Agenda for August 2025 Pharmacology and Therapeutics Advisory Committee (PTAC) meeting

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Source: PHARMAC

Information on what the Pharmacology and Therapeutics Advisory Committee (PTAC) will be considering at its upcoming meeting in August 2025.

Applications

Fremanezumab (Ajovy) to prevent chronic and episodic migraines

The Committee will discuss a new application for funding fremanezumab (branded as Ajovy) for the prevention of chronic and episodic migraines.

Migraine disease is a debilitating condition causing severe headaches, pain, sensitivity to light and noise, nausea and vomiting. People with chronic migraine have a headache at least 15 days per month and those with episodic migraine have a headache at least 4 days per month. 

Fremanezumab is an injection that can be given once a month or once every three months to reduce the number days people with migraine have a headache.

Application for fremanezumab for chronic and episodic migraine(external link)

Tirzepatide (Mounjaro) to treat diabetes type 2  

The Committee will discuss a new application for funding tirzepatide (branded as Mounjaro) for people living with type 2 diabetes whose blood sugar is high despite other treatments.

Type 2 diabetes is a long-term condition where the body either doesn’t produce enough insulin or can’t properly use the insulin it produces, leading to high blood sugar levels. Over time high blood sugars can cause serious health problems like heart disease and nerve damage.

Tirzepatide is a once weekly injection that helps manage type 2 diabetes by mimicking natural hormones to regulate blood sugar and appetite.

Application for tirzepatide for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise(external link)

Avacopan (Tavneos) to treat a group of autoimmune disease inflammatory conditions.

The Committee will discuss a new application for avacopan (branded as Tavneos) for both the induction and maintenance treatment of ANCA vasculitis.

Anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis is a group of rare diseases that cause inflammation in small- to medium-sized blood vessels in the body. This inflammation can reduce blood flow and damage organs and how they work.

Induction treatment aims to control vasculitis symptoms for a period without symptoms, although symptoms can return. Regular maintenance treatment is used before symptoms return and to maintain the benefit of treatment.

Application for avacopan for the treatment of ANCA vasculitis(external link)

Inclisiran (Leqvio) for a genetic condition that results in high cholesterol

The Committee will discuss a new application for inclisiran (branded as Leqvio) for heterozygous familial hypercholesterolemia.

Heterozygous familial hypercholesterolemia is a genetic condition that causes high levels of low-density lipoprotein (LDL) cholesterol. This high cholesterol increases the risk of developing heart disease at a younger age if  not treated.

Inclisiran is an injection that can be used, together with other medicines, to reduce the cholesterol level in people with Heterozygous familial hypercholesterolemia.

Application for inclisiran for heterozygous familial hypercholesterolemia(external link)

Pembrolizumab (Keytruda) to treat mesothelioma

The Committee will discuss a new application for pembrolizumab (branded as Keytruda) for the first-line treatment of advanced mesothelioma in the lung.

Mesothelioma is a cancer that starts as a growth of cells in the mesothelium, a thin layer of tissue that covers many internal organs. It most often happens in the tissue around the lungs (pleural mesothelioma), however, also affects some other parts of the body.

Pembrolizumab is a medicine that’s used to treat certain cancers by working with your body’s immune system to detect and destroy cancer cells. Pembrolizumab belongs to a group of medicines called immune checkpoint inhibitors. 

Application for Pembrolizumab(external link) for the first-line treatment of advanced malignant pleural mesothelioma 

Advisory meeting agenda setting

The scheduling and agenda setting process for advisory meetings considers multiple factors. We aim to balance the relative priorities of clinical advice needed across indications, the factors for consideration for each application (for example unmet health need), the time since applications were received and the internal and advisor resource available to support each meeting.

MIL OSI

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