Medication for unapproved age

[MARX22]

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Hey guys. I’m looking at aripiprazole it isnt approved in peds for depression but epocrates still shows it for teens and kids for other indications like irritability in autism 6-17 yo etc... usually the indication isnt on the rx so as long as the child is the minimum approved age of the medication id dispense but if lets say the child is younger than the approved age for ANY indication for that med... i would call. Once u call if they say theyre aware and okay do u just document and dispense or do u refuse bc it isnt FDA approved for that age?

 

[Sine Cura]

Where I work 100% of pediatric psych Rx are written for Medicaid recipients, so there would never be a situation where the script would be covered without undergoing some sort of PA process.

One time we got an atypical psych Rx for a someone under the age of 5. Needless to say that PA was denied because of lack of clinical justification

 

[MARX22]

Where I work 100% of pediatric psych Rx are written for Medicaid recipients, so there would never be a situation where the script would be covered without undergoing some sort of PA process.

One time we got an atypical psych Rx for a someone under the age of 5. Needless to say that PA was denied because of lack of clinical justification

Interesting, so would the PA allow it to be covered or as in the <5 yr old case it’s going to be denied if its for an unapproved age? I’m just curious as to how everyone else does it assuming it isnt medicaid/PA situation

 

[BidingMyTime]

Not being FDA approved, is not the same as being contraindicated for use. Many medicines are not approved for use in pediatrics, but they are used all the time anyway. Unless a company wants to market it for pediatric use, there is little reason to get it FDA approved for pediatric use, because pediatricians can use it anyway. Seriously, look up some of the drugs that you know are used in little children all the time (like antibiotics), and see what ages they are approved for. So no, just because a medicine is not approved for pediatric use, in itself, is no reason to call the doctor or to not fill a prescription.

Now, with your concern specifically, of aripiprazole, I would want to know the history of what else the pt has been on, and what exactly is being treated. I would question aripiprazole if it's the first drug being tried in a 5 year or younger person, especially if not being prescribed by a psychiatrist, and double that if being prescribed by a non-MD/DO. I think it very well may be appropriate to call the prescriber about this prescription, but the fact that it's not FDA approved for <6 is not the reason why.

 

[owlegrad]

Not being FDA approved, is not the same as being contraindicated for use. Many medicines are not approved for use in pediatrics, but they are used all the time anyway. Unless a company wants to market it for pediatric use, there is little reason to get it FDA approved for pediatric use, because pediatricians can use it anyway. Seriously, look up some of the drugs that you know are used in little children all the time (like antibiotics), and see what ages they are approved for. So no, just because a medicine is not approved for pediatric use, in itself, is no reason to call the doctor or to not fill a prescription.

Now, with your concern specifically, of aripiprazole, I would want to know the history of what else the pt has been on, and what exactly is being treated. I would question aripiprazole if it's the first drug being tried in a 5 year or younger person, especially if not being prescribed by a psychiatrist, and double that if being prescribed by a non-MD/DO. I think it very well may be appropriate to call the prescriber about this prescription, but the fact that it's not FDA approved for <6 is not the reason why.

If I recall correctly to encourage manufacturers to do trials in pediatrics the FDA grants an additional six months exclusivity for branded products to any manufacturer who will do the trials. So there is some incentive for manufacturers to test their products in pediatrics. Obviously it doesn’t apply to the legion of drugs that are already generic of course.

 

[Sine Cura]

Interesting, so would the PA allow it to be covered or as in the <5 yr old case it’s going to be denied if its for an unapproved age? I’m just curious as to how everyone else does it assuming it isnt medicaid/PA situation

The PA was denied not merely because it was off-label but because there was no clinical justification provided. If treating autism symptoms, why not aripiprazole or risperidone blah blah blah (the drug being prescribed wasn't either one)

I assume most pharmacy benefit coverage criteria you would normally see would never cover atypicals without a pre-auth.

 

[Saisri_PharmStdnt]

I can't speak specifically to this medication, but I can speak to how PA works. (Some of you probably know this, but there may be others who don't.)

Generally speaking, the insurance usually has a Formulary, Prior Authorization (PA) list or not covered. (Keeping it in simple terms, and not talking about Tiers.)

Formulary generally is what just pays at the pharmacy. It's the list of meds the insurance pays for that don't need any qualifiers on them to get them. Patient shows up with a script, it gets filled.

Prior Authorization medications are the ones that a particular insurance says they are willing to pay for, but only if the patient meets a set of criteria standards of what the medication should be used for and how its used (this includes age restrictions, quantity limits, actual diagnosis, supporting diagnosis information, etc)

The criteria is usually based mainly on the Product Insert. They *may* also cover it for off-label uses, especially when a number of patients who appeal get approved for that off-label use.

If the patient meets the insurance's criteria for the PA and it's approved, the PA will override the age restriction if it was approved for that patient.

The PA can also override quantity restrictions, some DURs, etc.. based on how the authorization is done and what limitations were put on it.

 

[MARX22]

Very interesting, thanks! I assume the same goes for controls? Controls in general just scare me more so pair that with a ped under the FDA approved age, ahhhh. Like oxycontin is for 11 yrs and up. What if u have a kid younger than that, what’s your approach?

Not being FDA approved, is not the same as being contraindicated for use. Many medicines are not approved for use in pediatrics, but they are used all the time anyway. Unless a company wants to market it for pediatric use, there is little reason to get it FDA approved for pediatric use, because pediatricians can use it anyway. Seriously, look up some of the drugs that you know are used in little children all the time (like antibiotics), and see what ages they are approved for. So no, just because a medicine is not approved for pediatric use, in itself, is no reason to call the doctor or to not fill a prescription.

Now, with your concern specifically, of aripiprazole, I would want to know the history of what else the pt has been on, and what exactly is being treated. I would question aripiprazole if it's the first drug being tried in a 5 year or younger person, especially if not being prescribed by a psychiatrist, and double that if being prescribed by a non-MD/DO. I think it very well may be appropriate to call the prescriber about this prescription, but the fact that it's not FDA approved for <6 is not the reason why.