an introduction to the essential medicines concept
TRANSCRIPT
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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
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Séminare sur les poliitiques pharmaceutiques, Sept 2015
EML 2017: 40th anniversary
Nicola Magrini Secretary
WHO Expert Committee on the Selection and Use of Essential Medicines Essential Medicines Department
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Essential Medicines List: Concept and Procedures 3 |
20th EML & 6th EMLc - 2017
20th EML: 433 medicines
– 6th EMLc (children): 314 medicines
602 pages, >800 references
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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
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2. Essential medicines … why some drugs are more important than other
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EML 1977: early evidence-based adopter
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• No medicines listed subsequently withdrawn for unexpected risks (e.g., cox-2 inhibitors)
• 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
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Essential Medicines List: Concept and Procedures 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 cost-
effectiveness
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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
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Essential Medicines List: Concept and Procedures 9 |
Lancet editorial October 24, 2015
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3. EML rules and procedures
The WHO EB resolution 2001 EB109/8
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Essential Medicines List: Concept and Procedures 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
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Essential Medicines List: Concept and Procedures 12 |
The EML reform in 2002:
more explicit criteria
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Essential Medicines List: Concept and Procedures 13 |
WHO EB 109/8 - Medicines strategy
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Essential Medicines List: Concept and Procedures 14 |
A more transparent and
evidence-based process (EB109/8 2001)
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Essential Medicines List: Concept and Procedures 15 |
A more transparent and
evidence-based process (EB109/8 2001)
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Essential Medicines List: Concept and Procedures 16 |
A more transparent and
evidence-based process (EB109/8 2001)
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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”
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Essential Medicines List: Concept and Procedures 18 |
3. EML 2017: what has changed
The format for the final report
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Essential Medicines List: Concept and Procedures 19 |
TRS TEMPLATE 2017
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Essential Medicines List: Concept and Procedures 20 |
3. EML 2017: what will be available
An electronic version of the EML and
An EML database
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ELECTRONIC DATABASE
ONLINE SEARCH ENGINE
LINK TO WHO GUIDELINES
TEMPLATE EVIDENCE SYNTHESIS
eEML: database & formats
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Essential Medicines List: Concept and Procedures 22 |
eEML
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The new
EML 2017
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Essential Medicines List: Concept and Procedures 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
• …
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Essential Medicines List: Concept and Procedures 25 |
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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 2nd line medicines
Gabapentin Oseltamivir (del)
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EML 2017 Cancer & cancer pain
Recommendations
• Dasatinib (CML) • Nilotinib (CML) • Zoledronic acid (bone
metatsteses)
• Fentanyl (transdermal) • Methadone (already listed
for substitution treatment)
Rejections/standby • Enzalutamide (prostate) • Trastuzumab emtansine
(breast)
• TKIs, crizotinib (NSCLC)
• Tramadol (cancer pain)
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Low Medium High
