Medicines Not Reimbursed Through National Prices and Directly Commissioned by Nhs England

Total Page:16

File Type:pdf, Size:1020Kb

Medicines Not Reimbursed Through National Prices and Directly Commissioned by Nhs England MEDICINES NOT REIMBURSED THROUGH NATIONAL PRICES AND DIRECTLY COMMISSIONED BY NHS ENGLAND VERSION 11 PUBLISHED DECEMBER 2016 SUITABLE FOR SUITABLE FOR SHARED CARE SPECIALIST SHARED CARE BETWEEN PRIOR CENTRE ONLY WITH PRIMARY SPECIALIST MONITORING/AUDIT APPROVAL (includng outreach CARE (IF DRUG NAME INDICATION COMMISSIONER PBR CATEGORY TA/POLICY STARTING CRITERIA STOPPING CRITERIA AND REQUIREMENTS PROFORMA when delivered as SUPPORTED BY SECONDARY REQUIRED part of a provider LOCAL CARE VIA network) PRESCRIBING NETWORK COMMITTEE) MODEL HIV IN COMBINATION WITH OTHER ANTI- ABACAVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS AGREED REGIONALGUIDELINES BHIVA GUIDELINES (8) BHIVA GUIDELINES (8) HARS DATASET √ RETROVIRAL DRUGS NHS ENGLAND CLINICAL HIV IN COMBINATION WITH OTHER ANTI- NHS ENGLAND AIDS/HIV ANTIRETROVIRALS COMMISSIONING POLICY: BHIVA GUIDELINES (8) BHIVA GUIDELINES (8) HARS DATASET √ ABACAVIR + LAMIVUDINE + RETROVIRAL DRUGS DOLUTEGRAVIR (TRIUMEQ®) B06/P/b/AGREED REGIONAL GUIDELINES HIV IN COMBINATION WITH OTHER ANTI- ABACAVIR + LAMIVUDINE NHS ENGLAND AIDS/HIV ANTIRETROVIRALS AGREED REGIONALGUIDELINES BHIVA GUIDELINES (8) BHIVA GUIDELINES (8) HARS DATASET √ RETROVIRAL DRUGS ABALOPARATIDE DRUGS AFFECTING BONE MALE AND JUVENILE OSTEOPOROSIS NHS ENGLAND NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ METABOLISM NHS ENGLAND CLINICAL ABATACEPT JUVENILE ARTHRITIS-PAEDIATRIC NHS ENGLAND CYTOKINE MODULATORS COMMISSIONING POLICY: E03/P/d; TA NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ √ 373 PAEDIATRIC INDICATIONS (WHERE ABATACEPT NHS ENGLAND CYTOKINE MODULATORS AS PER ADULT TA'S (TA195, TA280) NICE NICE NICE √ ADULT TA AVAILABLE) TA259, 387 (SEE ALSO SSC1438) NICE/NHS ENGLAND POLICY NICE ABIRATERONE CANCER NHS ENGLAND HORMONE ANTAGONISTS ONLY IN ENZALUTAMIDE NAÏVE SACT √ √ PATIENTS NHS ENGLAND CLINICAL ADALIMUMAB JUVENILE ARTHRITIS-PAEDIATRIC NHS ENGLAND CYTOKINE MODULATORS COMMISSIONING POLICY: E03/P/d; TA NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ √ 373 NHS ENGLAND CLINICAL ADALIMUMAB UVEITIS - PAEDIATRIC NHS ENGLAND CYTOKINE MODULATORS NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ √ COMMISSIONING POLICY:D12X02 NOT ROUTINELY COMMISSIONED ADALIMUMAB UVEITIS - ADULTS NHS ENGLAND CYTOKINE MODULATORS (NHS ENGLAND CLINICAL AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ COMMISSIONING POLICY: D12/P/a) HIGHLY SPECIALISED HIGHLY SPECIALISED ADALIMUMAB BEHCETS SYNDROME NHS ENGLAND CYTOKINE MODULATORS HIGHLY SPECIALISED CRITERIA ONLY HIGHLY SPECIALISED CRITERIA √ CRITERIA ONLY CRITERIA ONLY PAEDIATRIC INDICATIONS (WHERE AS PER ADULT TA'S (TA130, TA143, ADALIMUMAB NHS ENGLAND CYTOKINE MODULATORS NICE NICE NICE AUDIT √ ADULT TA AVAILABLE) TA146, TA187, TA199) ADALIMUMAB HIDRADENITIS SUPPURATIVA NHS ENGLAND CYTOKINE MODULATORS NICE TA 392 NICE NICE NICE AUDIT √ √ VIRAL HEPATITIS (B&C) & NOT ROUTINELY COMMISSIONED ADEFOVIR HEPATITIS B NHS ENGLAND AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RESPIRATORY