or IV (appendix C); 4. Prescribed dose of Letairis does not exceed 10 mg once daily. Approval Duration: 3 months B. Other diagnoses/indications: Refer to ERX.SPMN.16 - Global Biopharm Policy. II. Continued Approval A. Pulmonary Arterial Hypertension (PAH) (must meet all): 1. Currently receiving medication via health plan benefit or member has previously met all initial approval criteria. Approval Duration: 6 months B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via health plan benefit and documentation supports positive response to therapy; or 2. Refer to ERX.SPMN.16 - Global Biopharm Policy. Page 1 of 5 CLINICAL POLICY Ambrisentan Background Description/Mechanism of Action: Letairis is the brand name for ambrisentan, an endothelin receptor antagonist that is selective for the endothelin type-A (ETA) receptor. -
Therapeutic Classes Additions (Preferred) Removals (Non-Preferred)
Connecticut Medicaid Preferred Drug List (PDL) Changes ***Effective 7/1/2021*** Therapeutic Classes Additions (preferred) Removals (non-preferred) ACNE AGENTS, TOPICAL EPIDUO FORTE GEL W/PUMP (TOPICAL) AZELEX (TOPICAL) ANALGESICS, CODEINE (ORAL) NARCOTICS SHORT HYDROCODONE / IBUPROFEN (ORAL) OXYCODONE / APAP TABLET (PROLATE) (ORAL) TRAMADOL 100 MG (ORAL) ANDROGENIC AGENTS ANDROGEL GEL PUMP (TRANSDERM) TESTOSTERONE GEL (AG) (VOGELXO) (TRANSDERM) TESTOSTERONE GEL (VOGELXO) (TRANSDERM) TESTOSTERONE GEL PACKET (AG) (VOGELXO) (TRANSDERM) TESTOSTERONE GEL PUMP (AG) (ANDROGEL) (TRANSDERM) TESTOSTERONE GEL PUMP (AG) (VOGELXO) (TRANSDERM) TESTOSTERONE GEL PUMP (ANDROGEL) (TRANSDERM) ANGIOTENSIN AMLODIPINE / VALSARTAN / HCTZ (ORAL) MODULATOR COMBINATIONS ANGIOTENSIN BENAZEPRIL (ORAL) MODULATORS OLMESARTAN (AG) (ORAL) OLMESARTAN (ORAL) OLMESARTAN HCTZ (AG) (ORAL) OLMESARTAN HCTZ (ORAL) ANTIBIOTICS, GI TINIDAZOLE (ORAL) VANCOMYCIN CAPSULE (AG) (ORAL) VANCOMYCIN CAPSULE (ORAL) ANTIBIOTICS, VAGINAL METRONIDAZOLE (VAGINAL) VANDAZOLE (VAGINAL) ANTIEMETIC/ANTIVERTI EMEND CAPSULE (ORAL) GO AGENTS ANTIFUNGALS, ORAL NOXAFIL TABLET (ORAL) ANTIFUNGALS, TOPICAL NYSTATIN-TRIAMCINOLONE CREAM (TOPICAL) NYSTATIN-TRIAMCINOLONE OINT (TOPICAL) ANTIMIGRAINE AGENTS, UBRELVY (ORAL) DIHYDROERGOTAMINE MESYLATE (NASAL) OTHER NURTEC ODT (ORAL) ANTIMIGRAINE AGENTS, IMITREX (NASAL) SUMATRIPTAN (AG) (NASAL) TRIPTANS SUMATRIPTAN (NASAL) PDL Changes Effective: 7/1/2021 Connecticut Medicaid Preferred Drug List (PDL) Changes ***Effective 7/1/2021*** Therapeutic Classes Additions -
84 November 2008 Produced by NHS Tayside Drug and Therapeutics Committee Medicines Advisory Group (MAG)
TAYSIDE PRESCRIBER Tayside DTC Supplement No 84 November 2008 Produced by NHS Tayside Drug and Therapeutics Committee Medicines Advisory Group (MAG) SMC Advice issued in November 2008 Medicine Indication Local recommendation Comments and useful category links Ambrisentan tablets Treatment of patients with class Restricted for use within SMC advice (Volibris®) II and III pulmonary arterial national treatment centre SPC link hypertension to improve exercise capacity Anidulafungin powder and Treatment of invasive Pending AMG decision SMC advice solvent (Ecalta®) - candidiasis in adult non- SPC link Resubmission neutropenic patients Bosentan film-coated tablets Class II pulmonary arterial Not recommended SMC advice (Tracleer®) - hypertension Bosentan was previously Non submission accepted in 2003 for restricted use in grade III pulmonary arterial hypertension Icatibant solution for Symptomatic treatment of acute Not recommended SMC advice subcutaneous injection attacks of hereditary (Firazyr®) angioedema in adults Insulin glulisine solution for Treatment of adolescents and Non-formulary SMC advice subcutaneous injection children, 6 years or older with SPC link (Apidra®) - Abbreviated diabetes mellitus where a short Diabetes Handbook submission acting insulin analogue is appropriate Insulin lispro solution for Adults and children with Non-formulary SMC advice injection (Humalog® diabetes mellitus SPC link KwikPen) - Diabetes Handbook Abbreviated submission Insulin lispro (Humalog® Patients with diabetes mellitus, Non-formulary SMC advice Mix25 -
