An introduction to the Essential Medicines concept: balancing innovation with public health priorities
|
|
- Neal Griffin
- 5 years ago
- Views:
Transcription
1 An introduction to the Essential Medicines concept: balancing innovation with public health priorities WHO HQ, Geneva 11 October 2017 Nicola Magrini Secretary, WHO Expert Committee on the Selection and Use of Essential Medicines, Essential Medicines Department, WHO
2 EML 2017: 40 th anniversary Nicola Magrini Secretary WHO Expert Committee on the Selection and Use of Essential Medicines Essential Medicines Department Séminare sur les poliitiques pharmaceutiques, Sept 2015
3 20th EML & 6th EMLc th EML: 433 medicines 6th EMLc (children): 314 medicines 602 pages, >800 references 3 Essential Medicines List: Concept and Procedures
4 Contents of the presentation 1. EML a successful evidence-based idea: guiding principles 2. Essential medicines or why some drugs are more important than others 3. Last update (2015): an important one 4. Next update 2017 or what s next 4 Essential Medicines List: Concept and Procedures
5 2. Essential medicines why some drugs are more important than other
6 EML 1977: early evidence-based adopter Important medicines for: Antibiotics Neglected diseases Pain Mental health Chronic diseases Cancer Concise and clear Promoting uptake of best research findings on medicines into healthcare and national policies No medicines for: Memory loss and dementia Hepatoprotectants Immunostimulants Osteoporosis Medicines for dubious conditions (disease mongering) No medicines listed subsequently withdrawn for unexpected risks (e.g., cox-2 inhibitors)
7 Essential Medicines Guiding principle: A limited range of carefully selected medicines leads to better health care, better medicines management, and lower costs Definition: Essential medicines are those that satisfy the priority health care needs of the population Selection: Selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative costeffectiveness 7 Essential Medicines List: Concept and Procedures
8 EML criteria (EB 109/8, 2001) Disease burden and public health need/relevance Sound and adequate data on the efficacy (on relevant outcomes), safety and comparative cost-effectiveness Absolute cost of the treatment will not constitute a reason to exclude a medicine from the Model List that otherwise meets the stated selected criteria Affordability changed from a precondition into a consequence of the selection (Hogerzeil, BMJ, 2004) WHO responsible management and oversight of CoIs 2008 WHO new Guideline Manual, adopting GRADE Other considerations: regulatory status (off-label), availability, guidelines 8 Essential Medicines List: Concept and Procedures
9 Lancet editorial October 24, Essential Medicines List: Concept and Procedures
10 3. EML rules and procedures The WHO EB resolution 2001 EB109/8
11 EML: why it is a 'model List' Model for its selection process ( one medicine per class approach unless clinically relevant differences demonstrated) Model to facilitate efforts to 'improve health' of population Regulation Quality (Rational) Responsible and evidence-based use Procurement and Supply Access: Availability, Affordability, Accessibility and Acceptability 11 Essential Medicines List: Concept and Procedures
12 The EML reform in 2002: more explicit criteria 12 Essential Medicines List: Concept and Procedures
13 WHO EB 109/8 - Medicines strategy 13 Essential Medicines List: Concept and Procedures
14 A more transparent and evidence-based process (EB109/8 2001) 14 Essential Medicines List: Concept and Procedures
15 A more transparent and evidence-based process (EB109/8 2001) 15 Essential Medicines List: Concept and Procedures
16 A more transparent and evidence-based process (EB109/8 2001) 16 Essential Medicines List: Concept and Procedures
17 EML criteria (EB 109/8, 2001) Essential medicines are those that satisfy the priority health care needs of the population (it was deleted the majority of the population) Disease burden and public health need Sound and adequate data on the efficacy, safety and comparative cost-effectiveness of available treatments Need for special diagnostic or treatment facilities considered Absolute cost of the treatment will not constitute a reason to exclude a medicine from the Model List that otherwise meets the stated selected criteria 17 Essential Medicines List: Concept and Procedures
18 3. EML 2017: what has changed The format for the final report 18 Essential Medicines List: Concept and Procedures
19 TRS TEMPLATE Essential Medicines List: Concept and Procedures
20 3. EML 2017: what will be available An electronic version of the EML and An EML database 20 Essential Medicines List: Concept and Procedures
21 eeml: database & formats ONLINE SEARCH ENGINE ELECTRONIC DATABASE TEMPLATE LINK TO WHO GUIDELINES EVIDENCE SYNTHESIS
22 eeml 22 Essential Medicines List: Concept and Procedures
23 The new EML 2017
24 EML 2017 major CHANGES/UPDATES Antibiotic comprehensive review 3 tiered categorisation: ACCESS, WATCH and RESERVE 23 syndromes reviewed: first and second choice Cancer: 8 medicines, 2 approvals HIV: dolutegravir, PreP HepC: sofosbuvir + velpatasivir (pangenotypic) Contraception: ulipristal and MPA 24 Essential Medicines List: Concept and Procedures
25 25 Essential Medicines List: Concept and Procedures