SYNCYTIAL VIRUS (CG165) AFATINIB CANCER NHS ENGLAND CANCER EXCLUSION TA310 NICE NICE SACT √ NOT ROUTINELY COMMISSIONED AFLIBERCEPT CANCER NHS ENGLAND CANCER EXCLUSION AS PER CDIFR APPROVAL AS PER CDIFR APPROVAL SACT √ (TA307) DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED AGALSIDASE ALFA FABRY'S DISEASE NHS ENGLAND NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED AGALSIDASE BETA FABRY'S DISEASE NHS ENGLAND NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY ALBUTREPENONACOG ALFA HAEMOPHILIA B NHS ENGLAND BLOOD-RELATED PRODUCTS SSC 1652 SSC 1652 SSC 1652 PRODUCTS ON CMU FRAMEWORK √ ALBUTROPIN ADULT ONSET GROWTH HORMONE GROWTH HORMONE & GROWTH DEFICIENCY NHS ENGLAND NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ HORMONE RECEPTOR ANTAGONIST ALDESLEUKIN CANCER NHS ENGLAND IMMUNOMODULATING DRUGS NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL SACT √ DRUGS AFFECTING THE IMMUNE ALEMTUZUMAB MULTIPLE SCLEROSIS NHS ENGLAND TA312 NICE NICE NICE AUDIT √ √**** RESPONSE TRUST GUIDELINES: ISLET PRE-TRANSPLANT DRUGS AFFECTING THE IMMUNE ALEMTUZUMAB NHS ENGLAND TRANSPLANTATION (ONLY IF PROVIDED TRUST GUIDELINES TRUST GUIDELINES √ IMMUNOSUPPRESSION RESPONSE AT ZERO DRUG COST) DRUGS AFFECTING THE IMMUNE TRUST GUIDELINES: (ONLY IF ALEMTUZUMAB CLL NHS ENGLAND TRUST GUIDELINES TRUST GUIDELINES SACT √ RESPONSE PROVIDED AT ZERO DRUG COST) HIGHLY SPECIALISED CRITERIA ONLY HIGHLY SPECIALISED HIGHLY SPECIALISED ALEMTUZUMAB BEHCETS SYNDROME NHS ENGLAND CYTOKINE MODULATORS (ONLY IF PROVIDED AT ZERO DRUG HIGHLY SPECIALISED CRITERIA √ CRITERIA ONLY CRITERIA ONLY COST) DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED ALGLUCOSIDASE ALFA POMPE DISEASE NHS ENGLAND NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY DRUGS USED IN METABOLIC ALIPOGENE TIPARVOVEC LIPOPROTEIN LIPASE DEFICIENCY NHS ENGLAND NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DISORDERS VIRAL HEPATITIS (B&C) & ALISPORIVIR HEPATITIS C NHS ENGLAND NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RESPIRATORY SYNCYTIAL VIRUS DRUGS USED IN METABOLIC ALPHA-1 ANTITRYPSIN ALPHA-1 ANTITRYPSIN DEFICIENCY NHS ENGLAND NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DISORDERS ALPHA MANNOSIDASE DRUGS USED IN METABOLIC ALPHA MANNOSIDASE DEFICIENCY NHS ENGLAND NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RECOMBINANT HUMAN DISORDERS VASODILATOR ANTIHYPERTENSIVE PULMONARY ARTERIAL NHS ENGLAND CLINICAL AMBRISENTAN NHS ENGLAND DRUGS/PULMANORY ARTERIAL NHS ENGLAND POLICY NHS ENGLAND POLICY AS PER POLICY √ HYPERTENSION COMMISSIONING POLICY: A11/P/c HYPERTENSION NOT ROUTINELY COMMISSIONED AMIFAMPRIDINE PHOSPHATE LEMS NHS ENGLAND NEUROMUSCULAR DISORDERS AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ NHS ENGLAND POLICY: 16009/P AMIKACIN INHALATION CYSTIC FIBROSIS NHS ENGLAND ANTIBACTERIAL DRUGS NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ CYSTIC FIBROSIS AMIKACIN LIPOSOMAL NHS ENGLAND ANTIBACTERIAL DRUGS NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ NUMBER OF PATIENTS TREATED AMPHOTERICIN LIPOSOMAL FUNGAL INFECTION NHS ENGLAND ANTIFUNGALS AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES PROPORTION GIVEN FOR SPC √ INDICATIONS