Funding of lisdexamfetamine

OIA response

Thank you for your request dated 5 September 2023 under the Official Information Act 1982 (OIA) for information relating to lisdexamfetamine. You requested:

I’m enquiring with regard to the funding of lisdexamfetamine, an extended amphetamine formulation for the treatment of ADHD. Currently, there are no funded long-release formulations of amphetamine medications for the treatment of ADHD. Instead the only long release stimulant is various formulations of methylphenidate. 

A Pharmac application was made by the then exclusive patent holder, Takeda Pharmaceuticals, in May of 2021. While this application is still considered ‘Under Assessment’, lisdexamfetamine has since been allowed to be prescribed by certain “vocational medical practitioners” — albeit without Pharmac subsidy. 

Additionally since this application began, Takeda has also lost its exclusive patent rights over its lisdexamfetamine formulation Vyvanse, and other nations have begun approving generics. So I would like to know: 

  1. Does Pharmac plan to assess the funding of generic lisdexamfetamine formulations?

Pharmac response: Before a medicine is funded by Pharmac, it needs to be evaluated and approved by Medsafe. Medsafe is the government agency responsible for the regulation of medicines in New Zealand. Pharmac will assess the funding of additional formulations when there are Medsafe registered alternatives. 

  1. Does the emergence of generic lisdexamfetamine formulations affect the approval of Vyvanse, the Takeda formulation? e.g. cost-utility of approving cheaper generics instead 

Pharmac Response: Without Medsafe approved alternatives, the new formulations do not directly impact the Vyvanse-branded lisdexamfetamine formulation application. However, the loss of patent protections for any drug is a significant point in the commercial lifecycle of any medication which is understood by both Pharmac and medicine suppliers. 

  1. Are there any ongoing Pharmac applications for alternative forms of extended release amphetamine ADHD medication? Namely, dextroamphetamine, dexamphetamine, and Adderall.

Pharmac response: No, there are no ongoing applications for the named medications. Ongoing ADHD treatment applications include:

We trust that this information answers your queries. Please note, you have the right to make a complaint to the Ombudsman about our response to your OIA, under section 28(3) of the OIA. Details of how to make a complaint(external link) are on the Ombudsman’s website.

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