Issues With Fentanyl

Lissa asked

Hello, I really apologize for the length, I didn’t know how else to explain it. I also am so grateful for your objective opinion.  My mother has been on the Fentanyl 100mcg patch for quite some time. We started having episodes of mother having a high level of pain and discomfort, we thought she was seriously ill and took her to the emergency room on several occasions. This continued to happen and mystified me, what was happening, did she have undiagnosed cancer? I finally figured out it was happening on the third day after applying the patch. I researched this on the internet and found that this happened to a lot of people and their doctor just changed the prescription to applying the patch every other day. Her doctor did this and it worked. (I later realized during these episodes, she was having extreme pain and going into withdrawal) Calm and equilibrium finally achieved. I was so happy, no more episodes, no more er visits. 
This seemed very strange to me, but, whatever, it worked. Now the problems started. Her insurance was denying payment. Once changing it to every other day, they wanted additional information from the Dr. Forms started being faxed to the Dr. from the pharmacy, I saw one of them once, and it was so confusing. I don’t think the Dr. knew what they wanted from him, he would write on the form “no prior authorization needed” and fax it back. (an additional form of terrorizing the physician, so he/she no longer wants to prescribe )This went back and forth for several weeks. I finally started talking to the insurance company, finally after the fourth call and fourth hour, it was explained to me.
 Something had triggered , it was the MED, at first, this was really confusing, but, I found the calculator, https://www.ohiopmp.gov/MED_Calculator.aspx As you can see below, the MED changed from 240 to 360 by changing the day the patch is changed. I spoke to a person at this agency who was a pharmacist and explained that I believed this calculator to be faulty, and due to this, it was causing a lot of problems for me, and if it was causing problems for me, it was probably causing problems for a lot of people. I stated that I believed if anyone changed the patch every 10 minutes or every three days they were still being given the same strength of medication as this was a a transdermal system providing continuous systemic delivery of fentanyl, (per the label, exceptions, not withstanding) The lady I spoke to stated that the calculator was not taking into effect that this was a transdermal system, I said, then it is useless. She laughed (she was a very nice lady) and then said, it was all mathematical. I said, that doesn’t change what I just said. I knew she agreed with me, but, wasn’t going to say it.
 Then to see that the trigger was at 80 just floored me, why didn’t this trigger way back when my mom first started on the 100mcg? So, this fault calculator is causing me all this grief, time and total frustration (not to mention all the other hoops I have to jump through to get my mother’s prescription, that is another story).

Question number two (exceptions which have nothing to do with the above calculator as a calculator such as this cannot be build on exceptions.) If my mother is for some reason,  is clearing or metabolizing the medication quicker than normal, does this mean she has a higher level of the drug in her system, or quite simply, it is going through her body faster than anticipated? Question number three, on an almost routine manner, she remarks how hot she is, other people nearby will look at her and say it is cold out. Maybe, for whatever reason, her body heat is enough to move the drug quicker out of the patch??? Although, I know she doesn’t have a fever of 104, and she doesn’t feel hot to the touch. (PLEASE SCROLL BELOW THIS FOR THE NEXT QUESTION)
 So, I called one of the manufactures of this drug and spoke to another pharmacist, I needed to know if my thought process on this was correct or not, because I intended to do something about it (in the way of letters to my representatives and other government officials), the pharmacist I spoke to agreed with me.

The last two times, we have just paid for the drug ourselves, NOW, the pharmacy will not fill it. The pharmacist explains he is good with the doctor, good with the prescription, BUT, since, insurance is not covering it, he will not fill it. He told me, he would personally try to call the Dr. and get it worked out. I had explained to him, about the Dr. trying to accommodate the requested information, but, that I thought it was very confusing to him as it was initially to me before I spent hours on the phone with the insurance company. This pharmacist also agreed that the above calculator was shaky. Upon thinking about this further, I have decided the pharmacist is WRONG, he has a valid prescription in his hands, a patient willing to pay for it, he has told me that he is good with the Doctor. His duty is to the patient, it does not matter that there is a bureaucratic issue going on with the insurance company. This has nothing to do with him. Am I wrong in thinking this? 
Update: I went to the pharmacy and the manager, was not in. The attending pharmacist started with the same story, we need a prior authorization, I explained everything to her and that I believe the manager was wrong, that the issue with the insurance company was not a concern of theirs, that they had a legal prescription and a patient willing to pay. She called the manager and the doctor’s office and then came back and now said “they would not accept the pharmacy discount card of Blink (which I used to pay the last two times, then I asked if they would use goodrx, which they had told me before that they used, and she said no again. I said ok, I will pay for it, at this time, I think, she started to realize just how furious I was (I was cool, calm and collect) and she said I could sign up at rxinsider and she would sell me one box for $200.00. I purchased it and have let good rx and blink know what has happened. I am really beginning to think this is some type of discrimination because of the drug. 2nd update – I just received an email from GoodRX below. I think my discrimination thoughts are beginning to be supportedHello,
Thank you for letting us know, and we apologize for the trouble you've had trying to use a discount at the Kroger pharmacy.
All pharmacies are contractually obligated to honor most discounts we display, however Walmart accepts GoodRx Coupons at the individual discretion of the pharmacist. Very rarely, consumers with GoodRx discounts encounter pharmacists who may not be aware of the agreement they have to honor GoodRx coupons, although they are contractually obligated to accept them.
If you'd like to reach us via phone you can call us at (855) 487-0694 Monday - Friday 9 AM - 6 PM CST.
The prices we list are typically very accurate - they are negotiated and contracted between the coupon providers we work with and the pharmacies we list, and pharmacies are contractually obligated to honor them in most cases.
The quickest way to resolve any issue with a coupon is to have the pharmacist call the phone number on the coupon while you're at the pharmacy, and someone from the helpline can speak directly to the pharmacist to clear up the problem while you're there. If the helpline isn't available or if they don't resolve the issue, you can always get in touch with us, and we can generally work with the coupon provider to resolve any misunderstandings.
If your prescription is still at Kroger we will certainly be happy to reach out to the pharmacy. Please note we can only reach out to the pharmacy during our business hours.
We are now aware of your issue and will be working to getting it resolved as soon as possible.

