AbbVie's Chris Stemple spoke with BioPharmaDispatch ahead of the reimbursement of the first biosimilar adalimumabs and the listing of the company's new HUMIRA (adalimumab) formulation.
Mr Stemple joined AbbVie from Biogen at the start of 2020, succeeding Kirsten O'Doherty as the company's general manager.
"It has been a very busy time. I got about five or six weeks in as business as usual before we had to shut down in response to the pandemic. We had a normal annual sales conference during which I got to meet everyone. Kirsten was still doing a formal handover and that was really good.
"Then we had three months of lockdown and that was pretty trying, particularly as I was quite new to the organisation and wanting to develop the relationships you would normally expect. That said, everyone responded so well, and then we had to work on the integration of the Allergan business.
"So, to this day, we have not all come together as a single company to celebrate our coming together."
Mr Stemple said Allergan is still operating as a separate legal entity but that the plan is for integration.
"A lot of the back-office functions are being fully integrated, such as human resources, finance and IT. On the commercial side, what we are calling the Allergan Aesthetics business will always be separate, with Allergan's therapeutic business being fully integrated.
"This is great because it gives our specialty care business another dimension. We will also look at other opportunities to collaborate and synthesise between the businesses."
Mr Stemple said the pandemic was a challenge but that AbbVie, which has had a strong reputation for workplace flexibility, was able to quickly adjust and ensure it kept working effectively during the lockdown. "It was really about taking advantage of the systems that had already been designed and put in place."
He said it is still too early to know what changes adopted as a result of the pandemic will remain permanent. "What we do know is that people now have an expectation they can do their job in a slightly different way. That does not mean we will never work in offices again. I think there is a 'richness' in having more people interacting in person and the 'jury is out' on how long we can work remotely.
"It is also important for our customers. We are starting to have in-person educational events and the attendance has been outstanding - everyone wants to come and participate."
Mr Stemple spoke with BioPharmaDispatch just days before the loss of exclusivity of the company's HUMIRA (adalimumab). In a major milestone, four biosimilars will be listed on the PBS on Thursday (1 April). However, at the same time, a new reduced volume citrate-free formulation of HUMIRA will also be listed.
"It is a huge day and a great opportunity to reflect on how HUMIRA has changed the lives of hundreds of thousands of people around the world, including tens of thousands in Australia.
"HUMIRA also changed how people understand and appreciate what a therapy is capable of doing for patients. It has been so successful because of its impact on patients who are now living more full and productive lives. It was a part of a wave of new therapies - the most successful of that wave - but they have all led to a new understanding of patient care."
He said AbbVie has spent several years "preparing for this moment".
"We think our planning has been good and we have anticipated most of what we are seeing play out. We feel pretty comfortable with where things are at and we do acknowledge the importance of biosimilars. Patents expire and competitors have the right to launch and should launch. Yet we also know they are not the same - they are similar."
"Physicians and patients should have the choice about what they use and that is a great strength of the Australian system in that it enables that behaviour. It generates savings for taxpayers but it allows for patient choice and not being forced to switch onto something they would prefer not to use.
"For us, we are absolutely here to support patients and ensure they have access to what is the right brand of adalimumab for them. We are launching new formulations of HUMIRA and other new immunology products.
"We are here to support continued innovation and we are not the company that relies on HUMIRA, maybe the way we did three, four or five years ago. Our teams promoting the new formulations will, for the most part, also be promoting other products.
"We are absolutely prepared to talk to our customers about biosimilars and how they might make that choice."
AbbVie's acquisition of Allergan means it also acquired rights to BOTOX (botulinum toxin type A) that is listed on the PBS for a range of conditions, including chronic migraine.
Mr Stemple said the company is following the progress of the new class of biologics (CGRP inhibitors) for the treatment of migraine. None of the CGRP inhibitors has yet made it to the PBS but the Department of Health recently confirmed Lilly has submitted the paperwork required to progress the recommended listing of its EMGALITY (galcanezumab).
"I think the issue is frustrating because it suggests there is not a real understanding of the disease and the burden it creates for patients. If there is not a real understanding of the burden then maybe there is not a real understanding of the benefit of relieving that burden. It feels as if a decision has been made to only invest so much in migraine and that means the government is only willing to fund treatment for a certain number of patients. It is a real shame and, if I lived with chronic migraine, I would be very frustrated by that."
Ms Stemple said, "I think decision-making can struggle, and it is reasonable, with translating a clinical trial and submission to the actual outcome through clinical familiarity. In other words, what does it actually mean for the patient?
"Unfortunately, currently there is no way to get that discussion until you fail in a PBAC submission, then you can organise patient and clinician hearings. The problem is that you spend six months getting to that point."
In a recent interview, PBAC chair Professor Andrew Wilson told BioPharmaDispatch the committee would like to see changes that allow for greater and earlier clinical input to its decision-making.
Mr Stemple, who is also on the Medicines Australia board, recently appeared at a public hearing of the current parliamentary inquiry into approval processes for new drugs and novel medical technologies.
"The opportunity is that a large number of patient groups have expressed a high degree of frustration with the current process so it seems something needs to be done. The first thing that needs to be done is to acknowledge the fact these groups have expressed frustration."
He said, "In the end, reform requires willing partners. Some reform requires changes to law and some just policy and procedure. They can all be adjusted if there is a willingness. We sometimes get the sense that the willingness is not there."
Mr Stemple said a very positive development in recent years that has been reflected in submissions and evidence given to the current parliamentary inquiry is that timely access has become the "yardstick".
"The government, opposition, patients, all stakeholder groups and the community are now measuring the performance of our systems based on timely access. Are we meeting that standard? It seems not in every case but I am optimistic that more and more people are recognising the need for change."
