With Thanks to Ken Paterson SMC Tom Walley NIHR

1. Cost-Effective HTA – Lessons for Russia from the UKAlan HaycoxUniversity of Liverpool NOVEMBER 2015 With Thanks to Ken Paterson SMC Tom Walley NIHR

2. What is HTA attempting to achieve? “I expect the truth and nothing but the truth. I expect assistance in discerning between the truth rather than marketing and advertisement. I expect presentation of scientific proofs in favour of or against current health care policy.” Dutch Minister of Health Cochrane Colloquium, Rome 2000

3. How do we achieve this? Identify the important policy questions Undertake research on these questions Generate timely and robust information to guide healthcare policy Ensure that information generated is effectively used to guide policymaking

4. Data requirements Early evaluation (it is easier to shape clinical practice rather than change it!) Head to Head studies (clinicians want comparisons with existing best practice) How does treatment extend the Quantity and Quality of life provided to patients (what else is important?) Effectiveness rather than efficacy (how does the treatment work in real life clinical practice?)

5. Elements to be addressed in introducing HTA to Russia Structure of healthcare funding and delivery The ‘cultural expectations’ of the population concerning healthcare delivery What skills and resources are available to support the development of HTA in Russia? What ‘intensity’ (‘heavy’ or ‘soft touch’) of HTA would be optimal for Russia?

6. What are ‘heavy’ and ‘light’ touch HTA structures?

7. HTA with a heavy touch – NICE • NICE from 1999 appraises selected health technologies and issues guidance to NHS • On basis of ‘clinical and cost effectiveness’ • 160 appraisals in 10 years, covering 25%-50% new drugs issued • ‘Above …. £30k/QALY, the case for supporting the technology … has to be increasingly strong’ (NICE, 2004)

8. NICE - structure Values Politics Patients Professionals Ethics DoH NHS Assessment Appraisal Organisations Education etc. • Scientific exercise • generalisable • reproducible • transparency • but - no guidance Implementation Totality

9. NICE - process • NICE uses independent academic groups for ‘assessment’ of scientific evidence of ‘clinical and cost effectiveness’ • Decisions are made by ‘Appraisal Committees’ who consider the evidence and other factors • Hierarchy of evidence for clinical effectiveness – systematic review/meta analysis • Cost effectiveness – generally based on modelling • Highly transparent – all published (except if ‘commercial in confidence’) and extensive consultation • Right of appeal – around 25% are appealed

10. NICE methodology • Perspective: NHS and social services • Outcome: QALY-Extensions in quantity and quality of life (measured using EQ-5D) • EQ-5D: 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) all scored low/medium/high • Focus on incremental cost effectiveness ratio (ICER) • Beyond trial: modelling required • Uncertainty: probabilistic sensitivity analysis

11. HTA with a light touch :Scottish Medicines Consortia Membership (30) - multi-disciplinary • Physicians (primaryand secondary care) • Pharmacists, Nurses, Economists • Board and Hospital Executives, ABPI • Drug industry & Patient Representatives • NHS Quality Improvement Scotland • Full declarations of interest

12. SMC - background • Formed 2001/2 as consortium of drug & therapeutics committees • To advise on the comparative effectiveness and cost-effectiveness of – • ALL new drugs, new indications and new formulations of existing drugs • Advice at (or as soon as possible after) launch • “shape practice, not change practice”

13. HTA ASSESSMENT - THE NEW DRUGS COMMITTEE (NDC) • 18 Members consisting of : Clinicians, Pharmacists, Health Economists Nurses, Public Health Consultants • Assessment through Evidence Review • Undertakes initial review and provides recommendations to SMC board • Sponsor company has ‘right of reply’ within a three week period

14. SMC: Division of labour • NDC looks at the facts/numbers • SMC takes a wider approach • Incorporates value judgments • Includes societal and other factors • Has a number of ‘modifiers’ such as Orphan diseases, no other therapies • Consensus decision rather than vote

15. Resource use and costs The annual cost of the SMC is £1,004,000 .

16. Decision making Process • Critical appraisal of the drug company’s submission • Efficacy /effectiveness /safety reviewed by critical appraisal pharmacist • Health economic case reviewed by health economist • Interaction with sponsor during review • Review lasts around 6 weeks • Burden of proof is on the manufacturer

17. Process timelines 12-14 weeks 4 weeks

18. Outcome of Assessments • Accepted for Use – 34% • Accepted for Restricted Use – 37% • Not Recommended – 28% • The ‘rule of thirds’ has remained stable over time %

19. SMC – NICE Comparisons Legal basis of guidance Industry involvement Consultation Outcome Cost

20. Legal basis of Guidance NICE – legal requirement for clinicians to comply with guidance within three months SMC – guidance is advisory but largely followed within Scotland

21. Industry Involvement • SMC – 3 full members from industry • Ensure due process and fairness • Act as informal channel of (2-way) communication • The first port of call for ‘unhappy’ companies • NICE – more limited industry involvement • May create unhelpful tensions • Limited channels for informal communication

22. Consultation • SMC – seek input from clinical experts and patient interest groups • No consultation on draft advice • NICE – input from clinical experts and patient interest groups • Extensive (open) consultation on draft advice

23. Outcome In 83% of cases, SMC and NICE come to the same decisions in their evaluations SMC is more likely to reject a drug (37%) in comparison to NICE (12%)

24. Cost – The big difference! SMC –£1M per year NICE -£78M per year Is the extra expenditure cost-effective? Is NICE 78 times more effective than SMC?

25. Is SMC – a preferable model for Russia? • NICE is a gold-standard for HTA • Respected & seen as a model by many other countries • High quality evaluations as soon as a new drug appears on the market • SMC model is perhaps more appropriate in resource constrained environments • Leaner, nimbler, quicker, more inclusive • And above all VERY much cheaper

26. Developing HTA in Russia A properly organised and managed ‘light touch’ agency can achieve a great deal The cost of HTA depends on its legal basis, structure, role and coverage The most appropriate structure of HTA is one that is specifically developed for the country concerned – but perhaps guided by international evidence In the long run, ‘Doing nothing’ may be the most costly policy of all

27. Does Russia have the necessary skills? European Commission, Health and Consumer Protection Directorate-General and Austrian Ministry of Health, Family and Youth. Pharmaceutical Pricing and Reimbursement Information, Turkey, June 2007. “Health economics and pharmacoeconomics capacity should be developed, both in the companies and public sector. Improvement of this capacity in the public sector would help decision-makers both in their pricing and reimbursement decisions”

28. Conclusion No health system can afford to fund all new healthcare interventions so we inevitably have to prioritise and choose HTA simply attempts to identify the healthcare interventions that provide sufficient clinical benefit to justify their cost HTA enables health systems to optimise the amount of patient benefit obtained from the limited resources available to the healthcare system HTA also enables an informed debate to be undertaken with the industry concerning the importance of linking drug pricing to drug effectiveness