Safe, Therapeutic, Economical, Pharmaceutical Selection (STEPSelect)

1. Safe, Therapeutic, Economical, Pharmaceutical Selection (STEPSelect) Development, introduction and use in Northern Ireland Dr. Robert Janknegt, clinical pharmacologist Orbis Medical Centre Sittard, the Netherlands Prof. Michael Scott, hospital pharmacist Antrim Hospital, Northern Ireland • Health Care Rationing, Rotterdam, December 2010

2. Selection criteria for drugs • Rational criteria (efficacy, safety, cost) • Emotional criteria (company, experience) • Hidden criteria (financial) • Unconscious criteria

3. SOJA method • System of Objectified Judgement Analysis • System is not objective!!! • Objectified---transparent drug selection

4. SOJA method • Panel of experts determines: • - selection criteria • - relative weight • - relative properties of each drug • - score per criterion • - total score

5. Methodology • Dosage frequency, standard score: • Authors • Once daily 100% • 1-2 x daily 90% • 2 x daily 80% • 2-3 x daily 60% • 3 x daily 40% • 4 x daily 10%

6. Methodology • Dosage frequency, standard score: • Authors Weight: 60 points • Once daily 100% • 1-2 x daily 90% • 2 x daily 80% • 2-3 x daily 60% • 3 x daily 40% • 4 x daily 10%

7. Methodology • Dosage frequency, standard score: • Authors Weight: 60 points • Once daily 100% 60 • 1-2 x daily 90% 54 • 2 x daily 80% 48 • 2-3 x daily 60% 36 • 3 x daily 40% 24 • 4 x daily 10% 6

8. Methodology • Safety: • Authors • Drug A 80% • Drug B 90% • Drug C 50% • Drug D 20% • Drug E 80% • Drug F 70%

9. Methodology • Safety: • Authors Weight 120 points • Drug A 80% • Drug B 90% • Drug C 50% • Drug D 20% • Drug E 80% • Drug F 70%

10. Methodology • Safety: • Authors Weight 120 points • Drug A 80% 96 • Drug B 90% 108 • Drug C 50% 60 • Drug D 20% 24 • Drug E 80% 96 • Drug F 70% 84

11. SOJA method: Procedure • 1. Determination of criteria by experts • 2. Medline search/Embase/Cochrane/EMEA/meta-analyses/reviews • 3. Article version 1 • 4. Article sent to industry/professional organisations for comments • 5. Interactive program • 6. Process takes 250 hours or more, so don’t do this at home!

12. Selection criteria • Efficacy • Effects on clinically relevant endpoints • Safety • Side-effects (tolerability) • Dosage frequency • Drug interactions • Acquisition cost (pharmacoeconomics) • Documentation

13. Selection criteria (2) • Pharmacokinetic properties • Number of formulations • Number of approved indications • Therapeutic drug monitoring necessary? • Contra-indications, warnings and precautions • Group specific criteria (development of resistance)

14. Validation • Standardised procedure • Standardised selection criteria • Experts serve as sounding board (correctness and completeness). Comments by email (cc to all) • Manuscript sent to all companies, including generic (correctness and completeness) • Comments of professional organisations • Publication in peer reviewed journals

15. Internet • www.sojaonline.nl / www.informatrix.nlwww.stepselect.com /www.medicines-management.ie • All interactive programs available • Continuous update of programs • Over 50 programs available • Monthly price adjustments

16. Interactive sessions content • User may assign weight to criteria (S) or criteria and drugs (I) • Results are highly predictable: • High weight: efficacy, end points, safety, dosage frequency • Look at effects of weighting factor variation • “Play the product manager” • The truth, the whole truth and nothing but the truth……. • Feedback from participants may be highly relevant (exclusion criteria in db studies)

17. Advantages (physicians) • Based on clinically relevant criteria, not primarily on cost! • Concrete discussions • Saves lots of time (SOJA) • Freedom of prescription maintained (but with limitations)

