Kaléo Pharmaceuticals – makers of the Auvi-Q epinephrine auto-injector – announced last night that sales of the device are beginning today.
The information was conveyed on a conference call for food allergy bloggers arranged by Jenny Sprague, founder of the Food Allergy Bloggers Conference (FABlogCon). Representing kaléo was Spencer Williamson, CEO and brothers Evan and Eric Edwards, the original developers of Auvi-Q.
The device is being reintroduced after Sanofi – a French company that had exclusive rights to manufacture and market the auto-injector – announced a recall of all units and later that they were exiting the auto-injector market.
The process for obtaining Auvi-Q will be substantially different than for other epinephrine auto-injectors in support of the innovative nature of their pricing structure (dubbed “AffordAbility”):
- Families with commercial health insurance, even those with high deductible plans, will pay $0 out-of-pocket regardless of whether or not their deductible has been satisfied (kaléo will absorb the out-of-pocket expenses.)
- Families without health insurance that earn less than $100,000 per year will pay $0 out-of-pocket (kaléo will absorb the entire expense.)
- Families without health insurance earning $100,000 or more will pay $360 for a two pack.
Kaléo is still negotiating coverage with government sponsored plans such as Medicare and Medicaid. Under current rules, these plans often require the purchase of a generic if one is available even if the brand-name version is cheaper.
How will kaléo make good on their $0 out-of-pocket commitment? The answer lies in a combination of two bold innovations: direct-to-consumer fulfillment and tiered pricing.
Though Auvi-Q will be carried in retail pharmacies, the majority of fulfillment and delivery will be performed directly by the company to the patient, avoiding much of the expense incurred in the kludgy and opaque system of pharmaceutical sales particular to the US. By selling direct to the consumer, the company can also assure the patient they are receiving fresh product with an expiration date 12-18 months in the future.
To help realize their $0 out-of-pocket commitment, the company sets the retail price at $4500, which – Williamson asserts – insurers never pay. Through negotiations, a number of insurers have already made agreements with kaléo with more expected in the future, a necessity if the pricing structure is to be successful. (Williams said that reports of insurers refusing to cover Auvi-Q were largely about companies that only cover generics when they’re available and that negotiations with those companies were ongoing.)
How you purchase and receive your Auvi-Qs is also radically different. To circumvent issues with insurers and pharmacies and take advantage of the $0 out-of-pocket pricing, the process works as follows:
- You download and fill out a form from the Auvi-Q website and hand it to your doctor during your visit;
- After the doctor prescribes Auvi-Q, their office submits the form on your behalf;
- You receive a call from Auvi-Q to verify insurance and shipping information. Your Auvi-Qs are then shipped directly to you and will generally arrive within 24-48 hours.
This process ensures you receive Auvi-Q (instead of a substituted generic) with the longest expiration date available.
We wish kaléo success with their innovative approach to making epinephrine auto-injectors affordable. A successful Auvi-Q will bring much needed boost to a market in desperate need of competition.
For more information, visit the Auvi-Q site at www.auvi-q.com.