26 Applications not endorsed (n=20) COBI+ELV+FTC+TAF Gatifloxacin Polypill Bevacizumab (del) Hypoclorous acid RUTF Elabasvir+grazoprevir Insulin analogues Tenofovir alafenamide (TAF) FTC+RLP+TAF Lisinopril + HCTZ Tramadol FTC + TAF Misoprostol (del) Trastuzumab emtansine Enzalutamide NSCLC (TKIs, crizotinib) T2D 2 nd line medicines Gabapentin Oseltamivir (del) 26 Essential Medicines List: Concept and Procedures
27 EML 2017 Cancer & cancer pain Recommendations Rejections/standby Dasatinib (CML) Nilotinib (CML) Zoledronic acid (bone metatsteses) Fentanyl (transdermal) Methadone (already listed for substitution treatment) Enzalutamide (prostate) Trastuzumab emtansine (breast) TKIs, crizotinib (NSCLC) Tramadol (cancer pain)
28 Methodology to Develop Proposal for Revisions TREATMENT GOAL Cure or near cure Testicular and ovarian Leukemia and germ cell tumors Lymphomas in CML Children and Adults GTN Early-Stage Breast Cancer Early-Stage Colon Cancer HIGH PRIORITY Significant prolongation of survival GIST Stage III Ovarian Cancer Metastatic Breast Cancer Metastatic Prostate Cancer Palliation of symptoms with small benefit in survival LOWEST PRIORITY Metastatic Pancreatic Cancer Metastatic Bladder Cancer LOW PRIORITY Metastatic Lung Cancer Low Medium High Slide credit: Dr. Gilberto Lopes INCIDENCE OF DISEASE
29 21st EML (*6th EMLc) Cytotoxic and adjuvant medicines All-trans retinoid acid (ATRA) Cytarabine* Gemcitabine Procarbazine Allopurinol* Dacarbazine* Hydroxycarbamide Rituximab Asparaginase* Dactinomycin* Ifosfamide* Tioguanine* Bendamustine Dasatinib Imatinib Trastuzumab Bleomycin* Daunorubicin* Irinotecan Vinblastine* Calcium folinate* Docetaxel Mercaptopurine* Vincristine* Capecitabine Doxorubicin* Mesna* Vinorelbine Carboplatin* Etoposide* Methotrexate* Zoledronic acid Chlorambucil Filgrastim* Nilotinib Cisplatin* Fludarabine Oxaliplatin* Cyclophosphamide* Fluorouracil Paclitaxel*
30 21st EML (*6th EMLc) Cytotoxic and adjuvant medicines All-trans retinoid acid (ATRA) Cytarabine* Gemcitabine Procarbazine Allopurinol* Dacarbazine* Hydroxycarbamide Rituximab Asparaginase* Dactinomycin* Ifosfamide* Tioguanine* Bendamustine Dasatinib Imatinib Trastuzumab Bleomycin* Daunorubicin* Irinotecan Vinblastine* Calcium folinate* Docetaxel Mercaptopurine* Vincristine* Capecitabine Doxorubicin* Mesna* Vinorelbine Carboplatin* Etoposide* Methotrexate* Zoledronic acid Chlorambucil Filgrastim* Nilotinib Cisplatin* Fludarabine Oxaliplatin Cyclophosphamide* Fluorouracil Paclitaxel* BLUE: added in 2015 GREEN: added in 2017
31 21st EML (*6th EMLc) Hormones and antihormones Anastrazole Hydrocortisone* Bicalutamide Methylprednisolone* Dexamethasone* Prednisolone* Leuprorelin Tamoxifen
32 21st EML (*6th EMLc) Hormones and antihormones Anastrozole Hydrocortisone* Bicalutamide Methylprednisolone* Dexamethasone* Prednisolone* Leuprorelin Tamoxifen BLUE: added in 2015 GREEN: added in 2017
33 EML 2017: medicines (by 32) cancers Indication Medicines Acute lymphoblastic leukaemia (EML and EMLc) Acute myelogenous leukaemia (EML) Acute promyelocytic leukaemia) (EML) Asparaginase Cyclophosphamide Cytarabine Daunorubicin Doxorubicin Cytarabine All-trans retinoic acid Cytarabine Etoposide Mercaptopurine Methotrexate Tioguanine Vincristine Daunorubicin Daunorubicin Mercaptopurine Dexamethasone Hydrocortisone Methylprednisolone Prednisolone Methotrexate Burkitt lymphoma (EML and EMLc) Chronic lymphocytic leukaemia (EML) Chronic myeloid leukaemia (EML) Calcium folinate Cyclophosphamide Cytarabine Bendamustine Chlorambucil Cyclophosphamide Hydroxycarbamide Imatinib Doxorubicin Etoposide Vincristine Cyclophosphamide Fludarabine Prednisolone Rituximab Prednisolone Chronic myeloid leukaemia IMATINIB RESISTANT (EML) Diffuse large B-cell lymphoma (EML) Dasatinib Nilotinib Cyclophosphamide Doxorubicin Rituximab Vincristine Prednisolone
34 EML 2017: medicines (by 32) cancers Indication Medicines Head and neck cancer (EML) Early-stage breast cancer (EML) Early-stage cervical cancer (EML) Early-stage colon cancer (EML) Early-stage rectal cancer (EML) Epithelial ovarian cancer (EML) Ewing sarcoma (EML and EMLc) Follicular lymphoma (EML) e e e Cisplatin Carboplatin Cyclophosphamid Docetaxel Doxorubicin Cisplatin Calcium folinate Capecitabine Calcium folinate Capecitabine Carboplatin Gemcitabine Cyclophosphamid Doxorubicin Bendamustine Cyclophosphamid Fluorouracil Methotrexate Paclitaxel Trastuzumab Fluorouracil Oxaliplatin Fluorouracil Paclitaxel Etoposide Ifosfamide Doxorubicin Rituximab Anastrozole Leuprorelin Tamoxifen Mesna Vincristine Vincristine Prednisolone
35 EML 2017: medicines (by 32) cancers Indication Medicines Gastrointestinal stromal tumour (EML) Gestational trophoblastic neoplasia (EML) Hodgkin lymphoma adults* and paediatric (EML and EMLc) Kaposi sarcoma (EML) Malignancy related bone disease (EML) Metastatic breast cancer (EML) Metastatic colorectal cancer (EML) Metastatic prostate cancer (EML) Nasopharyngeal cancer (EML) Imatinib Calcium folinate Cyclophosphamide Bleomycin* Cyclophosphamide Dacarbazine* Bleomycin Doxorubicin Zoledronic acid Capecitabine Cyclophosphamide Docetaxel Calcium folinate Capecitabine Docetaxel Bicalutamide Carboplatin Cisplatin Dactinomycin Etoposide Doxorubicin* Etoposide Vinblastine* Paclitaxel Vinblastine Doxorubicin Paclitaxel Trastuzumab Fluorouracil Irinotecan Leuprorelin Fluorouracil Paclitaxel e Methotrexat Vincristine Vincristine Prednisolone Vincristine Vinorelbine Anastrozole Tamoxifen Oxaliplatin
