38 years of EML

38 years of EML

WHO Essential Medicines List Concept/Process and Update on EML 2015 WHO Technical Briefing Seminar Nicola Magrini WHO, EMP November 4, 2014 WHO Geneva 1| Essential Medicines List: Concept and Procedures Essential Medicines

Guiding principle: A limited range of carefully selected essential 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. 2| Essential Medicines List: Concept and Procedures

38 years of EML 1977 1st Model list published, 208 active substances - List is revised every two years by WHO Expert Committee - 2002 Revised procedures approved by WHO (EB109/8) - Last revision EML (April 2013) contains 374 medicines The first list was a major breakthrough in the history of medicine, pharmacy and public health Mdecins sans Frontires, 2000 3|

Essential Medicines List: Concept and Procedures 4| Essential Medicines List: Concept and Procedures The Essential Medicines List and concept "The concept of essential medicines is one of the major public health achievements in the history of WHO. It is as relevant today as it was at it inception over 30

years ago." Dr Margaret Chan Director-General, WHO 5| Essential Medicines List: Concept and Procedures Why is it 'model' 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 6| Essential Medicines List: Concept and Procedures 18th WHO Model List of Essential Medicines 2013 Report of the WHO Expert Committee, 2013

N. = 208 7| Essential Medicines List: Concept and Procedures N. = 374 EML 2013 in numbers 374 total number of drugs/medicines Core list: 282 (FDC: 23) Complementary list: 68 (FDC: 1)

8| Essential Medicines List: Concept and Procedures EML 2013 in numbers Adult List 374 total number of drugs/medicines Core list: 282 (FDC: 23) Complementary list: 68 (FDC: 1) Pediatric List

278 in total Core list: 206 (FDC: 11) Complementary list: 60 (FDC: 1) 9| Essential Medicines List: Concept and Procedures Process Evidence Based and Transparent Applications invited - addition/deletion/modification Format proposed (see Applications) and WHO technical Dpt involved

Deadlines: a semester the year before next EC (, 2013, 2015, yearly?) All applications go online Applications peer reviewed by experts Peer reviews go online Comments invited from any one interested (WHO Depts., Professional Societies, International agencies, Academia) Comments go on line Expert Committee makes final decisions

Report goes on line 10 | Essential Medicines List: Concept and Procedures EML criteria (EB 109/8, 2001) 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 11 | Essential Medicines List: Concept and Procedures Application period for EML 2015 (Expert Committee April 2015) Open for 6 months: 15 June 2014 30 November 2014 Applications evaluated for methodology: systematic

review, evidence appraisal and synthesis (when needed, changes and new application requested) Application can be rejected (by EML secretariat) for lack of sufficient rigour in reporting available evidence Application sent to 2 or 3 Panel members (acting indipendently as blinded referees) 12 | Essential Medicines List: Concept and Procedures EML: applications, referees and EC

The opinions and evaluations expressed by the 2 (or 3) referees are brought to the attention of WHO Expert Committee (EC) EC has a plenary discussion and takes a decision Usually without voting 13 | Essential Medicines List: Concept and Procedures A walk through the process http://www.who.int/selection_medicines/committees/en/

14 | Essential Medicines List: Concept and Procedures The application form/template 15 | Essential Medicines List: Concept and Procedures EML Application: additional info posted

on how to prepare an applicatio 16 | Essential Medicines List: Concept and Procedures EML criteria and GRADE the basics A systematic review of the best available evidence A systematic review (synthesis and appraisal) is more important than a metanalysis (pooled estimate) Importance of summary evidence table with appraisal of risk of bias (study defect/reliability) to evaluate

confidence in estimates (for both outcomes of efficacy and safety) this was once called quality of evidence 17 | Essential Medicines List: Concept and Procedures EML and evidence table for benefits and harms GRADE example 1 18 |

Essential Medicines List: Concept and Procedures EML and evidence table for benefits and harms GRADE example 2 19 | Essential Medicines List: Concept and Procedures EML and evidence table for benefits and harms GRADE example 2

20 | Essential Medicines List: Concept and Procedures EML and evidence table for benefits and harms GRADE example 2 21 | Essential Medicines List: Concept and Procedures EML and evidence table for benefits and harms

GRADE example 2 22 | Essential Medicines List: Concept and Procedures EML and evidence table for benefits and harms GRADE example 3 23 | Essential Medicines List: Concept and Procedures

