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

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).
4. 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(external link) 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(external link) as of April 2025).

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
   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 lisdexamfetamine (see note); and
   5. 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
      3. There is significant concern regarding the risk of diversion or abuse of immediate release dexamfetamine sulfate; or
      4. 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
      5. There is significant concern regarding the risk of diversion or abuse of immediate release methylphenidate hydrochloride; or
      6. 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.
      7. 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(external link) as of April 2025).

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:
       3.1 Applicant is a paediatrician or psychiatrist; or
       3.2 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(external link) 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(external link) as of April 2025).

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
      1.3 Either:
         1.3.1 Applicant is a paediatrician or psychiatrist; or
         1.3.2 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 methylphenidate (see note); and
   4. 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/latest/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(external link) as of April 2025).

You told us

Many respondents considered this proposal would provide the following benefits:

• improve access to diagnosis and treatment for people with ADHD
• reduce costs and wait times due to fewer specialist appointments
• promote equity and remove barriers for people who can access general practice services but not specialist services. Particularly for those people living in urban areas where care is able to be obtained by the GP where needed in a timely manner
• support overstretched specialist clinicians and free up appointments for people with other concerns and conditions who need to see psychiatrists or paediatricians
• result in better health outcomes for people with ADHD, their families, schools and wider communities
• enable clinicians in primary care to support their patients from treatment initiation.

Our response

We are pleased to be progressing a proposal which would meet the health needs of New Zealanders. These themes are in line with the clinical advice Pharmac received on this proposal.

You told us

Many respondents highlighted the need for additional and sufficient training to be provided for GPs and NPs. Concerns included:

• current training is not sufficient to provide the expertise needed to diagnose and prescribe treatment for people with ADHD. This may result in misdiagnosis, poor advice, insufficient care and inadequate assessment.
• as current training/ education is inadequate this results in greater rates of abuse of stimulants and more adverse events associated with treatment.
• clinicians will need supervision and the support of a multi-disciplinary team, particularly in cases where there is diagnostic uncertainty.
• there is no certification process or regulated training in place allowing patients to identify suitably skilled prescribers in the diagnosis and treatment of ADHD. There is a need for a register of qualifications in this area.
• there is no differentiation between patients aged under 18 years (i.e. ages 0-17) and those aged 18 years and over in this proposal. Under 18-year-olds have greater diagnostic uncertainty due to the developing brain.
• the current model of care has practitioners who are medical practitioners specialised in paediatrics or psychiatry and nurse practitioners working within paediatric services or child and adolescent mental health services making the initial assessments and diagnosis for those aged 17 years and under. This is a high-risk group of patients risking life changing medication harms from misdiagnosis, but this is not identified as such in the proposed changes.
• respondents recommended that ADHD diagnosis for individuals aged 17 years and younger remain within specialist services. Diagnosis and management of ADHD requires specialist skills and expertise in neurodevelopmental conditions and differential diagnosis.
• clear partnerships with specialists, clinical psychologists and ADHD assessment clinics need to be established, including referral pathways, ongoing continuing medical education (CME) for prescribers and auditing of new prescribers. There needs to be a consistent, rigorous approach to diagnosing ADHD.
• GPs and NPs have limited or no funded access to CME, therefore they will not be able to maintain professional standards in diagnosis and initiation.
• Specialist Interest Groups at the RNZCGP will need to be established.

Our response

We understand that clinicians may choose to undergo additional training to be able to diagnose and treat people with ADHD under the new regulations.

The responsibility for training and resourcing these services resides with the relevant professional colleges (e.g. Royal New Zealand College of General Practitioners and Nurse Practitioners New Zealand) and Health NZ. These organisations have been involved in this proposal and are in the process of scoping and developing training resources.

The implementation date is now later than initially proposed, which will allow more time to develop and implement training pathways before the regulations change.

We appreciate all of the feedback respondents have provided on training and resourcing and this will be passed on to the appropriate organisations.

You told us

• Prescribers may feel pressured by patients and families to prescribe stimulants because they are legally allowed to, and they have a long-term caring relationship for the patient and their family and want to do all they can to help the person.
• There may be an increase in diversion and misuse of stimulant medicines if they become easier to access.

Our response

We acknowledge there is concern around overprescribing and diversion/ misuse of these medicines. Clinicians would be able to access support and specialist referral when undertaking diagnosis.

