by Joe Pugliese | President and CEO, Hemophilia Alliance
A little more than a year after the worldwide recall of Stimate, there is cGMP manufactured DDAVP NS available in the USA. The product is being produced and distributed by STAQ Pharma, a registered 503B Outsourcing Facility. They shipped 57 vials on Monday, 9/13/2021. They are presently able to ship into 31 states across the country (see map) and are working on getting licensed nationally. This product was made possible because the Alliance Board of Directors funded its upfront development costs. Additionally, a limited number of vials are available through the DDAVP challenge program. The product will only have about 70 days dating when you get it. Subsequent lots will have increasingly longer dating.
The product is listed on First Data Bank, Medispan and Redbook. United Healthcare has said they will reimburse under UHC and OptumRX Commercial Plans and UHC Community Plans (Managed Medicaid in states where UHC controls the formulary) and Missouri Medicaid has indicated they will reimburse for the product. The Alliance payer team, and the Advocacy teams at the National Hemophilia Foundation and the Hemophilia Federation of America have all been working together so the product is covered. We have notified commercial pharmacies and PBMs including CVS/Caremark, Express Scripts, Optum and numerous smaller regional and local home care providers that the product is available. The pharmacies need to set up an account with STAQ Pharma, the point of contact is email@example.com. If your pharmacy is not aware that the product is available, please share this newsletter with them.