An introduction to the Essential Medicines concept: balancing innovation with public health priorities
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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Immunostimulants Osteoporosis Medicines for dubious conditions (disease mongering) No medicines listed subsequently withdrawn for unexpected risks (e.g., cox-2 inhibitors)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
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