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News & Trends - Pharmaceuticals

New PBS listings for chronic respiratory disease and rare disease come into effect

Health Industry Hub | April 3, 2023 |

The Hon Mark Butler MP, Minister for Health and Aged Care, announced the listing of three new drugs on the Pharmaceutical Benefits Scheme (PBS) from 1 April.

GSK’s Nucala (mepolizumab) will be subsidised as an add-on treatment for adult patients (18 years and above) with chronic rhinosinusitis with nasal polyps (CRSwNP) that is severe, eosinophilic and recurrent post-surgery.

Chronic rhinosinusitis is a common chronic respiratory disease that affects one in ten Australians. Nucala is the first monoclonal antibody to be PBS-subsidised for CRSwNP.

Professor Richard Harvey, a leading Otolaryngology Head and Neck Surgeon, said “The treatment journey for CRSwNP patients can be long and complex. The PBS listing of Nucala means affordable access for Australian patients to a monoclonal antibody treatment for the first time. This is welcome news as it means patients, who have not had an adequate response to other treatments, have a new option that can improve their quality of life and potentially reduce the number of future surgical procedures for this group of patients.”

Dr Alan Paul, Country Medical Director at GSK Australia, said the PBS listing is an important milestone for the treatment of CRSwNP, and GSK is proud to bring this option to patients.

BioMarin Pharmaceutical Australia announced the expanded listing of Kuvan (sapropterin dihydrochloride) on the PBS which will now be available for sapropterin-responsive Australian adults with hyperphenylalaninemia (HPA) due to phenylketonuria (PKU), a rare genetic metabolic disorder.

Around 2,400 Australians are thought to be living with PKU, with an estimated 1 in 10,000 babies born with the condition each year.

“BioMarin welcomes the Australian Government’s decision to expand access to Kuvan for eligible adults with PKU,” said Dr Kathryn Evans, Managing Director of BioMarin Australia and Co-Chair of Medicines Australia’s Rare Disease Working Group. “While treatment responsive people with PKU aged under 18 years and those with maternal PKU have had subsidised access to oral pharmacological therapy through the PBS for some time, treatment options for adults with PKU have been limited, until now.”

“We are extremely pleased with the Government’s decision to list Kuvan on the PBS for adults with PKU who are responsive to this therapy,” said Monique Cooper, President of Metabolic Dietary Disorders Association (MDDA).

“MDDA, with the support of our PKU community, has been actively campaigning for a number of years to secure access to this therapy for PKU people of all ages who are responsive to treatment. This welcome result has been the outcome of extensive ongoing political, media and public advocacy by our PKU and broader metabolic dietary disorders communities.”

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