Proposal to change the regulatory and funding restrictions for stimulant treatments for ADHD

The Ministry of Health and Pharmac are proposing to make changes to who can prescribe and apply for the funding of stimulant medicines for ADHD.

Currently, to start on funded stimulant medicines for ADHD (like methylphenidate, lisdexamfetamine, or dexamfetamine), you need a Special Authority approval and a prescription from a specialist psychiatrist or paediatrician. Your doctor or nurse practitioner can only apply for a Special Authority and prescribe treatment on the recommendation of a specialist psychiatrist or paediatrician.   

If these changes are approved, more prescribers will be able to apply for funding and start people with ADHD on stimulant medicines.

This would mean that people diagnosed with ADHD would find it easier to start ADHD stimulant treatments, as they will be able to see a wider range of medical and nurse practitioners.

We expect that psychiatrists and paediatricians will continue to support the assessment and diagnosis of ADHD for many people. But these changes would also encourage a larger number of doctors and nurse practitioners to be trained to assess and diagnose ADHD. The full impact of these changes may not happen immediately, as more prescribers may need additional training, education, and resourcing to diagnose someone with ADHD and start people on stimulant medicines.

There would also be significant work needed by the health sector to improve access to diagnosis and treatment of ADHD.

We are seeking feedback on behalf of the heath sector about how prescribers and people with ADHD could be supported to ensure successful implementation of this proposal. See below for more detail under Implementation of this Proposal.

To start someone on funded stimulant treatment for ADHD people currently need a Special Authority approval. A Special Authority approval requires certain criteria to be met and an application from a specialist psychiatrist or paediatrician. Medical or nurse practitioners can only submit Special Authority applications on the written recommendation of a paediatrician or psychiatrist who has been consulted within the last two years.

We are proposing to allow more medical and nurse practitioners to be able to submit Special Authority applications and prescribe stimulant treatment for someone diagnosed with ADHD. It would not be necessary to obtain written recommendation from a paediatrician or psychiatrist if this proposal is approved.

If you are a medical practitioner with a vocational registration in general practice or a nurse practitioner working in a scope of practice relevant to the treatment of ADHD, you would be able to submit a Special Authority application for people diagnosed with ADHD who are eligible for funded stimulant treatment.

If you are a medical practitioner without a vocational registration in general practice or nurse practitioner not working within a scope of practice relevant to ADHD treatment, you would continue to be able to submit Special Authority applications on the recommendation of a practitioner authorised to start prescribing of stimulant treatment for ADHD.

We expect psychiatrists and paediatricians would continue to support the assessment and diagnosis of ADHD for many people, but these changes would also encourage a larger number of medical and nurse practitioners to become trained to diagnose and prescribe treatments for ADHD.

The impact of these changes may not happen immediately, as prescribers may need additional training, education, and resourcing to diagnose someone with ADHD and prescribe stimulant medicines. There would also be significant work needed by the health sector to improve access to diagnosis and treatment of ADHD.

We are seeking feedback on behalf of the health sector about how prescribers and people with ADHD could be supported to ensure successful implementation of this proposal. See below for more detail under Implementation of this Proposal.

To start someone on stimulant treatment for ADHD funded by Pharmac, people currently need a Special Authority approval. A Special Authority approval for stimulant medicines requires certain criteria to be met and an application from a specialist psychiatrist or paediatrician. Medical or nurse practitioners can only submit Special Authority applications on the written recommendation of a paediatrician or psychiatrist who has been consulted within the last two years.

We are proposing to allow more medical and nurse practitioners to be able to submit Special Authority applications and prescribe stimulant treatment for someone diagnosed with ADHD. It would not be necessary to obtain written recommendation from a paediatrician or psychiatrist if this proposal is approved.

We expect psychiatrists and paediatricians would continue to support the assessment and diagnosis of ADHD for many people, but these changes would also allow a larger number of medical and nurse practitioners to become trained to diagnose and prescribe treatments for ADHD.

The impact of these changes may not happen immediately, as prescribers may need training, education, and resourcing to diagnose someone with ADHD and prescribe ADHD medicines. There would also be significant work needed by the health sector to improve access to diagnosis and treatment of ADHD.

We are seeking feedback on behalf of the health sector on how prescribers and people with ADHD could be supported to ensure successful implementation of this proposal. See below for more detail under Implementation of this Proposal.

The eligibility criteria for the medicines listed under methylphenidate would be amended in Section B of the Pharmaceutical Schedule as follows, (additions in bold, deletions in strikethrough).

ADHD in people aged 5 years or over

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. I am a practitioner authorised to prescribe treatment consistent with the approval notice for stimulants. The approval notice can be found on the Medsafe website https://www.medsafe.govt.nz/profs/riss/restrict.asp.
   
   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.

ADHD in people aged under 5 years

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:

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. I am a practitioner authorised to prescribe treatment consistent with the approval notice for stimulants. The approval notice can be found on the Medsafe website https://www.medsafe.govt.nz/profs/riss/restrict.asp.

The eligibility criteria for dexamfetamine would be amended in Section B of the Pharmaceutical Schedule as follows, (additions in bold, deletions in strikethrough).

ADHD in people aged 5 years or over

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. I am a practitioner authorised to prescribe treatment consistent with the approval notice for stimulants. The approval notice can be found on the Medsafe website https://www.medsafe.govt.nz/profs/riss/restrict.asp.
   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.

ADHD in people aged under 5 years

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:

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. I am a practitioner authorised to prescribe treatment consistent with the approval notice for stimulants. The approval notice can be found on the Medsafe website https://www.medsafe.govt.nz/profs/riss/restrict.asp.

The eligibility criteria for the below medicines listed under methylphenidate extended-release would be amended in Section B of the Pharmaceutical Schedule as follows, (additions in bold, deletions in strikethrough).

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:

All of the following:

1. ADHD (Attention Deficit and Hyperactivity Disorder); and
2. Diagnosed according to DSM-IV or ICD 10 criteria; and
3. I am a practitioner authorised to prescribe treatment consistent with the approval notice for stimulants. The approval notice can be found on the Medsafe website https://www.medsafe.govt.nz/profs/riss/restrict.asp; and
   
   4.   Either:
         4.1   Applicant is a paediatrician or psychiatrist; or
         4.2   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. 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.

The eligibility criteria for the lisdexamfetamine dimesilate would be amended in Section B of the Pharmaceutical Schedule as follows, (additions in bold, deletions in strikethrough).

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 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 or ICD 11 criteria; and
   3. I am a practitioner authorised to prescribe treatment consistent with the approval notice for stimulants. The approval notice can be found on the Medsafe website https://www.medsafe.govt.nz/profs/riss/restrict.asp; and
      
      2.4.   Either:
            2.4.1   Applicant is a paediatrician or psychiatrist; or
            2.4.2   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. Any of the following:
      1. Patient is taking a currently subsidised formulation of atomoxetine or methylphenidate hydrochloride (extended-release) and has not received sufficient 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; and
      7. Funded lisdexamfetamine dimesilate is not to be used in combination with another funded methylphenidate presentation.