Can you explain the details of the new medicine now available on the Pharmaceutical Benefits Scheme for people with Parkinson's disease?

Ongentys (opicapone) 50mg capsules have from 1 February 2023 been listed on the PBS for the first time as additional therapy to treat Parkinson’s disease.

Ongentys is indicated as adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

How will this new medicine benefit people with Parkinson's disease compared to other existing treatments?

Australia’s Therapeutic Goods Administration (TGA) approved opicapone as an ‘adjunctive therapy’ to preparations of levodopa/DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Opicapone is a peripheral, selective and reversible catechol-O-methyltransferase [COMT] inhibitor endowed with a high binding affinity [sub-picomolar] that translates into a slow complex dissociation rate constant and a long duration of action [>24 hours] in vivo.

In the presence of a DDCI, COMT becomes the major metabolising enzyme for levodopa, catalysing its conversion to 3-O-methyldopa [3-OMD] in the brain and periphery. In patients taking levodopa and a peripheral DDCI, such as carbidopa or benserazide, opicapone increases levodopa plasma levels thereby improving the clinical response to levodopa.

How much will this medicine cost for patients on the PBS and what measures are in place to ensure affordability for those who need it?

For general patients, Ongentys will cost A$30 per script of 30 one-a-day capsules. The cost for patients with a concession card will be A$7.30.

Minister for Health and Aged Care, the Hon Mark Butler MP, stated: “We delivered on our election commitment to cut the cost of medications for millions of Australians by reducing the PBS co-payment to a maximum of $30 per script. This was the biggest cut to the price of medicines in the 75-year history of the PBS.”

What steps have been taken to ensure the availability of this medicine for patients who need it across Australia?

STADA Australia is making every effort to ensure that there is full availability of Ongentys in the Australian market.

Effective Parkinson’s disease (PD) treatment in the community is achieved with shared care between primary and secondary care centres. The STADA nursing support program works in partnership with all relevant healthcare professionals, providing a high-quality service for patients, their families and/or carers.

The company and its partner BIAL actively supported the process of review that resulted in this therapy being available to patients with Parkinson’s disease through the PBS on the terms described in the prior question.

How does the government plan to work with healthcare providers to increase awareness and education about this new treatment option for Parkinson's disease?

While STADA cannot speak for the Australian government, Minister for Health and Aged Care, Mark Butler, has already made a public announcement on the availability of this new Parkinson’s disease treatment through the PBS.

Are there any plans to expand access to similar treatments for other chronic conditions in the future?

Ongentys adds to STADA Australia’s existing portfolio that includes therapies in neurology, insomnia and post-operative pain management, as well as consumer healthcare brands such as Cerumol, Duofilm, Eurax, Hedrin, Paroven and Zoflora.
In particular, Ongentys complements STADA Australia’s Movapo (apomorphine) pens, pre-filled syringes and ampoules that are indicated to reduce the number and severity of ‘off’ phases in patients with Parkinson’s disease severely disabled by motor fluctuations refractory to conventional therapy. Initiation of therapy with apomorphine should be undertaken in a specialist unit in a hospital setting. Conventional therapy should be continued during ‘on’ phases.
STADA Australia continues to work towards extending the portfolio of prescription and consumer healthcare options it offers to Australian patients and their caregivers.

Can you speak to the safety and efficacy of this new medicine and the measures that have been taken to ensure its quality?

Ongentys underwent a thorough review of the medicine’s safety, efficacy and quality by Australia’s Therapeutic Goods Administration (TGA).

The TGA says it made its decision to approve Ongentys based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Ongentys was considered favourable for the therapeutic use approved.

Regarding safety, Ongentys (opicapone) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Ongentys must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.

The Ongentys European Union (EU)-Risk Management Plan (RMP) (version 3.0, dated 15 October 2015, data lock point 30 April 2015), with Australian Specific Annex (version 3.0, dated 29 June 2020), included with submission PM-2019-03218-1-1, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).

Dr. Arcilla Fran 

arcilla.fran@biopharmaapac.com