EML and evidence table for benefits and harms example 4 24 | Essential Medicines List: Concept and Procedures The application review process (EB109/8) 25 |

Essential Medicines List: Concept and Procedures EML: transparency and dialogue All applications - public Expert reviews public Comments and clarifications letters public Technical Report (summarising all the discussion) public 26 | Essential Medicines List: Concept and Procedures

EML transparency: web applications 27 | Essential Medicines List: Concept and Procedures EML transparency: Expert Reviews 28 | Essential Medicines List: Concept and Procedures

EML transparency: Comments 29 | Essential Medicines List: Concept and Procedures EML criteria (EB 109/8, 2001) 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 30 | Essential Medicines List: Concept and Procedures EML 2015 A few big challenges 31 |

Essential Medicines List: Concept and Procedures Opportunity to improve EML updating When highly effective drugs are available Cancer drugs: how to choose the few highly effective (patented, high cost) medicines (2 discussed in EML 2013: trastuzumab in breast cancer and imatinib in chronic myeloid leukemia). Other medicines: see next table, New HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens) TB large update

New anticoagulants: oral (NAC) and surely LMWH 32 | Essential Medicines List: Concept and Procedures Opportunity to improve EML updating When highly effective drugs are available Cancer drugs: how to choose the few highly effective (patented, high cost) medicines (2 discussed in EML 2013: trastuzumab in breast cancer and imatinib in chronic myeloid leukemia). Other medicines: see next table,

New HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens) TB large update New anticoagulants: oral (NAC) and surely LMWH 33 | Essential Medicines List: Concept and Procedures EML cancer update: first line treatment 34 |

Essential Medicines List: Concept and Procedures EML cancer drugs: candidates (15-20) 35 | Essential Medicines List: Concept and Procedures Opportunity to improve EML updating When highly effective drugs are available Cancer drugs: how to choose the few highly effective (patented, high

cost) medicines (2 discussed in EML 2013: trastuzumab in breast cancer and imatinib in chronic myeloid leukemia). Other medicines: see next table, New HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens) TB large update New anticoagulants: oral (NAC) and surely LMWH 36 | Essential Medicines List: Concept and Procedures

EML and New HepC drugs Very effective oral drugs (IFN free regimens) A WHO GL with a strong recommendation Sofosbuvir and Ledipasvit/sofosbuvir combination (already IN the applications) What to di with financial implications What to do with new drugs in the pipeline 37 | Essential Medicines List: Concept and Procedures

Opportunity to improve EML updating When highly effective drugs are available Cancer drugs: how to choose the few highly effective (patented, high cost) medicines (2 discussed in EML 2013: trastuzumab in breast cancer and imatinib in chronic myeloid leukemia). Other medicines: see next table, New highly HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens) TB large update New anticoagulants: oral (NAC) and surely LMWH 38 |

Essential Medicines List: Concept and Procedures WHO guidance on the management of drug-resistant TB, 1996-2014 The candidate drugs 1) New molecules Bedaquiline, Delamanid 2) Repurposed for TB, in EML Amoxicillin-clavulanate, Azithromycin, Clarithromycin, Clofazimine, Imipenem/cilastatin,

Meropenem 3) Repurposed, not in EML Linezolid, Gatifloxacin, Terizidone Opportunity to improve EML updating When highly effective drugs are available Cancer drugs: how to choose the few highly effective (patented, high cost) medicines (2 discussed in EML 2013: trastuzumab in breast cancer and imatinib in chronic myeloid leukeima). New highly HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens) TB drugs (12)

WHO could have a leadership role in improving access to highly effective medicines (as was for HIV in 2002) 41 | Essential Medicines List: Concept and Procedures EML timeline 42 |

Essential Medicines List: Concept and Procedures EML 2014 - 2015 timeline Apr 2014 June-Dic 2014 Jan-March 2015 Apr 2015 EML TRS 2013

printed Preparation of a 6 month application period (15th June 1st December 2014) Contacts and exchanges with WHO technical Dpts and other UN agencies Reviewing application forms and criteria towards full systematic reviews and GRADE adoption 43 | Essential Medicines List: Concept and Procedures

EML 2014 - 2015 timeline Apr 2014 June-Dic 2014 Jan-March 2015 Apr 2015 Application period open Commissioning and coordination of applications

Alignment of WHO GL with EML timeline (HIV, TB, RH, MH Verify the full adoption of systematic reviews and GRADE approach Manage questions and feedbacks from countries on EML adoption and implementation December (10th 15th): web publication of all applications 44 | Essential Medicines List: Concept and Procedures EML 2014 - 2015 timeline