36 EML 2017: medicines (by 32) cancers Indication Medicines Non-small cell lung cancer (EML) Carboplatin Cisplatin Etoposide Gemcitabine Paclitaxel Vinorelbine Osteosarcoma (EML and EMLc) Calcium folinate Carboplatin Cisplatin Doxorubicin Ifosfamide Mesna Methotrexate Ovarian germ cell tumours (EML and EMLc) Bleomycin Cisplatin Etoposide Ifosfamide Mesna Paclitaxel Vinblastine Retinoblastoma (EML and EMLc) Carboplatin Etoposide Vincristine Rhabdomyosarcoma (EML and EMLc) Cyclophosphamide Dactinomycin Ifosfamide Mesna Vincristine Testicular germ cell tumours (EML and EMLc) Bleomycin Cisplatin Etoposide Ifosfamide Mesna Vinblastine Wilms tumour (EML and EMLc) Dactinomycin Doxorubicin Vincristine
37
38 EML 2017 HIV & Hepatitis B/C Recommendations Atazanavir + ritonavir Dolutegravir Raltegravir EFV TC + TDF INH + B6 + CTX PrEP: TDF, TDF + FTC/3TC Sofosbuvir + velpatasvir Rejections COBI + ELV + FTC + TAF FTC + RLP + TAF FTC + TAF Tenofovir alafenamide Elbasvir + grazoprevir
39 EML 2017 Malaria & TB Recommendations Artesunate+pyronaridine DHA + PQP Rejections Gatifloxacin Delamanid (paediatrics) Ofloxacin (deletion) Isoniazid (+pyrazinamide) + rifampicin FDC (paediatrics)
40 EML 2017 Reproductive health Recommendations Rejections Ulipristal (emergency contraception) Medroxyprogesterone acetate (new SC formulation) Misoprostol (deletion) prevention PPH - unchanged in EML
41 EML: why so many contraceptives To increase women choice To consider patients preferences To incorporate values
42 EML 2017 Non-communicable diseases Recommendations Erythropoiesis-stimulating agents
43 EML 2017 Non-communicable diseases Erythropoiesis-stimulating agents
44 EML 2017 Non-communicable diseases Erythropoiesis-stimulating agents
45 EML 2017 Non-communicable diseases Recommendations Erythropoiesisstimulating agents Budesonide + formoterol Lamotrigine - epilepsy Losartan Rejections Bevacizumab (deletion) unchanged in EML Gabapentin Insulin analogues T2D 2 nd line medicines Lisinopril + HCTZ Polypill
46 Oseltamivir Deletion NOT recommended Restricted use: moved to the Complementary List critically hill patients with influenza with a positive influenza test Access to all clinical data led to revision of the magnitude of benefit associated with treatment WHO guidelines expected in 2018 Review of clinical data in 2019: flagged for deletion BMJ Tamiflu timeline 46 Essential Medicines List: Concept and Procedures
47 EML 2017 Non-communicable diseases Recommendations Erythropoiesisstimulating agents Budesonide + formoterol Lamotrigine - epilepsy Losartan Rejections Bevacizumab (deletion) unchanged in EML Gabapentin Insulin analogues T2D 2 nd line medicines Lisinopril + HCTZ Polypill
48 Gabapentin NOT recommended for neuropathic pain Uncertainty in reported efficacy estimates related to publication and outcome reporting biases 48 Essential Medicines List: Concept and Procedures
49 Gabapentin Reporting bias occurs when the dissemination of research findings is influenced by the nature and direction of the results. There is extensive, even shocking, evidence of reporting biases in the studies of Neurontin that I reviewed for this report. Studies were biased in their design Ghost authors Hiding of negative results Patients inappropriately excluded from or included in the analyses 49 Essential Medicines List: Concept and Procedures
50 EML: why NOT gabapentin
51 EML: why NOT gabapentin
52
53 EML: why NOT gabapentin
54
55 EML 2017 Non-communicable diseases Recommendations Erythropoiesisstimulating agents Budesonide + formoterol Lamotrigine - epilepsy Losartan Rejections Bevacizumab (deletion) unchanged in EML Gabapentin Insulin analogues T2D 2 nd line medicines Lisinopril + HCTZ Polypill
56 EML 2017: insulins analogues
57
58 EML 2017: diabetes second line 58 Essential Medicines List: Concept and Procedures
59 EML 2017: diabetes second line 59 Essential Medicines List: Concept and Procedures
60 EML 2017: diabetes second line 60 Essential Medicines List: Concept and Procedures
61 5. EML and pharmacological classes Listing: one drug only per pharmacological class implications for selection and procurement
62 EML and therapeutic equivalency 1/3 62 Essential Medicines List: Concept and Procedures
63 EML and therapeutic equivalency 2/3 63 Essential Medicines List: Concept and Procedures
64 Example 1 64 Essential Medicines List: Concept and Procedures
65 Example 2 : limited square boxing 65 Essential Medicines List: Concept and Procedures
66 Example 3: limited square boxing 66 Essential Medicines List: Concept and Procedures
67 EML and therapeutic equivalency 3/3 WHO supports pooled procurement mechanisms that can increase competition among available alternatives/options Generic substitution and biosimilars role 67 Essential Medicines List: Concept and Procedures
68 Example 4: Erythropoetins and respective biosimilars 68 Essential Medicines List: Concept and Procedures
An introduction to the Essential Medicines concept: balancing innovation with public health priorities
An introduction to the Essential Medicines concept: balancing innovation with public health priorities World Oncology Forum Lugano 20 October 2017 Nicola Magrini Secretary, WHO Expert Committee on the
More informationCOST CONSIDERATIONS Union for International Cancer Control 2014 Review of Cancer Medicines on the WHO List of Essential Medicines!!!!!!!!!
