State and Specialty Pharmacy Drug Reimbursement Rates
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September 11, 2018 DUR Minutes
Maine Department of Health and Human Services PAUL R. LEPAGE MaineCare Services BETHANY L. HAMM GOVERNOR Pharmacy Unit ACTING COMMISSIONER 11 State House Station Augusta, Maine 04333-0011 TO: Maine Drug Utilization Review Board DATE: 9/14/2018 RE: Maine DUR Board Meeting minutes from September 11, 2018 ATTENDANCE PRESENT ABSENT EXCUSED Linda Glass, MD X Lisa Wendler, Pharm. D., Clinical Pharmacy Specialist, X Maine Medical CTR Mike Antoniello, MD X Kathleen Polonchek, MD X Kenneth McCall, PharmD X Steve Diaz, MD X Erin Ackley, PharmD. X Corinn Martineau, PharmD. X Non –Voting Mike Ouellette, R.Ph., Change Healthcare X Jeffery Barkin, MD, Change Healthcare X Christopher Pezzullo, State Health Officer DHHS, DO X Jill Kingsbury, MaineCare Pharmacy Director X Guests of the Board: Ed Bosshart, PharmD, Jeff Caulfield, Lead Epidemiologist for Viral Infections from CDC: Discussed HCV treatment. CALL TO ORDER: 5:30PM Jill Kingsbury called the meeting to order at 5:30 PM. PUBLIC COMMENTS Robert Mead from Pfizer: Highlighted the attributes of Retacrit. Jane Guo from Otsuka: Highlighted the attributes of Jynarque. OLD BUSINESS DUR MINUTES The June DUR meeting minutes were accepted as written. MAINECARE UPDATE No update at this time. NEW BUSINESS INTRODUCTION: USE OF CHRONIC TRIPTANS The use of triptans has become standard of care for the treatment of acute migraine headaches, given their effectiveness, safety and tolerability. However, like many medications used to treat migraine, overuse renders them less effective. Additionally, rebound headaches from triptan overuse is common. For patients who experience frequent headaches, or whose headaches are long lasting or chronic, use of headache prophylactic medications are recommended by several medical associations, including the American Headache Society and the American Academy of Neurology. -
DRUGS REQUIRING PRIOR AUTHORIZATION in the MEDICAL BENEFIT Page 1
Effective Date: 08/01/2021 DRUGS REQUIRING PRIOR AUTHORIZATION IN THE MEDICAL BENEFIT Page 1 Therapeutic Category Drug Class Trade Name Generic Name HCPCS Procedure Code HCPCS Procedure Code Description Anti-infectives Antiretrovirals, HIV CABENUVA cabotegravir-rilpivirine C9077 Injection, cabotegravir and rilpivirine, 2mg/3mg Antithrombotic Agents von Willebrand Factor-Directed Antibody CABLIVI caplacizumab-yhdp C9047 Injection, caplacizumab-yhdp, 1 mg Cardiology Antilipemic EVKEEZA evinacumab-dgnb C9079 Injection, evinacumab-dgnb, 5 mg Cardiology Hemostatic Agent BERINERT c1 esterase J0597 Injection, C1 esterase inhibitor (human), Berinert, 10 units Cardiology Hemostatic Agent CINRYZE c1 esterase J0598 Injection, C1 esterase inhibitor (human), Cinryze, 10 units Cardiology Hemostatic Agent FIRAZYR icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent HAEGARDA c1 esterase J0599 Injection, C1 esterase inhibitor (human), (Haegarda), 10 units Cardiology Hemostatic Agent ICATIBANT (generic) icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent KALBITOR ecallantide J1290 Injection, ecallantide, 1 mg Cardiology Hemostatic Agent RUCONEST c1 esterase J0596 Injection, C1 esterase inhibitor (recombinant), Ruconest, 10 units Injection, lanadelumab-flyo, 1 mg (code may be used for Medicare when drug administered under Cardiology Hemostatic Agent TAKHZYRO lanadelumab-flyo J0593 direct supervision of a physician, not for use when drug is self-administered) Cardiology Pulmonary Arterial Hypertension EPOPROSTENOL (generic) -
TEXAS MEDICAID Clinical Edit Prior Authorization Epoetin Alfa (PROCRIT)
