38 years of EML

38 years of EML

WHO Essential Medicines List Concept and Process IPC Meeting June 6, 2014 WHO Geneva Nicola Magrini WHO, EMP 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): more evidence-based, more transparent and participated process Last revision EML (April 2013): 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

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 4| 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 5|

Essential Medicines List: Concept and Procedures 18th WHO Model List of Essential Medicines - 2013 Report of the WHO Expert Committee, 2013 N. = 208 6| 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) 7| 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) 8| Essential Medicines List: Concept and Procedures Process

Evidence Based and Transparent Applications invited and received - 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 EC member (2 or 3 indipendent reviewers) 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 (full report - TRS) 9| 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 10 | 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) 11 | 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 12 | Essential Medicines List: Concept and Procedures A walk through the process http://www.who.int/selection_medicines/committees/en/ 13 |

Essential Medicines List: Concept and Procedures The application form/template 14 | Essential Medicines List: Concept and Procedures EML criteria: evidence review is central A systematic review of the best available evidence Systematic review (synthesis and appraisal) more important than metanalysis

Importance of evidence table presentation and appraisal of risk of bias (study defect/reliability) to evaluate confidence in estimates (for both outcomes of efficacy and safety) once called quality of evidence 15 | Essential Medicines List: Concept and Procedures GRADE evidence table for benefits and harms example 1: single RCTs 16 |

Essential Medicines List: Concept and Procedures EML and evidence: for benefits and harms GRADE example 2 17 | Essential Medicines List: Concept and Procedures GRADE evidence table for benefits and harms example 2: RCTs and observational studies

18 | Essential Medicines List: Concept and Procedures GRADE evidence table for benefits and harms example 3: systematic review (meta-analysis) 19 | Essential Medicines List: Concept and Procedures EML and evidence table for benefits and harms

GRADE example 4 20 | Essential Medicines List: Concept and Procedures EML and evidence table for benefits and harms example 5 21 | Essential Medicines List: Concept and Procedures

Simplifying (by commenting) the application form 22 | Essential Medicines List: Concept and Procedures Opportunity to improve EML updating (2015) 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:

rituximab, erlotinib/gefitinib, sunitinib/everolimus, New highly HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens) 23 | Essential Medicines List: Concept and Procedures Opportunity to improve EML updating (2015) 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). Other medicines: rituximab, erlotinib/gefitinib, New highly HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens) WHO could have a leadership role in improving access to highly effective medicines (as was for HIV in 2002) 24 | Essential Medicines List: Concept and Procedures Opportunity to improve EML updating

(2015) 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: rituximab, erlotinib/gefitinib, sunitinib/ everolimus, New highly HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens) New anticoagulants: oral (NAC) and surely LMWH Endocrinology medicines chapter, anti-TNF medicines (for rheumatoid arthritis and IBD),

25 | Essential Medicines List: Concept and Procedures EML 2015 timeline 26 | Essential Medicines List: Concept and Procedures EML 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 27 | Essential Medicines List: Concept and Procedures EML 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 28 |

Essential Medicines List: Concept and Procedures EML 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 29 |

Essential Medicines List: Concept and Procedures EML 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 with a summary of decisions taken TRS finalisation for publication () In progress: Availability of a EML database of decisions taken and indications evaluated (history and summary of all decisions) 30 | Essential Medicines List: Concept and Procedures WHAT ABOUT DEVICES IN EML?

31 | Essential Medicines List: Concept and Procedures Just a few devices 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) 32 |

Essential Medicines List: Concept and Procedures Conclusions Application for EML will be opened soon and will remain open for 6 months It is strongly reccomended to make an application connected with a WHO technical department And to frame the proposal within a WHO policy document/ GL Send it early enough to be reviewed Expert Committee 2015 EML Meeting: April 2015 33 |

Essential Medicines List: Concept and Procedures

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