WITHIN POLICY NHS ENGLAND CLINICAL ANAKINRA JUVENILE ARTHRITIS-PAEDIATRIC NHS ENGLAND CYTOKINE MODULATORS NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ √ COMMISSIONING POLICY: E03/P/d SPECIALIST AUTOINFLAMMATORY ANAKINRA NHS ENGLAND CYTOKINE MODULATORS NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DISEASE ANAKINRA PAEDIATRIC INDICATIONS NHS ENGLAND CYTOKINE MODULATORS NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ CRYOPYRIN ASSOCIATED PERIODIC CRYOPYRIN ASSOCIATED PERIODIC HIGHLY SPECIALISED HIGHLY SPECIALISED ANAKINRA NHS ENGLAND CYTOKINE MODULATORS HIGHLY SPECIALISED DATABASE √ SYNDROME SYNDROME SERVICE SPECIFICATION CRITERIA ONLY CRITERIA ONLY NHS England drugs-list v11 v4 NHSE Commissioned PbRE Drugv11 1 22/12/2016 SUITABLE FOR SUITABLE FOR SHARED CARE SPECIALIST SHARED CARE BETWEEN PRIOR CENTRE ONLY WITH PRIMARY SPECIALIST MONITORING/AUDIT APPROVAL (includng outreach CARE (IF DRUG NAME INDICATION COMMISSIONER PBR CATEGORY TA/POLICY STARTING CRITERIA STOPPING CRITERIA AND REQUIREMENTS PROFORMA when delivered as SUPPORTED BY SECONDARY REQUIRED part of a provider LOCAL CARE VIA network) PRESCRIBING NETWORK COMMITTEE) MODEL NUMBER OF PATIENTS TREATED ANIDULAFUNGIN FUNGAL INFECTION NHS ENGLAND ANTIFUNGALS AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES PROPORTION GIVEN FOR SPC √ INDICATIONS WITHIN POLICY ANTIHAEMOPHILIC FACTOR/VON AS PER BCSH GUIDELINES FOR NHS ENGLAND BLOOD-RELATED PRODUCTS BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES PRODUCTS ON CMU FRAMEWORK √ WILLEBRAND FACTOR COMPLEX SPECIALISED INDICATIONS APLASTIC ANAEMIA DRUGS USED IN HYPOPLASTIC, ANTILYMPHOCYTE GLOBULIN NHS ENGLAND BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ ORGAN TRANSPLANT HAEMOLYTIC, AND RENAL ANAEMIAS ANTIPSEUDOMONAS AERUGINOSA CYSTIC FIBROSIS NHS ENGLAND ANTIBACTERIAL DRUGS NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ IgY AS PER BCSH GUIDELINES FOR ANTITHROMBIN III NHS ENGLAND BLOOD-RELATED PRODUCTS BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ SPECIALISED INDICATIONS ANTITHYMOCYTE APLASTIC ANAEMIA DRUGS USED IN HYPOPLASTIC, NHS ENGLAND BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ IMMUNOGLOBULIN ORGAN TRANSPLANT HAEMOLYTIC, AND RENAL ANAEMIAS APREMILAST PAEDIATRIC INDICATIONS NHS ENGLAND CYTOKINE MODULATORS NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS ARAGAM AS PER NATIONAL DMP NHS ENGLAND IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) DRUGS USED IN METABOLIC ASFOTASE ALFA HYPOPHOSPHATASIA NHS ENGLAND NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DISORDERS
Recommended publications
  • Clinical Commissioning Policy: Susoctocog Alfa for Treating Bleeding Episodes in People with Acquired Haemophilia a (All Ages)
