Ezetimibe products will remain Authority Required (Streamlined) with the same PBS item codes following a major PBS review, however the current streamlined codes have changed effective 1 October 2018.
The red tape tweaking appears to be minimal considering the extensive Post-market Review of Ezetimibe including literature review, reference group meetings, stakeholder forum and public consultation program.
The initial PBS review concluded in 2017 with recommendations to move ezetimibe to a Restricted Benefit to prevent its inappropriate first line use, but this prompted many submissions from cardiologists opposing such a move, saying that ezetimibe usage was mostly appropriate.
Associate Professor David Colquhoun, the CSANZ representative on the reference group, told the limbic the streamlining codes simply remind people that ezetimibe is a second line therapy.
“Apart from changing the Authority Streamlined number you would have to say it is hard to find any changes.”
“The red tape still stands, mainly as a barrier so that you will use a statin first and then go on to ezetimibe. It’s not a barrier for safety; it’s a barrier to keep our practice ‘statin first, then ezetimibe’.”
He said the drug was coming off patent in the near future, so it would be as inexpensive as a statin.
“If you’ve got as far as you can go on a statin, this is the one that you add. Questran [colestyramine] is too hard to use; nicotinic acid is too hard to use. So if you are not at target, this is the one you use.”
“The next step to lipid lowering is a PCSK9 inhibitor and that is about $700 a month versus about $40 a month for ezetimibe while a statin is about $5 a month,” Professor Colquhoun noted.
He said the average improvement in LDL-cholesterol with ezetimibe was 0.5-1.0 mmol/L while some patients might get a 1.5 mmol/L reduction.
“It’s a great add-on, second line drug. It is efficacious in lowering LDL like a weak statin and it’s more effective if added to a statin. If you can’t tolerate a statin, use this first but you rarely get to target on ezetimibe alone.”
“And it’s very rare for people with statin intolerance to be totally intolerant, so some people can have tiny doses of rosuvastatin. Adding this on gives a nice synergism.”
The Post-market Review of Ezetimibe found only 46% of initiations on ezetimibe were consistent with PBS restrictions; 18.4% of initiations were not consistent and compliance was unknown in 34.8%.
PBS statistics show that the number of subsidised prescriptions for ezetimibe-only products increased from 700,000 in 2007 to a peak of 1.3 million in 2015, then fell slightly. Ezetimibe combination products with atorvastatin and rosuvastatin reached levels of almost 500,000 and 95,000 scripts respectively in 2017.