90 days ‘can be done’ says MSD head

By Megan Bohensky 3 years ago | In Comment, Regulatory
  • 3 years ago
BeiGene APAC Head of Market ACcess, Megan Bohensky

30 April 2021

In 2020, we saw a once-in-a-100 years health crisis. I believe now is the time to step back from the year that was and have a holistic conversation about how our health system is serving our community.

The Parliamentary Inquiry into Approval Processes for New Drugs and Novel Medical Technologies, known as the Zimmerman Inquiry, has afforded us a unique opportunity to look at the systems in place for medicines and medical devices. These systems have served us well until now, but the inquiry submissions and hearings have made it clear our needs and expectations are changing, while at the same time medicines and devices are also changing as science and technology evolve.

First, we need to have a conversation about the timely delivery of the most effective and valuable treatments. There are clear patient benefits for getting important medicines to patients faster, and there are health system benefits too.

Cost savings arise from true efficiencies in the system – they do not arise from cost-shifting, rationing of care, or reducing the quality of care. I have read several proposals in submissions to the Parliamentary Inquiry on how we might increase efficiencies in the system by developing early funding arrangements, similar to those in other countries, and I think these are certainly worth exploring.

At MSD, we believe that no one should have to wait more than 90 days after TGA registration for a medicine they need to stay healthy or treat their disease. That’s how long it would take if:

1. a product is parallel-processed through the TGA;
2. receives a first-time PBAC approval; and
3. is listed within three months.

Ninety days from registration to reimbursement would align Australia with other leading systems such as Great Britain, Japan and Germany.

This timeline is entirely possible within our current system because Australia has one of the fastest times to first reimbursement decision, but it’s not frequently realised due to the fact that most novel medicines are rejected by the PBAC at their first consideration.

In fact, MSD did achieve a listing 139 days after registration with our first-in-class melanoma listing (just six weeks shy of the 90-day target). From this example, we can see that it can be done – but it is the exception rather than the norm.

The new streamlined pathways processes are intended to reduce listing timeframes and resubmissions, so we hope to see more medicines achieving faster listing timeframes. However, we need to monitor our progress and remain committed to a world-class target.

If nothing else, the COVID-19 pandemic has made clear what can be achieved when health is our collective priority. There can be stunning progress when governments, the biopharmaceutical industry and partners in the wider community collaborate to achieve important goals. It is critical that we continue to challenge ourselves to deliver better health for all Australians.

*Megan Bohensky is Head of Policy and Access Strategy at MSD Australia and is a guest author for MedNews. The views expressed are those of the author and do not necessarily reflect the views of MedNews.

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