    Clinical Commissioning Policy: Susoctocog alfa for treating bleeding episodes in people with acquired haemophilia A (all ages) NHS England Reference: 170061P 1 NHS England INFORMATION READER BOX Directorate Medical Operations and Information Specialised Commissioning Nursing Trans. & Corp. Ops. Commissioning Strategy Finance Publications Gateway Reference: 07603 Document Purpose Policy Clinical commissioning policy: Susoctocog alfa for treating bleeding Document Name episodes in people with acquired haemophilia A (all ages) Author Specialised Commissioning Team Publication Date 29 June 2018 Target Audience CCG Clinical Leaders, Care Trust CEs, Foundation Trust CEs , Medical Directors, Directors of PH, Directors of Nursing, NHS England Regional Directors, NHS England Directors of Commissioning Operations, Directors of Finance, NHS Trust CEs Additional Circulation #VALUE! List Description Routinely Commissioned - NHS England will routinely commission this specialised treatment in accordance with the criteria described in this policy. Cross Reference 0 Superseded Docs 0 (if applicable) Action Required 0 Timing / Deadlines By 00 January 1900 (if applicable) Contact Details for [email protected] further information 0 0 0 0 0 0 Document Status This is a controlled document. Whilst this document may be printed, the electronic version posted on the intranet is the controlled copy. Any printed copies of this document are not controlled. As a controlled document, this document should not be saved onto local or network drives but should always be accessed from the intranet. 2 Standard Operating Procedure: Clinical Commissioning Policy: Susoctocog alfa for treating bleeding episodes in people with acquired haemophilia A (all ages) First published: June 2018 Prepared by the National Institute for Health and Care Excellence (NICE) Commissioning Support Programme Published by NHS England, in electronic format only.
    [Show full text]
  • Scientific Program Saturday, 17. July 2021 Factor VIII, Factor IX and Rare
    Scientific programThe XXIX Congress of the International Society on Thrombosis and Haemostasis July 17-21, 2021 Philadelphia, U.S. Saturday, 17. July 2021 SSC Session 08:00 - 10:00 R1 Factor VIII, Factor IX and Rare Coagulation Disorders Introduction 08:00 - 08:02 Speaker: Johnny Mahlangu, ZA Non-Factor Replacement Therapies 08:02 - 08:02 Moderators: Johnny Mahlangu, South Africa, Tarek Owaidah, Saudi Arabia In Patients on Non-Factor Therapies, Exposure to Clotting 08:02 - 08:14 Factor Replacement Should Be Early (Debate) Speaker: Manuel Carcao, CA In Patients on Non-Factor Therapies, Exposure to Clotting 08:14 - 08:26 Factor Replacement Should Be Early (Debate) Speaker: Jayanthi Alamelu, GB Non-Factor Replacement Therapy Versus Factor Replacement 08:26 - 08:38 Therapy Risks -There Is No Free Lunch (Debate) Speaker: Bhavya Doshi, US Non-Factor Replacement Therapy Versus Factor Replacement 08:38 - 08:50 Therapy Risks -There Is No Free Lunch (Debate) Speaker: Gili Kenet, IL Beyond Annualized Bleed Rates What Should Be the Alternative 08:50 - 09:02 Endpoints for Non-Replacement Therapies Speaker: Alok Srivastava, IN Q&A Session 09:02 - 09:06 Gene Therapy 09:06 - 09:06 Moderators: Valder Arruda, United States, Savita Rangarajan, United Kingdom Anti Adeno-Associated Virus Antibodies Antibodies: What Are 09:06 - 09:18 the Standardization Issues? Speaker: David Lillicrap, CA Rationale for Adeno-associated Virus (AAV) Mediated Gene 09:24 - 09:30 Therapy in Patients With Anti Adeno-associated Virus Antibodies Speaker: David Cooper, NL What Should We Be Following-up Post Gene Therapy? 09:30 - 09:42 Speaker: Barbara A.
