Esketamine guidelines

The provision of esketamine treatment

These guidelines are in line with the Workplace Injury Rehabilitation and Compensation Act 2013 (WIRC Act) and the Accident Compensation Act 1985.

WorkSafe will have regard to these guidelines when making decisions for the provision of esketamine to people who have an accepted claim under the Victorian Workers Compensation Scheme.

Throughout these guidelines, any reference to WorkSafe also includes WorkSafe’s agents and self-insurers.

Esketamine

WorkSafe can, in certain circumstances, fund esketamine (sold as Spravato®) to assist people to effectively recover from workplace injuries and safely return to work and life.

Spravato® is currently the only formulation registered by the Therapeutic Goods Administration (TGA) and available through the Pharmaceutical Benefits Scheme (PBS).

These guidelines apply solely to this approved product. Spravato® will be referred to as esketamine throughout these guidelines.

Esketamine is indicated for treatment-resistant major depression in adults who have not responded adequately to at least 2 different antidepressants. These antidepressants must have been of adequate dose and duration to treat the current moderate to severe depressive episode.

Esketamine is not considered first line treatment for depression. It should only be considered when other treatments, such as psychotherapy or medications, do not provide adequate benefit.

While esketamine is likely to be effective for some people the magnitude of benefit and effectiveness of long-term use remains uncertain. Careful consideration should be given to the associated risks and potential side effects compared to other available treatments. The person receiving the treatment must be appropriately advised and their informed consent must be obtained.

These guidelines detail what WorkSafe will and will not fund in relation to esketamine treatment and the information required for funding to be considered.

What we can pay for

WorkSafe can pay for the reasonable costs of esketamine treatment and services a person needs for a work-related injury or illness under the Victorian workers compensation legislation.

The treatment or service must meet the following criteria.

• Be clinically justified, safe and effective.
• Be likely to achieve measurable improvement in a person’s functioning.
• Promote progress toward a person’s functional independence, participation and self-management.
• Be for rehabilitation purposes for a work-related injury only.
• Be delivered in line with the Clinical Framework.

The treatment or service must be requested by the worker’s treating psychiatrist.

The treatment or service is subject to written prior approval.

We can pay for the following.

• PBS prescribed esketamine to treat treatment-resistant major depression associated with the work-related injury or illness.
• Treatment delivered in line with existing evidence-based guidance.

Due to the risks associated with esketamine medication, esketamine funding will only be considered following provision of the clinical information outlined below, and is subject to review by WorkSafe’s Clinical Panel.

WorkSafe will periodically review a person’s entitlement to esketamine to make sure the treatment and services remain reasonable, clinically justified, outcome focused and payable under the legislation.

Services we will not pay for

Under the Victorian workers compensation legislation, WorkSafe cannot pay for the following esketamine services.

• Services that are not required as a result of a worker’s accepted injury or illness.
• Services for a person other than the person with an accepted claim.
• Services that are not a reasonable cost as determined in accordance with the Victorian workers compensation legislation.
• Services provided outside of Australia without prior approval from WorkSafe.
• Services provided by a person who is not registered under the Health Practitioner Regulation National Law to practice in the medical profession.

WorkSafe will not pay for esketamine treatment and services provided without prior approval from WorkSafe.

Under WorkSafe’s determination of reasonable cost, WorkSafe will not pay for costs relating to the following.

• Non-PBS privately prescribed esketamine. Refer to WorkSafe’s Drugs of Dependence Guidelines.
• Esketamine prescribed for clinical indications other than treatment-resistant major depression or treatment not in line with existing evidence-based guidance.
• Esketamine prescribed concomitantly with other ‘end stage’ treatments. This includes, but is not limited to ECT, TMS or with non-established, new or emerging treatments and services. Refer to WorkSafe’s non-established, new or emerging treatments and services guidelines.
• Esketamine treated interchangeably with any other drugs or interventions. Alternative preparations of ketamine and similar compounds are not deemed as evidence-based or suitable alternatives.
• Treatment requests submitted by a person who is not the treating psychiatrist.
• Dispensing and handling fees for the medication are not payable unless exceptional circumstances exist. WorkSafe will review any exceptional circumstances on a case-by-case basis to determine if an exemption applies.

How much we can pay

WorkSafe will pay for the reasonable costs of the following.

• Esketamine medication prescribed in accordance with the Pharmaceutical Benefits Scheme (PBS).
• Consultation fees related to the treatment in line with WorkSafe’s reimbursement rates for medical services fee schedule.
• Esketamine facility fee (inclusive of administration and monitoring) as an outpatient treatment. Contact the agent for information on billing the facility fee.

WorkSafe strongly encourages the delivery of esketamine in an outpatient setting. Provision of esketamine alone is not a sufficient indication for an inpatient admission. Approval of inpatient esketamine will be considered in exceptional circumstances only. If esketamine is approved as part of an inpatient admission, then it is included in the inpatient bed fee and cannot be billed in addition to the bed fee. Refer to WorkSafe’s Private hospital non-arrangement services fee schedule.

