Speaker 1: Good morning, everybody, and welcome to the second in our series of educational videos sponsored by PPF. This is Pass the Mic with Dr. Mike, the pharmacist. That's me. I'm Mike Regas. I'm a clinical pharmacist for the last 40 years, with the last 30 years specializing in home infusion area and having the distinct honor of helping thousands of autoimmune blistering disease patients receive their medication. This is a complex subject, and because the PAPs are not mandated by the government, they're voluntary programs from the drug maker or non-profit organizations, they vary widely in what patients they serve, what services they offer, and the end results, and that can be quite complicated. And therefore, today, we'll go over some of the basic tenets that will allow you to manage this better for you or your loved one, and at the end, I'll give you a bunch of links. So it's important to think about the fact that this amount of assistance may be predicated upon your disease state, it may be predicated on your insurance company, it may be predicated on the drug that you've been ordered, as well as the site of care, whether you want to get it at home or an infusion center. And also, it's important to note that most of these programs, the drug maker programs, don't cover any patients with Medicare or Medicaid, only the patient assistance plans that are from non-profits cover those, and they're diagnosis-based. So there are four main types of programs. The first one is the manufacturer program that is sponsored by a drug maker. It is a longer term for the whole course of therapy. You have to have a disease that's FDA-approved for that drug, and since there are only one FDA-approved drug for pemphigus or pemphigoid right now, and that is rituxan, all the other IVIGs, none of them is FDA-approved. It's important to note that the drug GammaPlex has a patient assistance program that is not based on diagnosis. So if you do need IVIG and you can't afford it out of pocket, GammaPlex has a program that you may qualify for that is not diagnosis-based. The second kind of program is a shorter term pharmaceutical manufacturer program that's intended as a bridge, that is until you actually get your insurance coverage, it may allow you one or two months or three months therapy to be covered so that you can start the therapy while you're waiting for your authorization to occur. The third kind is non-profit organization sponsored, and that's where the drug companies and other groups donate money to them, and they make it available to patients that qualify, again, based on the diagnosis. So since most autoimmune blistering disease do not have any FDA-approved IVIG, and the only other drug FDA-approved is Rituxan, so most of these non-profit organizations do not offer any funds to blistering disease patients because there are no FDA-approved therapies except for, as I said, Rituxan is FDA-approved, as well as the drug GammaPlex is not diagnosis-based. And the fourth kind is a patient assistance plan that is either made by the pharmacy that serves you directly or through such a thing as a good RX or some other card they may offer. So these programs are then further impacted by state and federal regulations, and it can be very complicated when this all comes together. So knowing some of these things are important, and in order for you to get these funds is most likely going to take a while and it's going to take a lot of work, so knowing some important things are going to help you with that. So first I want to talk about how this actually works. So when a doctor gives a prescription to a pharmacy, they give you a patient-specific and drug-specific prescription, the pharmacy obtains authorization from the insurance company, and that authorization then lets the patient and the pharmacy know what your out-of-pocket costs are. The pharmacy then calls the patient and lets you know what that is, and if it's something you can't afford and don't have any means of affording it right off the bat, then it's possible that there may be a starter dose, as we talked about, that you can apply for. This typically only applies for the drugs that are subcutaneous, that is, the drugs Hyquvia, Hyzentra, Cubitru and Zembify, and Cutiquig, and typically those are not used for autoimmune blistering disease patients because they're sub-Q and obviously your skin is very tender and you may not be able to take anything subcutaneous, so those bridge or starter programs may not work. So if the drug is approved by the payer and the patient can't afford the out-of-pocket costs, then they should let their pharmacist know and their ordinary physician know so they can begin to see what, if any, drug-maker-sponsored, non-profit organization-sponsored discount card or pharmacy-sponsored program is available. Based on their diagnosis, as we said, based on the level of insurance or lack of insurance, based on the amount of financial assistance they need, in some of these cases the patient may need $10,000 or $20,000 a year worth of financial assistance, which could be really untenable for the patient. Patients that cannot immediately afford their out-of-pocket and no bridge dose, bridge program is available, they will need to decide to delay the start of therapy while working closely with their doctor or pharmacist to help them work through the ins and outs of their application for financial assistance. This may take days, weeks, or months, so patients should be prepared for delays and complex, time-consuming follow-up interactions. So as you can see, putting all this together needs to have significant planning and organizing. I will also include websites listing in alphabetic order various programs for drug companies as well as non-profits. And so I'd like to sort of wind this down right now and again remind you this is complex, time-consuming, and the fact that I'm offering assistance directly from me to you and your family. I hope you found this video helpful, and please feel free to contact me if you want me to work with you directly with you or your doctor to try to figure out how to afford this complicated program that can definitely have a significant impact on your ability to afford your out-of-pocket costs. Thank you, and have a good afternoon. Bye.