By Henry Ehrlich
We have been following the state of competition in epinephrine auto-injectors ever since we first spotted EpiPen® advertising on television, which seemed to indicate that a new product might be on its way. It turned out to be Auvi-Q. As time passed, we continued to follow the fortunes of the talking upstart as Sanofi, the company that made it, fought a series of battles over speed of uptake after injection, and adoption by insurance companies, which are slow to put new products in their formularies. We have also noted supply chain issues as patients found themselves acquiring new Auvi-Qs with expiration dates less than the 12 months they were entitled to.
However, it seems you can’t keep a good idea down. Patients, caregivers, and doctors registered clear preference for the upstart in a survey published by the Journal of Allergy and Clinical Immunology, echoing the sentiments of people who have spoken to me personally. The Institute of Safe Medication Practices has warned that certain design features make EpiPen hazardous to use. Dr. Paul Ehrlich, my cousin and co-founder of this website, said recently on Doctor Radio that he only prescribes Auvi-Q for newly diagnosed food-allergy patients unless, as happens,the pharmacist charges an outrageous amount for it. As a pediatric allergist he finds that everyone five years old and up reacts to the trainer with the word “cool.”
After years of EpiPen dominance, the whole shoe hasn’t made its way to the other foot but maybe one sock. A friend of ours forwarded an article from a West Virginia newspaper that said Auvi-Q is now the sole auto-injector approved for use by the State’s Department of Health and Human Resources, which affects 7,000 Medicaid patients.
According to the Charleston Daily Mail, “Roger Graham, president of Mylan Specialty, a subsidiary of Mylan Pharmaceuticals, said about 22,000 EpiPens are prescribed in West Virginia, with 7,000 of those specifically for Medicaid patients. He argued his company will ‘undoubtedly’ experience irreparable harm both to its bottom line and reputation if DHHR is allowed to replace Mylan’s product on the preferred drug list.”
Mylan filed for an injunction against the decision, but it was denied. Assistant Attorney General Chris Dodrill argued that market share and reputation weren’t valid arguments against the move, which will save taxpayers an estimated $1 million a year. “’If that were the case, if that were enough to stop DHHR from making these decisions, no drug would ever be removed from the (preferred drug list),’ Dodrill said. ‘If that were the case, the state would lose all of its leverage in the PDL process and its ability to negotiate prices with drug manufacturers. It weighs against the public interest….Mylan’s market share should not be supported on the backs of West Virginia taxpayers.’”
I agree, but I also think that health care shouldn’t hinge on legal arguments and number crunching. Seeing as how its market dominance was built by adapting a device financed by the Department of Defense for injecting nerve-gas antidotes in battle (your tax dollars at work, now enriching the private sector) maybe Mylan ought to combat the competitive threat with a little R&D instead of legal challenges and lobbying. EpiPen is good, and has doubtless saved countless precious lives, but it could do better.
As long as patients are regarded as “consumers of health care,” all things being equal, being cool like Auvi-Q is an advantage, but if the idea of a competitive marketplace has any benefit at all, it should result in new and better products. In this investor-driven pharmaceutical environment, with shrinking budgets for innovation, that’s a big if.
Map by http://quickfacts.census.gov/
Hazel Gowland says
Although there is information on the company website about the needle gauge, there doesn’t seem to be anything about needle length. Some studies indicate that needle length is a critical factor to ensure effective delivery of the drug across the fascia into the muscle. See the Canadian paper here http://www.aacijournal.com/content/10/1/39 and references. Similarly the larger dose of 0.3mg is less than the recommended clinical dose of 0.5ml https://www.resus.org.uk/pages/reaction.pdf
R&D for products to manage anaphylaxis in the community should address both these factors as well as size and ease of use. Those of us at risk urgently need devices which are a significant improvement on the bulky military designs which have been around for decades but which are also intuitive to use and have adequate needle length and dose.