How Delayed Coverage Decisions Affect Innovation

We're in an exciting era of pharma innovation. Over the last decade, innovation in medicines has increased survival and delivered solutions to patients with a range of complex health problems. But despite these rapid advances, medicines access systems are struggling to keep up. Increasing delays to innovation are driving yet more access inequity across Europe, as the latest EFPIA W.A.I.T. (Waiting to Access Innovative Therapies) data show*. The average time to reimbursement for innovative treatments across European Economic Area (EEA) countries has reached 531 days, ranging from 126 days in Germany to 990 days in Turkey.* Once again, where we live and access our healthcare significantly impacts our ability to benefit from the most innovative medicines. In my own area of Western Europe, the data highlight double trouble with a fall in availability of medicines coupled with an increase in time to access.* Analysing 66 representative medicines, a deeper dive into the delay between a medicine receiving central EU marketing authorisation and then being available to patients reveals that, on average, 71% of the time was attributed to waiting for a reimbursement decision and only 29% was down the time taken by companies to file their reimbursement dossier (see image). In Western Europe, delay in filing was reported to be mostly driven by the complex requirements of the value assessment process.*** At Pfizer, we endeavour to address this at a regional and country level. Locally, I work closely with colleagues to define the value of our medicines in a clear, sophisticated and differentiated way and for procedures to be inclusive, timely, open, and transparent – based on a range of expert opinions, including patients’. Externally, we collaborate with policymakers, governments and stakeholders to understand and overcome barriers to access. As part of my role on EFPIA’s Patient Access Committee, I also work to strengthen the life sciences industry voice to drive equity of access across the region. As WAIT data’s accompanying ‘root causes’ report shows, the challenges to equitable access are multifactorial and interrelated, requiring collaboration across industry, regulatory bodies, governmental organisations and health systems to resolve. The first step in finding a shared solution is accepting we have a problem, fuelling unacceptable patient delays and regional disparities. Through the WAIT data, EFPIA not only provides year-on-year evidence of the shape and scale of access inequities, it also seeks to shine a spotlight on the causes and thus the potential solutions. For Europe to continue to prosper, we need healthcare that upholds thriving economies across the region. As these data show, there is still much to be done.  #EFPIA #AccessToMedicines *The Patient W.A.I.T. Indicator 2023 Survey **The Patient W.A.IT. Indicator 2022 Survey *** European Access Hurdles Portal 2024

The True Cost of Delayed Innovation in Healthcare We often talk about how long it takes to move scientific discoveries from lab to bedside. But there's a hidden delay we rarely discuss: How long does it take for healthcare policy and financing to catch up with innovative science? Think about it: While breakthrough treatments exist, financial barriers and policy constraints can delay their implementation for a decade or more. Yet we rarely measure the real human cost of these delays: Lives lost Preventable hospitalizations Unnecessary emergency room visits Increased disability rates Reduced quality of life Lost workforce productivity Here's the challenging question: When healthcare policy delays innovation, why do we focus only on presumed cost saving while ignoring patient risk and additional cost brough on by delayed care? Shouldn't we track with equal rigor: The cost to manage uncontrolled disease The risk and cost of poor outcomes from delayed treatment The human toll of preventable complications The impact on quality of life The burden on families and caregivers After all, every delay in implementing proven innovations means someone's mother, father, child, or friend faces higher health risks. When did we decide that managing financial risk was more important than managing patient risk? What if we measured not just what we spend, but what we lose when policy delays keep innovation from reaching patients? Questions to consider: Have you experienced or witnessed delays in accessing innovative treatments due to policy or financial barriers? What metrics should we use to measure the cost of delayed implementation? How can we better align healthcare policy with scientific advancement?

We have an innovation problem in Med Tech. A study published in JAMA Health Forum (2023) reported the median time for a medical device/diagnostic (approved by the FDA through premarket approval and de novo pathways) to achieve at least nominal explicit or implicit Medicare coverage was 5.7 years. This was a dominant talking point at the "Understanding The Reimbursement Landscape" town hall session this past Monday at TCT 2024. And it's an issue that is suffocating the cycle of innovation in Med Tech. Several panelists noted that historically FDA approval was the "end game". A disproportionate amount of an early stage company's risk was tied up in garnering regulatory approval. However, this is no longer the "beginning of the end" from a risk perspective. It now must be considered the "end of the beginning". The Market/Patient Access (Coding, Coverage, Payment) process now requires an equal amount of heavy lifting. It's often ambiguous, frustrating, seemingly impossible to navigate. It's a huge deterrent for innovators considering the development of a life saving technology that could address an unmet need in medicine. This issue is also contributing to the broken venture model we see in Med Tech at present. A typical venture fund has a 10 year time horizon. When you consider the time needed for research & development, regulatory pathway, market access, and establishment of meaningful ARR, many potential investments just simply do not "pencil out". Especially for those highly disruptive technologies that require longer regulatory approval processes. And unfortunately, those are the very innovations that we drastically need to solve really hard problems in healthcare at present. IS TCET the answer??? In June CMS released a final procedural notice intended to expedite Medicare coverage of novel medical devices and get the devices to Medicare beneficiaries faster, the Transitional Coverage for Emerging Technologies (TCET). “TCET gives device manufacturers what they have long asked for: a more efficient and transparent Medicare coverage review process,” CMS said in a statement. The program is intended to provide increased pre-market engagement with CMS and to allow evidence gaps to be filled with fit-for-purpose studies. This temporary national coverage decision status will be retained for an indefinite period of time, until they can generate sufficient evidence to determine permanent status. Unfortunately, this program will initially be limited up to 5 devices per year for review. Will that be enough to make a huge impact on problems outlined above? Probably not. But it's a start!

💡 Innovation in healthcare is only as powerful as the insurance that covers it. The reality? No matter how groundbreaking a new treatment, drug, or technology is, if insurance won’t pay for it, adoption stalls, or worse, never happens. 🚫💰 🔍 Health insurance isn’t just about coverage: it’s a gatekeeper to progress. Insurers decide who gets access, which innovations survive, and how fast healthcare evolves. 🔥 Think about telehealth. Before COVID-19, insurers were slow to reimburse virtual visits. Post-pandemic? Coverage expanded, and adoption skyrocketed. 🚀💻 The lesson? Reimbursement drives innovation. ⚡ But it’s not just about approval—it’s about access. ✅ High costs. ✅ Prior authorizations. ✅ Tiered formularies. These roadblocks can mean patients wait until they’re sicker before receiving life-saving treatments. 😡 💡 The Future? We need reimbursement models that reward innovation, efficiency, and patient outcomes. A healthcare system that moves at the speed of technology, not red tape. 👇 What do you think? Have you seen an innovation struggle due to insurance barriers? Let’s discuss. #HealthTech #HealthcareInnovation #DigitalHealth #InsuranceMatters #AccessToCare #ValueBasedCare #MedTech #HealthPolicy #StayCrispy #DrMatt #FutureOfHealthcare #InnovationBarriers 🚑⚕️

The biggest threat to medtech innovation isn’t regulation, it’s reimbursement. In my latest episode, Dr. Josh Makower breaks down how coding bottlenecks, slow coverage decisions, and payment delays are stalling great technologies before they reach patients. Here’s what you’ll learn:  • Why the FDA isn't the real barrier • How obscure AMA coding rules block patient access • Why breakthrough startups are dying too soon • What changes are needed to fix the system now If you're building, funding, or regulating in healthcare, this one is worth your time. #medtech #healthpolicy #healthcare #leadership #medicaldevices