TEXAS MEDICAID Clinical Edit Prior Authorization epoetin alfa (PROCRIT) STEP 1: CLEARLY PRINT AND COMPLETE TO EXPEDITE PROCESSING Date: Prescriber First & Last Name: Patient First & Last Name: Prescriber NPI: Patient Address: Prescriber Address: Patient ID: Prescriber Phone: Patient Date of Birth: Prescriber Fax: STEP 2: MEDICATION INFORMATION Medication Requested (Name): Quantity Requested: Dose Requested: Dosing Instructions: Patient’s Primary Diagnosis: ____________________________________ ICD 10 Code: __________ Please indicate ONE (1) of the following: OR STAR / STAR KIDS client (Go to Step 3 - PDL PA Criteria Applies) OR CHIP / PERINATE client (Go to Step 4) STEP 3: PDL PRIOR AUTHORIZATION CRITERIA FOR NON-PREFERRED PRODUCT 1. Has the client failed a 30-day treatment trial with at least 1 preferred agent in the last 180 days? Yes (Go to Step 4 Question 1) No (Go to #2) 2. Is there a documented allergy or contraindication to preferred agents in this class? Yes (Go to Step 4 Question 1) No (Go to #3) 3. Is the drug necessary for treatment of stage-4 advanced metastatic cancer and associated conditions? Yes (Go to Step 4 Question 1) No (Deny) Rev. 11/18/2020 Page 1 of 3 Version 1.5 STEP 4: CLINICAL PRIOR AUTHORIZATION CRITERIA 1. Does the client have a diagnosis of chronic renal failure in the last 730 days? Yes (Go to #7) No (Go to #2) 2. Does the client have a diagnosis of cancer in the last 730 days? Yes (Go to #3) No (Go to #5) 3. Does the client have a history of an antineoplastic agent in the last 30 days? Examples of antineoplastic -
Freedom of Information Act 2000
FREEDOM OF INFORMATION ACT 2000 THE ROYAL CORNWALL HOSPITALS NHS TRUST RESPONSE TO INFORMATION REQUEST Date Request Received: 15th November 2019 FOI Ref: 8454 Requested Information Question for your pharmacy and/or procurement team regarding the number of medicines and/or nursing services provided to NHS patients by an Independent Homecare Provider 1) In your organisation, which named individuals have the overall responsibility for any homecare provision for your patients? 2) Do you currently have in post an operational lead for homecare services in your organisation – If so, what is their name/role? 3) What are your organisations minimum requirements for accepting a homecare provider? 4) If you have an outsourced outpatient pharmacy, are they able to provide nurse services / training for patients on how to self-inject for medicines administered by sub-cutaneous injection as part of their contract? Can you please advise of total numbers of NHS patients who; 5) Received a homecare delivery service of drug and/or nurse service at dates Jan 2018 / Jan 2019 / October 2019 – please provide these numbers by; a) Drug name b) Therapy / clinical area c) Name of the homecare provider who provided/provides this service d) If possible please identify if these services are NHS funded or pharmaceutical / manufacturer funded services. Response 1) The Chief Pharmacist at the Royal Cornwall Hospitals Trust has overall responsibility for Medicines Homecare services. 2) The Royal Cornwall Hospitals Trust Chief Pharmacy Technician is the Operational Lead -
Biosimilar Epoetins and Other ``Follow-On