Answer

I certainly hope my answer can help you with your situation. Since the questions you submitted are lengthy, we are going to break them up in sections.

Issue 1: Insurance is not paying for fentanyl any longer.

This is an extremely common occurrence and the process is rather simple when all parties understand what is being asked for and what needs to be done. The main point is that the dose your mother is being prescribed is outside of the formulary limits for the insurance company. The usual dosage for fentanyl patches is one patch every 3 days (although there are reasons for it to be dosed more often as I will discuss below). When a dose falls outside that range, it will generally not be covered without a 'prior authorization'.

Again, prior authorizations are very common and any retail pharmacist likely sees many of them on a daily basis. In a nutshell, a prior authorization occurs when your insurance company denies initial payment for a drug for whatever reason (e.g. unusual dose, safety concerns, expensive brand name drug etc...). When a prior authorization occurs, you doctor must supply valid reasoning of medical necessity for the prescription, directly to the insurance company. In other words, the doctor needs to explain why your mother needs fentanyl dosed outside the usual dosage guidelines.

It is important to note that the insurance company isn't telling your doctor they can't prescribe the medication as is...they are saying they won't pay for it without a prior authorization. In your mothers situation, the doctor could discuss prior therapy your mother has been on, stating that one patch every 3 days provided inadequate pain control. I don't know if your mother is taking medication for breakthrough pain, but often times if a patient needs to take 3-4 doses of breakthrough medication, that could be indicative that the chronic pain control needs to be adjusted, such as changing fentanyl dosing from one patch every three days to one patch every two days.

Your mother's doctor stating 'no prior authorization needed' does not solve the issue and will result in the prior authorization being denied. They MUST submit paperwork supplying justification. 

Our recommendation is to do the following:

• Contact the insurance company to understand the reason for the prior authorization requirement. They most likely will say it is a 'high dose' and outside of the 'usual prescribing guidelines'. If you can't get a clear answer from the insurance company, your pharmacy may be able to help in this regard. When a pharmacy transmits a claim via their computer, they typically will receive a reason from the insurance company in regard to why the claim was denied. 

• Contact your mother's doctor and make them aware specifically why the prescription was denied. Once they know the reason, they can supply medical justification as to why your mother is being prescribed the drug as it is. Furthermore, the insurance company should be able to provide the appropriate form that needs to be filled out.

To conclude this question, please know that these situations are very common but can be confusing and difficult to navigate. It appears to me to be as simple as the dose prescribed being too high per the insurance company. If the dose falls outside of their formulary range, it will require a prior authorization. Prior authorizations follow a well defined process (e.g. filling out the appropriate paper work). Please look at the Wikipedia article on 'Prior Authorizations' as it describes the process well.

Issue 2: Pain control is not lasting the full 3 days

This is a well known issue with fentanyl. In fact, the brand name product (Duragesic) specifically lists this in the prescribing information:

"A small proportion of adult patients may not achieve adequate analgesia using a 72-hour dosing interval and may require systems to be applied at 48 hours rather than at 72 hours, only if adequate pain control cannot be achieved using a 72-hour regimen."

In addition, many medical journals discuss this issue and give possible explanations for it. One article states the following:

"... In many patients, the analgesic effect lasts for 72 hours; however, some patients may find that the effect begins to decline after 48 hours, usually at around 60 hours. Fentanyl is delivered to the systemic circulation from the transdermal patch by diffusion from a higher to a lower concentration gradient. As the two concentrations become closer, the system becomes less efficient and less fentanyl is delivered, especially during the last 48 to 72 hours after patch application."