Market Access

A potential decline in mRNA vaccine protection against the Delta variant is raising questions about the need for booster shots in the US. Ocugen Inc. and partner Bharat Biotech hope the changing dynamic of COVID-19 in the US will induce the FDA to reconsider additional clinical trial requirements for Covaxin, an inactivated whole virus vaccine authorized for emergency use in 16 countries. 

Royal Philips’ image-guided therapy business has rebounded, as expected, after the COVID-19 dip, and is now targeting expansion in a number of areas, as business leader Bert van Meurs explains. 

As the global access debate adapts to the stark inequities exposed by the COVID-19 pandemic, the UN-backed Medicines Patent Pool is emerging as a key player on issues ranging from vaccine tech transfer to making more drugs affordable against the spread of non-communicable diseases like cancer to middle- and low-income countries.

Start-up pharmacy benefit managers such as Capital Rx and Evio hope to shake up the traditional PBM service model with increased drug price transparency, aggregated real-world data and outcomes-based contracting. The big three PBMs which dominate the market represent a formidable challenge.

Opioids are cheap, but the economics of clinical practice, including the shift of care from inside the hospital to outpatient or ambulatory facilities, are creating new opportunities for Pacira BioSciences’ non-opioid treatments for pain. Improved reimbursement and increased usage among anesthesiologists are the biggest revenue drivers for the company’s two marketed products.

With COVID-19 a residual but still very real issue globally, Novo Holdings asked the big diagnostics question at a recent high-level roundtable: How can stakeholders capitalize on this moment of acute public awareness of diagnostics to improve adoption of tests and screening in the long term? The CEOs of Roche Diagnostics, GE Healthcare, Labcorp and Synlab, among others, gave their thoughts on how the system must change.

Treating opioid addiction successfully requires an individualized approach, and a lot of money. Executives at addiction treatment centers discuss existing barriers in the recovery pathway and the need to destigmatize addiction and mental health disorders.

The divide between developed and developing countries for access to health care innovations has been spotlighted by the ongoing COVID-19 pandemic. Civil society groups pile on the pressure.

Concern looms in many countries as cases of COVID-19 continue to rise due to the delta variant. Vaccines are having a positive effect, but what is the outlook for those still vulnerable to the virus after inoculation? Not everyone will respond to vaccinations in the same way.

Brazil has established an accelerated pathway for approval of drugs for ultra-rare diseases, encouraging development activity – but the definition of qualifying drugs is narrow. Expansion to include more treatments could boost clinical trials activity and companies’ overall development presence.

Shaped by Brexit, driven by COVID, squeezed by budgets and being engineered for the future, it seems that almost every element within UK health delivery and market access is undergoing change. How should the medtech industry prepare, and will there be implications beyond the UK?

Biosimilar interchangeability is a hot topic in the US, with the first FDA decision on a formal interchangeability designation expected this month. But across the industry, views differ dramatically on the desirability and likely impact of this additional standard to biosimilarity.