Finally, and thank you!
by Joe Pugliese

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 mramirez@staqpharma.com. If your pharmacy is not aware that the product is available, please share this newsletter with them.

Thank you!

On the policy front, I want to say thank you to Reps. Abigail Spanberger (D-VA) and David McKinley (R-WV), who have introduced bipartisan legislation called the Protect 340B Act. We were joined by the NHF advocacy team on a call with Rep. Spanberger’s health aide to discuss the bill and its many pros and few potential cons. Our goal is to support the provisions that would prohibit payers/PBMs from interfering with patient choice and imposing discriminatory pricing for covered entities. We see all the time when patients/families are not able to choose their pharmacy provider, and we support efforts to prohibit that practice. But, we also want to ensure that these protections don’t inadvertently make it more difficult for HTCs to get into network. What we would like to see prohibited is for PBMs and health plans to be able to cut in our discount. NHF has long had the position that each plan includes at least one commercial provider and 340B providers, who are providing the patient’s clinical care.

The bill also takes aim at discriminatory, and arbitrary attempts to exclude HTCs from networks. Things like multiple accreditations that simply drive-up costs without improving outcomes. Another favorite tactic is the requirement to carry a variety specialty. Why would a bleeding disorders center carry cancer drugs? Finally, there is the exclusive contract pharmacy arrangements, where the PBM assures the employer or the health plan that they can only offer the best pricing and on all the drugs. If you want to carve out hemophilia products and save 25- 30%, they will raise your price on everything else.

We applaud the effort and will do everything in our power to help this critical piece of legislation get enacted. If you’d like to join us in advocating for the bill, please let me know and we can provide you with the information you need.