    [Show full text]
  • Bebulin VH Corifact Factor VII Concentrate
    P RODUCTS TO TREAT RARE FACTOR DEFICIENCIES Product Plasma source Fractionation Viral inactivation Vial size Storage Availability USA: volunteer, Vapour heat @ 60°C for 10 hr at Available through Special Bebulin VH remunerated Ion exchange 190 mbar, then 80°C for 1 hr @ 600 IUs 2‐8°C Access Programme. Manufactured by plasmapheresis adsorption 375 mbar Shire donors distributed in all provinces. Comments Factor IX complex containing factors II, VII, IX and X, heparin added. Product Plasma source Fractionation Viral inactivation Vial size Storage Availability Purification steps: 1) Precipitation/adsorption 250 IUs USA: volunteer, (4 mL of diluent) 2) Ion exchange chromatography Corifact remunerated Multiple Licensed by Health Canada. 1,250 IUs 2‐8°C Manufactured by plasmapheresis precipitation 3) Heat‐treatment (+60°C for 10 (20 mL of diluent) Distributed in all provinces. CSL Behring donors hours in an aqueous solution) 4) Virus filtration over two 20 nm Mix2Vial filters in series Comments Indicated for routine prophylaxis and peri‐operative management of surgical bleeding in patients with congenital factor XIII deficiency. Product Plasma source Fractionation Viral inactivation Vial size Storage Availability Factor VII USA: volunteer, Aluminium Vapour heat @ 60°C for 10 hr at Available through Special remunerated concentrate hydroxide 190 mbar, then 80°C for 1 hr @ 600 IUs 2‐8°C Access Programme. Manufactured by plasmapheresis adsorption 375 mbar Distributed in all provinces. Shire donors Comments Used to treat factor VII deficiency. 1 Product Plasma source Fractionation Viral inactivation Vial size Storage Availability Factor XI USA: volunteer, Affinity heparin Available through Special concentrate remunerated sepharose Dry heat @ 80°C, 72 hr 1,000 IUs 2‐8°C Access Programme.
    [Show full text]
  • Australian Public Assessment for Efmoroctocog Alfa (Rhu)
    Australian Public Assessment Report 1 for efmoroctocog alfa (rhu) Proprietary Product Name: Eloctate Sponsor: Biogen Idec Australia Pty Ltd January 2015 1 The non-proprietary name has changed post registration from efraloctocog alfa to efmoroctocog afla to harmonise with the International Non-proprietary Name. Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) · The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and is responsible for regulating medicines and medical devices. · The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. · The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. · The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. · To report a problem with a medicine or medical device, please see the information on the TGA website <http://www.tga.gov.au>. About AusPARs · An Australian Public Assessment Record (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. · AusPARs are prepared and published by the TGA. · An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations, and extensions of indications. · An AusPAR is a static document, in that it will provide information that relates to a submission at a particular point in time.
    [Show full text]
  • 2018 Annual Report on Eudravigilance for the European Parliament, the Council and the Commission Reporting Period: 1 January to 31 December 2018
    21 March 2019 EMA/906394/2019 Inspections, Human Medicines Pharmacovigilance and Committees Division 2018 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission Reporting period: 1 January to 31 December 2018 Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged. Table of contents Abbreviations used in the document ...................................................................................... 3 1. Executive summary ............................................................................................................ 4 2. Operation of EudraVigilance including its new functionalities ............................................ 6 3. Data collection and data quality ......................................................................................... 7 Medicinal product information ..................................................................................................... 7 Reporting of ADR reports and patient involvement ........................................................................ 7 Data Quality ............................................................................................................................. 8 4. Data analysis ....................................................................................................................
