As you’ve likely heard by now, the FDA finally approved Neffy in early August. The ARS website indicates it will be available later this month. Congratulations to ARS Pharma for doing the hard work to develop and get this drug approved. While this is very exciting to the allergy community, there are many decisions that will need to made by everyone as this exciting, needle free new delivery device rolls out and is easily accessible.This long awaited development needs careful consideration by those managing their life threatening allergies. Parents will need to discuss with their allergists how they should think about shifting from the decades old epinephrine-auto-injectors to this new needle free option. Might families consider carrying both EAIs and Neffy, just in case? Sometimes those managing their allergies forget to carry their EAIs. There will likely be pushback from carrying yet another set of delivery devices. Will people be comfortable enough with make the switch from EAIs to this nasal delivery device.
Allergists and other medical professionals will need to train themselves on the use of Neffy and be able to answer questions from their patients and prescribe appropriately. As of this writing, the allergists in our network haven’t received any requests for Neffy. But they expect that to change, as Neffy becomes available at more pharmacies and public and private insurers begin to cover it.
Schools and camps will likely require revised 504 plans.
Regarding public stocking of epinephrine, Neffy is a game changer. All of the state and federal level laws that reference epinephrine auto injectors. All of those laws will need to be amended to reflect this news delivery model. Advocacy groups are beginning to plan the approach to amend the applicable laws and programs in their states.
For those that consider public stocking of epinephrine the ultimate in providing a safe environment for those with life threatening allergies, this is very good news. Now that there is a needle-free way to administer epinephrine, it is hoped that entities will be more inclined to stock non-patient-specific epinephrine.
As you can imagine, all of this will take time. With your help, Allergy Advocates NY will do what is needed at the grass roots level to ensure a smooth rollout of this vitally important new device.
Article Source: Great News! FDA Finally Approves Neffy. Now What? as originally posted on AllergyAdvocatesNY.org