The Swedish Council on Technology Assessment in Health Care Måns Rosén

1. Health Technology Assessment in Sweden The Swedish Council on Technology Assessment in Health CareMåns Rosén

2. The Swedish Health Care system – a decentralised system National level Legislation, supervision (Government) reimbursement for drugs, approval of drugs, evaluation, Health technology assessment (HTA) County level Responsible for prioritisation and 21 providing of health care Municipalities Responsible for providing care289 for elderly and disabled (also social services, child care, schools etc)

3. National governmental agencies • Medical Products Agency (MPA) Approval of drugs • Dental and Pharmaceutical Benefits Board (TLV) Reimbursement of drugs and dental care • Swedish Council on Technology Assessment in Health Care (SBU) Health technology assessment, systematic reviews • National Board of Health and Supervision, evaluation, Welfare (NBHW) guidelines

4. National guidelines for major disease groups (NBHW): Guidelines for major disease groups Recurrent revisions Guidelines are developed for asthma-chronic obstructive lung disease, breast-, colorectal- and prostate cancer, dementia, depression, diabetes, heart disease, stroke, schizofrenia, dental care, musculoskeletal disease, alcohol and other abuses Interventions are ranked in 10 groups according to evidence and cost-effectiveness

5. The Swedish Council on Technology Assessment in Health Care SBU Established in 1987 Independent governmental agency Government funded Annual budget: 5.3 million euro Employs 43 people 200 contracted researchers Board and 2 scientific councils

6. Objectives of SBU Health technology assessments of new and established medical interventions. Clinical, economic, social, and ethical implications should be assessed Disseminate the results of HTAs Assess the impact of HTA reports Serve as an international contact point for health technology assessment (INAHTA, EUnetHTA etc)

7. SBU's Main Criteria for Selecting Projects Scientific information is available in the international literature The intervention has a major potential impact on health and quality of life Many people affected, important health problem for those affected Important economic, ethical, organizational, and/or professional consequences Large practise variations. The value of the intervention is uncertain and/or controversial

8. SBU's Assessment Process New project suggested Discussed by Scientific Advisory Group Formal approval by Board of Directors Board appoints Project Group (≈ 10 clinicians & researchers) Task defined in detail by Project Group Project Group trained in systematic review Protocol for literature searching and review Articles searched + scrutinized

9. Systematic literature review Make all efforts to avoid bias – strict methods, settled before start Expert group Scientific competence Expert knowledge (epidemiology, economy) Advocates – resistors Conflict of interest Men, women, countries/regions

10. Examples of published Reports • Periodontitis (2004) • Moderately Elevated Blood Pressure (2004, 2008) • Treatment of depression (2004) • Osteoporosis (2003) • Hearing devices for impaired hearing (2003) • Sickness absence (2003) • Preventing caries (2002) Childhood vaccination against HPV 16 and 18 (2008) Ranibuzumab in treating age-related macular degeneration (2008) Methods of Treating Chronic Pain (2006) Interventions to Prevent Obesity (2005) Treatment of Anxiety Disorders (2005)

11. Some Ongoing Projects Vaccination during childhood Drug use among the elderly Antibiotic prophylaxis in surgical interventions Dietary treatment for diabetes Triage methods and patient flow processes at emergency departments

12. SBU SBU has no legislative power to implement change SBU makes no decisions concerning approval or reimbursement of drugs SBU has no supervision function SBU can only rely on our ability to convince decision makers and the professionals to change practise if they believe we are right and trustworthy.

13. Implementation strategy applied by Semmelweis(Best, Neuhauser, QSHC, 2004) ”Insult your enemies, accuse your superiours of causing the death of mothers, actively join political factions, abandon your friends, refuse to publish, but when you do so write incomprehensively, use public humilation and haranguing to change behaviour, and be arrogant and angry yourself.” P.S. This is not the implementation strategy applied by SBU

14. What is the impact of HTA in Sweden?

15. What was the impact of a SBU Report: Preoperative routines? • X-rays of hearts and lungs should not be performed routinely • ECG should only be performed on special indications • Lab tests should only be performed on special indications • More patients could be admitted on the day of operation

16. Percentage of otherwise healthy individuals examined preoperatively by x-ray, EcG, and laboratory testing before and after the SBU report. Also presented is the percentage of patients admitted on the day of the surgery at the time of the two studies.

17. Benefits of SBU-reports (”Good examples”) • The project on preoperative routines resulted in savings in the range of 24 million euros annually • The project on hearing screening for newborns resulted in substantial practise change. Coverage of the more effective method increased from 25 % (before) to 75 % after the report was published. • One out of four dentists and dental hygienists intensified anti-tobacco advice to their patients due to a SBU report saying it was an effective measure

18. Benefits of SBU-reports (”Good examples”) • Bone density measurements were not recommended for screening in a SBU report and sales of equipment have declined after the publication of the report • In a SBU report, the use of neuroleptics as unspecific calming therapy for old persons were discouraged due to serious side effects. The frequency of patients given this medication diminished from 34 % to 28 % at nursing homes after 1 year. • Nicotine substitution medications for smoking cessation were supported by a SBU report. The use has increased after the publication of the report.

19. The importance of identifying knowledge gaps.We need a process for stimulating research in areas where we lack knowledge and where the economic incentives for research is small

20. SBU- report: Mild head injury • Alternative 1: Admission for observation • Alternative 2: Immediate computed tomography • The year 2000: SBU-report: Lack of studies on the most effective administration • SBU initiated a randomized multicentre trial, OCTOPUS • The year 2006: SBU-report/BMJ articles: No difference in effects and risks between the two alternatives, but immediate computed tomography is more cost-effective.

21. Potential benefits of SBU-reports (”Good examples”) • The report on mangement of mild head injury shows potential savings of about 40 million Swedish crowns. • There is no evidence that calcium and D-vitamin prevent osteoporosis among women under the age of 80. Potential savings in Sweden 32 million Swedish crowns.

22. Some problems concerning HTA in Sweden • Lack of scientific evidence for many interventions (worldwide problem) • Revisions of reimbursement for drug therapy groups have so far not been based on systematic reviews • All national guidelines are not based on systematic reviews

23. Problems concerning HTA in Sweden • Too little regulatory demands on medical devices (worldwide problem) • Too few health economists • Too little emphasis on disinvestments • Too few studies on long term adverse events of drugs

24. What about the development of HTA in Sweden? • Mostly a very positive development • Intensified collaboration between the governmental agencies • Increased interest from regions/county councils to use HTA in their decision-making processes • SBU will probably have a more comprehensive responsibility for all systematic reviews in Sweden. • Requests from NBHW as a basis for guidelines • Requests from the Dental and Pharmaceutical Benefits Agency as a basis for revisions of reimbursement for therapeutic groups