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

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

3. Department of Medicines Policy and Standards Essential medicines n Are selected on the basis of  disease prevalence,  evidence of comparative efficacy, safety and cost- effectiveness n 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. Department of Medicines Policy and Standards ‘Levelled’ lists  Core and complementary  Complementary medicines require specialist facilities or services  Default position is 'core'

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

6. Department of Medicines Policy and Standards 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. Department of Medicines Policy and Standards Updating the list

8. Department of Medicines Policy and Standards Adding new medicines to the WHO Model List of Essential Medicines 1. Identification of public-health need for a medicine 2. Development of the medicine; phase I - II - III trials 3. Regulatory approval in a number of countries > Effective and safe medicine on the market 4.More experience under different field circumstances; post- marketing surveillance 5.Price indication for public sector use 6.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 7.Submission to WHO Expert Committee on Essential Medicines > Medicine included in WHO Model List

9. Department of Medicines Policy and Standards Role of treatment cost and global cost-effectiveness analyses 1. High cost alone should not exclude an essential medicine 2. Cost-effectiveness (C/E) comparisons are made among alternative medicines within the same therapeutic group 3. Price information from existing UN sources are used; all information sources will be identified 4. 'Formal' cost effectiveness analysis not yet required because methods for international analysis are not developed

10. Department of Medicines Policy and Standards Application review process 1.Application on WHO Medicines web site http://www.who.int/medicines/publications/essentialmedicines/en/index.html 2. Specialist assessment of comparative efficacy, safety and cost- effectiveness 3. Review of assessments by Expert Committee member (“presenter”); formulation of draft recommendation 4. Review of draft recommendation by relevant Expert Advisory Panel members; and posted on WHO Medicines web site 5. Review by presenter, prepares final draft recommendation 6. Discussion of draft recommendation and proposed text for WHO Model Formulary by the Expert Committee

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

13. Department of Medicines Policy and Standards Updating WHO guidelines 1. Guideline development group with wide representation 2. Careful consideration of conflict of interest 3. Systematic search for evidence 4. Evaluation of quality of evidence 5. Systematic cost-effectiveness analysis 6. for WHO: evaluation of public health considerations 7. Graded recommendations with linked references 8. External review of draft recommendations Systematic and transparent process

14. Department of Medicines Policy and Standards So what does this mean for palliative care?

15. Department of Medicines Policy and Standards Guidelines and the list n The 14 th list recommends that everything in 'Cancer Pain Relief' be available. n Is that right?

16. Department of Medicines Policy and Standards Conditions covered n Pain in cancer patients n Analgesics, adjuvants ……… other symptoms? n Nausea/hiccups/dry mouth etc etc

17. Department of Medicines Policy and Standards Current medicines 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

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

19. Department of Medicines Policy and Standards 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. Department of Medicines Policy and Standards 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