Where has all the epinephrine gone?
The Advocacy Council (AC) has recently been contacted by several members with complaints of bulk injectable epinephrine costs going up exponentially. Epinephrine has always been inexpensive, and it seems incomprehensible why it’s suddenly become so expensive. 30cc multi-dose vials have increased from around $50 to as much as $200. At one time, it was available from at least three manufacturers; it is currently only available from one (Par) – this is the branded Adrenalin™. Pfizer (formerly Hospira) and Amphastar are no longer manufacturing 30cc vials.
Single dose 1mg/ml vials have jumped from under $4.00 per vial up to as much as $17.00 per vial. The AC has been researching why this has happened and has gathered information from a variety of sources, including large pharmaceutical distributors, smaller independent pharmacies, practices, a review of the FDA website, etc.
The potential reasons seem to be a perfect storm: mergers and acquisitions, FDA plant shutdowns, shortages, increased demand, limited number of manufacturers, price increases by manufacturers, and drug rebate incentives built into the Affordable Care Act (ACA).
- Hospira, acquired by Pfizer, was/is the world’s largest manufacturer of injectables. However, Hospira had a longstanding problem with the FDA due to aging equipment and plants, which came to a head earlier this year. It appears that Hospira has had multiple warnings – dating back nearly 10 years – related to its plants around the world. Pfizer was aware of this prior to the acquisition, but apparently the problem was much greater than expected. This resulted in the “voluntary recall of drugs in shortage due to sterility concerns” of numerous injectables. The shortage included not only epinephrine, but also drugs that contain epinephrine (e.g. lidocaine with epi, mepivacaine with epi, and sodium bicarb, atropine, etc.) Any product that contained epi manufactured by Hospira disappeared from the market. Pfizer stopped distributing epinephrine 30 cc vials some time ago and the 1 mg/mL vials on May 10, 2017. Pfizer states the 1mg/ml vials should be available mid-August.
- Currently, it appears there will be two manufactures supplying epinephrine and there are at least perceived shortages. Lack of competition appears to be driving up prices.
- In addition, drug rebates to Medicaid managed care organization systems mandated by the ACA, and the effects of the way systems get paid by CMS – by a multiple of the wholesale acquisition cost – may be eliminating incentives to hold generic drug prices down.
- There appears to be no relation to the EpiPen cost issues.
We hope this is a short-term phenomenon that will sort itself out as manufacturing catches up with demand. The AC will continue to monitor the situation and keep membership apprised of any further developments.