CIRM is hosting a webinar on June 20th to help those developing cell-based therapies get ahead of reimbursement issues.
We have often heard the phrase, “begin with the end in mind”. None of us want to be part of the team that develops an amazing, life altering therapy only to have it be left on the shelf, underutilized because no one can afford to pay for it. Unfortunately, that is a real risk. One only has to look at the experiences of the cell based therapies that have been approved by the FDA and which are currently on the market in the United States to see that reimbursement can be a real issue that may prevent broad product adoption.
Dermagraft is a product for wound closure of diabetic foot ulcers comprised of allogenic human fibroblasts on a dissolvable mesh material. Dermagraft is currently marketed by Shire, after they acquired Advanced BioHealing in 2011 for $750 million. Part of the press release about the transaction noted that Dermagraft is a product with “further growth potential” and that it has a “favorable reimbursement profile”. Yet, Shire immediately set about improving that reimbursement profile and within the year had two new American Medical Association CPT procedure codes to streamline the reimbursement for Dermagraft.
Another FDA approved cell based therapy on the market is Provenge, an autologous dendritic cell therapy for use in advanced prostate cancer. Provenge experienced hurdles with the FDA approval process only to then have the Centers for Medicare and Medicaid Services (CMS) decide to review payment for Provenge rather than automatically extending coverage. (There’s more on that decision in this story from Fierce Pharma). The CMS did finally decide that Provenge’s $93,000 treatment would be covered by Medicare (more on that in this Bloomberg story).
As these two examples illustrate, reimbursement codes may not currently exist for emerging cell therapies. As the baby boomer generation ages and healthcare continue to rise as a percentage of GDP, having a sound reimbursement strategy in place demonstrating the healthcare economic benefits of your product is essential, arguably as essential as securing FDA approval since products without reimbursement will struggle to be adopted in the marketplace.
Therefore, sponsors who hope to register their product in the US will do well to join the June 20 webinar and listen to expert speakers Michael Werner and Randy Fenninger discuss new reimbursement rules and payment models and why it is critical to adopt a reimbursement strategy early in product development.