Decision to remove the renewal criteria for stimulant treatments

11 November 2024

Medicines Decision

What we’re doing

We’re pleased to announce that we have made a decision to remove the renewal criteria for stimulant treatments - methylphenidate, dexamfetamine, and modafinil from 1 December 2024

These medicines are used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy.

We expect that this decision will make it easier to access ongoing funding for treatment for an estimated 65,500 people with attention deficit hyperactivity disorder (ADHD) or narcolepsy who use these treatments.

What does this mean for people?

Methylphenidate, dexamfetamine, and modafinil are funded for the treatment of ADHD and narcolepsy.

From 1 December 2024, the renewal criteria will be removed from methylphenidate, dexamfetamine, and modafinil, making it easier for people who need these treatments to access them. This means that:

Anyone starting on a stimulant treatment which requires a Special Authority approval, will be able to access funded treatment without the requirement for this approval to be renewed.
Anyone with a current or recent (expired within the last two years) Special Authority approval for these treatments will automatically be issued an approval that is valid without the need for it to be renewed. Pharmac and Health New Zealand will manage this so people do not need to do anything for this to happen.

Prescribers (medical or nurse practitioners) would need to continue to manage ongoing prescribing and seek specialist input as needed to consider whether treatment remains appropriate and whether an individual is benefitting from it.

In addition to the changes to the renewal criteria, from 1 December 2024 we are also making a change to the initiation criteria for dexamfetamine for individuals with ADHD aged 5 years and over. This change will mean that nurse practitioners can submit a Special Authority application for dexamfetamine on the recommendation of a paediatrician or psychiatrist. This makes it the same as methylphenidate funding criteria.

Who we think will be interested

People with ADHD or narcolepsy, their whānau, and caregivers
Paediatricians, psychiatrists, psychologists, medical practitioners, nurse practitioners and other health professionals involved in the care of people with ADHD.
Sleep specialists, neurologists, respiratory physicians and other health professionals involved in the care of people with narcolepsy.
Support and advocacy groups.
Health New Zealand | Te Whatu Ora and professional organisations
Pharmaceutical suppliers and wholesalers.

Any changes to the original proposal?

This decision was subject to a consultation letter released on 12 September 2024. We received feedback from clinicians, advocacy groups, consumers, and health sector stakeholders.

We’re grateful to those who took the time to respond to our consultation. This is an important part of our decision-making process. It gives us the opportunity to listen to the voices of the community and acknowledge and respond to feedback.

Overall, the feedback received was supportive of the proposal and no changes have been made from the original proposal as a result of the feedback received.

A key feedback theme we received was the importance of ongoing review of treatment for people prescribed stimulant treatments. Some people requested an amended renewal criteria remain in place for younger age groups with inclusion of medical or nurse practitioners with additional training.

We acknowledge that treatment reviews for people with ADHD or narcolepsy remain important. However, we do not consider that funding restrictions are the best way to ensure that this occurs. We consider that review of ongoing stimulant treatment is best managed by treating clinicians, with support from relevant professional organisations. We will share this feedback with Health NZ and professional organisations that support medical and nurse practitioners in treating people with ADHD or narcolepsy.

Implementation activities

We also received feedback in relation to the implementation activities that would be required to support implementation of this proposal.

Informed by this feedback, we have a range of planned implementation activities to support implementation of this proposal. We intend to:

Work with organisations such as the Royal College of General Practitioners (RNZCGP) Royal Australian New Zealand College of Psychiatrists (RANZCP), Health Pathways, Goodfellow, BPAC and the New Zealand Formulary to provide relevant information, training and resources to support prescribers with ADHD and narcolepsy management.
Work with Healthify to update their webpages to support awareness of the removal of renewal criteria, explaining the impact and what the changes mean for peoples treatment.
Work with Health NZ and a clinical reference group led by members of RNZCGP, RANZCP and other professional organisations on a HealthPathway update to support the ongoing management of ADHD and narcolepsy treatment.

A summary of the feedback we received and our responses

Details about the decision

From 1 December 2024 the renewal criteria for stimulant treatments will be removed from Section B of the Pharmaceutical Schedule. Similar changes will be made for stimulant treatments in Part II of Section H of the Pharmaceutical Schedule.

