Spravato (intranasal esketamine, DIN 02499290 — Drug Identification Number) is the only Health Canada-approved psychiatric ketamine form. It was approved in May 2020 for adults with treatment-resistant major depressive disorder (TRD), in combination with oral SSRI/SNRI, after failure of at least two adequate antidepressant trials in the current depressive episode. Distribution is controlled through the Janssen Journey program (Canada's REMS-equivalent): clinics, prescribers, and pharmacies must enroll; doses are administered in-clinic only with mandatory ≥2-hour supervised observation; no take-home dosing. CDA-AMC (formerly CADTH) issued a Do Not Reimburse recommendation in December 2020 — most provincial drug plans are non-benefit. The practical access pathway in Canada is private insurance with prior authorization — Spravato is the form most likely to have prior-auth coverage for documented TRD, particularly through Canada Life (PSHCP for federal public servants), Manulife, Sun Life, and Green Shield. Compounded racemic intranasal ketamine is a different product — not Health Canada or FDA approved as a manufactured drug, with FDA safety alerts and Health Canada Product InfoWatch caution; this article explains the distinction.
Key takeaways
- Spravato (esketamine, S-enantiomer of ketamine) is Health Canada-approved as of May 2020 for treatment-resistant MDD in adults, in combination with oral SSRI/SNRI.
- Distribution is via the Janssen Journey program: in-clinic supervised administration only, ≥2-hour observation post-dose, no take-home.
- CDA-AMC December 2020 recommendation: Do Not Reimburse. Most provincial drug plans are non-benefit; Quebec INESSS recommended against listing November 2020; BC PharmaCare is non-benefit.
- Spravato is the form most likely to have private insurance prior-auth coverage in Canada — particularly Canada Life PSHCP (Form M7520 for federal public servants), Manulife, Sun Life, and Green Shield.
- WSIB Ontario lists Spravato on the Psychotraumatic and Serious Injury formularies. VAC covers as non-formulary case-by-case for service-related TRD.
- Compounded racemic intranasal ketamine is NOT Spravato. Compounded preparations are not Health Canada or FDA approved as manufactured drugs; FDA safety alerts (February 2022 and October 2023) and Health Canada Product InfoWatch (March 2022) describe risks of unsupervised compounded use.
- Pivotal Spravato RCTs: Daly 2018 (JAMA Psychiatry), Popova 2019 (TRANSFORM-2, Am J Psychiatry), Daly 2019 (SUSTAIN-1 maintenance, JAMA Psychiatry), Wajs 2020 (SUSTAIN-2 long-term safety, J Clin Psychiatry), Fedgchin 2019 (TRANSFORM-1), Ochs-Ross 2020 (elderly TRD).
What is Spravato?
Spravato is the brand name for esketamine, the S-enantiomer of ketamine, formulated as a nasal spray and approved by Health Canada for treatment-resistant MDD in May 2020 (DIN 02499290). Each spray device delivers 28 mg; therapeutic doses are 56 mg or 84 mg per administration (two or three sprays). Spravato is given in combination with an oral SSRI or SNRI; it is not approved as monotherapy in Canada.
Esketamine versus racemic ketamine. Pharmaceutical ketamine is a racemic mixture (50% S, 50% R enantiomer). Spravato isolates the S-enantiomer, which has approximately 4× greater NMDA receptor affinity than the R-enantiomer. The clinical translation of this molecular difference remains a topic of ongoing study; the practical effect for patients is that Spravato has its own pivotal RCT base (Daly, Popova, Wajs studies) distinct from the racemic ketamine literature.
Form and administration. Spravato is a nasal spray, self-administered by the patient under direct healthcare provider supervision. It is not injected, not an infusion, and not taken at home. The Janssen Journey program (below) governs delivery.
How Spravato is delivered — the Janssen Journey program
The Janssen Journey program is Health Canada's controlled-distribution framework for Spravato — the Canadian equivalent of the U.S. REMS (Risk Evaluation and Mitigation Strategy). Key requirements:
- Clinic enrollment. The administering clinic must enroll in the Janssen Journey program and complete training.
- Prescriber enrollment. The prescribing physician must enroll and complete the program training.
- Pharmacy enrollment. The dispensing pharmacy must be a Janssen Journey-enrolled pharmacy.
- Patient enrollment. Patients must be enrolled in the program at first dose.