    [Show full text]
  • Human and Recombinat Coagulation Factor VIII
    08 July 2016 EMA/PRAC/471535/2016 PRAC List of questions To be addressed by the marketing authorisation holder(s) for human and recombinant coagulation factor VIII containing medicinal products Referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data Procedure number: EMEA/H/A-31/1448 Advate EMEA/H/C/0520/A31/0078 Elocta EMEA/H/C/3964/A31/0006 Helixate Nexgen EMEA/H/C/0276/A31/0178 Iblias EMEA/H/C/4147/A31/0002 Kogenate EMEA/H/C/0275/A31/0185 Kovaltry EMEA/H/C/3825/A31/0004 Novoeight EMEA/H/C/2719/A31/0014 Nuwiq EMEA/H/C/2813/A31/0015 Obizur EMEA/H/C/2792/A31/0003 Refacto AF EMEA/H/C/0232/A31/0134 Voncento EMEA/H/C/2493/A31/0022 Active substances: human coagulation factor VIII; efmoroctocog alfa; moroctocog alfa; octocog alfa; simoctocog alfa; susoctocog alfa; turoctocog alfa 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 1. Background Today’s standard treatment of congenital haemophilia (and acquired haemophilia A) is based on prophylactic or on-demand replacement therapy with coagulation factor VIII (FVIII), either with plasma derived or with recombinant FVIII products. Principally both substance classes may be used for prophylactic treatment as well as for therapeutic treatment in case of spontaneous bleedings. Inhibitor development in haemophilia A patients receiving FVIII products mostly occurs in previously untreated or minimally treated patients (PUPs), who are still within the first 50 days of exposure to the treatment.
    [Show full text]
  • The Impact of Biosimilar Competition in Europe December 2020
    White Paper The Impact of Biosimilar Competition in Europe December 2020 PER TROEIN, Vice President, Strategic Partners, IQVIA MAX NEWTON, Senior Consultant, Global Supplier & Association Relations, IQVIA KIRSTIE SCOTT, Analyst, Global Supplier & Association Relations, IQVIA Table of contents Introduction 1 Key observations 2 Methodology 11 Country and therapy area KPIs 14 Human growth hormone (HGH) 14 Epoetin (EPO) 16 Granulocyte-colony stimulating factor (GCSF) 18 Anti-tumour necrosis factor (ANTI-TNF) 20 Fertility (FOLLITROPIN ALFA) 22 Insulins 24 Oncology 26 Low-molecular-weight heparin (LMWH) 28 Appendix 30 EMA list of approved biosimilars 30 List of Biosimilars under review by EMA 32 Introduction ‘The Impact of Biosimilar Competition in Europe’ report describes the effects on price, volume, and market share following the arrival of biosimilar competition in Europe. The report consists of: observations on competitive markets, and a set of Key Performance Indicators (KPIs) to monitor the impact of biosimilars in 23 European markets. The report has been a long-standing source of information on the status of the biosimilars market. This iteration has been delayed due to the COVID-19 pandemic across the globe and has provided an opportunity to provide full-year 2019 data, and an additional data point (June 2020 MAT) which incorporates the impact on patients in Europe across major therapeutic areas to 30th June 2020. The direct impact of which is visible in the Low Molecular Weight Heparin (LMWH), and Fertility (somatropin) markets. This report has been prepared by IQVIA at the The European Medicines Agency (EMA) has a central request of the European Commission services with role in setting the rules for biosimilar submissions, initial contributions on defining the KPIs from EFPIA, approving applications, establishing approved Medicines for Europe, and EuropaBio.
