In the past, when HAE patients imported C1 Inhibitor from overseas, the product they imported was Berinert P under the FDA’s Personal Importation Policy. LevPharma (now ViroPharma) funded and imported Cetor® during its Cinryze clinical trials for compassionate use by participants in emergency situations. Cinryze has never been imported from Europe by HAE patients and did not, in fact, exist until it was approved by the FDA on 10 October 2008.
The manufacturer of Cetor® is the Sanquin Blood Supply Foundation, who was also hired by LevPharma (now ViroPharma) to manufacture Cinryze. A very important difference, and one of the cost driving factors, between Cetor® and Cinryze is that Cinryze must be manufactured using the US blood supply. This means whole blood must be collected in the US, undergo procedural screenings, be shipped to the Netherlands, undergo the manufacturing process designed specifically for LevPharma’s product (which includes the introduction of nanofiltration and removal of hepatitis B immunoglobulin according to STN 125267/0–and thus another cost driving factor), and be shipped back to the US. In other words, Cinryze was developed, produced and tested specifically for marketing in the United States. Another huge cost driving factor, of course, is the enormous RDT&E (research, development, test and evaluation) costs that must be recouped, which are significantly higher than what is required for RDT&E in Europe due to the stringent FDA standards and requirements.
The Berinert P product was selling for approximately $800/vial ($1,600/dose) in 2005 in Europe (Germany comes to mind, but this figure could be incorrect/outdated, hence the use of the word “approximately”) and at that point in time the US HAEA was able to import Berinert P through an intermediary HAEA counterpoint in Argentina for $400/vial ($800/dose) because of the very favorable exchange rate until that source was asked (in polite terms) to desist (one source shows Berinert P is currently selling for $764US/vial ($1,528/dose); Berinert P has been available since 1985). I am not familiar with any means by which C1 Inhibitor was imported for $350/vial from LevPharma as has been claimed and think this is a misstatement (I believe they are referring to Berinert P), but I am the first to admit I don’t know everything. In 2007, Cetor® was about $750/vial ($1,500/dose) in Europe and “has long been used.”
If anyone believes I exaggerated the cost information I provided Saturday, December 10, I will happily provide them with a copy of my EOB and delivery slip so they can do the math.
I have two HOPES regarding the cost of Cinryze, if it will bring anyone comfort:
- That the cost my insurance paid was negotiated between my insurance company and TheraCom/CVS/Caremark and therefore the cost your insurance company may be different (and if so, lower not higher!). I do not know whether this was the case, however, and the per unit price of $2,316 may be the same for everyone. If I hear either way, I will let you know.
- That the cost of Cinryze will decrease quickly with time, especially if an alternative market/use for Cinryze emerges soon. This is a two-edged sword of hope, however, for if an alternative market/use emerges, the supply of Cinryze might become limited and difficult to obtain. It is not always possible to predict the effect of supply and demand on availability and cost.
I must confess I had a bit of a heads-up from Sand in WV, who had a heads-up from another HAE friend, who caught a streaming video of a ViroPharma stockholder’s meeting where the high unit cost of Cinryze was announced, and so I was not as shocked as I otherwise would be, which is not to say I’m not shocked (I am totally flabergasted, just like you!). However, having worked in research and development of both weapons and training devices for the Navy as a Contract Negotiator for 25+ years, I fully appreciate why the cost of Cinryze cannot be judged or predicated on the price of Cetor® or Berinert P, drugs with extensive (10+) year pricing histories and far, far easier (and cheaper) European approval requirements.
Items in red are corrections; see this post for explanations.