- In-clinic-only administration. No take-home dosing. Every dose is administered under supervision in a Janssen Journey-certified clinical setting.
- ≥2-hour observation post-dose. Patients remain in clinic for at least 2 hours after administration. Vitals are monitored; any sedation or dissociation must resolve before discharge.
- No driving for the rest of the day. Patients require a designated driver or rideshare for departure.
The induction protocol is twice-weekly dosing for 4 weeks, followed by a transition to weekly or every-other-week dosing depending on response (the schedules studied in TRANSFORM-2, SUSTAIN-1, and SUSTAIN-2). Most patients receive Spravato in psychiatric private practice or select hospital-affiliated clinics: the Royal Ottawa BMO Innovative Clinic for Depression, the Jewish General Hospital Montreal model, Edmonton hospital affiliates, and Numinus locations are among Canadian sites with confirmed or marketed Spravato availability.
The pivotal Spravato evidence
Daly et al. 2018 — JAMA Psychiatry — Phase 2 dose-response RCT of intranasal esketamine adjunctive to oral antidepressant in TRD. Established the dose-response signal that supported registration (PubMed).
Popova et al. 2019 — TRANSFORM-2 — American Journal of Psychiatry — pivotal short-term efficacy trial of flexibly dosed esketamine + newly initiated oral antidepressant in TRD. Significant MADRS reduction at day 28 (PubMed).
Fedgchin et al. 2019 — TRANSFORM-1 — International Journal of Neuropsychopharmacology — fixed-dose Phase 3 RCT in TRD (PubMed).
Daly et al. 2019 — SUSTAIN-1 — JAMA Psychiatry — randomized maintenance-of-efficacy trial. Patients in stable remission on esketamine + oral antidepressant who continued treatment had significantly longer time to relapse than those switched to placebo + oral antidepressant (PubMed).
Wajs et al. 2020 — SUSTAIN-2 — Journal of Clinical Psychiatry — long-term open-label safety study of up to one year. 802 patients on esketamine + oral antidepressant; demonstrated acceptable long-term safety profile, no cases of interstitial cystitis observed (PubMed).
Ochs-Ross et al. 2020 — TRANSFORM-3 — American Journal of Geriatric Psychiatry — Spravato in elderly TRD patients (PubMed).
The evidence picture: Spravato has a robust short-term efficacy signal in TRD with concurrent oral antidepressant, sustained maintenance benefit (SUSTAIN-1), and acceptable long-term safety up to one year (SUSTAIN-2). The CDA-AMC December 2020 Do Not Reimburse recommendation does not contest the existence of efficacy — it raises clinical concerns about magnitude of benefit relative to comparators and about appropriate use criteria.
Coverage and access in Canada
Public coverage — mostly non-benefit
| Program | Status |
|---|---|
| CDA-AMC (formerly CADTH) recommendation | December 2020: Do Not Reimburse (PDF) |
| Ontario Drug Benefit / EAP | Not on standard formulary; Exceptional Access via SADIE portal possible but not standard |
| BC PharmaCare | Non-benefit decision |
| Quebec RAMQ / INESSS | INESSS recommended against listing November 2020 |
| Saskatchewan Drug Plan | Non-benefit |
| Manitoba Pharmacare | Non-benefit |
| Alberta Health / AHCIP | Not publicly covered through provincial plan |
| Alberta Blue Cross PAT (March 2024) | Psychedelic-assisted therapy coverage focuses on off-label IM/IV ketamine; verify whether Spravato is included |
Private insurance — the realistic pathway
Spravato is the form most likely to be privately covered with prior authorization in Canada. Specific pathways:
- Canada Life PSHCP (federal public servants) — Spravato Prior Authorization Form M7520. Particularly relevant for Ottawa's federal workforce. Reimbursement is typically at 80% of the lowest-priced generic alternative.
- Manulife, Sun Life, Green Shield, Blue Cross provincial branches — generally accept prior authorization for documented TRD with failed antidepressant trials.
- Documentation required: TRD diagnosis with documented failure of two or more adequate antidepressant trials in the current episode; prescriber justification; Janssen Journey enrollment.
WSIB and VAC
- WSIB Ontario — Spravato listed on Psychotraumatic (22WS) and Serious Injury (27WS) formularies with prior authorization.
- Veterans Affairs Canada — covers Spravato as non-formulary case-by-case for service-related TRD; reported FY2024–25 coverage of approximately 433 veterans at average ~$10,109 per person across ketamine modalities.