Prescribers are required to comply with their regulatory body’s standards for clinical practice. For example, the Medical Council of New Zealand requires medical practitioners to only prescribe medicines when they have adequately assessed the patient’s condition and/ or have adequate knowledge of the patient’s condition.

You told us

• It is not clear how primary care clinicians are going to be paid for their time undertaking ADHD assessments and where they will find the time given the current 15-minute appointment model. 
• This could negatively impact an already overstretched primary care system if it is inadequately resourced and the capitation funding formula in its current form does not include funding for this. 
• Clinicians will need to be supported, including funding to attend on-going professional development so that they can maintain their competencies.

Our response

The responsibility for resourcing for these services resides with the relevant professional colleges (e.g. Royal Australasian and New Zealand College of Psychiatrists, Royal New Zealand College of General Practitioners, Nurse Practitioners New Zealand) and Health NZ. 

These organisations have been involved in the discussions for this proposal and are aware of the current limitations of primary care to deliver these services.

You told us

Allowing primary care to diagnose ADHD and prescribe stimulants would still result in inequities as accessing primary care (e.g. general practice) remains a barrier for people from low-socioeconomic backgrounds, particularly those also living in rural areas and the primary care model has not been adapted to deliver the consultations needed for initiation and diagnosis of ADHD. 

Our response

We acknowledge that this proposal would not remove all inequities in access to stimulant medicines for ADHD, as barriers to primary care continue to exist for some New Zealanders. However, we consider that the proposed access in primary care would still be more accessible and thus reduce some inequities compared to the status quo. 

You told us

There are global stock shortages of methylphenidate and widening access would worsen this, particularly if there is misdiagnosis and inappropriate use. This would impact all people who are currently taking methylphenidate and people initiating medication. This may lead to higher rates of non-accidental injuries and suicide in people living with ADHD. 

Our response

We acknowledge there are ongoing supply issues that are affecting the lives of people with ADHD. Pharmac is exploring several options to assist with the supply of methylphenidate. 

To ensure that people can access their medicines, we have delayed the implementation of this proposal to allow time for the supply outlook to improve before making these changes.

You told us

Respondents submitted a range of suggestions to ensure effective implementation of the regulatory changes. These included:

• resources for clinicians to upskill and guide clinical practice.
• a public list of registered practitioners trained to diagnose and treat ADHD that is accessible by patients and their whānau.
• a different funding model for primary care.
• taking a holistic approach to treating ADHD when training clinicians.

Feedback was also specifically provided on implementation of these changes suggesting:

• Implementation needs to have a consumer centric approach.
• Consumers should be able to identify if a clinician has completed ADHD training or has a special interest. This could include register of qualifications.
• Accessible information in print and online.

Implementation needs to show respect to all and be neurodivergent friendly.

Our response

Most of the implementation suggestions are in relation to work required in the health sector and are therefore more appropriate to be actioned by Health NZ. As Medsafe was involved in the consultation, it has also received this feedback and has fed these suggestions back to Health NZ. Medsafe’s response to consultation feedback can be found here:

Proposal to change the regulatory restrictions for stimulant treatments for ADHD – Consultation Outcome(external link)

However, as the medicine funder, Pharmac has developed an implementation plan to align with the feedback to support the sector in this change.

Our plan includes collaborating with the sector to:

• support the development of clinical pathways for the diagnosis and treatment of ADHD.
• commission and develop further resources from educational providers to support prescribers initiating treatment.
• provide appropriate messaging to consumers.
• Commission resources to support consumers with the changes.

Health practitioners are already registered with their professional bodies and their qualifications and scope of practice are available on their respective websites.

You told us

Scope of authorised prescribers should be expanded to include pharmacist prescribers. 

Our response

Changing the regulatory restrictions is within Medsafe’s scope and this has been considered by Medsafe. Medsafe has indicated that it intends to develop a proposal to include pharmacist prescribers as a result of this feedback. 

Pharmac is proposing to change the Special Authority criteria to “any relevant practitioner” which would accommodate any future changes to regulations.

You told us

The differentiation between diagnosis and prescribing was often confused by respondents. Some suggested these should be done by different clinicians.

Our response

We acknowledge that diagnosis and prescribing are key parts of the journey for people with ADHD. Medsafe and Pharmac plan that in all communication and resources it is clear what is involved in the ‘initiation of treatment’, i.e. clinical assessment and prescribing of medicine.