In this interview Brian Williams, Director, Healthcare Strategy and Innovation at PwC, talks about the impact of med-tech trends such as outcomes based reimbursement, lessons learned in emerging markets, and impact of the device tax.
The reality is that often data cannot speak for itself. Even a high-quality randomized study may need the additional support of providers, key opinion leaders and most importantly specialty societies. So what can manufacturers do to address the payers’ stiff evidence requirements?
Reimbursement strategy can no longer be overlooked when planning the regulatory and clinical strategy for a product, particularly if it is a 510(k) product.
Presenting clinical evidence to payers is the most efficient method of gaining coverage. But when this strategy is unsuccessful or hits a wall, a ground-up approach is required, relying on consistent and steady support from local physician champions that demonstrates broad acceptance of a technology.
No matter how tortuous the path to durable coverage and adequate payment for a new technology, the bedrock of the entire reimbursement process relies on the clinical evidence of safety and effectiveness. This inaugural blog post is the first in a series focused on the key reimbursement issues in this fluid health care environment.