Before Harvoni, Sovaldi, Before Viekira Pak there was Incivek (telaprevir)
When it came out it was heralded as “represent(ing) a new direction in the treatment of hepatitis C and a significant improvement over the current standard of care,” Dr. Margaret A. Hamburg, the commissioner of the F.D.A (in 2011) , because it nearly doubled the cure (SVR) rate of meds at the time.
It was later found out to have been a direct contributor to several deaths, and thousands who took it were left with permanent skin damage regardless of success of treatment or not.
When the drug was pulled from the market, when a treatment with rates that good is pulled, even if it carries a black-box label from the FDA(may cause death), some would risk it.
Victrelis, a comparable drug did not carry the same black box label, but was the runner up when they both launched. The drug still relied on the combination of injection based Interferon and Ribavirin.
In 2013 Sovaldi and Viekira Pak were undergoing trials and it was believed by many that there would be a host of new drugs being released within a few years (referring to 2014/2015). From this the term warehousing became popularized with HCV patients.
The existing treatments’ side effects were troublesome, and the results were poor in late 2012 after Incivek became taboo. Patients who could have taken those treatments opted not to because when the options are to feel terrible for 48 weeks and 50% chance, or wait a year or two for a 12-24 week treatment with a 90%+ chance...it’s not hard to see the appeal of holding out. Especially when you consider that the majority of the deferring patients would have been in the F0-F2 category, which has minimal symptoms.
Now, back to 2015. Sovaldi, Harvoni, Viekira Pak and other partner medications like Olysio and Daclatasvir have been released.
Drug makers are ensuring that each of the drugs targets specific genotypes, and it’s not purely scientific. In doing so it allows them to rush the FDA approval process for what’s called “Breakthrough therapy” designation. The result is a whole lot of new HCV drugs that treat lots of genotypes of HCV.
With lots of high priced drugs on the market, both AbbVie (Viekira Pak maker) and Gilead(Sovaldi/Harvoni maker) offered direct to discounts to consumers. Insurers and Medicaid/Medicare had to figure out a way to handle the tidal wave of some of the largest groups of HCV patients warehoused.
The restrictions are now at such a point where those patients still warehoused now find the door locked by health insurance restrictions. Even the newest drugs (like Merck’s pending grazoprevir elbasvir combo in the FDA fast track process) will likely find a limited number of keys to distribute.
This is the Locked Warehouse Door.
The reality of new HCV patients is one of the locked warehouse door. For those who await treatment, either existing or pending treatments, they must wait for the bureaucracy of the key. Hopefully by then the price of that key becomes affordable.
if you were denied Sovaldi, Harvoni, Viekira Pak, or any other new HCV med, if you had to go through lots of hurdles for treatment; I urge you to tweet/post about them with the hash tag: #LockedWarehouseDoor.
My hope is that insurance companies, lawmakers, and pharmaceutical companies see those people they’re denying and restricting access to.
I also encourage using #LockedWarehouseDoor when tweeting about health insurance or Medicaid restrictions and high-cost HCV Meds.