I know this is a long post, but if you’ve got a few minutes, I hope you’ll read and continue your support of my family and others like ours. The more you know!
The Orphan Drug Act (ODA) passed in the US in 1983. Its purpose was to encourage drug companies to research and develop therapies for those with rare diseases. Why is it called “orphan”? Because, rare disease therapies generally lack sponsors to develop them. The market is small, research is expensive, and there is very little return on investment. There are over 30 million Americans suffering from over 7,000 rare conditions. Only 5% of those diseases have an approved treatment. Which means, the majority of those suffering have no treatment options at all. Taking your loved one home and being told to “make the best of the time they have left”, is a very real reality for many. Being granted an orphan drug designation by the #FDA, manufacturers and sponsors receive a 50% tax credit on qualified clinical testing, there are also several grants available. Which in turn helps recover development costs. According to the FDA, in the decade before the ODA was passed, only 10 treatments had been developed for rare diseases. That’s not a typo, TEN. This incentive, since inception, has helped bring nearly 500 new medications to patients. It has a proven track record of success.
Today, the House passed the Tax Cuts and Jobs Act. The Senate will vote after Thanksgiving. Included in this bill is the proposal to repeal or weaken the Orphan Drug Tax Credit. This is one of the only credits that is proven to save lives. I’m asking that you consider joining the #raredisease community in fighting to ensure it will not be weakened or repealed as part of the tax reform.
How can you help? Follow the link below. At the bottom of the form you will enter your address and zip code. A letter to your senators and representative will be filled out for you. The letter asks your representatives to oppose repeal or weakening of the Orphan Drug Tax Credit. All you need to do is enter your name, home address, email address and hit submit. It’s really that easy. I hope you’ll consider doing it.
As always, thank you so much for the support. xoxo
#themoreyouknow #wehaveHIhopes #hyperinsulinism #orphandrugs #taxreform
The CGM was finally approved and we love it! We had to go through the State of Texas Independent Review Organization (IRO) for a final appeal but UHC’s decision was over turned!
The reviewing doctor responded with:
This young infant was diagnosed around four months of age with altered mental status and seizures. There was concern that he had been hypoglycemic and possibly experiencing seizures for some time. He has since stabilized on diazoxide. However, despite diligence to do blood glucose monitoring every three hours, frequent feedings, and conscientious medication administration, he continues to have severe hypoglycemia spells. He is unable to communicate symptoms with his parents, increasing likelihood of severe hypoglycemia. This inturn increases his risk of brain damage and intellectual disability. Use of a Dexcom G5 continuous glucose monitoring system would allow for near continuous glucose monitoring, allowing the family to intervene as needed, preventing periods of severe hypoglycemia and reducing potential risk for brain damage. This device is medically necessary and appropriate for this baby boy.
This was a long fight that required standing over fax machines, staying on hold for hours, tons of phone calls, and possibly a few tears on my end. I’ll never understand why I had to fight so hard but in the end, the reviewing doctor understood the severity of the situation and did the right thing.
Right now we have the CGM placed on the top of his thigh. The first insertion was a challenge and he cried a lot but now we’re getting the hang of it. He uses an iPhone to act as a transmitter and as long as he’s on wifi (like at daycare), I can check his sugar through an app on my phone every five minutes. There are alerts for when his sugar is dropping too fast, under 70, and under 55. Definitely worth the fight.
The Dexcom was denied once again after an urgent appeal to United Healthcare.
Ugh. This is frustrating. The letter stated I was out of appeals and my next step would be to get a third party involved. The reason: The FDA has only approved the CGM for Type 1 Diabetes. I’m just one mom, there’s no way I can get the FDA to help us, right?
I know insurance companies are all about the bottom line. I get that. I understand that. I really do but this morning when Jackson’s sugar dropped into the 60s without warning, we would have known he was declining if he had this machine.
To the doctor who gets to make these critical decisions: To you he may just be another “claim”, to me, he is my whole world. Please do the right thing.
Jackson’s endocrinologist requested that he receive a Dexcom G5 Continuous Glucose Monitor. He warned it would likely be denied by the insurance company.
I seriously thought, there’s no way. How could the insurance company deny a device that could literally save his life? I have talked to the insurance company several times since Jackson’s birth and truth be told, they’ve been incredibly pleasant to talk to. No issues whatsoever.
When the insurance company denied the claim, even after prior authorization, I was a little shocked. I know, I had been warned but they had been so easy to work with, I expected more from them. I decided to call and talk to them. Surely, if they understood Hyperinsulinism, there’s no way they would deny it, right? WRONG
Their reason? “BECAUSE PATIENT DOES NOT HAVE TYPE 1 DIABETES, THIS DEVICE IS NOT MEDICALLY NECESSARY”. Ok, deep breaths. So I go into a long drawn out explanation of HI, the risks and the need for continuing to monitor blood glucose levels. I try to stick with simple facts:
- He doesn’t have diabetes, but has a disease that affects his glucose level.
- He is severely hypoglycemic.
- If his blood glucose level (BGL) drops and I don’t catch it, he could suffer brain damage or worse.
- He’s six months old, he can’t tell me if he doesn’t feel good. This machine will communicate for him.
- This machine isn’t just necessary for diabetics, it’s necessary for all people who have to monitor BGL 24-7.
That wasn’t enough justification. So in a desperate plea, I submitted an appeal. Telling them everything I knew about the disease and basically begged that they’d re-consider. Julie with Congenital Hyperinsulinism International also wrote a letter encouraging them to reconsider. Asked that they look at the facts. The truth is, if he suffers brain damage, the medical expenses will far exceed that than the coverage of this device. It’s the right thing for them to do and could save them money in the long run.
They said they’d make a determination on the appeal in 30 days. So… we wait.