Ånen Ringard 1 , Berit Mørland 1,2

1. Supporting tough decisions: linking Health technology assessment (HTA) and national priority setting in Norway Ånen Ringard1, Berit Mørland1,2 1Secretariat - Norwegian Council for Priority Setting in Health Care 2Norwegian Knowledge Centre for the Health Services The International Society for Priorities in Health Care, April 23-25, 2010, Boston, Massachusetts, USA

2. Historical context: • Priority setting has for several decades remained high on the health policy agenda in Norway. • The Lønning I-report (1987) • The Lønning II-report (1997) • The Patient Rights Act (PRA) (2001) • Secondary legislation related to the PRA (2001/2004) • Guidelines for priority setting (2009/2010)

3. Values underpinning priority setting : • The severity of the condition. • The magnitude of the expected outcome from the intervention. • Reasonable cost-effectiveness ratio. • The quality of the evidence: Is the documentation for the three first points satisfactory? • Question: About open and fair processes?

4. From principles to policy advise/decisions: • National health plan (2007-2010) states a: • “Need for a more comprehensive approach to important issues of priority setting”. • Consequently, The Ministry of Health (MoH) established – The Norwegian Council (NC) for Priority Setting in 2007. • The aim of the council: • Clarify the roles and responsibilities of agents responsible for the work on prioritisation • Improve interaction between actors on different “levels” • Produce more comprehensiveness and transparency around the work on and prioritisation in the health service. • The NC – 25 members (heads of health services and patient organizations). • First meeting in April 2007. Meets 5 times a year (for one day). • Until now provided advice in 40-50 major cases.

5. Current system for national priority setting in:

6. The quality of the evidence - the link to HTA? • Health Technology Assessment is a multi-disciplinary field of policy analysis that examines the medical, economic, social and ethical implications of the incremental value, diffusion and use of a medical technology in health care. • Oortwijn and colleagues (1998) identify the following as relevant dimensions for conducting a HTA: • burden of disease, • uncertainty about the effectiveness of an intervention, • potential benefits of the assessment, and • potential impact of the proposed project.

7. Use of HTA (From Kent Woods, UK) Health TechnologyAssessment /HTA Politics Reimbursement Clinical research Assessment Appraisal Guideline Scientific documentation Clinical effect Cost/effectiveness Consequences:Organization Patient perspective Ethics/Law Resources/-economyEducation Priority Clinical practice

8. HPV-vaccination – an example of the ”linkakge” of HTA and NC’s desicions: • 2005/2006 – Initial discussions among Norwegian health authorities about HPV vaccination. • September 2006 – Gardasil® receive market authorization (MA) within the EU. • September 2007 – Cervarix® receive MA in EU. • November 2007 – First round of discussion about HPV-vaccination within the NC. • March 2008 – Second round in the NC – advice to introduce the vaccine in the national program. • October 2008 – DoH propose to fund the vaccination (national budget process) • December 2008 – The parliament approves the national budget – thereby funding the introduction. • Spring 2009 – NIH – decides on Gardasil® • 2009/2010 – The program starts operating.

9. Results (I) – The NC’s advice based upon HTAs providing information on: • Efficacy Expected outcomes of the intervention: The majority of the council concluded that sufficient evidence existed on the protective effect of HPV vaccines on cervical cancer. • SafetyConcerns about safety aspects (esp. long term) of the vaccines were expressed by all NC-members. Most pronounced by the opponents of the vaccine. • Cost-effectivenessEmphasis was put on the costs, judged to be high, but not too high to not recommend the vaccine.The vaccine was to be financed within the existing health care budgets.

10. Results (II): • Organizational consequencesThe vaccine was to be integrated into a national cervix cancer-program which also include the existing screening program. • Ethical aspectsEthical concerns were expressed throughout the discussions. Arguments were made both against and in favour of introducing the vaccine. • The decision making process:Stakeholders and NC-members have all emphasised the importance of having a transparent process (through open access to all meetings and all documents).

11. Concludingremarks: • The NC is still very much ”work in progress”. • The commitment by all members to base its discussion on best evidence, implies an important and continuous role for HTA when considering the implementation of new technologies. • There are, on the other hand, limitations to the kind of answers HTA can provide. In these cases other kind of methods and documentation will become important.