How do new medicines become available in New Zealand?

Before a therapeutic medicine can be distributed for use in New Zealand it has to pass through two separate approval processes. It must be approved as safe and effective through Medsafe, and it will need a decision on funding from PHARMAC.

A Medsafe assessment may take up to two years to complete, and the average time from application to a positive funding decision by PHARMAC is currently three years. To avoid unnecessary delays manufacturers will often attempt both processes concurrently.

Registration as a medicine with Medsafe

Medsafe is responsible for regulating therapeutic products in New Zealand on behalf of the Minister of Health. Before a manufacturer can distribute a therapeutic medicine in New Zealand it must be registered with, reviewed and approved by Medsafe.

There are two types of application. New Medicines Applications (NMAs) are for products that have not yet been approved or have been materially changed, with different ingredients, strengths or dose forms. Changed Medicine Notifications (CMNs) are for previously approved products which are now intended to be used to treat something different.

New Medicines Applications (NMAs)
The evaluation of a NMA is carried out by the Medicines Assessment Advisory Committee (MAAC).The manufacturer submits a separate NMA form for each name, dose form, strength and flavour of a new medicine. They also must supply data about quality, safety and efficacy, labelling, and other documentation.

There are several stages in the evaluation process, some of which involve quite lengthy time periods of up to 200 days. Once the evaluation has been finalised the product is either forwarded for publication of a notice of approval in the New Zealand Gazette or it’s referred for the next MAAC meeting for further consideration.

Two other registration paths are available. If the medicine meets certain criteria the manufacturer may apply for an abbreviated evaluation process. Although the same material is provided for each application, this type of assessment is based on a review of reports by other regulatory authorities recognised by Medsafe (for example, the Australian Therapeutic Goods Administration or the USA Federal Drug Agency) rather than a review of the full medicine dossier.

Medicines which offer significant clinical advantage or potential cost savings for the tax payer may be granted priority assessment status. When this occurs the application is allocated to an evaluator, who undertakes it as the next piece of work he or she will complete. In this case, the time to Medsafe approval may well be shorter.

Changed Medicine Notifications (CMNs)
When a manufacturer wishes to have a previously approved medicine approved for use in another indication the company must submit an application for a Changed Medicine Notifications (CMN).

Funding by PHARMAC

PHARMAC is the New Zealand Government’s pharmaceutical management agency. It evaluates medicines and determines which ones it will fund.

PHARMAC first receives and considers the evidence submitted by the applicant. PHARMAC’s Pharmacology and Therapeutic Advisory Committee (PTAC), , then assesses the relative clinical value of a new medicine compared with other treatment options. Finally, after prioritising the application, PHARMAC then negotiates pricing with the manufacturer, reprioritising the application based on the outcome of those negotiations.

The initial application must include full information on the medicine’s Medsafe registration, the condition the medicine is for, and the pharmaceutical itself. The application covers pharmacology and epidemiology, and the medicine’s effectiveness, safety and potential impact on the health sector. The application must also provide information on pricing, the market, patents and lead times. All this must be submitted to PHARMAC ten weeks prior to the monthly Board meeting where it will be considered.

PHARMAC reviews the application for completeness, notes receipt of the application on its website and prepares a summary for its Board. Based on the summary the Board makes a preliminary economic assessment and identifies areas in which it requires objective clinical advice on the application.
If PHARMAC requires clinical advice, it refers the application to PTAC, whose Board meets every three months. In some cases, the application will be referred to one of the specialist PTAC Subcommittees, which meet every five months.

A cycle of negotiations between PHARMAC and the manufacturer then begins. An assess-prioritise-negotiate process repeats until, if the application is successful, a preliminary agreement is reached.  PHARMAC then consults with the health sector on the proposal and takes this feedback into account before submitting the final proposal to the PHARMAC Board.

If the Board accepts the proposal, the health sector is notified, the Pharmaceutical Schedule updated and the medicine funded.