In addition, the eligibility criteria for dexamfetamine, for individuals with ADHD aged 5 years or over, will be amended to allow Special Authority applications from nurse practitioners on the recommendation of a paediatrician or psychiatrist in writing. This aligns with the eligibility criteria for methylphenidate and the legal prescriber restrictions for dexamfetamine.

Methylphenidate hydrochloride

The eligibility criteria for the medicines listed under methylphenidate will be amended in Section B of the Pharmaceutical Schedule as follows, (additions in bold, deletions in strikethrough). As the renewal criteria will be removed, it is not shown.

ADHD in people aged 5 years or over

Initial application — (ADHD in patients aged 5 years or over) only from a paediatrician, psychiatrist, medical practitioner on the recommendation of a paediatrician or psychiatrist (in writing) or nurse practitioner on the recommendation of a paediatrician or psychiatrist (in writing). Approvals valid for 24 months without further renewal unless notified for applications meeting the following criteria:

All of the following:

ADHD (Attention Deficit and Hyperactivity Disorder) in patients aged 5 years or over; and
Diagnosed according to DSM-IV or ICD 10 criteria; and
Either:
1. Applicant is a paediatrician or psychiatrist; or
2. Applicant is a medical practitioner or nurse practitioner and confirms that a paediatrician or psychiatrist has been consulted within the last 2 years and has recommended treatment for the patient in writing.

ADHD in people aged under 5 years

Initial application — (ADHD in patients aged under 5 years) only from a paediatrician or psychiatrist. Approvals valid for 12 months without further renewal unless notified for applications meeting the following criteria:

Both:

ADHD (Attention Deficit and Hyperactivity Disorder) in patients under 5 years of age; and
Diagnosed according to DSM-IV or ICD 10 criteria.

Narcolepsy

Initial application — (Narcolepsy*) only from a neurologist or respiratory specialist. Approvals valid for 24 months without further renewal unless notified where the patient suffers from narcolepsy.

Note: *narcolepsy is not a registered indication for Methylphenidate ER – Teva.

Methylphenidate hydrochloride extended-release

The eligibility criteria for the below medicines listed under methylphenidate extended-release will be amended in Section B of the Pharmaceutical Schedule as follows, (additions in bold, deletions in strikethrough). As the renewal criteria will be removed, it is not shown.

Initial application — (ADHD) only from a paediatrician, psychiatrist, medical practitioner on the recommendation of a paediatrician or psychiatrist (in writing) or nurse practitioner on the recommendation of a paediatrician or psychiatrist (in writing). Approvals valid for 24 months without further renewal unless notified for applications meeting the following criteria:

All of the following:

ADHD (Attention Deficit and Hyperactivity Disorder); and
Diagnosed according to DSM-IV or ICD 10 criteria; and
Either:
1. Applicant is a paediatrician or psychiatrist; or
2. Applicant is a medical practitioner or nurse practitioner and confirms that a paediatrician or psychiatrist has been consulted within the last 2 years and has recommended treatment for the patient in writing; and
Either:
1. Patient is taking a currently subsidised formulation of methylphenidate hydrochloride (immediate-release or sustained-release) which has not been effective due to significant administration and/or difficulties with adherence; or
2. There is significant concern regarding the risk of diversion or abuse of immediate-release methylphenidate hydrochloride.

Dexamfetamine sulfate

The eligibility criteria for the dexamfetamine will be amended in Section B of the Pharmaceutical Schedule as follows, (additions in bold, deletions in strikethrough). As the renewal criteria will be removed, it is not shown.

ADHD in people aged 5 years or over

Initial application — (ADHD in patients aged 5 years or over) only from a paediatrician, psychiatrist or medical practitioner on the recommendation of a paediatrician or psychiatrist (in writing) or nurse practitioner on the recommendation of a paediatrician or psychiatrist (in writing). Approvals valid without further renewal unless notified for 24 months for applications meeting the following criteria:

All of the following:

ADHD (Attention Deficit and Hyperactivity Disorder) in patients aged 5 years or over; and
Diagnosed according to DSM-IV or ICD 10 criteria; and
Either:
1. Applicant is a paediatrician or psychiatrist; or
2. Applicant is a medical practitioner or nurse practitioner and confirms that a paediatrician or psychiatrist has been consulted within the last 2 years and has recommended treatment for the patient in writing.

