Recently, Swiss pharmaceutical giant Novartis made history as the first company to win FDA approval for a CAR-T therapy in the Unites States. Novartis announced that its genetically modified autologous (“self-derived”) immunocellular therapy, Kymriah, will cost $475,000 per treatment course. This week, Kite Pharma announced the approval of its CAR-T therapy, Yescarta, in the U.S. with a list price of $373,000.
While these prices are expensive, they are far from trendsetting.
Pricing of cell therapies is controversial, because most cell therapy products are priced exponentially higher than traditional drugs. Unfortunately, most drugs can be manufactured and stockpiled in large quantities for off-the-shelf use, while cell therapies involve living cells that require a different approach to commercial-scale manufacturing, transit, stockpiling, and patient use.
To date, the highest priced treatment has not been a cell therapy, but a gene therapy (Glybera). At the time of its launch, Glybera was the first gene therapy approved in the Western world, launching for sale in Germany at a cost close to $1 million per treatment. The record-breaking price tag got revealed in November 2014, when Uniqure and its marketing partner Chiesi, filed a pricing dossier with German authorities to launch Glybera. Unfortunately, Glybera was later withdrawn from the European market due to lack of sales.
Following the approval of Glybera, Kymriah, Yescarta and more than a dozen other cell therapies, conversations surrounding pricing and reimbursement have become a focal point within the cell therapy industry.
Pricing of Approved Cell Therapy Products
In contrast to pharmaceutical drugs, cell therapies require a different pricing analysis. Below, price tags are shown for the approved cell therapy products that have reached the market (prices in USD $) and for which there is standardized market pricing.
Pricing of Approved Cell Therapy Products:
Apligraf by Organogenesis & Novartis AG in USA = $1,500-2,500 per use 
Carticel by Genzyme in USA = $15,000 to $35,000 
Cartistem by MEDIPOST in S. Korea = $19,000-21,000 ,
Cupistem by Anterogen in South Korea = $3,000-5,000 per treatment 
ChondroCelect by Tigenix in EU = ~ $24,000 (€20,000) 
Dermagraft by Advanced Tissue Science in USA = $1,700 per application ,
Epicel by Vericel in United States = $6,000-10,000 per 1% of total body surface area 
Hearticellgram by FCB-Pharmicell in South Korea = $19,000 
HeartSheet by Terumo in Japan = $56,000 (¥6,360,000) for HeartSheet A Kit; $15,000 (¥1,680,000) for HeartSheet B Kit (*Each administration uses one A Kit and 5 B Kits) 
Holoclar by Chiesi Framaceutici in EU = Unknown (very small patient population)
Kymriah by Novartis in USA = $425,000 per treatment
Osteocel by NuVasive in USA = $600 per cc ,
Prochymal by Osiris Therapeutics and Mesoblast in Canada = ~ $200,000 
Provenge by Dendreon and Valeant Pharma in USA = $93,000 , 
Spherox by CO.DON AG in EU = $9,500 – $12,000 (€8,000 – €10,000) per treatment 
Strimvelis by GSK in EU = $665,000 (One of world’s most expensive therapies) ,
Temcell by JCR Pharmaceuticals Co. Ltd. in Japan = $115,000-170,000 
*Pricing of TEMCELL is $7,600 (868,680 ¥ per bag), with one bag of 72m cells administered twice weekly and 2m cells/kg of body weight required per administration
Yescarta by Kite Pharma in USA = $373,000
As shown in the list above, wound care products tend to have the lowest cell therapy pricing, typically costing $1,500 to $2,500 per use. For example, Apligraf® is created from cells found in healthy human skin and is used to heal ulcers that do not heal after 3-4 weeks ($1,500-2,500 per use), and Dermagraft is a “skin substitute” that is placed on your ulcer to cover it and to help it heal ($1,700 per application). Interestingly, Epicel is a treatment for deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%. It has higher pricing of $6,000-10,000 per 1% of total body surface area, because it is not used to treat a single wound site, but rather used to treat a large surface area of the patient’s body.
Next, cartilage-based cell therapy products tend to have mid-range pricing of $10,000 to $35,000. For example, Carticel is a product that consists of autologous cartilage cells (pricing of $15,000 to $35,000), CARTISTEM is a regenerative treatment for knee cartilage (pricing of $19,000 to $21,000), and ChondroCelect is a suspension for implantation that contains cartilage cells (pricing of $24,000). In July 2017, the EMA in Europe also approved Spherox as a product for articular cartilage defects of the knee with pricing of $9,500 – $12,000 (€8,000 – €10,000) per treatment.
The next most expensive cell therapy products are the ones that are administered intravenously, which range in price from approximately $90,000 to $200,000. For example, Prochymal is an intravenously administered allogenic MSC therapy derived from the bone marrow of adult donors (pricing of $200,000), Provenge is an intravenously administered cancer immunotherapy for prostate cancer ($93,000), and Temcell is an intravenously administered autologous MSC product for the treatment of acute GVHD after an allogeneic bone marrow transplant (pricing of $115,000-170,000).
Finally, many of the world’s most expensive cell therapies are gene therapies, ranging in price from $500,000 to $1,000,000. For example, Kymriah is the first CAR-T cell therapy to be FDA approved in the United States (pricing of $475,00 per treatment course). Strimvelis is an ex-vivo stem cell gene therapy to treat patients with a very rare disease called ADA-SCID (pricing of $665,000).
Although these generalizations do not hold true for every cell therapy product, they explain the majority of cell therapy pricing and provide a valuable model for estimating cell therapy pricing and reimbursement. This information is summarized in the following table.
Finally, one additional point of reference is valuable. The RIKEN Institute launched the world’s first clinical trial involving an iPSC-derived product when it transplanted autologous iPSC-derived RPE cells into a human patient in 2014. While the trial was later suspended due to safety concerns, it resumed in 2016, this time using an allogeneic iPSC-derived cell product. The research team indicated that by using stockpiled iPS cells, the time needed to prepare for a graft can be reduced from 11 months to as little as one month, and the cost, currently around ¥100 million ($889,100), can be cut to one-fifth or less.
Clearly, many factors contribute to cell therapy pricing, but key variables that can be used to predict market pricing include whether the cell therapy involves genetic manipulation, the type of cell therapy product, and if it is an autologous versus allogeneic treatment. Another compounding factor is market size, as wound healing and cartilage replacement therapies have fairly significant patient populations, while several of the more expensive therapies have smaller patient populations.
To learn more, view the “2017 Guide to Regulatory Pathways for Cell Therapies.”
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