Fortunately, Tzield’s added value was enough, despite a horrible two-week hospital stay with its side effects and the same efficacy + exorbitant price.
Yeah, and on top of that, lymphocyte depletion. And although the change observed during the Phase 2/3 study period is roughly in the same range as Diamyd, they shouldn’t necessarily be considered comparable.
From what I understand, Tzield’s effect works by momentarily lobotomizing the lymphocytes. After such a “factory reset,” the new lymphocytes being born are somewhat less aggressive toward the beta cells, but the cells are still just as prone to radicalizing again, which is why the disease progresses. In Diamyd too, the disease progresses with the doses in the research pipeline, but the mechanism is different. Diamyd modulates the immune response and, in a way, provides desensitization therapy.
Why the disease then still continues to progress, albeit more slowly, I don’t know exactly. But since the drug is safe, it can be injected more frequently. One explanation for the progression is the “Epitope Spreading” phenomenon, through which diabetes that has progressed too far is difficult to stop as the immune system starts to escalate, reacting also to markers other than the body’s own GAD65, where it all started. And at the point of diagnosis, the situation has already gotten out of hand (at the time of diagnosis, approx. 80% of cells have already been destroyed). At the same time, the remaining beta cells are overloaded. Thus, the GAD65 tolerance brought about by Diamyd slows down the disease but no longer stops it at a late stage. On the other hand, this doesn’t rule out the possibility that treatment started in the early stages, before the onset of the disease, could prevent this escalation entirely. For Tzield, I don’t see such a possibility.
Yeah, apparently Tzield has gained quite good reimbursement coverage in the US, and in some places, it’s available without a deductible. It’s also covered under Medicare Part B, where one can get by with a 20% copay.
However, that wasn’t enough everywhere. For example, in Canada, no reimbursement is provided.
The price for Tzield has been said to be around 200k, but that might not necessarily hold true as an average price. Apparently, the big pharma mafias negotiate large, shady discounts for expensive drugs with insurance companies to favor their own products. I don’t know if this applies to this drug since there are no competitors yet, but I’m under the impression that this practice is more the rule than the exception.