Summary and recommendations

The Norwegian Storting (Parliament) has approved the three criteria for priority-setting: health benefit, resources, and severity (i.e., absolute QALY-shortfall). Norway has two central systems for setting priorities for public access to new health technologies: The national system for managed introduction of new methods in the specialist health care service («New methods») and pre-approved reimbursement under The blue prescription scheme («Blue prescription scheme»). Together, these two systems contribute to ensuring that the technologies introduced fulfil the three priority-setting criteria and the requirements for transparency, equal treatment, and resources savings.

Through ten meetings, several external reports, advice and input from several specialist and interest organizations, The Expert Group for Priority Setting and Access (hereafter «The Expert Group») has investigated the current situation for the two priority-setting systems (New methods and the blue prescription scheme) regarding the relationship between group and individual level decision-making. The development of personalised medicine, novel gene therapies, and other advanced and expensive methods challenge this relationship.

The Expert Group has emphasised that the Norwegian population should be given timely and fair access to effective methods, within the current financial framework. The assessments made in the two priority-setting systems must also be understandable, well founded, and admissible, especially in the case of decision on not adopting a new health technology. In line with the value base of the Norwegian public health and care service, the principle of equal treatment was strongly emphasised in the assessment: «Equal cases must be treated alike».

The Expert Group recommends the following ten action points, which together will promote fair access to effective methods in the public health and care services:

1. improve information about the systems for priority setting and strengthen knowledge on priority-setting among clinicians and other decision-makers
2. tailor health technology assessment processes and subgroup analyses
3. increase the possibility for patients to participate in clinical studies
4. introduce a scheme for assessing individual access to methods that have received a negative reimbursement decision in New methods
5. introduce a scheme for assessing individual access and group exemptions when methods are on reassessment in New methods
6. do not open for that privately funded treatment can constitute an independent ground for access to treatment in the public health and care services
7. do not open for exemptions until the health technology assessment is completed for methods reimbursed through The blue prescription scheme
8. increased use of managed entry agreements to handle uncertainty with regards to effect and risk, particularly for rare diseases
9. facilitate compassionate use of medications for patients with an expected treament periode of shorter than six months
10. establish national systems for reporting and evaluating the use of exemptions and individual access