Sometimes there is a difference between what a provider charges and what WorkSafe will pay as the reasonable cost. If the provider charges more than what WorkSafe will pay, workers will need to pay the difference. In this instance, WorkSafe recommend the provider advise the worker prior to providing any services.

Who can provide these services

WorkSafe will fund esketamine treatment and services delivered only by providers that meet the following conditions.

• Registered under the Health Practitioner Regulation National Law as a psychiatrist.
• Psychiatrists holding the appropriate credentials to be able to deliver esketamine treatment.
• Hold the requisite insurance coverage to deliver esketamine treatment.

In addition to these conditions, the following also applies.

• The worker must be undergoing supervision at an accredited treatment centre for the administration of esketamine.
• The medication may be delivered by a healthcare professional with appropriate credentials, under the direct clinical supervision of the treating psychiatrist.
• The medication must be supplied by a registered pharmacist.
• Esketamine providers are expected to hold and maintain accreditation under a relevant quality standards agency such as the International Standards Organisation (ISO) or the Australian Council on Healthcare Standards (ACHS).

Accessing services

A request for esketamine will not be considered without the following information.

Information required prior to induction or re-initiating induction treatment

Before commencing induction esketamine treatment, the following information is required.

• Details of the accredited treating psychiatrist.
• Details of the accredited treatment centre.
• In cases where inpatient treatment is requested, rationale must be provided to explain why an outpatient setting is deemed inappropriate.
• Confirmed diagnosis of treatment resistant major depression and relationship to the work-related injury or illness.
• Evidence that the condition has been inadequately responsive to at least 2 oral anti-depressant drug therapies.
• Details of other previous treatment trialled (pharmacological and non- pharmacological) and their measurable outcomes.
• Details of all current treatment being undertaken and current medication list.
• Baseline objective outcome measures using a structured clinical rating scale. Broad, qualitative, subjective statements are not considered appropriate outcome measures.
• Fee breakdown and a treatment plan including the expected treatment protocol. This includes the number of sessions, frequency of sessions and dose.

The following information is also required if reinitiating induction treatment.

• Details of the previous esketamine treatment course.
• Reason(s) for the cessation of the previous esketamine treatment course(s).
• Evidence of at least a 4-week gap from last esketamine treatment course to re-initiation of treatment.
• Evidence, using a structured rating scale, of significant clinical therapeutic benefit of the prior course of treatment with esketamine.
• Evidence, using a structured rating scale, of a relapse in depression.

Information required prior to non-induction treatment

To consider funding non-induction treatment, the following information is required.

• Evidence demonstrating adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by objective outcome measures using a structured clinical rating scale.
• Updated fee breakdown and treatment plan including the expected treatment protocol (number of sessions, frequency of sessions and dose) and details of any changes to other treatment (pharmacological and non-pharmacological) currently undertaken to treat the worker’s treatment resistant major depressive disorder.

WorkSafe will consider approving funding for non-induction treatment for a maximum period of 6 months at a time. If further non-induction treatment is required, a new request detailing the esketamine treatment delivered to date, an updated fee breakdown and treatment plan including the expected treatment protocol (number of sessions, frequency of sessions and dose) and evidence demonstrating adequate response to treatment as evaluated by a structured clinical rating scale is required to be submitted for review and further consideration of funding.

Esketamine treatment would not usually continue for more than 12 months. However, a proportion of people may require treatment beyond 12 months for each major depressive episode. This may include workers who are continuing to respond to treatment but have not achieved remission or recovery. For WorkSafe to consider funding esketamine treatment beyond 12 months, the worker must continue to demonstrate a response to treatment. Treatment should be discontinued if the worker is no longer responding.

Once all the information is received, the request will be reviewed by a WorkSafe Clinical Panel psychiatrist who will provide a recommendation to the agent. The WorkSafe Clinical Panel psychiatrist may contact the requesting psychiatrist to seek further information and/or discuss the proposed treatment prior to making a recommendation to the agent.

Service delivery expectations

WorkSafe expects that all providers delivering esketamine treatment as part of the Victorian workers compensation scheme follow the below principles.

• Provide culturally safe and respectful services.
• Protect the person’s human rights and report any concerns of abuse, neglect or discrimination to an appropriate regulatory or complaints body.
• Support the person to maximise their independence, promote recovery and self-advocacy.

WorkSafe also expects that any treatment provided is reasonable, clinically justified, outcome focused, and in line with the Clinical Framework.

WorkSafe has reporting and engagement expectations for all providers delivering esketamine treatment. WorkSafe expects providers to communicate, collaborate and provide information to WorkSafe and other relevant parties as required.

For example:

• Providers should work with treating health practitioners or other providers, such as medical practitioners to enable the most appropriate treatment.
• Providers should work with occupational rehabilitation providers, treating health practitioners and employers in relation to return to work.

Providers are required to comply with the requirements set out in these guidelines and in the Application for registration to provide services to workers.

If a provider does not meet these requirements or WorkSafe has concerns about the provider’s conduct or services delivered, WorkSafe may take appropriate action in accordance with the legislation.