The Norwegian Institute of Public Health (NIPH) has published a health technology assessment of 177Lutetium-based peptide receptor radionuclide therapy for treating neuroendocrine tumors

Norway established in 2013 a framework for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. This framework is called the “New Method”.

In this framework, all innovations should undergo HTA before being funded. Selection of methods is performed by the Ordering Forum (Bestillerforum). If the method is of national concern, it undergoes Single Technology Appraisal at national level followed by the funding decision by the group of payers (Decision Forum, Beslutningsforum). Decision Forum has regular meetings to review results of assessments to the make funding decisions.

The Ordering Forum has asked the Norwegian Institute of Public Health (NIPH) to conduct a full health technology assessment (HTA) of Peptide receptor radionuclide therapy (PRRT) using 177Luthetium (177Lu-PRRT). Included in this assessment is the radiopharmaceutical Lutathera® (177Lu-DOTATATE) has recently been approved by the European Medicines Agency (EMA) with market exclusivity.

The key conclusions from the report are presented below:

• Background
  • Peptide receptor radionuclide therapy (PRRT) using 177Luthetium (177Lu-PRRT) has become an established treatment modality, which increasingly is being used for subgroups of patients with neuroendocrine cancers (tumors) or neoplasia (NET/NEN)
  • So far, Norwegian patients have been sent abroad for treatment, as 177Lu-PRRT has not been available in Norway
• Clinical effectiveness
  • 177Lu-PRRT probably reduces overall mortality and is likely to increase both general and progression-free survival, however the evidence is too sparse to draw any definitive conclusion
  • Tumor response rates assessed using the RECIST-criteria are likely to improve with 177Lu-PRRT
  • It is uncertain to what extent 177Lu-PRRT causes myeloplastic syndrome and acute leukemia, but the risk might be around 1%
• Health economic evaluation
  • In terms of prices and suppliers, it is not being possible to use today’s prices and suppliers, given that Lutathera® has marked exclusivity. The mean cost per patient per year when 177Lu-PRRT is carried out in Norway is estimated between 492, 000 and 870, 000 NOK, depending on organization and possible discount on Lutathera®
  • Total costs for establishing the treatment in Norway is estimated to be between 25,928,000 and 44,763,000 NOK the first year and between 24,595,000 and 43,518,000 NOK the following years, while the total costs for treating abroad are slightly lower, as it is expected that more patients will be offered the treatment if available in Norway
  • The major cost-driver is the price of Lutathera®, which is independent of the treatment being established in Norway or patients still being treated abroad
• Ethics
  • The treatment is expensive and might therefore challenge the principle of equal use of limited health care resources, although the number of eligible patients per year is low. On the other hand, it is not often a palliative cancer treatment with relatively few side-effects may extend life-time to up to three years

The next step in the process is evaluation of the HTA results and decision-making about coverage in Norway by the Decision Forum.

See the main results of the assessments in Norwegian and English here.

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