The move comes after the HTA found that a course of ketamine infusions would probably improve response rates more than placebo (saline), ECT, and midazolam; and that it would likely prove comparable to esketamine.

While the certainty of evidence surrounding those comparisons, which were made based on data from existing trials, was deemed to be moderate or low, with longer-term efficacy data particularly shaky, the authors said that “ketamine’s potential inclusion in Norway’s specialist healthcare system could reduce financial barriers and substantially improve outcomes for both patients and their families.”

Today’s decision by the Beslutningsforum appears in line with that finding, then.

Indeed, the new medicines body assumed the same price level used in prior analyses, like the HTA.

In that cost-comparison analysis, the cost of a treatment series involving six infusion sessions over the course of three weeks was NOK 18,000 ($1,800), with the cost of all consumables—including the drug itself—in each IV ketamine session placed at just NOK 306 ($30). That’s an order of magnitude less than Johnson & Johnson’s esketamine nasal spray product, Spravato.

The new medicines regulator makes certain stipulations around the use of ketamine in TRD, namely:

• Patients should be followed up via registries or clinical studies.
• Treatment should take place in hospitals or via the outpatient mental health service (DPS).
• Patients should be informed that the treatment is given off-label, the reason for that, and what it entails.
• The decision will be reviewed by the end of 2028.

As we noted in our earlier coverage, this decision is the result of a years-long research campaign by Norwegian practitioners and researchers.

Those individuals include Dr. Lowan Stewart, who began lobbying the Norwegian health department and psychiatric association to develop guidelines and integrate ketamine-assisted psychotherapy into the public health system back in 2017. Back then, he was “mostly met with skepticism and lack of interest”, he told Psychedelic Alpha,  “partially also as an American outsider and emergency specialist rather than a psychiatrist.”

Stewart co-founded Insight Ketamine in New Mexico with his father in 2016, but has spent most of his time in Norway since 2010. He went on to open a private clinic in Oslo in 2018 to provide ketamine for mental health and told us that he was “immediately challenged” via an investigation by the city’s medical board, which he says was at the request of the Norwegian Psychiatric Association. But Stewart has kept pushing on, having since been involved in the establishment of a psychedelics research group, the Norwegian Association for Psychedelic Science, and other developments. He is also Medical Director at Axon, a private clinic specialising in ketamine-assisted psychotherapy.

His experience shows just how far the effort has come. Today, the push has been institutionalised to some extent, including by the Norwegian Rapid Acting Antidepressant Network (NORAAD), which was established in January 2023 by Stewart and co. (As we mentioned in our earlier reporting, the group has received a NOK 24.9M ($2.5M) grant from the National Program for Clinical Treatment Research in Specialist Health Services to study ketamine for TRD across ten Norwegian hospitals.)

Back in 2022, the Ketamine Unit at Østfold Hospital’s DPS Nordre submitted the present application for IV ketamine’s approval for use in TRD. Since then, around 350 patients have been treated via Østfold’s protocol at a trio of public hospitals. According to a 2025 publication (Berthold-Losleben et al., 2025), more than half of 300 of those patients showed a significant reduction in depressive symptoms.

Interestingly, the protocol calls for some kind of psychotherapy post-infusions, preparatory sessions prior to them, and regular check-ins throughout the induction phase. It also covers what treatment rooms should feature, such as noise-cancelling headphones, duvets, and dimmable lights.

Even without considering any repercussions for the potential future roll-out of psychedelic therapies in the Nordic country, today’s move is remarkable in and of itself.

It marks the first time that a country has decided to reimburse off-label, generic ketamine for a depressive disorder at the national level.

What’s more, given the country’s principle of equal access to healthcare, eligible Norwegians should expect to get access to the treatment regardless of geography. In practice, that could include coverage of travel and accommodation, should a patient not be located near a suitable site.

If successful in its roll-out, Norway’s model of generic ketamine for TRD could serve as an example of affordable, equitable access to ketamine-assisted psychotherapy—something that other countries have struggled to achieve.

“Today’s decision is, above all, a victory for patients with depression who have waited far too long for new solutions,” Stewart said in a statement. “Norway now has the chance to show the world how innovative therapies can be integrated into public health safely and responsibly.”

Ingmar Clausen, a psychiatrist who heads up DPS North Østfold, told Psychedelic Alpha that he and his group “are proud and happy about the decision.” “The health authorities have put their trust in us”, he continued, “and now we have a brand new tool available to treat patients with depression.”

Lars Lien, chair of the Norwegian Psychiatric Association, meanwhile, told us that he is “happy on behalf of all patients with treatment-resistant depression in Norway.” “The decision comes with a limitation of 3 years to look more closely into the long-term effects”, he added, noting: “By then we hopefully have good enough proof of evidence to continue in a normal way.”