Clarification of Pharmaceutical Schedule from Prior Request

Amanda Ashley made this Official Information request to Pharmaceutical Management Agency

The request was successful.

From: Amanda Ashley

Dear Pharmaceutical Management Agency,

Following on from my request on February 03, 2018 to access a list of all of the Estradiol, Testosterone and Anti-Androgen pharmaceuticals that are currently available in New Zealand and their funding status for Transgender Health care.

I have managed to find the information required in the links that were provided but require clarification on some of the information contained in the Pharmaceutical Schedule.

1) The Hormone Replacement Therapy - Systemic Prescribing Guideline states “Evidence-based Best Practice Guideline on Hormone Replacement Therapy March 2004”. Can you please direct me to a copy of this guideline and who published it.

2) bicalutamide / goserelin notes that it is a restricted medicine http://www.nzf.org.nz/nzf_4083#prepg and http://www.pharmac.govt.nz/2018/02/01/Sc... states "Renewal — (adults and adolescents) only from a paediatric endocrinologist or endocrinologist. Approvals valid for 12 months for applications meeting the following criteria" for Trophic Hormones. Can you please clarify if a) this is a restricted medicine, and b) does it require an Endocrinolgist to prescribe.

3) Will / Can Estradiol Valerate Injection (Delestrogen) be made available in New Zealand? If so how can this be made so / what is the process to get it listed and funded.

Yours faithfully,

Amanda Ashley

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From: Donna Jennings
Pharmaceutical Management Agency

Hi Amanda
1. This Guideline referred to was produced by the NZ Guidelines Group. Please note that this is a guideline for prescribing only, it does not restrict funding for any of the medicines in that section.

2. There are no Special Authority restrictions for either bicalutamide or goserelin. (http://www.pharmac.govt.nz/Schedule?osq=... http://www.pharmac.govt.nz/patients/Phar... ). These medicines are not restricted to a specific prescriber (eg endocrinologist) or restricted to any particular indication.

3. We haven’t received a funding application for estradiol valerate injection so haven’t considered it for funding. I note that it is not yet registered with Medsafe. We generally require Medsafe registration prior to considering a medicine for funding.
You may wish to contact the supplier to ask if they intend seeking registration and funding in NZ.

I hope you find this information helpful.

Kind regards
Donna Jennings
PHARMAC

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Amanda Ashley left an annotation ()

1) Googling "NZ Guidelines Group"

The New Zealand Guidelines Group (NZGG) was an independent, not-for-profit organisation, set up in 1999 to promote the use of evidence in the delivery of health and disability services. The NZGG went into voluntary liquidation in mid-2012.

I did manage to find this document in the Ministry of Health Archives though -
Hormone replacement therapy : a Consensus Development Conference report to the National Advisory Committee on Core Health and Disability Support Services
http://www.moh.govt.nz/NoteBook/nbbooks....

2) Great! It is fully subsided and unrestricted.

3) That's actually a positive in that it hasn't been applied for and declined. I'll try to find who the NZ supplied would be and go from there.

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