PBAC tightens up on proton-pump inhibitors

Medicines

By Mardi Chapman

24 Aug 2018

Treatment of gastrointestinal acid related disorders with proton-pump inhibitors (PPIs) will change in response to concerns from the Drug Utilisation Sub Committee of the Pharmaceutical Benefits Advisory Committee (PBAC)

At its July 2018 meeting and following consultation with GESA, the PBAC has recommended increasing the restrictions on all standard dose PPIs from Restricted Benefit to Authority Required (Streamlined).

The recommendation applies to esomeprazole 20mg, rabeprazole 20mg, lansoprazole 30mg, omeprazole 20mg and pantoprazole 40mg.

They also recommended high dose esomeprazole 40mg with one repeat change from Restricted Benefit to Authority Required (Telephone).

The number of repeats on standard dose pantoprazole and rabeprazole for peptic ulcer will also be reduced from two to one, consistent with all other standard dose PPIs for this indication and with clinical guidelines which recommend 4-8 weeks of PPI treatment.

Professor Nick Talley, director of the Priority Research Centre for Digestive Health and Neurogastroenterology at the University of Newcastle, told the limbic they were ‘very sensible recommendations’.

“There is no argument that we should be using the lowest possible dose to control disease and no doubt, that if we can wean people off because they really don’t need them anymore, we should.”

“The risks are probably low but they are definitely there. On the other hand we’ve got to make sure people get enough of a dose to treat their disease properly. It’s really a matter of intelligent dosing – a balance of risk and sensible prescribing, and de-prescribing where appropriate,” he said.

In other PBAC recommendations regarding PPIs:

  • All high dose indications for esomeprazole 40mg (one and five repeats) will require a trial of standard dose PPI prior to initiation of a high dose PPI.
  • All standard dose PPIs with five repeats indicated for GORD will have clinical criteria included specifying they are to be used for long-term maintenance of GORD, in a patient inadequately controlled by a low dose PPI.
  • All peptic ulcer indications will require negative H. Pylori testing or failure of eradication therapy before commencement of a standard dose PPI.
  • The addition of a new clinical indication – initial and short-term maintenance treatment of symptomatic GORD for standard dose PPIs with one repeat.

“The PBAC noted this would draw a distinction between patients requiring long-term therapy for GORD (5 repeats) and those indicated for short-term use (1 repeat),” the Committee said.

It suggested PPI utilisation should be reviewed two years after implementation of their recommendations.

The PBAC did not recommend a proposal for PBS restrictions to include additional clinical criteria stating erosive oesophagitis be confirmed by endoscopy for patients treated with esomeprazole 40mg (1 repeat) and long-term standard dose therapy for GORD (5 repeats).

The Committee noted stakeholder concerns that this was clinically unnecessary and burdensome for patients.

It also did not recommend the addition of treatment criteria to PBS restrictions, which required treatment to be prescribed by a gastroenterologist or in consultation with a gastroenterologist, for all hypersecretory, scleroderma oesophagus and erosive oesophagitis indications.

The PBAC recommended that PBS terminology for PPI strengths change to be consistent with Therapeutic Guidelines and NPS terminology, i.e. high, standard and low dose. In further tidying up of terminology, all gastric ulcer indications should change to peptic ulcer.

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