Journal of Clinical Pathways spoke with Alex W Bastian, MBA, strategic advisor, ASCO Value In Cancer Task Force, about how his role in the Task Force has impacted his views concerning value-based care, health care reform, and clinical pathways.
What inspired you to work in the Value in Cancer Task Force and what is your role in your position?
Anytime you find someone that is proactive and constructive on a topic that you’re passionate about it is easy for me to join an initiative. The Value in Cancer Task Force set out to do something that hadn’t been done before – at least in the USA. The concept of “value” and its multiple means of expression in healthcare are something I am passionate about and that I work to reflect every day.
After spending many years in Europe, working in both biotech and market access, I became acutely familiar with the differences between European decision making and how the US system differs. Value assessment in almost every European market has its own unique approaches and – sometimes – the differences of opinion. There are also consequences to these different approaches that have unintended consequences that would likely not be desired by patients, physicians, or manufacturers in the USA. This includes restricted or blocked access and the time for a new technology to reach patients is often 1-2 years after US patients are already receiving therapies as part of standard practice.
The other thing that I quickly realized was how passionate and focused some of the leadership at ASCO was on dealing with this topic. That passion was easy to connect to.
My role was strategic advisor to the task force. When I joined it had already been pretty well baked and, so, they had an initial tool in their hands. In a way, I was brought in at first to be a sounding board and to represent the industry viewpoint on the framework.
After a few iterations I helped the ASCO leadership committee to facilitate some early dialog and feedback sessions with patient advocates, pharmaceutical leaders, industry groups, and payers. It was important to hear directly from groups and to engage early so that input could be gleaned into the development of the tool. All of this feedback was critical to the development of the tool and it helped to refine areas that were sometimes surprising to us all.
Later, I helped the taskforce to test the framework, run case studies through it, and to poke holes in it wherever we could find them. Luckily, I had a team of intelligent analysts and consultants that could assist because this was not a small task. As with any advisory role, I provided feedback, support, and critique wherever it was desired.
What do you believe the role of clinical pathways will be in health care moving forward?
In some ways, the existence of clinical pathways acknowledges two things: quality of outcomes should be evidence-based and that variability in care leads to worse outcomes or unnecessary cost. However, if there are data gaps – which is often the case in many areas such as orphan diseases or some cancers – how can one determine the best quality? If there are no comparative trials, how can one determine the best intervention in any given setting?
Clinical pathways have become a way for payers to defer decision making to another entity. This may partially be due to impotence in their ability to restrict or block coverage such as in oncology care. It also acknowledges the importance of shared decision making and the role of the clinician’s voice to be part of such decisions. Payers don’t often care which pathway you use – as long as you are willing to choose one.
Because the USA is a system of disparities, there will be tremendous utility to the implementation of pathways to stamp out poor quality (at the bottom end), and high cost (at the top end). However, there is an art and a human element that must remain and, so, I think there are limits to what clinical pathways can achieve. The question is, what do you do after you have 90% of patients on-pathway but costs are still high?
How do you see value-based care being addressed as health care reform continues to evolve?
Value is always in the eye of the beholder. In the USA, we are a consumer driven marketplace where competition reigns supreme. We are also a market that rewards power. Look at Walmart or any other large company. The power that they wield has resulted in cheaper toilet paper, cereal, and laundry detergent for consumers. However, this has come at the expense of most of the suppliers that sell to companies like Walmart.
If you look at Apple, they have squeezed their suppliers as well but they also wield a power on the prices they set for iPads and iPhones; it isn’t as if these haven’t gotten much cheaper for consumers over time. This is how Apple has decided to wield its market power. They can only do this because they have a monopoly over their technology.
In the same way, drug manufacturers have something people want – innovation. And that innovation has an expiry date. Once patent protection is gone the US market is great at transitioning over to cheaper generics.
