Market Access

Big changes are in store on the drug pricing front in Germany. Further reforms could depend on who is appointed health minister.

While US biosimilar approvals have been thin on the ground in 2021 – with products delayed due to the FDA’s inability to conduct certain facility inspections during the COVID-19 pandemic – the market has nevertheless seen several firsts this year, including two interchangeability designations and the first ophthalmic biosimilar approval.

From innovation to legislation, the US audiology market is being shaped by cutting-edge technology from device makers and legislation from the Biden administration to get more hearing aids to those that need them.

Alexander Natz, secretary general of EUCOPE, warns that changes to a pricing and reimbursement system that has so far worked well, particularly for orphans, could dissuade advanced therapy medicinal products manufacturers from launching in Germany.

Boston Consulting Group began writing the third iteration of its report on next-generation commercial models to meet evolving medtech customer needs before COVID struck. But it findings and recommendations were even more relevant once the report – dubbed Milkman 3.0  ̶  was finally released in spring 2021, when learnings from the pandemic were being factored in by the medtech industry.

One year on from its creation in 2020, a European project with a “new vision for collaboration between the public and private sectors” has set its sights on getting stakeholders across the medicines sector to make firm promises on ensuring equitable patient access to costly new drugs.

US biopharma stakeholders are getting a taste of how a single payer health care system can shape the fate of a new treatment with Medicare’s national coverage determination for amyloid-directed Alzheimer’s drugs including Biogen/Eisai’s Aduhelm.

China ambitiously wants to champion domestic medtech manufacturers in the global market. It also needs to ensure foreign manufacturers do not sustainably dominate its home market – while also benefiting from their technical expertise, for the time being at least. Against that backdrop, new Chinese data laws are being eyed by global medtechs with a certain trepidation.

As the threat of digital insurgents grows, traditional payers and providers will need to leverage advanced technologies to address core issues facing the US health care system. 

Deciding whether to build or rent development and commercial capabilities in China requires a deep understanding of the changing Chinese market. Individual product characteristics, and a management team’s tolerance for risk, should be used to determine which model can deliver the best results.

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.