UICCEMLCostingScenarios BackoftheEnvelope Calculations PreparedforWorkingGroupSession:19621November2014,Geneva MethodsSummary We have chosen a conservative approach, calculating cost per vial. We have
More informationWorld Health Organization: Essential Medicines and Devices for Cancer:
World Health Organization: Essential Medicines and Devices for Cancer: Principles, Methodologies, and Outcomes Lawrence N. Shulman, MD Abramson Cancer Center, University of Pennsylvania Partners In Health
More informationUpdate on the WHO EML 2017 process: focus on the selection of antibiotics
Update on the WHO EML 2017 process: focus on the selection of antibiotics IPC Seminar, Geneva 9 th December 2016 Nicola Magrini EML Secretary, Policy, Access and Use - Essential Medicines Department Who
More informationCANCER PREVENTION AND ACCESS TO MEDICINES. Gracemarie Bricalli ESMO Head of International Affairs
CANCER PREVENTION AND ACCESS TO MEDICINES Gracemarie Bricalli ESMO Head of International Affairs ESMO s 2020 Vision: Access to cancer care ESMO s 2020 vision statement recognises that progress in the management
More informationASSESSMENT OF THE PAEDIATRIC NEEDS CHEMOTHERAPY PRODUCTS (PART I) DISCLAIMER
European Medicines Agency Evaluation of Medicines for Human Use London, September 2006 Doc. Ref.: EMEA/384641/2006 ASSESSMENT OF THE PAEDIATRIC NEEDS CHEMOTHERAPY PRODUCTS (PART I) DISCLAIMER The Paediatric
More informationWest of Scotland Cancer Network Guideline for Managing Chemotherapy Induced Nausea and Vomiting
West of Scotland Cancer Network Guideline for Managing Chemotherapy Induced Nausea and Vomiting Definitions Acute nausea and vomiting Delayed nausea and vomiting Anticipatory nausea and vomiting Initial
More information1 The Cancer Programs Regulation (AR 242/98) is amended by this Regulation.
Alberta Regulation 18/2005 Cancer Programs Act AMENDMENT REGULATION Filed: February 22, 2005 For information only: Made by the Minister of Health and Wellness (M.O. 9/2005) on February 17, 2005 pursuant
More informationGuidelines for the Use of Anti-Emetics with Chemotherapy
Guidelines for the Use of Anti-Emetics with The purpose of this document is to provide guidance on the rational use of anti-emetics for prevention and treatment of chemotherapy-induced nausea and vomiting
More informationProposing Trastuzumab as an Essential Medicine to Treat Cancer: Insight on Methodologies, Processes and Outcomes. Lorenzo Moja
Proposing Trastuzumab as an Essential Medicine to Treat Cancer: Insight on Methodologies, Processes and Outcomes Lorenzo Moja Essential Medicines List Secretariat Essential Medicines and Health Products
More informationProtocol Number Tumour Group Protocol Name on NCCP website 22/02/ Lung Afatinib Monotherapy 244 Gastrointestinal Regorafenib Monotherapy
Last Updated 22-Feb-18 Date of last update Protocol Number Tumour Group Protocol Name on NCCP website 22/02/2018 221 Afatinib Monotherapy 244 Gastrointestinal Regorafenib Monotherapy 249 Gynaecology Intrathecal
More informationExhibit B United States Patent Application 20020012663 Kind Code A1 Waksal, Harlan W. January 31, 2002 Treatment of refractory human tumors with epidermal growth factor receptor antagonists Abstract A
More informationProtocol Number Intrathecal Methotrexate for CNS 01/02/2018 Prophylaxis in GTN Gynaecology 249
Last updated Feb 9, 2018 Revision due Protocol Name on NCCP website Tumour Group Protocol Number Intrathecal Methotrexate for CNS 01/02/2018 Prophylaxis in GTN Gynaecology 249 Two Day Etoposide CISplatin
More informationDOXOrubicin, Cyclophosphamide (AC 60/600) 21 day followed by weekly PACLitaxel (80) Therapy (AC-T) 261 CARBOplatin (AUC4-6) Monotherapy-21 days
Last updated Oct 17, 2018 Tumour Group Protocol Number Protocol Name on NCCP website Breast 200 Trastuzumab (IV) Monotherapy 21 days 201 Trastuzumab (IV) Monotherapy 7 days 202 DOCEtaxel Monotherapy 100mg/m2
More informationGuidelines on Chemotherapy-induced Nausea and Vomiting in Pediatric Cancer Patients
Guidelines on Chemotherapy-induced Nausea Vomiting in Pediatric Cancer Patients COG Supportive Care Endorsed Guidelines Click here to see all the COG Supportive Care Endorsed Guidelines. DISCLAIMER For
More informationHaematology, Oncology and Palliative Care Directorate.
Anticancer Treatment for Administration on the Somerset Mobile Chemotherapy Unit The table below details the suitability of different types of anticancer treatment for administration on the Somerset Mobile
More informationICON Formulary - October 2018 Legend - ICON Protocols Essential (previously Standard), Core, Enhanced Core, Enhanced Enhanced
ICON Formulary - October 2018 Legend - ICON Protocols Essential (previously Standard), Core, Enhanced Core, Enhanced Enhanced Class Medicine Name Nappi Strength Form Size Route Abiraterone Acetate ZYTIGA
More informationH&HD ANTINEOPLASTIC DRUG CARD ASSEMBLY INSTRUCTIONS
H&HD ANTINEOPLASTIC DRUG CARD ASSEMBLY INSTRUCTIONS Each of you should have 37 new cards: 7 orange cards for antimetabolites 11 white cards for miscellaneous drugs (2 DNA synthesis inhibitors, 1 enzyme,
More informationOVERVIEW OF COMMENTS RECEIVED ON LIST OF PAEDIATRIC NEEDS ONCOLOGY I (CYTOTOXIC THERAPY)
European Medicines Agency Evaluation of Medicines for Human Use London, September 2006 Doc. Ref. OVERVIEW OF COMMENTS RECEIVED ON LIST OF PAEDIATRIC NEEDS ONCOLOGY I (CYTOTOXIC THERAPY) Table 1: Organisations
More informationProduct Visual Guide
Product Visual Guide Teamwork A team with an unflinching faith in one another is one of our core strength. Excellence Achieving excellence is not the end result, we begin with excelling in any endeavor.
More informationCommissioning policies agreed by PCTs in Yorkshire and the Humber at Board meeting of YH SCG on December
Commissioning policies agreed by PCTs in Yorkshire and the Humber at Board meeting of YH SCG on December 17 2010. 32/10 Imatinib for gastrointestinal stromal tumours (unresectable/metastatic) (update on
More informationEssentials. Oncology Practise Essentials. Oncology Basics. Tutorial 2. Cancer Chemotherapy
Practise Practise This tutorial introduces you to the history, goals of therapy, classification, and clinical uses of chemotherapy. It also reviews some of the barriers to successful therapy. Goals and
More informationTHE ESMO INTERNATIONAL ANTINEOPLASTIC MEDICINES SURVEY: HOW AVAILABLE ARE THE WHO ESSENTIAL CANCER MEDICINES?