Insurance exists for a purpose: it socializes risk. We all pay to be covered for catastrophic crises that might occur. Your town doesn’t require every citizen to buy a fire truck. The city buys one truck, through communal taxes, to ensure that a fire (a catastrophe) can be managed when the time arises. This is the same concept as health insurance. The coverage of many through regular payments should provide coverage for an equally catastrophic cancer or Alzheimer’s disease diagnosis.
Insurance is starting to move away from fulfilling this role. By shifting more financial responsibility onto patients through cost-sharing or copays, they’re pushing higher involvement in the immediate need. It isn’t like patients are choosing to be diagnosed with cancer or to have broken a hip. Imagine if the city started asking people for co-insurance when the fire truck showed up at your house as it burns down. This is a failure in the model of socializing risk – to insure against the unforeseen.
Current health care reform efforts are focused primarily on equity, comprehensiveness, and source of coverage. They don’t really address value in the purest sense. The president’s Tweets to negotiate pricing are really about market power; in this case the government’s power to negotiate. But this is not about value.
The challenge will be how the power is wielded. In most European systems the framework for value is structured so that winners and losers are transparently decided based on rules that are clear and processes that are known. How might decisions be made if the government negotiated? Would they pick winners and losers? Would these change with the ruling political party? My sense is that this would be unfair for the patient, the physician, and the manufacturers.
How has your experience working in pharmaceutical companies shaped your viewpoint of value-based care?
My views haven’t really changed. I think you can only truly talk about value if you understand the various perspectives that might exist. These perspectives should be communicated transparently so that they can be seen through a critical eye. For example, how many different estimates have you come across for the amount of total health spending on drugs? I’ve seen the NIH put out numbers around 10% but I hear commercial payers state a number that is almost double that. There are some reports that are excellent to provide this context but they’re not an open book in terms of critical assessment.
One of the problems is that our fragmented system has so many perspectives to take into account. The commercial nature of contracts with fragmented groups also means that these dealings are private and not always seen. Between the patient and the pharmaceutical company many, many intermediaries touch the drug. Who takes a cut of the economics is sometimes hard to discern but I would say that we’re confident that what we provide is of value. New innovations, drugs, and solutions for patients in areas of high unmet need are all valued.
I can say that the pharmaceutical company’s viewpoint is rarely taken into account. Regulatory demands are not the same as what we would consider as value. The regulator’s needs are to establish that a product works as intended and that it is safe. But they don’t look at the relative or comparative efficacy, nor do they look at the costs associated with treatment.
We don’t design trials to show small benefit, but there are limits to the progress of science. The evolution of data over time may sparkle before it shines. Take trastuzumab, for example, which had unforeseen benefits when launched for patients with HER2+ breast cancer. But as the drug continued to be researched, we now know today how much value it provides to patients. If we took that certainty of value to be a pre-requisite at the time of introduction to the market, how many drugs would we not have today?
As patients live longer and longer, demonstrating median overall survival in trials has become more difficult at the time of launch. That doesn’t mean that they don’t provide a benefit, just that you have to give them the benefit of the doubt that it will provide patients with meaningful value.
The mantra at our company is, “Follow the science!” I remind myself about this every time I see a negative article in the papers that bashes drug pricing. For every ounce of sweat that our scientists put into finding just one life-saving medication, there are countless hours, days, and years of trying and failing. The decisions made today will possibly – and I saw that with uncertainty that is every present in our line of work – bear fruit years from today.
I’m astounded by how much everything in healthcare costs. When I go online to buy a journal article, it is expensive. When we use a validated patient reported outcome (PRO) instrument in our trials – it is expensive. When I take my kids to the hospital, it is expensive.
What doesn’t surprise me, however, is the country’s ability to find new ways of innovating and to reflect value
The USA will figure it out, but first we have to look to understand each other’s perspectives and the potential unintended consequences of rash decision making towards value in healthcare. Lives are at stake and I hope that I have options to treat whatever my family members and friends might face as they age.
