Australia's reimbursement cost battle hits cancer drug access

Australia's reimbursement agency has lagged developed country counterparts in paying for newly approved cancer therapies, highlighting problems at the tail end of a system that patients and industry complain is broken.

Pfizer's Masum Hossain

Unsurprisingly, industry group Medicines Australia has called for a more flexible and fast-tracked approach to approving new cancer drugs, citing data that shows Australia ranked 18th out of 20 comparable OECD countries on access to innovative new medicines.

But the drug approval body, the Pharmaceutical Benefits Advisory Committee, has responded saying any change to the approval process would "greatly increase the cost to the community and diminish the sustainability of the Pharmaceutical Benefits Scheme without any commensurate gain in health outcomes."

The issue has filtered up to Australia's federal legislature with the upper house, or Senate, holding an inquiry on the availability of new cancer drugs.

The ins and outs of the debate are of particular interest to Masum Hossain, Asia-Pacific regional president for Pfizer Oncology responsible for the commercial operations for 12 countries in the region.

His comments also come as the U.S. Food and Drug Administration in February approved Pfizer's ($PFE) Ibrance, a potential new standard of care for advanced breast cancer, in a regulatory decision that came more than two months earlier than expected.

Wall Street has considered the drug, whose chemical name is palbociclib, to be one of the most promising medicines in Pfizer's development pipeline.

He spoke by phone to FiercePharmaAsia on March 20 while attending a regional conference on cancer in Hong Kong.

Hossain's background includes a medical degree in neuroscience and a stint at the Australian regulatory agency, the Therapeutic Goods Administration, putting him in a unique position to discuss access to cancer drugs in Australia.

Here's the interview:

FiercePharmaAsia: Can you tell us about the state of cancer drug reimbursement and approvals in Australia?

Hossain: Let me start by giving you a little bit of context.

Cancer in Australia is a pretty significant problem. We know that from data available from the Australian Institute of Health and Welfare that over the lifetime, a person in Australia has a one in two chance of developing cancer. We know that in 2015 around 125,000 people will be diagnosed with cancer, and around 44,000 people will die from cancer.

In fact, cancer accounts for around 19% of the total burden of disease in Australia, which is higher than any other disease area.

What that means is that cancer patients in Australia really need access to the latest cancer medicines as quickly as possible. You're probably familiar with the PBS system in Australia. This system has been around for 60 years, and over the past 60 years I feel that the PBS system has served people in Australia very well.

My concern is that the system has not--at least in the context of cancer--kept up with technology and has not kept up with the standard of clinical care. And what we're seeing now, as a result of that, is a substantial delay in access to cancer medicines.

There is an extremely high rejection rate for a new submission for a cancer ... It's more than 80%.

There was a report just released sponsored by Medicines Australia that shows that there is a broad problem with timely access to medicines in Australia

The average time for a medicine across any therapeutic area to be reimbursed between registration/reimbursement is around 383 days. Now, for cancer that is 573 days, so almost 19 months it takes between registration and reimbursement.

FiercePharmaAsia: Is cost the main issue?

Hossain: I think what we're talking about is value and how value is measured by the payers in Australia and whether that reflects value for innovation.

So, I think the healthcare system in Australia and, in fact, in any country is right to demand value for money. On the flip side, I think innovative organizations, biopharmaceutical companies, are right to request value for innovation. The problem that I see is the difference in the way value is interpreted.

From a payer's perspective, at least from PBAC's perspective, let's say in Australia, value is determined through a health economic process in which cost effectiveness is the main measure of value. And in that equation, value is determined mainly by patient outcomes as measure by overall survival and quality of life benefits that flow to patients.

What it ignores is a whole segment of value that flows to society, flows to the healthcare system through efficiencies, delivered by targeted agents and personalized medicines, which are the, I guess, latest innovative cancer medicines, and also the value that flows to the economy through increased productivity as a result of patients returning to work.

And this value is not a part of the health economic assessment that's done. And as a result, decisions are being made around cost effectiveness, around the value that's been delivered. And I think that's part of the reason why we're getting such a high rejection rate.

FiercePharmaAsia: Is that relatively new?

Hossain: It's actually been a part of the process for many, many years. When I say that the PBS system has not kept pace with technology, I can illustrate to you what I mean by that.

If you take personalized medicines, for instance, a personalized medicine is a medicine where one can very carefully select patients that are likely to respond through genetic testing. And by identifying those patients, you're delivering, I guess, value to the patient. So, a patient who has been identified to have a certain genetic mutation is much more likely to respond to that drug.

What it means for the payer is we're treating a much smaller patient group. And that means a much lower total budget impact to the healthcare system.

In addition to that, there's a large patient number that we're not treating as a result of being able to select patients. And by not treating those patients, we're doing no harm to them. They're not experiencing any side effects. And as a result, there is less utilization of medical resources. And that's another benefit that flows to the healthcare system.

So, the system needs to be able to account for this and be able to value the medicine in the context of the targeted agents in the context of personalized medicines. And the system's not able to do that right now.

FiercePharmaAsia: What are the prospects that might change?

Hossain: We know that there are lots of medicines currently in development. In fact, there are more than 900 cancer medicines in development globally. And many of these medicines are actually personalized medicines.

We know that around 70 to 80 of these medicines are actually in late-stage development. And over the next two to three years, somewhere between 40 and 45 of these will come to market. So, the system needs to be able to cope with this.

So, I guess, what needs to happen is for the industry to work very closely with the government to modernize the current PBS system. It may require fundamental reform, but what we need is a long-term solution--a long-term sustainable solution.

We know that this is going to take time. We know that there are budgetary constraints that the government needs to work under. And what we would propose is to do this in a fiscally responsible way. But what we must have is a system that is able to cope with the latest cancer medicines.

The point I want to make is that there are cancer patients today who need medicines and don't have access to these medicines. And what we would appeal to the government to do is set up an interim solution so that cancer patients who need treatment today are able to access the treatment through an interim solution while we collectively work on a long-term solution.

FiercePharmaAsia: Where does the doctor fit in?

Hossain: If a doctor prescribes a medicine that is currently not reimbursed through the PBS system, they will have to pay the full price out of pocket.

That creates a system where only the rich can pay. And most people are unable to pay. And there's inherent inequity in that. And the PBS system was created to overcome that inequity and to provide equitable access to new medicines. And we are certainly seeing a problem with equitable access to new cancer medicines.

FiercePharmaAsia: If approvals were quicker along with reimbursement in places like Australia and as far afield as China would drug prices fall?

Hossain: The duration it takes to reimburse a drug doesn't have an impact on how we price the drug. But you do raise an important point around registration. The FDA has a system whereby breakthrough medicines can have accelerated approval and recognition of very good data, very good clinical data. Many markets around the world don't have that. I know Australia doesn't have it.

Of course, that is quite separate to the reimbursement issue that I'm referring to. But access is a function of both registration and reimbursement. And any changes that improve timelines for registration and reimbursement is very welcome.

FiercePharmaAsia: Are there specific types of cancer and therapies you're focused on right now in Australia?

Hossain: There are certain cancers that are more common in Australia like melanoma, like prostate cancer. I know that breast cancer has one of the highest incidences in Australia. And naturally we will focus on those cancers.

I know globally, of course, we have a very robust clinical research and development program globally. And it makes sense to focus on a country like Australia when we do research in melanoma. So, there are certain cancers in Australia that we're particularly interested in.

- here is the the report from Medicines Australia