THE ESMO INTERNATIONAL ANTINEOPLASTIC MEDICINES SURVEY: HOW AVAILABLE ARE THE WHO ESSENTIAL CANCER MEDICINES? Alexandru ENIU, MD, PhD Chair, ESMO Global Policy Committee Department of Breast Tumors Cancer
More informationYear III Pharm D. Dr. V. Chitra
Year III Pharm D. Dr. V. Chitra 50.2 Rang Etiolopathology Cell Cycle = Growth, Division 18_01_cell_cycle.jpg Characteristics of Cancer Cells The problem: Cancer cells divide rapidly (cell cycle is accelerated)
More informationFor Health Professionals Who Care For Cancer Patients EDITOR S CHOICE
Inside This Issue: For Health Professionals Who Care For Cancer s March 2019 Vol. 22 No. 3 Editor s Choice New Programs: Rituximab Protocols in CLL/SLL Updated (LYCLLBENDR, LYCLLCHLR, LYCLLCVPR, LYCLLFLUDR,
More informationObjective: To provide a standard procedure for the recycling of unused medication and the disposal of medicines across all BCPFT Hospital sites.
WARDS/DEPARTMENTS By: 0 01/09/019 1 of 3 Objective: To provide a standard procedure for the recycling of unused medication and the disposal of medicines across all BCPFT Hospital sites. Scope: All Black
More informationMedication Review. Cancer Chemotherapy Drugs. Pharmacy Technician Training Systems Passassured, LLC
Medication Review Cancer Chemotherapy Drugs Pharmacy Technician Training Systems Passassured, LLC Medication Review, Cancer Chemotherapy Drugs PassAssured's Pharmacy Technician Training Program Medication
More informationSpecial article. Essential drugs for cancer therapy: A World Health Organization consultation
Annals of Oncology 10: 385-390, 1999. 1999 Kluwer Academic Publishers. Printed in the Netherlands. Special article Essential drugs for cancer therapy: A World Health Organization consultation K. Sikora,
More informationGuideline Update on Antiemetics
Guideline Update on Antiemetics Clinical Practice Guideline Special Announcements Please check www.asco.org/guidelines/antiemetics for current FDA alert(s) and safety announcement(s) on antiemetics 2 Introduction
More informationAdult Intravenous Systemic Anticancer Therapy (SACT) Section A. SUMMARY of SCHEME QIPP Reference
CA2 Nationally standardised Dose banding for Adult Intravenous Anticancer Therapy (SACT) Scheme Name CA2: Nationally Standardised Dose Banding for Adult Intravenous Systemic Anticancer Therapy (SACT) Section
More informationWorking Formulary January 2013 Oncology Chemotherapy Regimens
Working Formulary January 2013 Oncology Chemotherapy Regimens In the currently changing commissioning landscape, this document is intended to represent the up to date list of non clinical trial chemotherapy
More informationAppendix 2. Adjuvant Regimens. AC doxorubin 60 mg/m 2 every 3 weeks x 4 cycles Cyclophosphamide 600 mg/m 2
Appendix 2 Adjuvant Regimens AC doxorubin 60 mg/m 2 every 3 weeks x 4 cycles Cyclophosphamide 600 mg/m 2 CMF IV cyclophosphamide 600 mg/m 2 days 1 & 8 every 4 weeks methotrexate 40 mg/m 2 for 6 cycles
More informationMASCC Guidelines for Antiemetic control: An update
MASCC / ISOO 17 th International Symposium Supportive Care in Cancer June 30 July 2, 2005 / Geneva, Switzerland MASCC Guidelines for Antiemetic control: An update Sussanne Börjeson, RN, PhD Linköping University,
More informationSPECIAL AUTHORIZATION REQUEST FOR COVERAGE OF HIGH COST CANCER DRUGS
SPECIAL AUTHORIZATION REQUEST FOR COVERAGE OF HIGH COST CANCER DRUGS (Filgrastim, Capecitabine, Imatinib, Dasatinib, Erolotinib, Sunitinib, Pazopanib, Fludarabine, Sorafenib, Crizotinib, Tretinoin, Nilotinib,
More informationGUIDELINES FOR ANTIEMETIC USE IN ONCOLOGY SUMMARY CLASSIFICATION
GUIDELINES FOR ANTIEMETIC USE IN ONCOLOGY SUMMARY More than half of all cancer patients experience nausea or vomiting during the course of their treatment. If nausea or vomiting becomes severe enough,
More informationGeneral Authorization Criteria for ALL Agents and Indications:
Neulasta (peg-filgrastim; G-CSF) Neupogen (filgrastim; G-CSF) Neulasta Onpro (peg-filgrastim; G-CSF) Leukine (sargramostim; GM-CSF) General Authorization Criteria for ALL Agents and Indications: Prescribed
More informationStandard Regimens for Haematology
Regimens for Haematology ChlVPP Chlorambucil 6mg/m 2 PO D1 to 14 Vinblastine 6mg/m 2 (max 10mg) IV on D1 & 8 Procarbazine 100mg/m 2 PO on D1 to 14 Prednisolone 40mg PO D1 to 14 ABVD Doxorubicin 25mg/m
More informationIndex. Note: Page numbers of article titles are in boldface type.
Index Note: Page numbers of article titles are in boldface type. A Abdominal drainage, after hepatic resection, 159 160 Ablation, radiofrequency, for hepatocellular carcinoma, 160 161 Adenocarcinoma, pancreatic.