    [Show full text]
  • PRESS RELEASE Stockholm, Sweden, 8 July 2020
    PRESS RELEASE Stockholm, Sweden, 8 July 2020 Data to be presented at ISTH Virtual Congress highlights Sobi´s commitment to advancing rare haematology treatments Sobi™ will present data at the ISTH Virtual Congress (International Society on Thrombosis and Haemostasis), 12 – 14 July 2020, strengthening evidence for the efficacy and safety of Elocta® (efmoroctocog alfa) and Alprolix® (eftrenonacog alfa), for haemophilia A and B respectively, as well as pharmacokinetic data on BIVV001 (rFVIIIFc-VWF-XTEN). Data for Doptelet® (avatrombopag) in treatment for thrombocytopenia within Chronic Liver Disease (CLD) and Chronic Immune Thrombocytopenia (ITP) will be presented. Final data in previously untreated patients with haemophilia Final data from the long-term studies: PUPs A-LONG and PUPs B-LONG in previously untreated patients (PUP) with haemophilia A and B, treated with Elocta and Alprolix will be presented in collaboration with Sanofi. Factor replacement therapy remains a cornerstone of haemophilia management and data shared in presentations will add to a growing body of clinical evidence for rFVIIIFc and rFIXFc, extended half-life factor therapies for haemophilia A and B, respectively. Oral Communication • Final results of the PUPs A-LONG Study: Evaluating Safety and Efficacy of rFVIIIFc in Previously Untreated Patients with Haemophilia A. Oral communication #OC 03.2. Sunday, July 12, 2020 from 10:15 – 11:30 EDT (16.15-17.30 CET) (Joint with Sanofi) Abstracts • Final Results of PUPs B-LONG Study: Evaluating Safety and Efficacy of rFIXFc in Previously Untreated Patients with Haemophilia B. Poster presentation # PB0956. (Joint with Sanofi) • A French Multicentre Prospective, Non-Interventional Study (B-SURE) Evaluating Real-World Usage and Effectiveness of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in People with Haemophilia B: Baseline Data.
    [Show full text]
  • Annual Report 2016
    Annexes to the annual report of the European Medicines Agency 2016 Annex 1 – Members of the Management Board ............................................................... 2 Annex 2 - Members of the Committee for Medicinal Products for Human Use ...................... 4 Annex 3 – Members of the Pharmacovigilance Risk Assessment Committee ........................ 6 Annex 4 – Members of the Committee for Medicinal Products for Veterinary Use ................. 8 Annex 5 – Members of the Committee on Orphan Medicinal Products .............................. 10 Annex 6 – Members of the Committee on Herbal Medicinal Products ................................ 12 Annex 7 – Committee for Advanced Therapies .............................................................. 14 Annex 8 – Members of the Paediatric Committee .......................................................... 16 Annex 9 – Working parties and working groups ............................................................ 18 Annex 10 – CHMP opinions: initial evaluations and extensions of therapeutic indication ..... 24 Annex 10a – Guidelines and concept papers adopted by CHMP in 2016 ............................ 25 Annex 11 – CVMP opinions in 2016 on medicinal products for veterinary use .................... 33 Annex 11a – 2016 CVMP opinions on extensions of indication for medicinal products for veterinary use .......................................................................................................... 39 Annex 11b – Guidelines and concept papers adopted by CVMP in 2016 ...........................
