CRA Insights

Oncology vaccines: Are they positioned for PMA success?

November 9, 2023
Vaccine with syringe

With combinations taking center stage following the initial influx of immune checkpoint inhibitor monotherapies, the authors look ahead to the potential of mRNA vaccines in oncology and describe the pricing and market access opportunities and challenges that may await current and future competitors.

Cancer has posed a philosophical and pragmatic problem for payers since the arrival of the first biologics in the late 1990s. While payers want to provide patients with access to life-extending treatments, they must often pay large sums to do so. These problems have not abated, and despite the arrival of biosimilars, innovation with new treatments and combination-based therapeutic approaches has kept ahead of payers’ and policy makers’ ability to address these challenges. As we enter a new wave of innovation courtesy of mRNA technology, approaches to valuing and pricing oncology products will need to adapt yet again.

Cancer vaccines, or onco-vaccines, have been a holy grail for medicine for years, but instances of commercial success have been limited to two. First is Merck’s Gardasil (human papillomavirus 9-valent vaccine), which targets HPV, a virus implicated in cervical cancer. It succeeded mainly because it targeted a virus that plays a key role in oncogenesis and had a pricing strategy in line with payers’ expectations of a vaccine-type price, specifically ~€150 per dose in Germany, given up to three times every 10 years. Second is Imlygic (talimogene laherparepvec), perhaps the first example of a therapeutic vaccine, wherein an oncolytic virus is administered directly into melanoma lesions. However, issues with its clinical trial design and outcomes led to a somewhat disappointing health technology assessment (HTA) and reimbursement, with Amgen choosing to not seek reimbursement in many markets.[1] Another stark difference that may also have foiled its success was its ambitious pricing strategy. For example, in Germany, where the product was found to provide no additional benefit, Imlygic achieved prices of about €1300 per dose – over €5000 per cycle, which is repeated every two weeks.

The next generation of onco-vaccines is expected to be based on mRNA technology. Having been catapulted into the spotlight by the COVID-19 pandemic, mRNA vaccines have so far fit a model of preventative vaccines that payers are familiar with. While manufacturers can still build on the acceptance of the technology’s safety in humans, key questions remain for payers and the industry that can in turn impact pricing, sales, and revenue.

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