Request for Coverage of Desmopressin Acetate Nasal Spray (DDAVP)

In August of 2021, in a combined effort with the National Hemophilia Foundation (NHF) and Hemophilia Federation of America (HFA), we submitted a Desmopressin Acetate Nasal Spray (DDAVP) letter to all payers, PBMs, and brokers for which the Hemophilia Alliance has a relationship. The letter outlines the request for coverage of DDAVP, including the necessity of the drug to replace the voluntary recall of all batches of Stimate Nasal Spray. In particular, Exhibit A references dosage, corresponding NDC number, J code, WAC and AWP. As previously discussed STAQ is continuously updating their stability testing and extending the dating on DDAVP NS, current inventory has an expiration date of 6/28/2022. We expect to have 12 month dating by the middle of 2022.

For Medicaid claims:

As a rule, Medicaid agencies are not allowed to cover drugs that do not have a contract with CMS to pay rebates for each unit used and paid for by Medicaid. If the rebate contract is not in place, CMS will not provide matching funds (called federal financial participation or FFP) to the states for these products. As with many things, there are exceptions. Drugs that are used in compounding a prescription for Medicaid patient are exempt from this requirement. (Also, a state may choose to pay for the product with all state funds which is also allowed.)

In the case of the STAQ product, while it is part of the exception, it does not have the “look and feel” of a traditionally extemporaneously compounded product. Normally these compounded products are required to use a specific claim form that requires the pharmacist to list the active ingredients and the main “carrier” products. They also don’t have a unique NDC. And finally, the 503B outsourcing process approved and monitored by the FDA is relatively new and not familiar to many state pharmacy programs.

If you ask you Medicaid agency to cover the STAQ DDAVP product and they resist, please remind them of the letter. We sent to them last summer before the first batch was released explaining all of this in detail before the first batch was released. If there are still issues, feel free to provide George Oestreich with the detail of the state encounter. He will be happy to assist if you.

Additionally, there seems to be some confusion about STAQ Pharma’s status below is brief checklist describing their operation.

• STAQ Pharma is a FDA registered 503B Outsourcing Facility. While STAQ prepares compounded products, our process is nowhere near the same as what you might think of relative to a “local compounding pharmacy.”
• STAQ Pharma adheres to and are inspected to the Current Good Manufacturing Practices standards (cGMP). cGMP is the same manufacturing standards that generic and branded drug companies adhere to and are inspected by the FDA. STAQ is also inspected by the FDA (and by State Board of Pharmacy like California and by Hospital Systems).
• Not only are STAQ’s products produced according to the FDA cGMP standards, their product formulation and stability work is performed and governed by those same standards. The cGMP standard is a very difficult standard to meet and maintain. STAQ has had 2 FDA inspections, their first one is already closed, and was closed in what they believe is record time for our industry. Their 2nd inspection happened this past October and they have completed their responses to FDA and await communication from the FDA on whether there are any next steps, or we proceed to closure.
• Their Stability protocol and testing has recently passed the 180-day mark, so that is how they are dating the DDAVP product now. Their final timepoint for the product is 1 year.
• Their Stability work is not simply potency over time. STAQ does a complete and full stability test of their drug products including container closure tests, microbiology tests, endotoxin tests, spray geometry, spray droplet size (as is required for Intranasal delivered products).
• STAQ’s ownership structure includes some of the US most recognized names in Health Systems – University of North Carolina, Froedtert Health System and College of Medicine of Wisconsin, Children’s of Colorado, Nationwide Children’s, Cincinnati Children’s, University Hospitals, and Louisiana Children’s and Medical Center.
• The 503B Outsourcing Facility designation and regulatory category is relatively new in the United States, having only been developed through Congressional Act in 2014 and FDA Guidance becoming more clearly defined in 2016 and 2018. STAQ is most definitely not a local compounding pharmacy. They produce drug products in ready to administer forms that are very much needed by our nation’s healthcare system, including drug products on the FDA 506E shortage list. DDAVP is on that 506E list.
• The way the FDA categorizes their products, internal to Health and Human services, is also changing. Internally, the systems FDA uses to track their products are using the internal category designation of their products as “Outsourcing Facility Compounded Human Drug Product (Exempt From Approval Requirements)”. This was only recently announced by the FDA so it may take a year or two for that to work its way into CMS and other payor related systems and formularies.

If you have any questions, please contact a Team Member of the Hemophilia Alliance.