Notes from Joe, September 2020

Notes from Joe

Continued Opportunities and Threats Facing HTCs
By Joe Pugliese

As of this writing, we are in something like day 190 of the hostage crisis. It has been a remarkable, chaotic, and frightening time where many things have gone wrong, some things could have gone better, though there are some moments that bring out the best in people. Our thoughts and prayers go out to the people devasted by the recent hurricanes and fires; while it’s still early in the season for both, I know we are all thinking enough already! On the brighter side, many of our manufacturing partners are working on a hyperimuune for COVID-19. What they and our patients could really use, are more donors as plasma collection has fallen by 25% to 35%, which would impact availability of some plasma derived products in the future (likelier to affect other patient communities than ours but we should still do our part!). We all can help by heading to a plasma collection center to reverse the trend – visit

While progress on vaccines and treatments seems promising, I do not see us returning to ‘normal’ before the end of 2021 at the earliest, though I would be delighted to be wrong. The Alliance has shifted our 2020 and early 2021 programming to be virtual. The Zoom world is okay in the near term but does not replace the face to face interaction. I know we’re all anxious to be together again.

As was reported last month and updated later in this Newsletter, there has been a tremendous amount of activity in the 340B space, generally all negative. Several manufacturers have now adopted a program called 340B ESP to gather, deidentify and transmit data. While Sanofi is using the program for some of its drugs, it is important to note that Sanofi has given us written assurances that this program does not apply to federally funded HTCs.

There’s a new threat by way of a company called Kalderos, who is proposing changing the 340B discount from from an upfront discount to a back-end rebate. They may have contacted you to pitch on their product, but we caution Alliance members against pursuing this. It would add yet another middleman to the process that just adds costs without adding value. Read on to Issie’s article to learn more about this program and how we’ve been responding.

Both programs argue that manufacturers are at risk for duplicate discounts in Medicaid, but they are solutions in search of a problem. There is scant evidence that duplicate discounts occur and there are already remedies for manufacturers if they feel they are paying duplicate discounts on 340B and Medicaid.

These and other “reforms” or criticisms of 340B are framed around increasing value and lowering costs for the health care system. But what’s frustrating to me is that it so apparent that the best way to increase value and lower costs for our patient population, and then the broader health care system as a result, is by increasing the number of patients who are able to access HTC clinical and pharmacy programs. Just look at the recent CDC retrospective on the impact of the hemophilia treatment center program. Having our patients receive their treatments from their HTC will allow HTCs to have more resources to hire more staff and expand programming to reach even more patients. The idea that adding more middlemen and more hoops to jump through for covered entities is disingenuous at best.

Like we did with the contract pharmacy issue, we are reaching out to our manufacturing partners to express concern about the unnecessary burden these programs would place on HTCs. We are counting on their support to resist these overreaching attempts to undermine the financial well-being of the comprehensive care centers on which the bleeding disorders community relies.

I wanted to close by mentioning that there are opportunities to apply to join the Alliance Board, as well as the Alliance employee team. Read below to learn more about both opportunities and how to apply. Finally, NHF is asking for your feedback to their Blue Sky Initiative, which is your opportunity to weigh in on what we should do to secure the future of the bleeding disorders community. The link is below.

Also in this Issue…

Legal Update
· 340B Program Developments: The Latest

Payer Update
· Know Your Patients and their Insurance Status

Alliance Update
· Alliance Seeking Board Nominations
· Join Our Growing Hemophilia Alliance Team
· 2021 Meeting Schedule

Notes from the Community
· CDC Awards Cooperative Agreements to Bleeding Disorders Organizations
· Hemophilia Alliance Foundation Poster at NHF’s BDC Shows Impact of Grants
· NHF Seeks Input for Blue Sky Strategic Plan