Apr 2014 June-Dic 2014 Jan-March 2015 Apr 2015 EML reviewing and EC referees, and comments Verify applications (the early the better) for full adoption of

systematic reviews and GRADE approach Answers to questions and feedbacks from Countries to be presented to Expert Committee (EC) Summarise a TRS text for EC and prepare the List Merging adult and pediatric Lists into one List to facilitate readability Increase usefulness of EML database 45 | Essential Medicines List: Concept and Procedures

EML 2014 - 2015 timeline Apr 2014 June-Dic 2014 Jan-March 2015 Apr 2015 EML web publication EC meeting 20-25 April 2015 EML published end of April and summary of

decisions taken TRS finalisation for publication () TBC: Availability of a EML database of decisions taken and indications evaluated/approved/rejected 46 | Essential Medicines List: Concept and Procedures WHAT ABOUT DEVICES IN EML? 47 |

Essential Medicines List: Concept and Procedures Where do we start from 2006 48 | Essential Medicines List: Concept and Procedures 2008

Just few devices are in EML To strengthen a WHO policy (on contraception) To be consistent across various WHO GL/documents If apply, be supported by a WHO technical Dpt Suggestion: first be in a WHO policy document or GL and then apply to EML (rather than the other way round) 49 | Essential Medicines List: Concept and Procedures Conclusions

Application for EML will be opened soon and will remain open for 6 months It is strongly encouraged to make an application connected with a WHO technical department Frame your proposal within a WHO policy document/GL Send it early enough to be reviewed Expert Committee 2015 EML Meeting: April 2015 50 | Essential Medicines List: Concept and Procedures

51 | Essential Medicines List: Concept and Procedures Rational drug therapy (RDT) Quality use of medicines Appropriate use of medicines Responsible and evidence-based use Access to essential medicines and

implementation at country level 52 | Essential Medicines List: Concept and Procedures Selection process 53 | Essential Medicines List: Concept and Procedures

EML: why a model? A model for process and transparency Evidence-based rigorous process: high scrutiny on quality of evidence AND on its applicability at a global level Management of conflicts of interests Feed backs from country implementation 54 | Essential Medicines List: Concept and Procedures

Access and appropriate use of medicines: issues and challenges PUSH MODE How to give access to the best available evidence Full access to all available evidence Understanding: critically appraised, highly scrutinised with multidisciplinary considerations How? Are TRS report enough? Probably NOT Connection and good alignment with WHO guidelines Examples from: OC, TB, HIV, HepC, Mental Health,

55 | Essential Medicines List: Concept and Procedures Access and appropriate use of medicines: issues and challenges PULL MODE New drugs are introduced different from EML EML in delay important new drugs LMWH Cancer drugs

Drugs lacking good enough supporting evidence Drugs for memory 56 | Essential Medicines List: Concept and Procedures How to support good prescribing 57 |

Essential Medicines List: Concept and Procedures Two different level of action: one supporting the other 1. Access to available evidence Retrieval, systematic review, critical appraisal, synthesis and user-friendly presentation Understanding, applicability and relevance,

2. Guidelines and recommendation 58 | Standard and conditional recommendation and indicators of use Essential Medicines List: Concept and Procedures The importance of the context Actual medicines use at local/national level

Access to available evidence Guidelines and recommendations Drug utilization data: international comparison, small and large area variability, 59 | Essential Medicines List: Concept and Procedures The importance of the context Actual medicines use at local/national level

Access to available evidence Guidelines and recommendations Drug utilization data: international comparison, small and large area variability, The need for a comprehensive pharmaceutical policy: 60 | Essential Medicines List: Concept and Procedures

Pharmaceutical policy By pharmaceutical policy we mean the conscious efforts of national governments to influence the pharmaceutical system Pharmaceutical policy By pharmaceutical policy we mean the conscious efforts of national governments to influence the pharmaceutical system health system Equitable access Affordability Appropriate use

Functions of pharmaceutical sector

Registration of medicines Licensing of pharmaceutical business Inspection of establishment Medicine promotion Clinical trials and independent confirmatory research Indipendent drug information Guidelines program and evidence-based recommendations Selection of essential medicines Procurement of medicines Distribution of medicines

Drug utilization There is a difference Independent drug bulletins Cochrane reviews Clinical Evidence Uptodate

Guidelines Recommendations Consensus conferences Inappropriate uses

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