Biosimilar epoetins and other “follow-on” biologics: Update on the European experiences Wolfgang Jelkmann To cite this version: Wolfgang Jelkmann. Biosimilar epoetins and other “follow-on” biologics: Update on the European experiences. American Journal of Hematology, Wiley, 2010, 85 (10), pp.771. 10.1002/ajh.21805. hal-00552331 HAL Id: hal-00552331 https://hal.archives-ouvertes.fr/hal-00552331 Submitted on 6 Jan 2011 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. American Journal of Hematology Biosimilar epoetins and other “follow-on” biologics: Update on the European experiences For Peer Review Journal: American Journal of Hematology Manuscript ID: AJH-10-0229.R1 Wiley - Manuscript type: Critical Review Date Submitted by the 10-Jun-2010 Author: Complete List of Authors: Jelkmann, Wolfgang; University, Physiology Anemias, Erythropoietin, Hematology- medical, Neutropenia, Keywords: Pharmacology John Wiley & Sons Page 1 of 30 American Journal of Hematology 1 2 3 Table II. Benefits and problems related to the use of biosimilars 4 5 ________________________________________________________________ 6 Benefits Problems 7 ______________________________________________________________________ 8 9 10 Lower pricing than originator medicines Lack of long-term experience 11 (efficacy, safety, immunogenicity?) 12 13 Pressure on innovator companies Product-specific administration routes 14 15 to reduce prices of originator medicines (s.c. -
Erythropoiesis-Stimulating Agents (Esas) C15389-A
Drug and Biologic Coverage Criteria Effective Date: 08/01/2017 Last P&T Approval/Version: 07/28/2021 Next Review Due By: 08/2022 Policy Number: C15389-A Erythropoiesis-stimulating agents (ESAs) PRODUCTS AFFECTED Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Procrit (epoetin alfa), RETACRIT™ (epoetin alfa- epbx), Mircera'" (methoxy polyethylene glycol-epoetin beta) COVERAGE POLICY Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide Molina Healthcare complete medical rationale when requesting any exceptions to these guidelines Documentation Requirements: Molina Healthcare reserves the right to require that additional documentation be made available as part of its coverage determination; quality improvement; and fraud; waste and abuse prevention processes. Documentation required may include, but is not limited to, patient records, test results and credentials of the provider ordering or performing a drug or service. Molina Healthcare may deny reimbursement or take additional appropriate action if the documentation provided does not support the initial -
UWHC Guidelines for the Use of Darbepoetin and Epoetin
Use of Darbepoetin and Epoetin in Non-Nephrology Patients – Adult/Pediatric – Inpatient/Ambulatory Clinical Practice Guideline Table of Contents Executive Summary ......................................................................................... 3 Scope ............................................................................................................. 7 Methodology ................................................................................................... 7 Definitions (optional): ...................................................................................... 8 Introduction.................................................................................................... 8 Recommendations........................................................................................... 9 UW Health Implementation............................................................................ 19 References ................................................................................................... 19 Note: Active Table of Contents Click to follow link CPG Contact for Changes: Name: Philip Trapskin, PharmD, BCPS, Manager, DPP Phone Number: 608-263-1328 Email address: [email protected] CPG Contact for Content: Name: Jason Bergsbaken, PharmD Phone Number: 608-265-0341 Email address: [email protected] Copyright © 2015 University of Wisconsin Hospitals and Clinics Authority Contact: [email protected] Vermeulen, [email protected] Last Revised: 07/2015 Guideline Authors: Jason Bergsbaken, PharmD Coordinating -
Dr. Winegarden Presentation
