PAH prescribing restrictions out of step with evidence


22 Feb 2017

Doctors and patient support groups are urging the government to lift ‘senseless’ prescribing restrictions on drugs used to treat PAH in the lead up to a post market review of the medicines.

In submissions to the Department of Health review several medical specialists have criticised the current PBS restriction criteria for being out of step with international guidelines and evidence-based recommendations, which they say could lead to ‘inferior’ patient outcomes for Australians being treated for the condition.

Dr Richard Whitaker, Emergency medicine physician at Cairns & Hinterland Hospitals and Health Service in Queensland said it was difficult for patients and doctors to understand why more combination therapy was not available in Australia while patients overseas can easily access those treatments.

“Australian patients are very well informed and interact through social media with patients and patient groups overseas. There is a significant disparity in treatment options that patients are very well aware of,” he said in his submission.

Dr Whitaker, who revealed he is also the father of a child who died from PH, argued that current outcome measures that determine whether a patient gets reimbursed for treatment, such as the six minute walk test– are not suitable for measuring disease progression or response to treatment.

“Patients have significant issues with the absolute six-minute walk test (6MWD). Despite there being a national guideline on how to perform this test, patients report significant disparity between its performance in different centres, and also at different times in the same centre,” he said.

Patients from regional centres are often compromised by long travel and frequently feel they have not performed their best, he added.

Meanwhile patient advocacy group Pulmonary Hypertension Association Australia has said the current system puts an unprecedented amount of stress and anxiety on patients and their families because of the financial burden that comes with self funding costly combination treatments that are not reimbursed by the PBS.

“A large proportion of our members are on combination treatment for their PAH … only those that are financially able to can self-fund, many are selling property or cashing in retirement savings to do so.”

The patient support group also hit out at the drug regulator for only reimbursing PAH medicines with certain aetiologies and severity – a restriction it described as ‘senseless’.

“If a patient is lucky enough to be diagnosed as functional class II … it doesn’t make sense to have to wait until the disease worsens to class III before you have access to reimbursed medicines. PAH is PAH regardless of functional class and a small number of patients are discriminated against on the basis of how they got their disease or how severe it is.”

The Department of Health is inviting submissions from interested doctors addressing the draft Terms of Reference to the PBAC for this Review. Submissions must be lodged by 5pm Monday, 27 March 2017.

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