Dear Pharmaceutical Management Agency,

Pharmac’s decision to fund (the now generic) lisdexamfetamine, a new stimulant medicine that will provide an additional treatment option for people with ADHD follows a funding application by Takeda. Pharmac looks for a clear health benefit and how improved people's lives might be and for how long with the medicine

[1] It is very difficult to understand the scientific basis for safety and efficacy which provides the underlying data to support benefit. The medical data sheet does not fully disclose the details of trial data.
https://www.medsafe.govt.nz/profs/datash...
This request is to understand the risk-based information on efficacy and adverse effects considered in this decision.

Please supply application information containing the following:
(i) Efficacy: scientific information including mechanistic data, case reports, cohort studies, and population-level data.
Safety: scientific information and data on adverse events reviewed by these groups including case reports, cohort studies, and population-level data.
(including study author, year, title and funding)

[2] Please provide information and reports reviewed by Pharmac, that includes information from the Therapeutics Advisory Committee (PTAC) and Specialist Advisory Committees (SACs) that contains the following information:
a.Efficacy: scientific information reviewed by these groups including mechanistic data, case reports, cohort studies, and population-level data.
b. Safety: scientific information and data on adverse events reviewed by these groups including case reports, cohort studies, and population-level data.
c.Safety: All New Zealand and Australian adverse event reports considered.

[3] Please provide Pharmac estimated numbers of prescriptions by age and gender that have been budgeted for the next 3-5 years, and related costings - drug cost per unit/per quantity and administrative costs.

Thank you.

Yours faithfully,

J Bruning