Proposal to remove the renewal criteria for stimulant treatments

Medicines Consultation Closed

What we’re proposing

We’re asking for feedback on a proposal to remove the renewal criteria for stimulant treatments - methylphenidate, dexamfetamine and modafinil from 1 December 2024 to improve ongoing access to these medicines. These medicines are used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy.

We know there are increasing difficulties for many people to access these treatments and we want to make it easier for people who need these treatments.

Further detail on this proposal can be found below.

We understand that there are also regulatory and funding issues regarding which prescribers can start a person with ADHD on stimulant treatment. Minor changes are proposed to the initiation criteria for dexamfetamine to align with the initiation criteria for methylphenidate. However, we are not proposing any significant changes to the funding criteria for someone starting stimulant treatment at this time.

Consultation closes at 5pm, Thursday, 3 October 2024 and feedback can be emailed to consult@pharmac.govt.nz or through our online form.

What would the effect be?

We are proposing to remove the renewal criteria for methylphenidate, dexamfetamine, and modafinil to support people to be able to continue to receive funded stimulant treatments. This means that:

  • Anyone starting on a stimulant treatment which requires a Special Authority approval, would receive 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 would automatically be issued an approval that is valid without further renewal. Pharmac and Health New Zealand would manage this so people wouldn’t need to do anything for this to happen.

Prescribers (medical or nurse practitioners) would continue to manage ongoing prescribing and seek specialist input as needed to assess whether treatment remains appropriate and whether an individual is benefitting from it. We understand as part of clinical practice, specialists may outline any specific requirements for the management of an individual with ADHD in collaboration with an individual’s prescriber.

In addition to the changes above we are also proposing to make a minor change to the initiation criteria for dexamfetamine for individuals with ADHD aged 5 years and over. This would align the initiation criteria for dexamfetamine with methylphenidate for ADHD, enabling Special Authority applications to be submitted by nurse practitioners on the recommendation of a paediatrician or psychiatrist in writing.

Lisdexamfetamine

We are also consulting on a proposal to fund lisdexamfetamine for people with ADHD. In that proposal, we are proposing to list lisdexamfetamine without the requirement for a renewal application to continue ongoing treatment in line with this proposal.

Proposal to fund lisdexamfetamine for people with ADHD

Who we think will be interested

  • People with ADHD or narcolepsy, their whānau, and caregivers
  • Paediatricians, psychiatrists, psychologists, general 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.

About ADHD, narcolepsy and stimulant treatments

ADHD is a common neurodevelopmental disorder that affects the part of our brain that helps to plan, control impulses, and execute tasks. Narcolepsy is a chronic neurological disorder that affects the brain's ability to control sleep-wake cycles. ADHD and narcolepsy are typically managed through a combination of lifestyle changes, and medication. People with ADHD may also receive behavioural therapy.

The following stimulant medicines for the treatment of ADHD and narcolepsy are funded subject to eligibility criteria:

People need to meet the eligibility criteria and have a Special Authority approval to start funded treatment.

Currently people need to get another Special Authority (via a renewal application) every two years (or one year for people with ADHD under 5 years of age) to continue funded access to these treatments. For a person to get a renewal application, the treatment needs to remain appropriate, and the person needs to be benefiting.

Currently, all initial and renewal Special Authority applications need to be made by or have the input of a relevant specialist. Specialist input for ADHD is required from a paediatrician or psychiatrist. Other prescribers (medical or nurse practitioner prescribers) who care for people with ADHD can only apply on the written recommendation of a specialist. Specialist input for narcolepsy is required from internal medicine specialists who are neurologists or respiratory medicine specialists.

If this proposal is approved, there would be no need for renewal applications to be submitted.

Further information about the benefits and side effects of these medicines is available from the individual datasheets linked as follows:

Methylphenidate immediate and sustained release (Rubifen) | Medsafe datasheet [PDF](external link)

Methylphenidate immediate and modified release (Ritalin) | Medsafe datasheet [PDF](external link)

Methylphenidate extended release | Medsafe datasheet [PDF](external link)(Teva)

Methylphenidate extended release (Concerta) | Medsafe datasheet [PDF](external link)

Dexamfetamine | Medsafe datasheet [PDF](external link)

Modafinil | Medsafe datasheet [PDF](external link)

Why are we proposing this?

Special Authority renewal challenges

Approximately 65,500 people received methylphenidate, dexamfetamine, or modafinil in the 2023/24 financial year. The number of people accessing these treatments continues to increase each year.

We are aware of the increasing difficulties for people diagnosed with ADHD to renew their Special Authority to enable continued access to funded stimulant treatment in a timely way.

We have heard this from ADHD patients, their whānau/caregivers, professional organisations, clinicians, and consumer groups.

People with ADHD have expressed concern about the lengthy wait time for specialist appointments, the large cost of private appointments, and the significant stress of not receiving reassessment before an approval expires.

In July 2023 the renewal criteria for stimulant treatments for ADHD was considered by the Mental Health Advisory Committee. Our clinical advisors noted that:

  • there is strain on specialist services
  • there are challenges in managing timely renewals
  • adverse impacts were likely to increase

Our clinical advisors considered that if the renewal criteria were removed there would be benefits, such as:

  • avoiding treatment disruption for patients
  • freeing up specialist and primary care resource that could be focused on other areas of care or prioritised to higher need patient populations

Record of the July 2023 Mental Health Advisory Committee meeting [PDF, 137 KB]

We note there are fewer people treated with stimulant treatments for narcolepsy compared to ADHD and that access issues are not currently experienced to the same extent for individuals treated for narcolepsy. However, we have received clinical advice that access challenges are also experienced and there would be similar benefits for individuals treated for narcolepsy if the requirement for renewal applications was removed.

Methylphenidate and dexamfetamine are controlled drugs and are regulated differently to other medicines. The medicines regulations for methylphenidate and dexamfetamine determine which health professionals can prescribe these controlled drugs for an individual under their care.

Controlled Drugs | Ministry of Health website(external link)

Restriction on the Supply of Methylphenidate | Gazette.govt.nz(external link)

Restriction on the Supply of Dexamphetamine | Gazette.govt.nz(external link)

There are no specific periods or frequencies of specialist input outlined in the medicines regulations for these stimulant treatments. We consider that prescribers are able to determine the need for specialist input for people with ADHD and narcolepsy based on the individual clinical circumstances of the person they are caring for. We understand, as part of clinical practice, specialists can also outline any specific requirements for the management of an individual with ADHD or narcolepsy in collaboration with an individual’s prescriber.  Based on this, and the clinical advice we have received we consider there is no need for Pharmac to target funding of stimulant treatments via ongoing renewal criteria.

Details about our proposal

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

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

Other minor amendments are proposed to some initial Special Authority criteria for clarity.

Methylphenidate

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). The renewal criteria would be removed and are therefore 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:

  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.

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:

  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. 

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 extended-release

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). The renewal criteria would be removed and are therefore 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:

  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. 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

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

  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.

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:

  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.

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 would be amended in Section B of the Pharmaceutical Schedule as follows, (additions in bold, deletions in strikethrough). The renewal criteria would be removed and are therefore not shown.

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:

  1. The patient has a diagnosis of narcolepsy and has excessive daytime sleepiness associated with narcolepsy occurring almost daily for three months or more; and
  2. 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
  3. 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.

To provide feedback

Submit feedback through our online form or send us an email consult@pharmac.govt.nz by 5pm, Thursday, 03 October 2024.

All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on this proposal.

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