'Enough is enough' is one response to new screening process

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Mixed responses from advocacy groups in response to the federal government's new process for the expansion of Australia's newborn screening program.

Newborn screening is becoming increasingly important with the development and emergence of gene-based and other therapies that could offer the hope of curative outcomes for patients. However, their benefit significantly relies on early diagnoses.

Under the new process, which was welcomed by Rare Voices Australia (RVA), the addition of each new disease to the newborn screening program will need to navigate a complex process.

The new process essentially includes at least three distinct review processes. Any decision to add a disease to the newborn screening program will then be determined by individual states and territories.

The new process includes a review by the Department of Health and then consideration by the Commonwealth chief medical officer (CMO). If the CMO agrees to proceed, it will then be considered by the Health Chief Executives Forum, which has replaced the Australian Health Ministers' Advisory Council, with another review by the Newborn Bloodspot Screening (NBS) Program Management Committee. If it navigates that process, it will then require a formal submission to the Medical Services Advisory Committee (MSAC) and then consideration by the states and territories.

The Australian Health Ministers' Advisory Council, which is now called the Health Chief Executives Forum, would historically meet once or twice per year.

In addition, the new process does not actually require the states and territories to add a disease to their screening programs even if recommended by MSAC.

"RVA welcomes the Department of Health’s reform which we believe will give the assessment component of the NBS program ongoing sustainability and encourage more timely implementation at a state level. RVA believes this will increase both equity and transparency in NBS programs," said the organisation in a statement.

However, Better Access Australia (BAA) said the new process could take three years for a single disease to navigate only to then face the uncertainty of a funding decision by individual states and territories.

“Unfortunately, Australia currently only screens for 25 conditions and we are well behind comparable countries,” said BAA chair Felicity McNeill PSM. 

"California screens for 80 diseases. New York screens for 52 with a further 14 under a pilot program. All but four of these conditions have current treatments available."

“Australia currently loses 2,500 children each year to these conditions, many of which can be screened for and treated. But all levels of government are failing to act,” continued Ms McNeill. 

“The federal government recently abolished a failed newborn screening committee. However, rather than fixing the problem, it has now constructed a process that could take at least three years to consider and provide advice on screening for any single disease. 

“At that rate, we should catch up with California’s standard of care by 2170 – if they are ever recommended,” said Ms McNeill. 

“This single disease-approach demands the carers of patients themselves pull together a highly complex Health Technology Assessment (HTA) submission."

Ms McNeill said the federal government has spent the past five years reviewing 5,700 Medicare item numbers. 

“It has reviewed an average of 22 items per week or over 1,000 items per year. Conversely, it has been happy to watch newborn screening languish.” 

Since 2016, the joint federal-state committee has considered seven conditions for inclusion in the newborn screening program. Only one has been recommended. Yet it is not been actioned because of disagreement over who should fund the test. 

“This committee has been abolished and replaced with just another long-term process that provides little hope for families wanting to make sure their kids are diagnosed and treated as quickly as possible. 

“It’s not too much to ask and it’s time to stop asking patient groups to do the heavy lifting for these processes to protect all of Australia’s children. 

“Better Access Australia is asking all political parties to commit to an end to this discrimination against our children. We are calling for the adoption of a single six-month time-limited review of newborn screening with the goal of bringing the screening program we offer our children into the 21st century. 

"In the 1990s Australia was woefully behind the rest of the world in our childhood immunisation rates. It took direct intervention by Ministers to change that trajectory and today we are amongst the world leaders. We need that courage of conviction to intervene again. 

“We will be writing to all of the patient groups relying on this expansion to encourage them to say – ENOUGH IS ENOUGH. 

“We have a 1980s screening program for our children. It’s time to act for all children born in Australia that are not given the protections afforded them in so many other countries. 

“Newborn screening is the gateway to treatments, the gateway to genetic testing, the gateway to clinical trials, the gateway to parents doing everything they can to give their children the best start in life. 

“Newborn screening is the gateway to ending the preventable loss of 2,500 of our children each year,” added Ms McNeill.