Source: PharmaDispatch Author: Paul Cross. First Published: 11 March 2019

The PBAC is considering simplifying the PBS listing of the direct-acting antivirals for hepatitis C as the latest prescribing data continues to show a sustained slowdown in utilisation.

The Department of Health has published an outcome statement from a stakeholder conference call held in December.

The participants included medical, patient and research groups, but not the companies with PBS-listed direct-acting antivirals for hepatitis C. Companies were not even informed the meeting had taken place.

“Hepatitis Australia greatly appreciates the continued interest of the PBAC to ensure that its initial recommendation to provide universal access to these curative treatments via the PBS achieves its intended goal – elimination of the disease by 2030," said the patient organisation in response to questions from PharmaDispatch.

According to the outcome statement, the number of new patient initiations on the therapies "declined from 4,400 incident patients per month during the first four months of listing to an average of 1,280 patients per month by December 2017."

It added, "Based on current trends, stakeholders considered approximately 15,000–16,000 patients would initiate DAA therapy in 2018. Stakeholders considered that at this level of DAA initiation Australia may achieve WHO HCV elimination targets by 2030, however higher initiation rates (approximately 19,000 patients per year) would likely be required to meet National Hepatitis C Strategy targets for 2022."

Use of the word "may" could be interpreted as a tacit admission the decline in uptake is threatening the goal of elimination by 2030.

However, the admission is based on 12-month old prescribing data, with the most recent commercial data confirming the situation has worsened.

The Commonwealth's chief medical officer Professor Brendan Murphy previously told PharmaDispatch eliminating hepatitis C by the target date of 2030 required 1,500 to 2,000 new patient initiations every month. He said the government "would need to review its strategy" if initiations fell significantly below 1,500.

According to Hepatitis Australia, "The trend in prescribing of these treatments is continuing to decline. 2018 saw monthly initiations average well below 1500, and now the January 2019 statistics show we have fallen below the 1000 new treatments mark with February looking to result in a similar number. As our Chief Medical Officer stated last year, we need that number to be up around the 1500-2000 mark if we are to achieve elimination by 2030.

"14 months of consistently falling short of this target, and now with new treatment rates falling below 1000 in a month, we cannot sit here and wait for another report in six months before we act. The time to push for a dramatic uptake in the number of GPs prescribing DAAs is now.”

Professor Murphy and PBAC chair professor Andrew Wilson have both emphasised the importance of higher rates of prescribing by general practitioners.

The outcome statement from December's conference call says a utilisation review by the PBAC's Drug Utilisation Sub-Committee "revealed positive trends, such as the increasing proportion of DAA prescribing by general practitioners".

Yet the most recent data shows prescribing by general practitioners has remained at around 40 per cent for the past two years.

Hepatitis Australia said there are two groups of patients when it comes to access - those with current risk factors who need the opportunity for cure and to reduce the risk of transmission, and those not currently connected to care for hepatitis C who were diagnosed decades ago and are no longer at risk from injecting or acquired hepatitis C.

"We need to reach all the people in both groups or we will not meet our targets for treatment or our targets for reducing deaths," it said.

"This second group totals over 100,000 people. They represent 2-10 patients in every GP practice in Australia.

"Three years in, the comparisons between GP and specialist prescribing misses the point of the challenge we now face with this second group pf patients. The key metric now is how many GPs as a total of all GPs are prescribing.

"Currently, around only 10% of GPs prescribe DAAs (~4,000). Of this 10% currently prescribing the majority of prescriptions are by GPs looking after the at-risk populations. We need 90% of GPs to have prescribed DAAs to reach those 2-10 patients in every practice."

The ongoing decline in uptake, with new patient initiations in 2019 set to go as low as 12,000, would also undermine Australia much-vaunted pricing deal for the direct-acting antivirals.

The higher than expected initial uptake of the therapies meant Australia paid a very low per patient price for the first year. However, the dramatic and sustained decline since 2017 means Australia is now paying a higher per patient price.

Companies are already under significant pressure to re-open the current five-year deed of agreement and agree to a lower PBS published price based on prices paid in some markets overseas. Companies have already agreed to a lower published price, from August last year, a move that reduced topline spending on the PBS by around $1 billion over four years.

The standard deed has recently been changed to allow the government to unilaterally amend an agreement. The previous standard deed, including the agreements for the direct-acting antivirals, could only be varied for agreed and specified reasons or based on advice from the PBAC.

The outcome statement shows stakeholders backed the potential simplification of the PBS prescribing criteria with the removal of the mandatory requirement for pre-treatment genotyping.

"Stakeholders considered that without the mandatory requirement most patients would still have genotyping done. However, for some patients, awaiting the results of genotype testing may delay initiation of therapy and increase the risk of loss to follow up," it says, noting particular concern in the corrective services setting.

"Stakeholders considered that, while it was informative for monitoring purposes to have data on genotype recorded as part of the current Authority Required (In Writing or Telephone) listing, it may be counterproductive if it limits treatment use," it adds.

"Thanks to support from the Australian Government we are working hard on community awareness – the push for action by GPs from their newly informed patients, but we need the Government to increase the education and engagement level from GPs to find all those who may benefit from these treatments," said Hepatitis Australia.

"As part of the most recent MBS Taskforce review consultations we have once again asked the Government to consider targeting the chronic disease management plan for a two-three year period to include a focus on identification, diagnosis and treatment of hepatitis C."

It added, "We thank the PBAC for taking the lead in looking at any barriers to prescribing by GPs it can help address. We ask that government and clinicians now do the same.

Note: This article has been republished with the permission of PharmaDispatch, which is a subscription only news service.