18. Advantages (pharmacists) • Rational drug selection • SOJA saves huge amounts of time for formulary committees • National formulary useful, local adjustments can be made very easily • Central role for the hospital pharmacist • Sound basis for further protocols

19. Advantages (authorities) • Top-down information (quality) • Bottom-up decision (compliance) • Evidence based formularies • Rational drug selection • Generics perform well when these are available • Very suitable for guideline development • Major savings on time-expenditure • Major cost-savings

20. STEPSelect project • Part of an eight workstream programme • On-going project in Northern Ireland • Goal: Raise quality and safety and drive health gain and efficiency(S+Q=H+E) • Integrated medicines management for primary care and hospital care • Active participation of prescribers and pharmacists • Clnically driven not cost driven

21. STEPSelect methodology • Step I Clinical evaluation • Step II Risk assessment • Step III Budget impact analysis • Step IV Final product selection

22. Step 1 Clinical evaluation • Use of matrix models as a part of Integrated Medicines Management • Matrix models used for pre-selection of drugs within a class • Criterion of acquisition cost is excluded • Pre-selection on quality aspects only • Drugs with best score on efficacy, endpoints, safety, ease of use etc proceed to the next step • Northern Irish panel of experts judges existing matrices

23. Step II Risk assessment • Critical evaluation of packaging and labelling: English language, packaging, labelling, storage, blister, patient information leaflets • Added value: calendar packs, barcoding, etc. - Structured judgement of all items Knock-out criterion if anything is insufficient

24. Step II Risk assessment • Critical evaluation of packaging and labelling: English language, packaging, labelling, storage, blister, patient information leaflets • Added value: calendar packs, barcoding, etc. - Structured judgement of all items Knock-out criterion if anything is insufficient

25. Step III Budgetary impact analysis • Cost of each product determined and related to Defined Daily Dose (or Prescribed Daily Dose) • Fair comparison of drug-dosages within a class • Procurement for primary care • Tendered prices for hospital care • Use same packaging in primary and hospital care (reduces medication errors, patient recognises own medication)

26. Step IV Final procurement selection • Final selection based on tendered prices. Selection of one-three providers per drug. • Selection of 1-3 drugs within a class • These drugs are 70-80% of volume of the class • Combined with guidance aiding in optimal use of the drugs • 2010: guidance incorporated into an electronic prescription system, providing almost perfect adherence to guidance • Germany: any procurement/tendering system applicable

27. STEPSelect: drug classes • Drug classes included in STEPSelect: • Statins • Protonpump inhibitors • SSRIs • ACE inhibitors • Angiotensin II antagonists • Erythropoiesis stimulating agents • Biologicals in rheumatoid arthritis • Wound dressings

28. STEPSelect, outcome • Good compliance with guidance • Clear shift towards selected drugs • Significant savings: about 14 Euro per capita per year • Expected savings with full implementation: at least 25 Euro per capita per year

29. Key aspects of STEPSelect • Evaluation of all clinical evidence • Continuous updates • Interactive matrix model allows nationwide participation of physicians and pharmacists • Various interactive tools available • Preselection on quality aspects only • Risk management of packaging • Evidence based guidance • Flexibility (not 100% compliance needed) • Integration between primary and hospital care • Significant savings on drug expenditure • Savings partly reinvested to improve patient care

30. BENEFITS • Optimised patient care • Fully integrated product use in both sectors • Selection of product on safety and therapeutic efficiency as the prime determinant • Quality at best value for the service • Robust, transparent, defensible system of selection • Web-based guidance – evidence based • Dynamic with regular updates • Compliance with EU legislation

31. Implementation in other countries • Translation/adjustment of existing matrices • If necessary add new drugs to matrices • National panel of experts to judge matrices • National panel of pharmacists to look at packaging criteria • National panel of experts to judge dosages used in procurement phase • All these “steps” can be made quickly