2020 Aetna Standard Plan
Plan for your best health Aetna Standard Plan Aetna.com Aetna is the brand name used for products and services provided by one or more of the Aetna group of subsidiary companies, including Aetna Life Insurance Company and its affiliates (Aetna). Aetna Pharmacy Management refers to an internal business unit of Aetna Health Management, LLC. Aetna Pharmacy Management administers, but does not offer, insure or otherwise underwrite the prescription drug benefits portion of your health plan and has no financial responsibility therefor. 2020 Pharmacy Drug Guide - Aetna Standard Plan Table of Contents INFORMATIONAL SECTION..................................................................................................................6 *ADHD/ANTI-NARCOLEPSY/ANTI-OBESITY/ANOREXIANTS* - DRUGS FOR THE NERVOUS SYSTEM.................................................................................................................................16 *ALLERGENIC EXTRACTS/BIOLOGICALS MISC* - BIOLOGICAL AGENTS...............................18 *ALTERNATIVE MEDICINES* - VITAMINS AND MINERALS....................................................... 19 *AMEBICIDES* - DRUGS FOR INFECTIONS.....................................................................................19 *AMINOGLYCOSIDES* - DRUGS FOR INFECTIONS.......................................................................19 *ANALGESICS - ANTI-INFLAMMATORY* - DRUGS FOR PAIN AND FEVER............................19 *ANALGESICS - NONNARCOTIC* - DRUGS FOR PAIN AND FEVER......................................... -
List of Formulary Drug Removals
July 2021 Formulary Drug Removals Below is a list of medicines by drug class that have been removed from your plan’s formulary. If you continue using one of the drugs listed below and identified as a Formulary Drug Removal, you may be required to pay the full cost. If you are currently using one of the formulary drug removals, ask your doctor to choose one of the generic or brand formulary options listed below. Category Formulary Drug Formulary Options Drug Class Removals Acromegaly SANDOSTATIN LAR SOMATULINE DEPOT SIGNIFOR LAR SOMAVERT Allergies dexchlorpheniramine levocetirizine Antihistamines Diphen Elixir RyClora CARBINOXAMINE TABLET 6 MG Allergies BECONASE AQ flunisolide spray, fluticasone spray, mometasone spray, DYMISTA Nasal Steroids / Combinations OMNARIS QNASL ZETONNA Anticonvulsants topiramate ext-rel capsule carbamazepine, carbamazepine ext-rel, clobazam, divalproex sodium, (generics for QUDEXY XR only) divalproex sodium ext-rel, gabapentin, lamotrigine, lamotrigine ext-rel, levetiracetam, levetiracetam ext-rel, oxcarbazepine, phenobarbital, phenytoin, phenytoin sodium extended, primidone, rufinamide, tiagabine, topiramate, valproic acid, zonisamide, FYCOMPA, OXTELLAR XR, TROKENDI XR, VIMPAT, XCOPRI BANZEL SUSPENSION clobazam, lamotrigine, rufinamide, topiramate, TROKENDI XR ONFI SABRIL vigabatrin ZONEGRAN carbamazepine, carbamazepine ext-rel, divalproex sodium, divalproex sodium ext-rel, gabapentin, lamotrigine, lamotrigine ext-rel, levetiracetam, levetiracetam ext-rel, oxcarbazepine, phenobarbital, phenytoin, phenytoin sodium