How do you keep cost of goods (COGs) for viral vector-based medicines within reason to develop a product that is both affordable and financially viable?
In this 3-part series we take a deep-dive into how in silico cost modelling is being used to pinpoint the cost-drivers in development and manufacturing of viral vector-based vaccines and therapies. We’ll explore how better and earlier cost assessment can help biopharmaceutical companies improve decision-making throughout the development process, establish more robust and financially sustainable manufacturing processes, and keep COGs under control.
Viral Vector Affordability
From vectored vaccines to gene therapies to oncolytic agents, viral vectors are at the heart of many exciting scientific and medical breakthroughs. Yet companies in this sector face a difficult balancing act: how to keep these potentially life-changing treatments affordable for patients and payers, while still producing a product that is financially viable. The ongoing rapid expansion of markets and population sizes for viral-based treatments only intensifies the challenges, as manufacturers scramble to scale production capacity, often pushing traditional process technologies and facilities to their limits. In this high-stakes, high-pressure climate, success hinges on reaching new pinnacles of cost-efficiency and productivity in development and manufacturing of viral vectors.
The Cost of Cell & Gene Therapies
Gene and cell therapies: harsh economic realities put COGs in the spotlight.
Over the past decade, sky-high prices for emerging gene therapies have evoked public outcry. At $1.2 million per patient, jaws dropped when Glybera was launched in 2012. Less than 3 years later uniQure and its European partner Chiesi withdrew it from the market amidst rumors that only a single dose had been sold for commercial use. While the small patient base affected by this rare disease had a lot to do with the drug’s commercial implosion, high COGs were almost certainly part of the mix that made Glybera a losing proposition.
Thanks in large part to the adoption of innovative reimbursement schemes, more recent AAV1-based gene therapies such as Zolgensma for spinal muscle atrophy ($1.2m per dose) and Luxterna for inherited retinal disease ($425K/eye) have actually exceeded investor expectations, despite their higher price tags., Nevertheless, cost-effective manufacturing remains a challenge, and the spotlight on pricing practices and COGs contributions is not likely to fade anytime soon.