Empowering Market Competition through Biosimilars Presentation to National Council of Insurance Legislators (NCOIL) 2019 Summer Meeting Newport Beach, California July 12, 2019 Total Savings (in millions) 25% 50% 75% Originator Total Annual Savings for Current, 25%, Drug Class Current Biosimilar Biosimilar Biosimilar Biologic 50%, and 75% Biosimilar Share Share Share Share Scenarios Compared to All-Originator Infliximab Remicade $79.4 $318.2 $636.5 $954.7 Biologic Baseline Pegfilgrastim Neulasta $21.8 $121.9 $243.8 $365.7 Filgrastim Neupogen $152.1 $152.1 $152.1 $206.8 Epoetin Alfa Epogen & Procrit $0.5 $8.4 $16.9 $25.3 Bevacizumab Avastin $0.0 $199.2 $398.5 $597.7 Trastuzumab Herceptin $0.0 $208.0 $415.9 $623.9 • Biosimilars price discounts expected 30% - Rituxumab Rituxan $0.0 $280.6 $561.2 $841.8 40% off originator biologic Etanercept Enbrel $0.0 $324.0 $648.0 $972.1 • Forthcoming study estimates possible Adalimunab Humira $0.0 $861.1 $1,722.1 $2,583.2 health care savings from wider adoption of biosimilars. GRAND TOTAL $253.8 $2,473.6 $4,795.0 $7,171.2 • Estimates are based on the average sales price (ASP) data that are effective from April 2019 through June 2019 and rolling 12-month volume data through February 2019. Biosimilars have no “clinically meaningful difference” in safety, purity, • Methodology: compare potential savings to hypothetical all-originator biologic scenario and effectiveness relative to its reference originator biologic. Just like • Over 10 years, potential savings of $24.7 generic medicines, the benefits of biosimilars are the substantial price billion, $48.0 billion, and $71.7 billion respectively. -
2021 Prior Authorization List Part B Appendix a (PDF)
Medicare Part B PA List Effective 2021 Last Effective Part B Drugs: Drug Code Drug Name Action Updated Date (if Drug Description Comments STEP THERAPY Date available) C9050 INJECTION, EMAPALUMAB-LZSG, 1 MG C9122 MOMETASONE FUROATE SINUS IMPLANT 10 MCG SINUVA J0129 ABATACEPT INJECTION J0178 AFLIBERCEPT INJECTION J0570 BUPRENORPHINE IMPLANT 74.2MG J0585 INJECTION,ONABOTULINUMTOXINA J0717 CERTOLIZUMAB PEGOL INJ 1MG J0718 CERTOLIZUMAB PEGOL INJ J0791 INJECTION CRIZANLIZUMAB-TMCA 5 MG J0800 INJECTION, CORTICOTROPIN, UP TO 40 UNITS J0896 INJECTION LUSPATERCEPT-AAMT 0.25 MG J0897 DENOSUMAB INJECTION J1300 ECULIZUMAB INJECTION J1428 INJECTION ETEPLIRSEN 10 MG J1429 INJECTION GOLODIRSEN 10 MG J1442 INJ FILGRASTIM EXCL BIOSIMIL J1447 INJECTION, TBO-FILGRASTIM, 1 MICROGRAM J1459 INJ IVIG PRIVIGEN 500 MG J1555 INJECTION IMMUNE GLOBULIN 100 MG J1556 INJ, IMM GLOB BIVIGAM, 500MG J1557 GAMMAPLEX INJECTION J1558 INJECTION IMMUNE GLOBULIN XEMBIFY 100 MG J1559 HIZENTRA INJECTION J1561 GAMUNEX-C/GAMMAKED J1562 INJECTION; IMMUNE GLOBULIN 10%, 5 GRAMS J1566 INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, LYOPHILIZED (E.G. P J1568 OCTAGAM INJECTION J1569 GAMMAGARD LIQUID INJECTION J1572 FLEBOGAMMA INJECTION J1575 INJ IG/HYALURONIDASE 100 MG IG J1599 IVIG NON-LYOPHILIZED, NOS J1602 GOLIMUMAB FOR IV USE 1MG J1745 INJ INFLIXIMAB EXCL BIOSIMILR 10 MG J1930 Remove 1/1/2021 INJECTION, LANREOTIDE, 1 MG J2323 NATALIZUMAB INJECTION J2350 INJECTION OCRELIZUMAB 1 MG J2353 Remove 1/1/2021 INJECTION, OCTREOTIDE, DEPOT FORM FOR INTRAMUSCULAR INJECTION, 1 MG J2357 INJECTION, OMALIZUMAB, -
OMONTYS® Safely and Effectively