ADHD in people aged under 5 years

Initial application — (ADHD in patients aged under 5 years) only from a paediatrician or psychiatrist. Approvals valid without further renewal unless notified for 12 months for applications meeting the following criteria:

Both:

ADHD (Attention Deficit and Hyperactivity Disorder) in patients under 5 years of age; and
Diagnosed according to DSM-IV or ICD 10 criteria.

Narcolepsy

Initial application — (Narcolepsy) only from a neurologist or respiratory specialist. Approvals valid without further renewal unless notified for 24 months where the patient suffers from narcolepsy.

Modafinil

The eligibility criteria for modafinil will be amended in Section B of the Pharmaceutical Schedule as follows, (additions in bold, deletions in strikethrough). As the renewal criteria will be removed, it is not shown.

Special Authority for Subsidy

Initial application only from a neurologist or respiratory specialist. Approvals valid without further renewal unless notified for 24 months for applications meeting the following criteria:

All of the following:

The patient has a diagnosis of narcolepsy and has excessive daytime sleepiness associated with narcolepsy occurring almost daily for three months or more; and
Either:
1. The patient has a multiple sleep latency test with a mean sleep latency of less than or equal to 10 minutes and 2 or more sleep onset rapid eye movement periods; or
2. The patient has at least one of: cataplexy, sleep paralysis or hypnagogic hallucinations; and
Either:
1. An effective dose of a subsidised formulation of methylphenidate or dexamfetamine has been trialled and discontinued because of intolerable side effects; or
2. Methylphenidate and dexamfetamine are contraindicated.

Our response to what you told us

We’re grateful to those who took the time to respond to our consultation. Responses were largely supportive of the proposal.