INCIDENCE OF DISEASE
TREATMENT
GOAL
Cure or “near
cure”
Significant
prolongation of
survival
Palliation of
symptoms with
small benefit in
survival
Leukemia and
Lymphomas in
Children and Adults
Early-Stage
Breast Cancer
CML Early-Stage Colon
Cancer
Testicular and ovarian
germ cell tumors
Stage III Ovarian
Cancer
Metastatic Breast
Cancer
HIGH
PRIORITY
Metastatic
Pancreatic Cancer
Metastatic
Lung Cancer
LOWEST
PRIORITY
GIST
Metastatic Prostate
Cancer
Metastatic
Bladder Cancer
LOW PRIORITY
Slide credit: Dr. Gilberto Lopes
Methodology to Develop Proposal for Revisions
GTN
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21st EML (*6th EMLc) 2017 8.2 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*
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21st EML (*6th EMLc) 2017
8.2 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
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21st EML (*6th EMLc) 2017
8.3 Hormones and antihormones
Anastrazole Hydrocortisone*
Bicalutamide Methylprednisolone*
Dexamethasone* Prednisolone*
Leuprorelin Tamoxifen
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21st EML (*6th EMLc) 2017
8.3 Hormones and antihormones
Anastrozole Hydrocortisone*
Bicalutamide Methylprednisolone*
Dexamethasone* Prednisolone*
Leuprorelin Tamoxifen
BLUE: added in 2015 GREEN: added in 2017
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Indication Medicines
Acute lymphoblastic
leukaemia
(EML and EMLc)
Asparaginase
Cyclophosphamide
Cytarabine
Daunorubicin
Doxorubicin
Etoposide
Mercaptopurine
Methotrexate
Tioguanine
Vincristine
Dexamethasone
Hydrocortisone
Methylprednisolone
Prednisolone
Acute myelogenous leukaemia
(EML)
Cytarabine
Daunorubicin
Acute promyelocytic
leukaemia)
(EML)
All-trans retinoic acid
Cytarabine
Daunorubicin
Mercaptopurine
Methotrexate
Burkitt lymphoma
(EML and EMLc)
Calcium folinate
Cyclophosphamide
Cytarabine
Doxorubicin
Etoposide
Vincristine
Prednisolone
Chronic lymphocytic
leukaemia
(EML)
Bendamustine
Chlorambucil
Cyclophosphamide
Cyclophosphamide
Fludarabine
Rituximab
Prednisolone
Chronic myeloid leukaemia
(EML)
Hydroxycarbamide
Imatinib
Chronic myeloid leukaemia
IMATINIB RESISTANT
(EML)
Dasatinib
Nilotinib
Diffuse large B-cell lymphoma
(EML)
Cyclophosphamide
Doxorubicin
Rituximab
Vincristine
Prednisolone
EML 2017: medicines (by 32) cancers
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Indication Medicines
Head and neck cancer
(EML)
Cisplatin
Early-stage breast cancer
(EML)
Carboplatin
Cyclophosphamid
e
Docetaxel
Doxorubicin
Fluorouracil
Methotrexate
Paclitaxel
Trastuzumab
Anastrozole
Leuprorelin
Tamoxifen
Early-stage cervical cancer
(EML)
Cisplatin
Early-stage colon cancer
(EML)
Calcium folinate
Capecitabine
Fluorouracil
Oxaliplatin
Early-stage rectal cancer
(EML)
Calcium folinate
Capecitabine
Fluorouracil
Epithelial ovarian cancer
(EML)
Carboplatin
Gemcitabine
Paclitaxel
Ewing sarcoma
(EML and EMLc)
Cyclophosphamid
e
Doxorubicin
Etoposide
Ifosfamide
Mesna
Vincristine
Follicular lymphoma
(EML)
Bendamustine
Cyclophosphamid
e
Doxorubicin
Rituximab
Vincristine
Prednisolone
EML 2017: medicines (by 32) cancers
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Indication Medicines
Gastrointestinal stromal tumour
(EML)
Imatinib
Gestational trophoblastic
neoplasia
(EML)
Calcium folinate
Cyclophosphamide
Dactinomycin
Etoposide
Methotrexat
e
Vincristine
Hodgkin lymphoma
– adults* and paediatric
(EML and EMLc)
Bleomycin*
Cyclophosphamide
Dacarbazine*
Doxorubicin*
Etoposide
Vinblastine*
Vincristine
Prednisolone
Kaposi sarcoma
(EML)
Bleomycin
Doxorubicin
Paclitaxel
Vinblastine
Vincristine
Malignancy related bone disease
(EML)
Zoledronic acid
Metastatic breast cancer
(EML)
Capecitabine
Cyclophosphamide
Docetaxel
Doxorubicin
Paclitaxel
Trastuzumab
Vinorelbine
Anastrozole
Tamoxifen
Metastatic colorectal cancer
(EML)
Calcium folinate
Capecitabine
Fluorouracil
Irinotecan
Oxaliplatin
Metastatic prostate cancer
(EML)
Docetaxel
Bicalutamide
Leuprorelin
Nasopharyngeal cancer
(EML)
Carboplatin
Cisplatin
Fluorouracil
Paclitaxel
EML 2017: medicines (by 32) cancers
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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
EML 2017: medicines (by 32) cancers
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EML 2017 HIV & Hepatitis B/C
Recommendations
• Atazanavir + ritonavir
• Dolutegravir
• Raltegravir
• EFV400 + 3TC + 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