    [Show full text]
  • Therapeutics Advisory Group
    Therapeutics Advisory Group CCG and NHS Trusts in Norfolk and Waveney Index of TAG recommendations Generic name Indication BNFclass Trafficlight IQoro euromuscular training Hiatus hernia - improving symptoms No BNF entry - device Double Red Not recommended for device routine use / Not commissioned (L-) Carnitine Carnitine Deficiency 9.8.1 Drugs used in Red Hospital / Specialist metabolic disorders only (Para-)aminosalicylic acid Tuberculosis 5.1.9 Antituberculosis Double Red Not recommended for drugs - routine use / Not Antimycobacterials commissioned 5-fluorouracil + salicyclic acid Hyperkeratotic actinic keratosis 13.8.1 Photodamage Double-GreenSuitable for GPs to topical solution initiate and prescribe 5-fluorouracil 5% w/w cream Non-hypertrophic actinic keratosis 13.8.1 Photodamage Double-GreenSuitable for GPs to initiate and prescribe Abacavir HIV infection in combination with other 5.3.1 HIV Infection Red Hospital / Specialist antiretroviral drugs only Abacavir + dolutegravir + HIV infection in combination with other 5.3.1 HIV Infection Red Hospital / Specialist lamivudine antiretroviral drugs only Abacavir and lamivudine HIV infection in combination with other 5.3.1 HIV Infection Red Hospital / Specialist antiretroviral drugs only Abaloparatide Male and juvenile osteoporosis 6.6.1 Calcitonin and Double Red Not recommended for Calcitonin and routine use / Not parathyroid hormone commissioned Abatacept Rheumatoid arthritis - 1st line biologic 10.1.3 Drugs that suppress Red Hospital / Specialist after failure of non-biologic DMARDs
    [Show full text]
  • Australian Public Assessment Report for Lonoctocog Alfa (Rch)
    Australian Public Assessment Report for lonoctocog alfa (rch) Proprietary Product Name: Afstyla Sponsor: CSL Behring Australia Pty Ltd January 2018 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) · The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and is responsible for regulating medicines and medical devices. · The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance) when necessary. · The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. · The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. · To report a problem with a medicine or medical device, please see the information on the TGA website <https://www.tga.gov.au>. About AusPARs · An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. · AusPARs are prepared and published by the TGA. · An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations and extensions of indications. · An AusPAR is a static document; it provides information that relates to a submission at a particular point in time. · A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA.
    [Show full text]
  • 2020, Vol. 16, Number 1, 1–40
    Oncology in Clinical Practice 2020, Vol. 16, Number 1, 1–40 Oncology in Clinical Practice 2020, Vol. 2020, Vol. 16, Number 1 ISSN 2450–1654 Beata Jagielska, Elżbieta Sarnowska, Tomasz Sarnowski, Katarzyna Śmiałek-Kania, Janusz Siedlecki, Andrzej Kawecki Contemporary diagnostic and therapeutic possibilities in patients with adenoid cystic carcinoma of the head and neck Łukasz Kwinta Febrile neutropenia prophylaxis with short- and long-acting granulocyte colony-stimulating factors during treatment of solid tumours Bartłomiej Żerek, Wojciech Straś, Piotr Rózga, Elżbieta Pękala The evolution of biologics in the context of oncological therapy Aleksandra Sobiborowicz, Anna M Czarnecka, Anna Szumera-Ciećkiewicz, Piotr Rutkowski, Tomasz Świtaj Diagnosis and treatment of malignant PEComa tumours Monika Misztal, Magdalena Krakowska, Monika Ryś-Bednarska, Mariusz Śliwa, Piotr Potemski Symptoms of nervous system damage in a patient undergoing anti-PD1 immunotherapy Róża Poźniak-Balicka, Dawid Murawa Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) ONCOLOGY IN CLINICAL PRACTICE Official Journal of the Polish Society of Clinical Oncology https://journals.viamedica.pl/oncology_in_clinical_practice Editor-in-Chief dr hab. med. Maria Litwiniuk prof. dr hab. med. Maciej Krzakowski dr med. Aleksandra Łacko prof. Ruggero De Maria (Rome, Italy) Deputy Editors dr Mario Mandala (Bergamo, Italy) prof. dr hab. med. Andrzej Kawecki dr hab. med. Radosław Mądry prof. dr hab. med. Piotr Potemski dr med. Janusz Meder prof. dr hab. med. Piotr Rutkowski dr hab. med. Sergiusz Nawrocki prof. dr hab. med. Krzysztof Składowski prof. dr hab. med. Włodzimierz Olszewski prof. dr hab. med. Piotr Wysocki prof. dr hab. med. Maria Podolak-Dawidziak dr hab. med. Barbara Radecka Scientific Board prof.
    [Show full text]