Theme	Pharmac Comment
Feedback was largely supportive of the proposal. Responders noted that, for many people, ADHD is a long-term condition and highlighted the proposal would: Reduce access barriers and cost to continue treatment. Alleviate stress and frustration at long wait times for appointments. Avoid treatment disruption and the adverse impacts of this. Alleviate strain on specialist services and free up resource for people that need specialist care the most.	We are pleased to progress a proposal that would improve the health outcomes of New Zealanders and reduce the burden on the health system.
Renewal criteria considerations
Some responders considered that people who had a Special Authority expire more than two years ago should also be issued a Special Authority that is valid without further renewal.	People that have had a Special Authority for stimulant treatment expire more than two years ago will need to speak to their prescriber about their treatment options. We understand that people who stopped stimulant treatment more than two years ago may be less likely to require stimulant treatment and therefore would need to meet the eligibility criteria for initiation again. If stimulant treatment is required, prescribers would need to resubmit an initial Special Authority application.
Some responders were not supportive of the proposal and considered there would be no checks or balances for access to stimulant treatments. These responders considered stimulant treatments to be addictive and have diversion and abuse risks and considered that specialists would be best placed to manage this. Some responders considered the renewal criteria should remain in place for people with ADHD who need to be monitored more closely, such as younger people. Some responders proposed measures to help ensure that treatment was accessed by those who need it, such as: including medical and nurse practitioners with additional training and support in the renewal criteria; or requiring that people have at least one Special Authority renewal before being issued an approval that then no longer requires renewal.	We acknowledge that treatment reviews for people with ADHD or narcolepsy are important. However, we do not consider that funding restrictions are the best way to achieve this. We consider that a review of the appropriateness of ongoing stimulant treatment is best managed by treating clinicians, with support from relevant professional organisations. We will share this feedback with Health NZ and the professional organisations that support medical and nurse practitioners in treating people with ADHD or narcolepsy. We have a range of planned implementation activities to support these changes. Please also see our planned implementation activities.
Implementation activities
We received feedback regarding the information and activities needed to support the implementation of the proposal, this included: Information, training and resources to support prescribers in the management of ADHD, in particular, prescribing stimulant treatments and stimulant treatment review. Information and resources in various formats to help people understand what the proposed changes will mean for their treatment management and to enhance understanding of stimulant treatment options.	> We would like to thank the responders for this feedback. As a result of the feedback we plan to: Work with organisations such as RNZCGP, RANZCP, HealthPathways, Goodfellow, BPAC and the New Zealand Formulary to provide relevant information, training and resources to support prescribers with ADHD and narcolepsy management. Work with Healthify to update their webpages to support awareness of the removal of renewal criteria, explaining the impact and what the changes mean for people’s treatment. Work with Health NZ and a clinical reference group led by members of RNZCGP, RANZCP and other professional organisations on a Health Pathway update to support the ongoing management of people with ADHD and narcolepsy.
Wider ADHD access considerations
Some responders noted the substantial cost of diagnostic assessments and requested the number of prescribers who can diagnose ADHD treatments should be expanded to support treatment access.	Stimulant medicines used in the treatment of ADHD are controlled medicines and have specific legal requirements that set out which prescribers can prescribe treatment for ADHD. More information on these requirements is outlined on the gazette government website(external link). The regulations determine who can prescribe stimulant medicines and to whom. We will continue to remain responsive to changes in this area moving forward to help ensure our funding criteria are fit for purpose.
A few responders considered that all stimulant medicines should be available on one Special Authority form to enable greater clinician and patient treatment choice and avoid subsequent specialist appointments to switch treatments that require a new Special Authority. One responder considered the Special Authority criteria for stimulant treatment should be removed and replaced with prescribing requirements and professional practice guidance on ADHD treatment instead. A few responders considered the diagnostic criteria in Pharmac Special Authority should be updated from DSM-IV to DSM-5.	We appreciate that access to funded ADHD treatment could be increased in other ways. Substantial changes to the initiation criteria for stimulant treatments or removing or combining the Special Authority criteria are out of the scope of this proposal. However, we intend to continue our work in this area regarding access to treatments for ADHD.
A few responders noted that three monthly dispensing of stimulant medicines would support access	Stimulant treatments (methylphenidate, dexamfetamine and lisdexamfetamine) are controlled drugs and are regulated differently to other medicines. More information about this is on the Ministry of Health Website(external link). Currently, three months supply of stimulant medicines (methylphenidate, dexamfetamine and lisdexamfetamine) can be prescribed, however pharmacists can only dispense one month at a time.
Feedback noted that the proposal’s benefits will be limited by supply challenges with methylphenidate extended release (brands Concerta and Methylphenidate- Teva ER) and noted a public consultation(external link) on medicine shortages in Australia that may present learning opportunities for supply management in New Zealand.	We acknowledge the global supply issues with methylphenidate extended release are frustrating and are impacting medicine access in New Zealand. We are working with both suppliers to understand their supply outlook and how we can secure additional supply for New Zealand. From 1 December 2024, we are also funding lisdexamfetamine, which will provide an additional once daily stimulant treatment option. We expect that this would help mitigate the impact of these supply issues. More information on the decision to fund lisdexamfetamine can be found below. Decision to fund lisdexamfetamine for the treatment of ADHD
Other
One responder considered that the eligibility criteria for methylphenidate extended release should enable access for people with ADHD where there is significant caregiver burden on managing multiple day dosing.	Methylphenidate extended release is funded for people if treatment with immediate or sustained release methylphenidate is ineffective due to significant administration challenges. We recommend people discuss their treatment options with their prescriber.
We received information that responded to previous considerations of the Mental Health Advisory Committee regarding treatment of ADHD, this included: Safety and efficacy of long term use of methylphenidate Diversion concern of stimulant treatments in New Zealand Effectiveness of Stimulant treatments and conversational behavioural therapy (CBT) Ethnic disparities in ADHD diagnosis and treatment.	We appreciate the feedback and will share this with the Mental Health Advisory Committee for its consideration at its next formal meeting.
A few responders considered that Pharmac should fund other treatments for ADHD, such as micronutrients and guanfacine.	Pharmac has received funding applications for micronutrients and guanfacine, more information on these funding applications can be found on Pharmac’s Application Tracker. The funding application for micronutrients for ADHD(external link) is currently under assessment, however is on hold as there is currently no Medsafe approved product. The funding application for guanfacine for ADHD with autism symptoms(external link) has been received and the next step for this application would be to seek clinical advice. However, this is on hold as guanfacine has not been submitted to Medsafe for approval.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 660 050