The WHO Model List of Essential Medicines – Palliative Care update

1. The WHO Model List of Essential Medicines – Palliative Care update Suzanne Hill World Health Organisation April 2006

2. Essential medicines • The concept of essential medicines A limited range of carefully selected essential medicines leads to better health care, better drug management, and lower costs • Definition of essential medicines Essential medicines are those that satisfy the priority health care needs of the population (2002)

3. Essential medicines • Are selected on the basis of • disease prevalence, • evidence of comparative efficacy, safety and cost-effectiveness • Are intended to be • Used in the context of functioning health systems • Available at all times in adequate amounts, • in the appropriate dosage forms, • with assured quality • at a price the individual and the community can afford

4. ‘Levelled’ lists • Core and complementary • Complementary medicines require specialist facilities or services • Default position is 'core'

5. The Essential Medicines Target National list of essential medicines Registered medicines All the drugs in the world Levels of use CHW S S dispensary Health center Supplementary specialist medicines Hospital Referral hospital Private sector

6. How many? • Ideally the best in each class for the purpose • Multiplicity confuses and may not help access • List one, up to 2-3 alternatives • Clear message • Flexibility in procurement • Competition between generics, rather than within class

7. Updating the list

8. Adding new medicines to the WHO Model List of Essential Medicines • Identification of public-health need for a medicine • Development of the medicine; phase I - II - III trials • Regulatory approval in a number of countries > Effective and safe medicine on the market • More experience under different field circumstances; post-marketing surveillance • Price indication for public sector use • Review by WHO disease programme; define comparative effectiveness and safety in real-life situations, comparative cost-effectiveness and public health relevance > Medicine included in WHO treatment guideline • Submission to WHO Expert Committee on Essential Medicines > Medicine included in WHO Model List

9. Role of treatment cost and global cost-effectiveness analyses • High cost alone should not exclude an essential medicine • Cost-effectiveness (C/E) comparisons are made among alternative medicines within the same therapeutic group • Price information from existing UN sources are used; all information sources will be identified • 'Formal' cost effectiveness analysis not yet required because methods for international analysis are not developed

10. Application review process • Application on WHO Medicines web site http://www.who.int/medicines/publications/essentialmedicines/en/index.html • Specialist assessment of comparative efficacy, safety and cost-effectiveness • Review of assessments by Expert Committee member (“presenter”); formulation of draft recommendation • Review of draft recommendation by relevant Expert Advisory Panel members; and posted on WHO Medicines web site • Review by presenter, prepares final draft recommendation • Discussion of draft recommendation and proposed text for WHO Model Formulary by the Expert Committee

11. Requirements for application • Who is applying • What the product is (INN, formulation) • What it is for • Availability and regulatory status • Supporting evidence: • Public health need • Comparative effectiveness and safety • Cost • Proposal for formulary text

12. Clinical guidelines and the model list of essential medicines List of common diseases and complaints Treatment choice Essential medicines list / National formulary Treatment guidelines Training and Supervision Financing and Supply of drugs Prevention and care

13. Updating WHO guidelines Systematic and transparent process • Guideline development group with wide representation • Careful consideration of conflict of interest • Systematic search for evidence • Evaluation of quality of evidence • Systematic cost-effectiveness analysis • for WHO: evaluation of public health considerations • Graded recommendations with linked references • External review of draft recommendations

14. So what does this mean for palliative care?

15. Guidelines and the list • The 14th list recommends that everything in 'Cancer Pain Relief' be available. • Is that right?

16. Conditions covered • Pain in cancer patients • Analgesics, adjuvants ……… other symptoms? • Nausea/hiccups/dry mouth etc etc

17. BASIC DRUGS Aspirin Paracetamol ibuprofen indometacin Codeine Morphine Naloxone Amitriptyline Carbamazapine Prednisolone Dexamathasone ALTERNATIVES Choline magnesium trisalcylate Diflunisal Naproxen Diclofenac Dihydrocodeine Dextropropoxyphene Standardised opium Tramadol Methadone Hydromorphone Oxycodone Levorphanol Pethidine Buprenorphine Imipramine Valproic acid Prednisone Betamethasone Current medicines

18. BASIC DRUGS Aspirin  Paracetamol ibuprofen Indometacin ? Codeine Morphine Naloxone Amitriptyline  Carbamazapine  Prednisolone  Dexamathasone  ALTERNATIVES Choline magnesium trisalcylate Diflunisal Naproxen Diclofenac Dihydrocodeine Dextropropoxyphene ? Standardised opium Tramadol Methadone  Hydromorphone Oxycodone Levorphanol Pethidine Buprenorphine  Imipramine  Valproic acid  Prednisone  Betamethasone ? Current medicines

19. Questions • What should be done to the guidelines? • Cancer pain control update? • General palliative care? • Population specific guidelines? • How can the guidelines be updated? • To do a WHO guideline =$200K minimum • Can this meeting 'scope' the guidelines? • Should the palliative care section of the Model EML change? To list the specific drugs? • What are the priority medicines for addition and deletion? • Who and how will the applications be prepared?

20. timelines • Guidelines • 'rapid advice' takes 4 months • Full guidelines take 12 months • EML • Next meeting March 2007 • Applications close October 15 2006 • Need for experts to advise the Committee