Decision to change the regulatory and funding restrictions for stimulant medicines for ADHD.

24 June 2025

What we’re doing

We're pleased to announce that Medsafe and Pharmac are making changes to the regulatory and funding restrictions that determine who can prescribe the stimulant medicines methylphenidate, dexamfetamine and lisdexamfetamine. These medicines are used to treat attention deficit hyperactivity disorder (ADHD).

We expect that these changes will make it easier for people to be diagnosed and prescribed treatment for their ADHD.

These changes will take effect from 1 February 2026. This date is later than what was originally proposed. Some of the medicines used for ADHD are currently experiencing supply issues. This date has been changed to make sure there is enough supply of these medicines when the changes are made. It will also allow more time for training to be developed for doctors and nurse practitioners.

What does this mean for people?

From 1 February 2026, nurse practitioners and general practitioners will be able to prescribe stimulant medicines for ADHD to adults (18 years and older). For children and teenagers (17 years and younger), nurse practitioners working in mental health services will also be able to prescribe these medicines. Psychiatrists and paediatricians will continue to be able to prescribe these medicines.

Stimulant medicines include:

• Methylphenidate hydrochloride (Ritalin, Rubifen, Rubifen SR, Methylphenidate ER – Teva, Concerta, and Ritalin LA)
• Dexamfetamine sulfate (Noumed Dexamfetamine)
• Lisdexamfetamine dimesilate (Vyvanse)

These changes mean that you won't always need to see a specialist, like a psychiatrist, to be diagnosed with ADHD and begin treatment with these medicines. However, not all doctors and nurse practitioners will provide this service, so it's important to talk to them about your options.

Changes made by Medsafe

Medsafe is part of the Ministry of Health and is responsible for the regulation of therapeutic products, including medicines for ADHD, in New Zealand. Medsafe issues approval notices for stimulant medicines used in the treatment of ADHD. These approval notices specify which prescribers can prescribe stimulant medicines.

Medsafe is changing the approval notices for ADHD medicines to allow more doctors and nurse practitioners to be able to begin treatment for people with stimulant medicines for ADHD. This would mean (additions in bold):

For people with ADHD aged 17 years and under

• Medical practitioners specialised in paediatrics or psychiatry and nurse practitioners working within paediatric services or child and adolescent mental health services may start people on stimulant treatments for ADHD.

For people with ADHD aged 18 years and over

• Medical practitioners specialised in paediatrics, psychiatry or general practice and nurse practitioners working within their area of practice may start people on stimulant treatments for ADHD.

For all age groups

• Any other medical practitioner or nurse practitioner may only prescribe stimulant treatment for ADHD when acting on the written recommendation of a practitioner described above authorised to start people on stimulant medicines for ADHD.

You can find more detailed information about the feedback that Medsafe received and their considerations on the Medsafe website:

• Medsafe’s consultation outcome document on the changes to the prescriber restrictions for stimulant medicines for ADHD.

Changes made by Pharmac

To support implementation of the regulatory changes, Pharmac is removing the prescriber restrictions and changing the Special Authority criteria for access to stimulant medicines. These changes align with the regulatory changes made by Medsafe and will allow more prescribers to submit Special Authority applications for funding of treatments for people diagnosed with ADHD.

The key changes to Pharmac Special Authority criteria include:

• allowing Special Authority applications from any relevant practitioner, and
• amending Special Authority criteria that outline specific specialist application or specialist written recommendation requirements.

The updated Special Authority criteria for stimulant medicines for ADHD can be found below – Changes to the Special Authority criteria.

Who will be interested in these changes

• People with ADHD, their whānau, families, partners, and caregivers.
• Paediatricians, psychiatrists, psychologists, general practitioners, medical practitioners, nurse practitioners, pharmacists, and other health professionals involved in the care of people with ADHD.
• Patient advocacy groups.

• Pharmaceutical suppliers and wholesalers.

Implementation of this proposal

The regulatory and funding changes will be made from 1 February 2026. However, we understand that it will take some time for these changes to take full effect in the community. This is because new prescribers will need additional training, education, and resourcing to safely diagnose someone with ADHD and prescribe stimulant medicines.

Key implementation initiatives would be led by Health NZ | Te Whatu Ora and professional organisations, such as the Royal New Zealand College of GPs (RNZCGP), and Nurse Practitioners NZ.

Implementation activities for new prescribers may include:

• training, education and guidance to support ADHD assessment, diagnosis and appropriate treatment
• practical resources to support prescribers
• resources to support consumers with the changes, such as updating information on Healthify

Supply of stimulant medicines

There have been ongoing worldwide shortages of methylphenidate tablets and capsules. These shortages have been caused by several issues:

• a global increase in demand
• restrictions in importing and exporting the medicines between countries
• manufacturing constraints.

In New Zealand, there are ongoing supply issues for extended release (ER) formulations of methylphenidate (Concerta and Methylphenidate ER - Teva). The supply of sustained release (Rubifen SR) and long-acting (Ritalin LA) formulations of methylphenidate have also been impacted. These supply issues started in September 2023 and are expected to continue until the end of 2025.

