Dummy group of undisclosed “experts” guillotining terminally ill patients’ treatment access before Christmas – MEDIA RELEASE – December 7, 2015

Dummy group of undisclosed “experts” guillotining terminally ill patients’ treatment access before Christmas

An ‘Expert Reference Group’ (ERG) recently established by the Federal Health Minister to assess ongoing applications for a life-saving medication has rejected its first patient, leaving her to face an almost certain death. 

Sarah Mulligan, 29, Cairns, a double-lung transplant recipient battling the devastating, ultra-rare blood disorder, atypical haemolytic uraemic syndrome (aHUS), fears this “dummy group” of undisclosed “experts” was established as a knee-jerk reaction to appease patients coming off life-saving treatment in the lead-up to Christmas.

Sarah must now wait for her kidneys to fail, yet again, to demonstrate her need for Soliris (eculizumab), the only available treatment clinically proven to prevent premature death and vital organ damage in those living with aHUS.

According to Sarah, the Federal Health Minister’s adviser, Mr Alex Best, recently met with her and Treasurer of the aHUS Patient Support Group Australia (aPSGA), Mrs Debbie Basham, to plead their need for continuing access to the life-saving treatment, as their initial 12-month continuous access agreement draws to an end. 

“Mr Best assured us it was his top priority to address the dire situation, given the number of patients due to be forced off drug just prior to this Christmas.

“Without any formal disclosure to the aPSGA, the ERG was announced on the PBS website on November 24, 2015 to manage returning applications for Soliris,” said Sarah. 

“I believe I am the first Australian to undergo ERG review, and have received a resounding rejection, despite my treating renal physicians’ confidence I had an extremely strong treatment-continuation case.

“Within the first five weeks of being on Soliris, my kidneys improved 10-fold,” Sarah said.

“The Minister’s ERG is now forcing me back into kidney failure.”

Sarah is living with cystic fibrosis, for which she required a double lung transplant in 2013. The ERG’s rejection of Sarah’s application for Soliris is based on her aHUS being a direct result of ongoing immunosuppressant treatment to protect her transplanted lungs.

“I need to be on immunosuppressants for the rest of my life. However, the ERG is asking me to either come off the immunosuppressants, or Soliris.

“Without access to my immunosuppressants, I will die from lung failure, and without access to Soliris, I will die from kidney failure,” said Sarah. 

Mrs Kerri Grey, President of the aHUS Patient Support Group Australia (aPSGA) and mother to Ashley, seven – the first Australian to be granted compassionate access to Soliris – says she is shocked and devastated at Sarah’s rejection, stating this is frightening news for those patients who met the Government’s initial funding criteria under the PBS Section 100: Highly Specialised Drugs Program on December 1, 2014.

“Our greatest fear in the lead-up to Christmas, was that those requiring reassessment early this month would need to be assessed at a time when hospitals and government departments were losing staff to the Christmas holiday season.

“Receiving news of the first rejection of one of our aPSGA members has left our small patient community facing the prospect of guillotining by a faceless and nameless ERG,” Mrs Grey said.                                                                               

“We’ve had our doubts over the past few days, following the announcement of the ERG, as to how bona-fide a group it was.

“While the ERG allegedly comprises renal physicians and haematologists, this does not make them aHUS experts,” said Mrs Grey.

“Only a patient’s treating specialist is qualified to make this life-determining decision.

“We’re terrified patient lives over the long summer break, are literally resting in the hands of an undisclosed ERG charged with vetting all treating doctors’ recommendations,” Mrs Grey said.

“The rejection of one of our strongest continuation cases crushes any hope for other patients coming off treatment.”

Despite several requests from aPSGA members, the Health Minister is refusing to disclose the decision making experts comprising the ERG, with reports from the aHUS patient community, that not one of their treating physicians is represented.

“We are completely in the dark as to whether this ERG constitutes Government bureaucrats, general practitioners, allied health professionals, or specialist renal physicians and/or haematologists who have patients living with aHUS – the latter of which is our preference,” said Mrs Grey.

“Following Sarah’s rejection, we’re not confident in this group, or their ability to convene over Christmas, to review individual patient cases, on a needs basis.

“Our loved ones are once again, facing an uncertain future, despite a long, protracted battle for funding in 2014,” Mrs Grey said.

Last year, the Federal Government earmarked $63 million over the ensuing four years, to fund Soliris for certain aHUS patients who met the stipulated treatment access criteria.

The Government announced the formation of an ERG on the PBS website in recent days, citing applications for continuation or re-initiation of Soliris would be assessed within 72 hours of receipt, upon correct and complete provision of information.

The aPSGA is yet to receive any formal notification regarding the formation of the ERG.

Under the current criteria, certain aHUS patients have access to Soliris for 12 months. Those whose 12-month access has either recently ceased, or is about to cease, will require regular, bi-weekly, weekly or fortnightly blood testing and monitoring. Together with aHUS patients who do not qualify for access to Soliris, they must experience another, potentially life-threatening aHUS flare before proving eligible for ongoing, or new treatment access.

“We urge the Federal Health Minister, The Hon. Sussan Ley MP, to ensure the ERG urgently reviews Sarah’s case again,” said Mrs Grey.

“We also call upon the Minister to disclose all members of the ERG to the public, to rescind their authority temporarily, and to delay any formal implementation of any restrictions for patients accessing Soliris, until after the holiday season, to give aHUS patients and their respective families, peace of mind.

“Furthermore we urge the Minister to re-consider the actual criteria surrounding patient access to Soliris.     An ERG is ineffective, if all they’re doing is reiterating and implementing the current restrictive criteria,” Mrs Grey said.

About the aPSGA

The aPSGA was founded in September, 2012 to advocate for Australians living with, or caring for those with aHUS. For more information, or to support the aPSGA cause, visit http://ahusaustralia.org.au

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