More informationPatient 1: Patient 2:
Appendix A Compiled by Dr. Raymond Ngeh and Dr. Robert Luk Clinical notes and PET/CT scan images of eleven patients: 1. Middle age woman has cancer of the pancreas in the body of the gland. After just
More informationAn international clinical program for the diagnosis and treatment of children, adolescents and young adults with ependymoma
This list covers the Principal Treatment Centre (Alder Hey) and POSCUs including community services. It covers solid tumour oncology and haemato-oncology clinical management protocols and agreed chemotherapy
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Kymriah) Reference Number: CP.PHAR.361 Effective Date: 09.26.17 Last Review Date: 11.18 Line of Business: Commercial, Medicaid, HIM-Medical Benefit Revision Log See Important Reminder
More informationCancerPACT Cancer Patients Alliance for Clinical Trials
TM CancerPACT Cancer Patients Alliance for Clinical Trials Listing of Ongoing Cancer Clinical Trials in the Salinas Valley Winter 2008 I. Solid Tumors 1. Breast p.1 2. Central Nervous System p.2 3. Gastrointestinal
More informationPharmacy Prior Authorization Colony Stimulating Factor (CSF)/Myeloid Growth Factor (MGF) Clinical Guideline
Neulasta (peg-filgrastim; G-CSF) Neupogen (filgrastim; G-CSF) Neulasta Onpro (peg-filgrastim; G-CSF) Leukine (sargramostim; GM-CSF) General Authorization Criteria for ALL Agents and Indications: Prescribed
More information2. Mitotic Spindle Inhibitors (modulators of tubulin polymerisation) 3. Antimetabolites (anti-folates, pyrimidine and purine analogues)
CANCER DRUG CLASSES The classes of drugs currently used in the cancer clinic are 1. DNA Binding Agents (intercalating and alkylating agents) 2. Mitotic Spindle Inhibitors (modulators of tubulin polymerisation)
More informationFor Health Professionals Who Care For Cancer Patients
May 2014 Volume 17, Number 5 For Health Professionals Who Care For Cancer Patients Inside This Issue: Editor s Choice New Programs: Breast Trastuzumab Emtansine for Metastatic Breast Cancer (UBRAVKAD);
More informationAdverse effects of anticancer drugs (Antimetabolites agents, Alkylating agents, Antimicrotubule agents, Miscellaneous agents, Immune therapies and
35 Adverse effects of anticancer drugs (Antimetabolites agents, Alkylating agents, Antimicrotubule agents, Miscellaneous agents, Immune therapies and Biologically directed therapies ) 1 1- Nausea and vomiting
More informationOpen / Closed to Recruitment. POSCU Involvement. Diagnosis Trial Oral Chemo Protocol Title Bone
This list covers the Principal Treatment Centre (Alder Hey) and POSCUs including community services. It covers solid tumour oncology and haemato oncology clinical management protocols and agreed chemotherapy
More informationCancer drug approvals for paediatric indications (n=43)
Appendix: Supplementary material [posted as supplied by author] Figure A. Identification of cohort of drugs Total number of antineoplastic and immunomodulating products approved by the EMA up to 31 December
More informationDisturbances of female reproductive system in survivors of childhood cancer
Disturbances of female reproductive system in survivors of childhood cancer Assoc. Prof. Zana Bumbuliene VU Faculty of Medicine Clinic of Obstetrics and Gynaecology 13 SEP 2014 Introduction Cancer is the
More informationActive Cancer Studies by Approval Date For additional information on any one of these studies contact the Lancaster General Cancer Center
Active Cancer Studies by Approval Date For additional information on any one of these studies contact the Lancaster General Cancer Center 717-544-3113 PROTOCOL NO STUDY TITLE PRINCIPAL INVESTIGATOR ECOG
More informationAdjuvant/Curative/Neo-adjuvant High Grade and Burkitt s Lymphoma Regimens. High Grade Lymphoma
Adjuvant/Curative/Neo-adjuvant High Grade and Burkitt s Lymphoma Regimens The following table lists the evidence-informed regimens (both IV and non-iv) for high grade and Burkitt s lymphoma used in the
More informationFor Health Professionals Who Care For Cancer Patients
March 2018 Volume 21, No. 3 For Health Professionals Who Care For Cancer s Inside This Issue: Editor s Choice New Programs: Nivolumab for Squamous Cell Cancer of the Head and Neck, Ibrutinib for Mantle-Cell
More informationPriority setting at a national level NICE - England. Gillian Leng Deputy Chief Executive, NICE September 2016
Priority setting at a national level NICE - England Gillian Leng Deputy Chief Executive, NICE September 2016 Areas to cover The role of NICE in the UK health system General approach to appraising new drugs
More informationUse of Prophylactic Growth Factors and Antimicrobials in Elderly Patients with Cancer: A
Supportive Care in Cancer Use of Prophylactic Growth Factors and Antimicrobials in Elderly Patients with Cancer: A Systematic Review of the Medicare Database Romina Sosa, Shuling Li, Julia T. Molony, Jiannong
More informationCCC Chemotherapy Protocols V9.0
CCC Chemotherapy Protocols V9.0 General observations 3 Breast cancer 5 Gastrointestinal cancer Oesophagus 17 Gastric 19 Pancreas 22 Cholangiocarcinoma 24 Hepatocellular carcinoma 25 Neuroendocrine tumours