For full insurance navigation, see Insurance Coverage for Ketamine Therapy.
Compounded racemic intranasal ketamine — a critical distinction
Spravato is the only Health Canada-approved intranasal ketamine product. Compounded racemic intranasal ketamine — sometimes marketed as "intranasal ketamine" through compounding pharmacies — is a different product entirely.
| Spravato | Compounded racemic intranasal ketamine | |
|---|---|---|
| Active ingredient | Esketamine (S-enantiomer only) | Racemic mixture (50% S + 50% R) |
| Regulatory status (Canada) | Health Canada approved for TRD (May 2020) | NOT approved as a manufactured drug; available only via compounding pharmacy |
| Administration setting | Janssen Journey-certified clinic, in-clinic only | Often dispensed for home use (significant safety concern) |
| Post-dose observation | Mandatory ≥2 hours under supervision | Typically none |
| Evidence base | Phase 2/3 RCTs (Daly, Popova, Wajs studies) | Limited; mostly observational and case reports |
| Safety alerts | Black-box-equivalent warnings managed via Janssen Journey | FDA safety alerts February 2022 and October 2023; Health Canada Product InfoWatch March 2022 |
FDA safety position (October 2023): the FDA alerted patients and healthcare providers about potential risks associated with compounded ketamine products, including respiratory depression, severe dissociation, and abuse/misuse — particularly with at-home use without supervision. Although this is U.S. FDA, the underlying clinical concerns apply equally in Canada.
Health Canada position: Health Canada's Product InfoWatch (March 2022) flagged that compounded ketamine preparations have not been assessed by Health Canada for risk-benefit and that adverse events should be reported to Canada Vigilance.
The honest patient framing: if a clinic offers "intranasal ketamine," ask specifically whether it is Health Canada-approved Spravato or a compounded racemic preparation. The distinction has implications for safety, regulatory oversight, insurance coverage, and at-home-use risks.
Where ATMA CENA fits
ATMA CENA's corporate clinics in Edmonton and Calgary deliver KAT primarily through intramuscular and sublingual ketamine. ATMA CENA's specific Janssen Journey certification and direct Spravato administration capacity should be confirmed during the information call. For Spravato-eligible patients, the access pathway is typically:
- The ATMA CENA intake call evaluates whether Spravato (TRD-indicated, often privately covered) or off-label IM/SL ketamine is the better fit.
- Where Spravato is the right pathway and ATMA CENA does not directly administer, the team can route to a Janssen Journey-certified provider — for example, the Royal Ottawa BMO Innovative Clinic for Depression, Numinus locations, or other psychiatric private practice.
- The coordinated care model can support the psychotherapy wraparound around Spravato delivery elsewhere.
For patients where insurance coverage is the deciding factor, Spravato's private prior-auth pathway is often the most accessible Canadian option.
Frequently asked questions
What is Spravato? Spravato is intranasal esketamine — the S-enantiomer of ketamine — approved by Health Canada in May 2020 for adults with treatment-resistant major depressive disorder, in combination with oral SSRI or SNRI.
Is Spravato the same as ketamine? Spravato is one enantiomer (the S-enantiomer) of ketamine. Pharmaceutical racemic ketamine is a 50:50 mixture of S- and R-enantiomers. The molecules differ in NMDA receptor affinity and have separate evidence bases.
Is Spravato approved for anything besides TRD? In Canada, no. Spravato's Health Canada indication is specifically TRD in adults with concurrent oral antidepressant. In the United States, Spravato also has an FDA indication for depressive symptoms in adults with MDD with acute suicidal ideation or behaviour.
Why doesn't insurance cover Spravato more broadly? CDA-AMC recommended against public reimbursement in December 2020, and most provincial drug plans are non-benefit. The practical access pathway is private insurance prior authorization for documented TRD. WSIB Ontario covers it on specific formularies.
Does ATMA CENA offer Spravato? ATMA CENA's corporate clinics deliver KAT primarily through IM and SL ketamine. ATMA CENA's specific Janssen Journey certification should be confirmed during the intake call. For Spravato-eligible patients where ATMA CENA does not directly administer, the team can route to a Janssen Journey-certified provider with coordinated care support.