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EML 2017 Malaria & TB
Recommendations
• Artesunate+pyronaridine
• DHA + PQP
• Delamanid (paediatrics)
• Ofloxacin (deletion)
• Isoniazid (+pyrazinamide) + rifampicin FDC (paediatrics)
Rejections
• Gatifloxacin
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EML 2017 Reproductive health
Recommendations
• Ulipristal (emergency contraception)
• Medroxyprogesterone acetate (new SC formulation)
Rejections
• Misoprostol (deletion) – prevention PPH - unchanged in EML
Rejections
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EML: why so many contraceptives
• To increase women choice
• To consider patients’ preferences
• To incorporate values
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EML 2017 Non-communicable diseases
Recommendations
• Erythropoiesis-stimulating agents
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EML 2017 Non-communicable diseases
• Erythropoiesis-stimulating agents
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EML 2017 Non-communicable diseases
• Erythropoiesis-stimulating agents
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EML 2017 Non-communicable diseases
Recommendations
• Erythropoiesis-stimulating agents
• Budesonide + formoterol
• Lamotrigine - epilepsy
• Losartan
Rejections
• Bevacizumab (deletion)
– unchanged in EML
• Gabapentin
• Insulin analogues
• T2D 2nd line medicines
• Lisinopril + HCTZ
• Polypill
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Essential Medicines List: Concept and Procedures 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
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EML 2017 Non-communicable diseases
Recommendations
• Erythropoiesis-stimulating agents
• Budesonide + formoterol
• Lamotrigine - epilepsy
• Losartan
Rejections
• Bevacizumab (deletion)
– unchanged in EML
• Gabapentin
• Insulin analogues
• T2D 2nd line medicines
• Lisinopril + HCTZ
• Polypill
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Essential Medicines List: Concept and Procedures 48 |
Gabapentin
• NOT recommended for neuropathic pain
• Uncertainty in reported efficacy estimates related to publication and outcome
reporting biases
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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
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EML: why NOT gabapentin
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EML: why NOT gabapentin
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EML: why NOT gabapentin
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EML 2017 Non-communicable diseases
Recommendations
• Erythropoiesis-stimulating agents
• Budesonide + formoterol
• Lamotrigine - epilepsy
• Losartan
Rejections
• Bevacizumab (deletion)
– unchanged in EML
• Gabapentin
• Insulin analogues
• T2D 2nd line medicines
• Lisinopril + HCTZ
• Polypill
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EML 2017: insulins analogues
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Essential Medicines List: Concept and Procedures 58 |
EML 2017: diabetes second line
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Essential Medicines List: Concept and Procedures 59 |
EML 2017: diabetes second line
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Essential Medicines List: Concept and Procedures 60 |
EML 2017: diabetes second line
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5. EML and pharmacological classes
Listing: one drug only per pharmacological class … implications for selection and procurement
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Essential Medicines List: Concept and Procedures 62 |
EML and therapeutic equivalency 1/3
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Essential Medicines List: Concept and Procedures 63 |
EML and therapeutic equivalency 2/3
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Essential Medicines List: Concept and Procedures 64 |
Example 1
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Essential Medicines List: Concept and Procedures 65 |
Example 2 : limited square boxing
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Essential Medicines List: Concept and Procedures 66 |
Example 3: limited square boxing
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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
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Essential Medicines List: Concept and Procedures 68 |
Example 4: Erythropoetins
and respective biosimilars