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Tisagenlecleucel (Kymriah) Reference Number: CP.PHAR.361 Effective Date: 10.01.18 Last Review Date: 07.13.18 Line of Business: Oregon Health Plan Revision Log See Important Reminder at
More informationCHEMOTHERAPY/ ANTICANCER DRUGS/ NEOPLASTIC AGENTS
CHEMOTHERAPY/ 1 Oncology, Misc, Vaccines ANTICANCER DRUGS/ NEOPLASTIC AGENTS Important Terms: Cancer: A group of diseases involving abnormal cell growth with the potential to invade or spread to other
More informationPharmacy Prior Authorization Colony Stimulating Factors Clinical Guideline. Neulasta Onpro (peg-filgrastim; G-CSF) Leukine (sargramostim; GM-CSF)
Neulasta (peg-filgrastim; G-CSF) Neupogen (filgrastim; G-CSF) Neulasta Onpro (peg-filgrastim; G-CSF) Leukine (sargramostim; GM-CSF) General Authorization Criteria for ALL Agents and Indications: Prescribed
More informationVI.2 Elements for a Public Summary VI.2.1 Overview of Disease Epidemiology Acute Nausea and Vomiting (N&V) Etiologies:
VI.2 Elements for a Public Summary VI.2.1 Overview of Disease Epidemiology Acute Nausea and Vomiting (N&V) Incidence: The incidence of acute and delayed N&V was investigated in highly and moderately emetogenic
More informationMEDICAL NECESSITY GUIDELINE
PAGE: 1 of 10 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review and consideration of generally accepted
More informationEssential Medicines: update on policies and standards
Essential Medicines: update on policies and standards Jane Robertson Technical Officer Health Technologies and Pharmaceuticals (HTP) WHO Regional Office for Europe Pharmaceutical sector is complex R&D
More informationDRUG PROPERTIES YOU NEED TO KNOW
Dr. Janet Fitzakerley Summer 2013 Med 6541 Hematopoiesis and Host Defences jfitzake@d.umn.edu www.d.umn.edu/~jfitzake Page 1 of 11 DRUG PROPERTIES YOU NEED TO KNOW 1. Mechanism of action a. chemical class
More informationEmetogenicity level 1. Emetogenicity level 2
Emetogenicity level 1 15 mins Pre-Chemo Maxalon 10mg po During chemo and Post Chemo 3 days Maxalon10mg po 8 hourly Increase Maxalon 20mg po 8 hourly Change to Cyclizine 50mg po 8 hourly 3 days If nausea
More informationAn Overview. Paediatric Oncology. In Malawi
An Overview of Paediatric Oncology In Malawi 15.6 % of all cancers are attributable to infections 21% -100,000/yr in Africa; 9% - 375,000/yr in West Pidani et al 1990 IN AFRICA EARLY ACQUISITION OF VIRUSES
More information6/22/2017 TARGETING THE TARGETS IN 2017 TARGETING THE TARGETS IN 2017
TARGETING THE TARGETS IN 2017 Primary Care Focus Symposium July 1, 2017 Grace Wang MD I do not have any relevant financial relationships to disclose at this time TARGETING THE TARGETS IN 2017 What are
More informationSCI. SickKids-Caribbean Initiative Enhancing Capacity for Care in Paediatric Cancer and Blood Disorders
1.0 Introduction The (SCI) is a not-for-profit collaboration between the Hospital for Sick Children (SickKids), Toronto, Canada, and seven Caribbean health care institutions across six countries that strive
More information18th Expert Committee on the Selection and Use of Essential Medicines. Reviewer No. 1 checklist for:
18th Expert Committee on the Selection and Use of Essential Medicines Reviewer No. 1 checklist for: Review of medicines for the treatment of common tumours in Children In the WHO Essential Medicines List
More informationNational Horizon Scanning Centre. Sunitinib (Sutent) for advanced and/or metastatic breast cancer. December 2007
Sunitinib (Sutent) for advanced and/or metastatic breast cancer December 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not
More informationWHO Technical Report Series The Selection and Use of Essential Medicines
WHO Technical Report Series The Selection and Use of Essential Medicines Report of the WHO Expert Committee on Selection and Use of Essential Medicines, 2017 (including the 20th WHO Model List of Essential
More informationMEDICAL PRIOR AUTHORIZATION
MEDICAL PRIOR AUTHORIZATION TAXOTERE (docetaxel) DOCEFREZ(docetaxel) docetaxel (generic) POLICY I. INDICATIONS The indications below including FDA-approved indications and compendial uses are considered
More informationPrimary malignant neoplasms, not lymphatic or hematopoietic. Secondary malignant neoplasms (i.e.metastatic) Malignant neoplasm, unknown site
Supplementary Table 1. ICD-9-CM codes used to define cancer ICD-9 Diagnosis code 140.xx-172.xx 174.xx-195.xx 196.xx 198.xx 199.xx 200.xx-208.xx Description Primary malignant neoplasms, not lymphatic or
More informationDRUG PROPERTIES YOU NEED TO KNOW
jfitzake@d.umn.edu www.d.umn.edu/~jfitzake Page 1 of 8 DRUG PROPERTIES YOU NEED TO KNOW 1. Mechanism of action a. chemical class b. resistance 2. Pharmacokinetics 3. Therapeutic uses 4. Major side effects/toxicities
More informationWASHINGTON. Spokane Cheney. Olympia. Tri-Cities. Walla Walla. Portland North Central Oregon City OREGON. Mt. Vernon. Port Angeles
2 3 Mt. Vernon Port Angeles Bremerton Tacoma 5 5 Olympia Everett Edmonds Seattle 90 WASHINGTON 90 Spokane Cheney Pullman Longview 82 Tri-Cities Portland North Central Oregon City 5 84 OREGON Walla Walla
More informationDocetaxel. Class: Antineoplastic agent, Antimicrotubular, Taxane derivative.
