New PBS listings to benefit patients living with severe asthma and HIV

Pharma News: A single inhaler triple therapy for severe asthma and the first long-acting treatment for Australians with HIV is reimbursed on the Pharmaceutical Benefits Scheme (PBS) from today 1st of April 2022.

GSK’s Trelegy (Fluticasone furoate, umeclidinium and vilanterol; 200/ 62.5/ 25mcg) triple therapy is indicated for the maintenance treatment of asthma in adult patients who are not adequately controlled with a combination of inhaled corticosteroid and a longacting beta2-agonist.

Australian respiratory specialist, Professor Greg King, said that having access to a new option was important for Australians with severe asthma.

“We need to help patients with severe asthma to control their symptoms, such as breathing difficulties and improve their quality of life. That’s why new evidence-based options are very welcome among doctors. TRELEGY ELLIPTA 200 is an addition to our options for patients with severe asthma” said Professor King.

Michele Goldman, CEO at Asthma Australia, said it can be a difficult journey for someone with severe asthma to find the right treatment.

“Severe asthma can be a debilitating breathing condition that is difficult to treat and can lead to multiple hospital admissions. Asthma Australia welcomes new severe asthma treatment options and their listing on the PBS, as they offer hope of better health for these people,” said Ms Goldman.

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Dr Alan Paul, Country Medical Director at GSK Australia, said the announcement was part of GSK’s ongoing commitment to improving the lung health of Australians.

“We are proud to be able to bring new options to Australians affected by severe asthma. GSK is committed to bringing our innovative medicines to the people that need them most and today’s announcement provides clear evidence of that,” said Dr Paul.

The three-in-one inhaler Trelegy crossed 1 billion pounds in global annual sales for the first time in 2021.

Additionally, ViiV Healthcare Australia (a GSK-Pfizer company) has welcomed the announcement that Cabenuva (cabotegravir prolonged-release suspension for injection and rilpivirine prolonged-release suspension for injection) has been listed on the PBS as the first long-acting treatment for Australians living with HIV.

It will be reimbursed for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies per mL) and have no known or suspected resistance to either cabotegravir or rilpivirine, to maintain viral suppression with six dosing days per year after initiation, which is a significant reduction from 365 doses per year that daily treatment requires.

In 2020, it was estimated that 29,090 people were living with HIV in Australia2. This reimbursement represents an opportunity for Australians living with HIV to have broader access to treatment options that may help increase adherence to treatment and improve quality of life.

In recommending the reimbursement, the Pharmaceutical Benefits Advisory Committee commented that “some people living with HIV (PLHIV) in certain populations, such as Aboriginal and/or Torres Strait Islander people, those living in rural or remote settings, and individuals with complex living or social circumstances, had issues adhering to a daily oral regimen and would potentially have improved quality of life from a long-acting injectable option.”

Dr David Baker from East Sydney Doctors said he welcomes the addition of Cabenuva as a new treatment option for people with suppressed viral loads who were living with HIV.

“Over the last 20 years we’ve made great progress in developing effective treatments for HIV that can suppresses the virus in the body to undetectable levels, however until now it has required daily treatment. The introduction of a long-acting injectable treatment means that eligible people living with HIV will only need to be treated every two months, rather than every day. This approach has the potential to help lessen the burden of treatment and reduce the worry and stigma that comes with having to take treatments daily,” said Dr Baker.

Dr Matthew Shields, a sexual health physician at Taylor Square Private Clinic, commented that the new long-acting treatment option will give people living with HIV increased control over their sexual health and well-being.

“We know that historically HIV treatments have played a significant role in reducing stigma, leading to improved sexual health and wellbeing for those living with HIV. The reimbursement of a long-acting injectable treatment will only help to further this progress, as it has the potential to improve quality of life for people living with HIV by reducing the daily reminder of their HIV status and also removing the anxiety around potentially forgetting the daily oral tablets,” said Dr Shields.

According to Scott Harlum, President of the National Association for People with HIV in Australia (NAPWHA), treatment innovations have the potential to reduce stigma for people living with HIV.

“The approval of long-lasting injectable anti-retroviral treatments are a welcome development for people with HIV. As an additional treatment option, long-lasting injectable treatments can reduce the burden of taking daily medication and further assist people with HIV adhere to their treatment regime. This, in turn, helps ensure people with HIV are able to maintain an undetectable viral load which is both good for their own health, but also eliminates any risk of transmission of HIV,” he said.

Dr Fraser Drummond, Medical Director at ViiV Healthcare Australia, said the reimbursement of Cabenuva represents a shift in the way HIV is treated by offering people living with HIV a completely new approach to care.

“Long-acting HIV treatments have the potential to reduce the fear of disclosure and the anxiety of having to remember to take a pill every day. At ViiV Healthcare we are dedicated to ensuring no one living with HIV is left behind,” said Dr Drummond.

“Adding this first-of-its-kind regimen to our industry-leading portfolio of innovative medicines in Australia shows how committed we are to this mission,” he said.

The listing of Cabenuva follows the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies that included more than 1,100 patients from 16 countries.

The follow up ATLAS-2M study confirmed that treatment was equally effective when administered every two months (i.e. six times per year).