Proposal to fund lisdexamfetamine for Attention Deficit Hyperactivity Disorder (ADHD)
What we’re proposing
We’re asking for feedback on a proposal to fund lisdexamfetamine, brand name Vyvanse, supplied by Takeda from 1 December 2024 for people with attention deficit hyperactivity disorder (ADHD). Further detail on this proposal can be found below.
Consultation closes at 5 pm, Thursday, 26 September 2024 and feedback can be emailed to consult@pharmac.govt.nz or through our online form
What would the effect be?
Lisdexamfetamine would be funded for people with attention deficit hyperactivity disorder (ADHD) who meet certain eligibility criteria. These are outlined in the ‘Details about our proposal’ section.
We anticipate over 6,000 people would receive lisdexamfetamine in the first year of funding. Approximately 13,000 people would receive lisdexamfetamine after five years.
We understand that there are people privately funding lisdexamfetamine. People privately funding this medicine would be able to access publicly funded treatment if they met the eligibility criteria when they first started treatment with lisdexamfetamine.
Who we think will be interested
- People with ADHD, their whānau, and caregivers
- Paediatricians, psychiatrists, psychologists, general practitioners, nurse practitioners and other health professionals involved in the care of people with ADHD.
- Groups who support and advocate for people with ADHD.
- Health New Zealand | Te Whatu Ora
- Pharmaceutical suppliers and wholesalers
About ADHD and lisdexamfetamine
ADHD and funded medicines
ADHD is a common neurodevelopmental disorder. It impacts the part of our brain that helps to plan, control impulses and execute tasks.
What is ADHD - ADHD New Zealand website(external link)
A significant number of New Zealanders have ADHD. Each person has a different experience of living with it. For many people there are both challenges and positive characteristics to their condition.
ADHD is typically managed through a combination of behavioural therapy, lifestyle changes, and medication. Pharmac currently funds three different treatments for ADHD: atomoxetine, methylphenidate and dexamfetamine.
Atomoxetine is a non-stimulant treatment, while methylphenidate and dexamfetamine are stimulant treatments. Dexamfetamine, is a short acting treatment and requires multiple daily dosing. Methylphenidate, is funded in various presentations including short-acting and long-acting formulations.
In New Zealand stimulant medicines can only be accessed if certain regulatory (legal) requirements are met. In addition to these legal requirements, there are eligibility criteria for accessing publicly funded treatment. Pharmac is responsible for the eligibility criteria.
Pharmac is consulting on a separate proposal related to the renewal criteria for stimulant treatments.
Proposal on removing renewal criteria for ADHD treatments
Lisdexamfetamine
Lisdexamfetamine is approved by Medsafe for use in the treatment of ADHD in children, adolescents, and adults and is taken once daily. It is a stimulant that affects the chemicals in the brain related to hyperactivity and impulse control.
Lisdexamfetamine is a prodrug. This means it is inactive until the body converts it into its active form, dexamfetamine. This conversion provides a controlled, gradual release of the medication throughout the day, which helps maintain consistent symptom management. This is different to dexamfetamine which must be taken throughout the day.
Why we’re proposing this
A funding application for lisdexamfetamine(external link) for ADHD was considered by the Mental Health Subcommittee of PTAC (now the Mental Health Advisory Committee) in September 2021.
Record of the September 2021 meeting of the Mental Health Subcommittee [PDF, 372 KB]
Our clinical advisors told us about the benefits from using lisdexamfetamine to treat ADHD. They told us that lisdexamfetamine would be particularly beneficial for people:
- whose ADHD does not respond to methylphenidate or
- who experience challenges with taking multiple doses of dexamphetamine throughout the day.
Our advisors told us lisdexamfetamine has similar effectiveness in treating ADHD to some of the currently funded treatments, methylphenidate and dexamfetamine.
Supply issues with methylphenidate extended-release
There have been ongoing worldwide shortages of methylphenidate extended release tablets. These shortages have been caused by several issues:
- a global increase in demand
- restrictions in importing and exporting the medicine between countries
- manufacturing constraints.
In New Zealand there are supply issues for extended release (ER) formulations of methylphenidate (Concerta and methylphenidate Teva ER). These started in September 2023 and are expected to continue for 2024 and into 2025.
Funding lisdexamfetamine would provide an additional once daily option for the management of ADHD. It would be funded alongside methylphenidate extended-release treatment options. Our clinical advisors have told us that funding lisdexamfetamine would improve the availability of funded simulant treatments for ADHD.
Details about our proposal
From 1 December 2024, lisdexamfetamine (Vyvanse) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:
|
Chemical |
Formulation |
Brand |
Pack size |
Price and subsidy |
|---|---|---|---|---|
|
Lisdexamfetamine dimesilate |
Cap 30 mg |
Vyvanse |
30 |
$60.00 |
|
Lisdexamfetamine dimesilate |
Cap 50 mg |
Vyvanse |
30 |
$60.00 |
|
Lisdexamfetamine dimesilate |
Cap 70 mg |
Vyvanse |
30 |
$60.00 |
A confidential rebate would apply to Vyvanse that would reduce the net price to Pharmac. Vyvanse would have protection from delisting and subsidy reduction until 1 June 2027.
Eligibility criteria
Vyvanse would be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria:
Special Authority for subsidy
Initial application 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:
- ADHD (Attention Deficit and Hyperactivity Disorder); and
- Diagnosed according to DSM-V or ICD 11 criteria; and
- Either:
- Applicant is a paediatrician or psychiatrist; or
- 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
- Any of the following:
- 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
- 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
- There is significant concern regarding the risk of diversion or abuse of immediate release dexamfetamine sulfate; or
- 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
- There is significant concern regarding the risk of diversion or abuse of immediate release methylphenidate hydrochloride; or
- Both:
- Patient would have been prescribed a subsidised formulation of methylphenidate hydrochloride (extended-release) but has been unable to access due to supply issues with methylphenidate hydrochloride (extended-release); and
- Other alternative stimulant presentations (methylphenidate or dexamfetamine) are not appropriate; and
- Lisdexamfetamine dimesilate is not to be used in combination with another funded stimulant.
Similar eligibility criteria would apply in Part II of Section H of the Pharmaceutical Schedule.
We are proposing to list Vyvanse without a renewal criteria as part of this proposal. This is consistent with a proposal Pharmac is currently consulting on proposing to remove the renewal criteria for other stimulant treatments.
Proposal to remove renewal criteria for other stimulant treatments
Quantity restriction for the 30 mg capsule
We are also proposing to limit the funded quantity of the 30 mg capsules someone can receive to one per day. Our clinical advisors have told us 50 mg or 70 mg a day would be clinically appropriate for people requiring higher strengths of lisdexamfetamine. The restriction ensures people who need a higher dose use the higher strength capsules. This would reduce the overall cost of lisdexamfetamine and ensure we can fund it within our fixed budget.
To provide feedback
Fill out our online form, or send us an email, consult@pharmac.govt.nz, by 5 pm, Thursday, 26 September 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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