It is expected that this decision will increase the demand for stimulant medicines, including methylphenidate. People have told us they are concerned that by increasing access to ADHD medicines, the supply issues currently affecting individuals will worsen. We have also heard from the suppliers of stimulant medicines that they would not have enough stock to support these changes, if they happened in 2025.

After hearing all of your feedback, we have made the decision to move the date that these changes come into effect. The changes to the regulatory and funding restrictions will happen on 1 February 2026. We expect by this time there will be enough medicine available to support an increase in demand.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 17 December 2024. Thank you to everyone who provided feedback. Pharmac and Medsafe received a large amount of feedback on the proposal which has been very helpful in our decisions.

Pharmac changes

You told us your concerns about the supply issues affecting methylphenidate and how this impacts you, your family,and whānau. As such, the implementation date has been changed to 1 February 2026.

We have also made some minor edits to the funding criteria to make sure they are easier to understand.

Medsafe changes

Consultation feedback indicated that nurse practitioners work within an “area of practice” rather than a “scope of practice”. As such, Medsafe will amend the wording in the gazette notice with respect to a nurse practitioners’ area of practice, for prescribing stimulant medicines for people with ADHD.

No other changes to the regulatory restrictions were made.

Changes to the Special Authority criteria

Dexamfetamine

From 1 February 2026, medicines listed under dexamfetamine sulfate would be subject to the following eligibility criteria in Section B of the Pharmaceutical Schedule (additions in bold, deletions in strikethrough, from status quo). No changes are proposed for the narcolepsy indication. Similar changes would be made in Part II of Section H of the Pharmaceutical Schedule:

Special Authority for Subsidy

Initial application — (ADHD in patients aged 5 years or over) from any relevant practitioner. 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 without further renewal unless notified for applications meeting the following criteria:

All of the following:

1. ADHD (Attention Deficit and Hyperactivity Disorder) in patients aged 5 years or over; and
2. Diagnosed according to DSM-IV or ICD 10 criteria; and
3. Applicant is a health practitioner authorised to prescribe treatment consistent with the approval notice gazetted for dexamfetamine (see note).

3.   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.

Note: prescribing practitioner detail is in the relevant approval notice published in the New Zealand Gazette. Approval notices are located through the ‘Medicines (controlled drugs) with restrictions under regulation 22 of the Misuse of Drugs Regulations 1977’ section of the Medsafe ‘Restrictions on the Supply, Prescribing or Administration of Medicines under the Medicines Act 1981 and Misuse of Drugs Regulations 1977’ webpage (https://www.medsafe.govt.nz/profs/riss/restrict.asp#MedicinesReg22 as of April 2025).

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

Both All of the following:

1. ADHD (Attention Deficit and Hyperactivity Disorder) in patients under 5 years of age; and
2. Diagnosed according to DSM-IV or ICD 10 criteria; and
3. Applicant is a health practitioner authorised to prescribe treatment consistent with the approval notice gazetted for dexamfetamine (see note).

Note: prescribing practitioner detail is in the relevant approval notice published in the New Zealand Gazette. Approval notices are located through the ‘Medicines (controlled drugs) with restrictions under regulation 22 of the Misuse of Drugs Regulations 1977’ section of the Medsafe ‘Restrictions on the Supply, Prescribing or Administration of Medicines under the Medicines Act 1981 and Misuse of Drugs Regulations 1977’ webpage (https://www.medsafe.govt.nz/profs/riss/restrict.asp#MedicinesReg22 as of April 2025).

Lisdexamfetamine

From 1 February 2026, medicines listed under lisdexamfetamine dimesilate would be subject to the following eligibility criteria in Section B of the Pharmaceutical Schedule (additions in bold, deletions in strikethrough from status quo). Similar changes would be made in Part II of Section H of the Pharmaceutical Schedule:

Special Authority for Subsidy

Initial application — (ADHD) from any relevant practitioner 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 without further renewal unless notified for applications meeting the following criteria:

Either:

1. Patient is currently on treatment with lisdexamfetamine dimesilate and met all remaining the following

criteria prior to commencing treatment; or

2. All of the following:
   1. ADHD (Attention Deficit and Hyperactivity Disorder); and
   2. Diagnosed according to DSM-V DSM-5 or ICD 11 criteria; and 2.3.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
   3. Applicant is a health practitioner authorised to prescribe treatment consistent with the approval notice gazetted for lisdexamfetamine (see note); and
   4. Any of the following:
      1. Patient is taking a currently subsidised formulation of atomoxetine or methylphenidate hydrochloride (extended-release) for ADHD and has not received sufficient clinical benefit or has experienced intolerable side effects; or
      2. Patient is taking a currently subsidised formulation of dexamfetamine sulfate (immediate release) which has not been effective due to significant administration and/or treatment adherence difficulties: or

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 treatment adherence difficulties; or
2. There is significant concern regarding the risk of diversion or abuse of immediate release methylphenidate hydrochloride; or
3. Both:
   1. Patient would have been prescribed a subsidised formulation of methylphenidate (extended release) but has been unable to access due to supply issues with methylphenidate (extended release); and
   2. Other alternative stimulant presentations (methylphenidate or dexamfetamine) are not appropriate.
4. Lisdexamfetamine dimesilate is not to be used in combination with another funded methylphenidate presentation.