HIGHLIGHTS OF PRESCRIBING INFORMATION ---------------------DOSAGE FORMS AND STRENGTHS---------------------- These highlights do not include all the information needed to use Dosage Form Strengths OMONTYS® safely and effectively. See full prescribing information for OMONTYS. Single use vials 2 mg/0.5 mL, 3 mg/0.5 mL, (preservative-free) 4 mg/0.5 mL, 5 mg/0.5 mL, and OMONTYS® (peginesatide) Injection, 6 mg/0.5 mL for intravenous or subcutaneous use Single use pre-filled syringes 1 mg/0.5 mL, 2 mg/0.5 mL, Initial U.S. Approval: 2012 (preservative-free) 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, and 6 mg/0.5 mL WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL Multiple use vials 10 mg/mL and 20 mg/2 mL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, (with preservative) THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE -------------------------------CONTRAINDICATIONS------------------------------ See full prescribing information for complete boxed warning. Uncontrolled hypertension (4). Chronic Kidney Disease: In controlled trials, patients experienced greater risks for -----------------------WARNINGS AND PRECAUTIONS------------------------ death, serious adverse cardiovascular reactions, and stroke Increased Mortality, Myocardial Infarction, Stroke, and when administered erythropoiesis-stimulating agents (ESAs) Thromboembolism: Using ESAs to target a hemoglobin level of to target a hemoglobin level of greater than 11 g/dL (5.1). greater than 11 g/dL increases the risk of serious adverse No trial has identified a hemoglobin target level, ESA dose, or cardiovascular reactions and has not been shown to provide dosing strategy that does not increase these risks (5.1). additional benefits (5.1). -
Presentation Title
The COMMANDS trial: a phase 3 study of the efficacy and safety of luspatercept versus epoetin alfa for the treatment of anemia due to Revised International Prognostic Scoring System Very Low-, Low-, or Intermediate-risk myelodysplastic syndromes in erythropoiesis stimulating agent-naive patients who require red blood cell transfusions Matteo Della Porta,1,2 Uwe Platzbecker,3 Valeria Santini,4 Guillermo Garcia-Manero,5 Rami S. Komrokji,6 Rodrigo Ito,7 Pierre Fenaux8 1Cancer Center IRCCS Humanitas Research Hospital, Milan, Italy; 2Department of Biomedical Sciences, Humanitas University, Milan, Italy; 3Medical Clinic and Policlinic 1, Hematology and Cellular Therapy, University Hospital Leipzig, Leipzig, Germany; 4Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy; 5Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX; 6Moffitt Cancer Center, Tampa, FL; 7Bristol Myers Squibb, Princeton, NJ; 8Service d'Hématologie Séniors, Hôpital Saint-Louis, Université Paris 7, Paris, France Presentation 2198 Presenting author disclosures M.D.P.: no conflicts of interest to disclose. 2 Introduction and objectives Introduction • Studies of epoetin alfa and darbepoetin alfa have demonstrated efficacy among patients with LR-MDS, but the patient population in which a clinically significant effect is observed may be limited1,2 • Luspatercept, a first-in-class erythroid maturation agent with a mechanism of action distinct from ESAs,3 is approved by the US FDA for the treatment of anemia failing an -
Erythropoiesis Stimulating Agents (ESA)
Drug and Biologic Coverage Policy Effective Date ............................................ 5/1/2020 Next Review Date… ..................................... 5/1/2021 Coverage Policy Number .................................. 5016 Erythropoiesis Stimulating Agents (ESA) Table of Contents Related Coverage Resources Coverage Policy ................................................... 1 FDA Approved Indications ................................... 5 Recommended Dosing ........................................ 7 General Background ............................................ 8 Coding/ Billing Information ................................. 10 References ........................................................ 11 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may