What about "intranasal ketamine" that isn't Spravato? Compounded racemic intranasal ketamine is not Health Canada-approved as a manufactured drug. FDA safety alerts (October 2023) and Health Canada's Product InfoWatch (March 2022) describe risks of unsupervised compounded use. If a clinic offers "intranasal ketamine," ask specifically whether it is Health Canada-approved Spravato or a compounded racemic preparation.
How long does a Spravato session last? Self-administered nasal spray takes a few minutes; the mandatory post-dose observation is at least 2 hours. Plan on 2.5–3 hours in clinic per session, plus arrangement for a designated driver.
How is Spravato dosed? The induction protocol is twice-weekly dosing for 4 weeks at 56 mg or 84 mg per session, followed by weekly dosing for weeks 5–8, then transition to weekly or every-other-week maintenance based on response.
Is Spravato safer than IV ketamine? "Safer" depends on the comparison. SUSTAIN-2 followed 802 patients on Spravato + oral antidepressant for up to a year and found acceptable long-term safety with no cases of interstitial cystitis. IV ketamine has a different but generally well-tolerated safety profile (Murrough 2015). Both are safer in supervised clinical settings than recreational ketamine misuse. See Ketamine Therapy Side Effects.
Can I take Spravato while continuing my SSRI? Yes — Spravato's pivotal trials specifically tested esketamine + newly initiated oral antidepressant (TRANSFORM-2). Concurrent oral antidepressant is part of the Health Canada-approved indication.
Where can I get Spravato in Canada? Janssen Journey-certified psychiatric private practice and select hospital-affiliated clinics including the Royal Ottawa BMO Innovative Clinic for Depression, the Jewish General Hospital Montreal, Edmonton hospital affiliates, and Numinus locations. Confirm current location-specific availability with ATMA CENA team or directly with the provider.
Sources
- Health Canada DPD — Spravato: https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98903
- Health Canada — Spravato Regulatory Decision Summary: https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00738
- Janssen Journey program (Canada): https://www.janssenjourneyform.ca/
- CDA-AMC — Spravato CDEC Final Recommendation (December 2020): https://www.cda-amc.ca/sites/default/files/cdr/complete/SR0621%20Spravato%20-%20CDEC%20Final%20Recommendation%20December%2018,%202020_for%20posting.pdf
- Daly EJ, et al. (2018). Phase 2 dose-response esketamine in TRD. JAMA Psychiatry. https://pubmed.ncbi.nlm.nih.gov/29282469/
- Popova V, et al. (2019). TRANSFORM-2 — flexibly dosed esketamine + new oral antidepressant in TRD. Am J Psychiatry. https://pubmed.ncbi.nlm.nih.gov/31109201/
- Fedgchin M, et al. (2019). TRANSFORM-1 — fixed-dose esketamine in TRD. Int J Neuropsychopharmacol. https://pubmed.ncbi.nlm.nih.gov/31290965/
- Daly EJ, et al. (2019). SUSTAIN-1 maintenance of efficacy. JAMA Psychiatry. https://pubmed.ncbi.nlm.nih.gov/31268507/
- Wajs E, et al. (2020). SUSTAIN-2 long-term safety. J Clin Psychiatry. https://pubmed.ncbi.nlm.nih.gov/32316080/
- Ochs-Ross R, et al. (2020). TRANSFORM-3 — esketamine in elderly TRD. Am J Geriatr Psychiatry. https://pubmed.ncbi.nlm.nih.gov/31734084/
- Canada Life — Spravato Prior Authorization Form M7520 (PSHCP): https://www.welcome.canadalife.com/content/dam/canadalife/documents/forms/you-and-your-family/1-0-employer/1-3-request-an-assessment/1-3-2-prior-auth-drugs/en/pshcp/spravato-m7520.pdf
- FDA — Compounded ketamine safety alerts (October 2023): https://www.fda.gov/drugs/human-drug-compounding/fda-warns-patients-and-health-care-providers-about-potential-risks-associated-compounded-ketamine
- Health Canada — Product InfoWatch (March 2022, ketamine): https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch/march-2022.html
Related articles in this cluster
- Ketamine Therapy in Canada
- Ketamine Infusion Therapy
- Intravenous Ketamine Therapy
- Group Ketamine Therapy
- Ketamine Therapy Side Effects
- Ketamine Therapy for Treatment-Resistant Depression (deep dive)
- Ketamine vs Spravato
- Insurance Coverage for Ketamine Therapy
- Ketamine Therapy Cost in Canada
Last updated: 2026-05-06