Note: prescribing practitioner detail is in the relevant approval notice published in the New Zealand Gazette. Approval notices are located through the ‘Medicines (controlled drugs) with restrictions under regulation 22 of the Misuse of Drugs Regulations 1977’ section of the Medsafe ‘Restrictions on the Supply, Prescribing or Administration of Medicines under the Medicines Act 1981 and Misuse of Drugs Regulations 1977’ webpage (https://www.medsafe.govt.nz/profs/riss/restrict.asp#MedicinesReg22 as of April 2025).

Methylphenidate

From 1 February 2026, medicines listed under methylphenidate hydrochloride would be subject to the following eligibility criteria in Section B of the Pharmaceutical Schedule (additions in bold, deletions in strikethrough from status quo). No changes are proposed for the narcolepsy indication. Similar changes would be made in Part II of Section H of the Pharmaceutical Schedule:

Special Authority for Subsidy

Initial application — (ADHD in patients aged 5 years or over) from any relevant practitioner). 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 without further renewal unless notified for applications meeting the following criteria:

All of the following:

1. ADHD (Attention Deficit and Hyperactivity Disorder) in patients aged 5 years or over; and
2. Diagnosed according to DSM-IV or ICD 10 criteria; and
3.   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.

3. Applicant is a health practitioner authorised to prescribe treatment consistent with the approval notice gazetted for methylphenidate (see note).

Note: prescribing practitioner detail is in the relevant approval notice published in the New Zealand Gazette. Approval notices are located through the ‘Medicines (controlled drugs) with restrictions under regulation 22 of the Misuse of Drugs Regulations 1977’ section of the Medsafe ‘Restrictions on the Supply, Prescribing or Administration of Medicines under the Medicines Act 1981 and Misuse of Drugs Regulations 1977’ webpage (https://www.medsafe.govt.nz/profs/riss/restrict.asp#MedicinesReg22 as of April 2025).

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

Both All of the following:

1. ADHD (Attention Deficit and Hyperactivity Disorder) in patients under 5 years of age; and
2. Diagnosed according to DSM-IV or ICD 10 criteria; and
3. Applicant is a health practitioner authorised to prescribe treatment consistent with the approval notice gazetted for methylphenidate (see note).

Note: prescribing practitioner detail is in the relevant approval notice published in the New Zealand Gazette. Approval notices are located through the ‘Medicines (controlled drugs) with restrictions under regulation 22 of the Misuse of Drugs Regulations 1977’ section of the Medsafe ‘Restrictions on the Supply, Prescribing or Administration of Medicines under the Medicines Act 1981 and Misuse of Drugs Regulations 1977’ webpage (https://www.medsafe.govt.nz/profs/riss/restrict.asp#MedicinesReg22 as of April 2025).

Methylphenidate extended-release

From 1 February 2026, medicines listed under methylphenidate hydrochloride extended-release would be subject to the following eligibility criteria in Section B of the Pharmaceutical Schedule (additions in bold, deletions in strikethrough from status quo). No changes are proposed for the narcolepsy indication. Similar changes would be made in Part II of Section H of the Pharmaceutical Schedule:

Special Authority for Subsidy

Initial application — (ADHD) from any relevant practitioner. 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 without further renewal unless notified for applications meeting the following criteria:

Either:

1. All of the following:

1. ADHD (Attention Deficit and Hyperactivity Disorder); and
2. Diagnosed according to DSM-IV or ICD 10 criteria; and
3. 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
4. Applicant is a health practitioner authorised to prescribe treatment consistent with the approval notice gazetted for methylphenidate (see note); and
5. 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; or

2. Both:
   1. Patient meets the Special Authority criteria for SA2411 methylphenidate hydrochloride; and
   2. Patient is unable to access other methylphenidate hydrochloride presentations under Special Authority criteria SA2411 due to an out of stock (see note).

Note: Criterion 2 is to permit short-term funding to cover an out-of-stock on tab extended-release Methylphenidate ER – Teva and tab sustained-release 20 mg Rubifen SR subsidised under SA2411 (https://schedule.pharmac.govt.nz/2025/02/01/SA2411.pdf).

Note: prescribing practitioner detail is in the relevant approval notice published in the New Zealand Gazette. Approval notices are located through the ‘Medicines (controlled drugs) with restrictions under regulation 22 of the Misuse of Drugs Regulations 1977’ section of the Medsafe ‘Restrictions on the Supply, Prescribing or Administration of Medicines under the Medicines Act 1981 and Misuse of Drugs Regulations 1977’ webpage (https://www.medsafe.govt.nz/profs/riss/restrict.asp#MedicinesReg22 as of April 2025).

Our response to what you told us

Thank you to the people who took the time to respond to this consultation. A summary of the main themes raised and our responses are below.