Docetaxel Class: Antineoplastic agent, Antimicrotubular, Taxane derivative. Indications: -Breast cancer: -Non small cell lung cancer -Prostate cancer -Gastric adenocarcinoma _Head and neck cancer Unlabeled
More informationAPPHON/ROPPHA Guideline for the Prevention and Management of Chemotherapy Induced Nausea and Vomiting in Children with Cancer
APPHON/ROPPHA Guideline for the Prevention and Management of Chemotherapy Induced Nausea and Vomiting in Children with Cancer 5850/5980 University Avenue, PO Box 9700, Halifax, N.S. B3K 6R8 PEDIATRIC HEMATOLOGY/ONCOLOGY
More informationDRUG EXTRAVASATION. Vesicants. Irritants
DRUG EXTRAVASATION Vesicants Irritants Vesicants Antineoplastic drugs Amsacrine Dactinomycin Daunorubicin Docetaxel (rare) Doxorubicin Epirubicin Idarubicin Mechlorethamine Mitomycin Oxaliplatin (rare)
More informationCancer-Drug Associations: A Complex System
Cancer-Drug Associations: A Complex System Ertugrul Dalkic 1,2,3, Xuewei Wang 1,4, Neil Wright 1,5, Christina Chan 1,2,3,4,6,7 * 1 Center for Systems Biology, Michigan State University, East Lansing, Michigan,
More informationOPCS Classification of Interventions and Procedures Version 4.6 (April 2011)
Chemotherapy Regimens Clinical Coding Guidance OPCS-4.6 Version 1.0 Programme Sub Programme Data Standards & Products Clinical Classifications Document Record ID Key NPFIT-SHR-SHI-0318.01 Programme Director
More informationThe AngCN Antiemetic Guidelines
The AngCN Antiemetic Guidelines Guidelines for the Management of Nausea and Vomiting in Adult Patients Receiving Chemotherapy and/or Radiotherapy AngCN Document Reference: AngCN-CCG-C31 CONTENTS 1.0 Introduction
More informationPrevention and Management of chemo-and radiotherapy-induced nausea and vomiting
Prevention and Management of chemo-and radiotherapy-induced nausea and vomiting Focusing on the updated MASCC/ESMO guidelines Karin Jordan Department of Hematology and Oncology, University of Heidelberg
More informationCancer Chemotherapy. Munir Gharaibeh MD, PhD, MHPE School of Medicine, The University of Jordan December 2018
Cancer Chemotherapy Munir Gharaibeh MD, PhD, MHPE School of Medicine, The University of Jordan December 2018 Modalities of Cancer Chemotherapy Curative: Only in 10-15% of cases. In certain disseminated
More informationThe problem. The treatment. Special situations. Brief background on HBV Definitions of HBV reactivation. The role and timing of antiviral therapy
Pr Raymond Sayegh The problem Brief background on HBV Definitions of HBV reactivation The treatment The role and timing of antiviral therapy Special situations Lone anti-hbcpositive, rituximab, BMT, reactivation
More informationSystemic Treatment of Cancer
Systemic Treatment of Cancer Irwin H. Krakoff, MD It was demonstrated in the early 1940s that changing the hormonal milieu of certain cancers could result in their regression and that administration of
More informationAdditional information to support. The National Patient Safety Agency s Rapid Response Report Risks of incorrect dosing of oral anti-cancer medicines
Additional information to support The National Patient Safety Agency s Rapid Response Report Risks of incorrect dosing of oral anti-cancer medicines Reference: NPSA/2008/RRR001 - issued on 22 January 2008
More informationInpatient Antineoplastic Medication Administration And Associated Drug Costs: Institution of a Hospital Policy Limiting Inpatient Administration
Inpatient Antineoplastic Medication Administration And Associated Drug Costs: Institution of a Hospital Policy Limiting Inpatient Administration Alexandra E. Foster, PharmD; and David J. Reeves, PharmD,
More informationTreatment of tumours Cancer therapy
Treatment of tumours Cancer therapy (overview) 29.11.2017 Botond TIMÁR CANCER THERAPY GENERAL Cancer Care 30 Years Ago. Cancer treated primarily based on histology, location and size Three basic treatment
More informationESCMID Online Lecture Library. by author
Immunosuppression and Hepatitis B Virus Reactivation Prof. Hakan Leblebicioglu, MD hakan@omu.edu.tr www.leblebicioglu.org Immunotolerance Immune Clearance HBV reactivation HBeAg+ HBeAg- HBeAb+ HBV DNA
More informationUniversity of Groningen. Health economics of targeted cancer therapies Mihajlovic, Jovan
University of Groningen Health economics of targeted therapies Mihajlovic, Jovan IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please
More informationPrinciples of chemotherapy
Principles of chemotherapy Chemotherapy first coined by Paul Ehrlich Aim to selectively destroy cancer cells whilst relatively sparing tumours cells Growth characteristics of cancer cells allows for selective
More informationJob title: Consultant Pharmacist/Advanced Practice Pharmacist
Title : Guidelines for the Use of Antiemetics Purpose: To provide trust-wide guidance on the safe and effective use of antiemetics for the prevention and treatment of chemotherapy and radiotherapy induced
More informationELECTRONIC HEALTH RECORD (EHR) ENHANCEMENTS FOR MARCH 15, 2016 SUMMARY
ELECTRONIC HEALTH RECORD (EHR) ENHANCEMENTS FOR MARCH 15, 2016 SUMMARY Problem Opening PACS Images on ipads or ibooks has Been Fixed Changes have been made in PROD to enable user credentials to be passed
More information8. Malignant disease and immunosuppression
1 8. Malignant disease and immunosuppression An ever increasing number of cytotoxic drugs and biological therapies - now referred to as Systemic anticancer therapy (SACT) - are used in the management of
More informationCURRENTLY ENROLLING ONCOLOGY TREATMENT STUDIES (as of )
Leukemia AALL0932 closed after Induction CURRENTLY ENROLLING ONCOLOGY TREATMENT STUDIES (as of 10.10.2017) Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized
More informationEuropean consortium study on the availability of anti-neoplastic medicines
European consortium study on the availability of anti-neoplastic medicines Nathan I Cherny Alexandru ENIU, MD, PhD Norman Levan Chair in Humanistic Chair, Emerging Countries Committee Medicine Department
More informationMedical Therapies in Ovarian Cancer The Arabic Perspectives. Mezghani Bassem -Tunisia
Tunisian Health System: Social Welfare with a Public insurance for all citizens including Indigent persons. (± Additional private insurance) Choice: Public Hospital/Private Clinics (Indigents Public H)
More informationthrough the cell cycle. However, how we administer drugs also depends on the combinations that we give and the doses that we give.
Hello and welcome to this lecture. My name is Hillary Prescott. I am a Clinical Pharmacy Specialist at The University of Texas MD Anderson Cancer Center. My colleague, Jeff Bryan and I have prepared this
More informationThe Clinical Research E-News
Volume 3: ISSUE 4: March 2, 2011 The Clinical Research E-News Now Open: E1608, A Phase II Trial of GM-CSF Protein Plus Ipilimumab in Patients with Advanced Melanoma E2208, Randomized Phase II Study of
More informationAzacitidine Vidaza Non-transplant myelodysplastic syndrome Funded Funded Funded Funded Funded Funded Not Funded
Provincial Fundin Summary The interim Joint Oncoloy Dru Review (ijodr) was the precursor oncoloy dru review process prior to pcodr, which provided evidence-based recommendation for cancer treatments from
More informationGuideline for Classification of the Acute Emetogenic Potential of Antineoplastic Medication in Pediatric Cancer Patients
Guideline for Classification of the Acute Emetogenic Potential of Antineoplastic Medication in Pediatric Cancer Patients POGO Antineoplastic Induced Nausea and Vomiting Guideline Development Panel: L.
More information