Trade-offs are at the core of many decisions we make in everyday life – when you’re going on a trip with just one suitcase, you need to make decisions about what to pack in that limited space. With an ever-increasing number of drugs with growing price tags on the market, and plan sponsors with limited budgets to cover employee benefits, it is not a surprise that a similar question has jumped to the forefront of the healthcare space.
In fact, it is the core of what we do at Reformulary Group. Our proprietary formulary ranks drugs based on how much they cost and how well they work. Sometimes a new drug comes onto market to treat a medical condition that costs more than an existing alternative drug but works better. That represents good value. Other times, new drugs cost a lot more but work the same – that provides less value.
An invaluable resource in navigating these questions is our Expert Committee, made up of 12 physicians representing 9 different specialties. Committee Co-Chair Dr. Muhammad Mamdani recently spent some time talking to us about how he sees healthcare value, and the advantages that a committee-based approach brings to fully understanding value.
“It’s a trade off of, ‘I’ve got a fixed budget, and I’ve got unlimited options of what I can fund, so am I going to focus on the broader population with marginal benefits typically, or a small number of patients with larger benefit?’” is how Muhammad described the lens through which value questions get tackled.
An Expert Committee structure that brings together different clinical expertise and experience can offer a more holistic understanding of patient impact. Clinical trial data is often presented in binary terms that appeal to regulators’ need to say Yes or No to approving or funding a new drug. But underneath the surface are nuances and complexities that greatly affect the real-world value a drug offers.
A classic example Muhammad pointed to is the 1999 RALES Trial, published in the New England Journal of Medicine. It found that the drug spironolactone significantly reduced mortality (death) among heart failure patients, becoming an overnight game-changer. There was just one problem: researchers knew that the drug caused high potassium, a potentially fatal side effect, and took great care to control for that in selecting study participants. Once spironolactone went on to be used more broadly, others noticed skyrocketing incidents of hyperkalemia, the condition associated with high potassium, to such a large extent that it resulted in no improvement in overall mortality (death).
“That was a case where different people with different expertise, such as people who know a lot about trial design or know a lot about observational epidemiology, can get together and say, ‘this is what it looks like in a clinical trial, but how will this work in the real world?’”, Muhammad told us.
When trying to solve the value question for a given drug, our Committee looks at several factors. One is efficacy and effectiveness (how well the drug works), another is safety (side effects, how people tolerate the drug, etc.), and the third is convenience. Convenience is an important consideration because drugs that are easier to take (fewer doses or easier to administer form) may result in better adherence, which could result in better outcomes. Reviewing all these factors requires a broad set of expertise to understand how they will play out in real life. With that understanding, then cost is considered – that is, how much the drug costs compared to other drugs or therapies to treat the same condition.
So where does that leave us in trying to solve the value question, one of the most important issues facing drug plans? For Reformulary Group, it means careful monthly reviews of new drugs as they come to market. With some drugs exceeding $100,000 per year (and even some blockbuster drugs north of $1 million per year), getting value right is critical to maximizing private and public payers’ limited budgets. We are very fortunate to have experts like Muhammad guiding us.