Government extends CSO contracts and links outcome to SPA changes

Sydney-based Pharmaxis (ASX:PXS) has announced positive results from the Phase 1 clinical trial for the second of its Lysyl Oxidase Like 2 (LOXL2) inhibitor compounds.

Under the announced plan, Alcon will be listed on the New York Stock Exchange as an independent, publicly-traded company, under the ticker symbol 'ALC'.

The new CEO has 26 years of international experience in the pharmaceutical industry, working in Australia, the US and Canada, including over ten years with Apotex.

More speakers are in the process of being confirmed and over 80 people have already registered for the conference.

Medicines Australia has decided to take another look at the proposed changes to new PBAC submission and PBS listing pathways to ensure there are protections to prevent a future re-purposing of the policy.

There was no discussion on controversial issues dividing much of the sector, including the ongoing review of the PBS wholesaler CSO, and the proposed reform of the supply chain payment system.

The Department of Health and pharmaceutical sector are now facing a confirmed and significant shortfall in the $1.8 billion saving target negotiated as part of the 2017-18 Budget.

The Senate has backed a second motion calling on the government to table its response to a Senate report that recommended a 're-examination' of current regulatory and reimbursement processes for medicines that treat cancers with low survival rates.

Australia is not alone in wanting to create processes that seek to accelerate access to new and innovative medicines providing a significant benefit to patients.

Imagine what the MYEFO process must be like for Minister Hunt and his officials if they are having to confirm a significant shortfall in the $1.8 billion in PBS savings negotiated with the sector as part of the 2017-18 Budget and higher than expected spending.

Discretion, categories, priorities, deferrals and rankings, are all words used by governments over the years to describe the potential differential treatment of PBAC submissions or outcomes.

We know exactly how Department of Health officials are thinking about the new PBAC submission pathway system based on a statement at a briefing of companies in Sydney in late September.

Successive governments have attempted to introduce systems that categorise and prioritise medicines in the PBS-listing process. These are the ones we know about it.

The wider context in 2019 and 2020 will be the apparent return to PBS growth, a significant shortfall in savings, the need to fund new listings and whatever is negotiated as part of the next 7CPA, and a process that deems the reimbursement of some medicines as something other than a priority.

Is industry at risk of backing a system reform that explicitly prioritises the interests of some patients over others? Is it at risk of being in a position where putting patients first actually means putting some or only some patients first?

Representatives of the pharmaceutical industry, government and non-government organisations, came together last week to share their expertise and experience at The Bridge Program’s Residential Training Program.

The Department of Health will host forums with the industry to discuss the implementation of how ministerial discretion will be applied, or not applied, to statutory price reductions.