Tuesday, December 30, 2014

Concerta, Methylphenidate ER formulations, Shortages and Formularies

The popular ADHD medicine, Concerta, has been subject of a lot of debate in the past couple of years, and that is continuing into 2015.

This is from a Canadian blogger, but I love the picture showing the difference inside.


Problem #1: Generics vs Concerta

It started when companies started making generic formulations that had a different delivery system.  (If you haven't heard of the issue, you need to read this before reading further for it to make any sense.)

The FDA said that the non-OROS formulations are not acceptable substitutions in November 2014.

Even the same active ingredient in a different delivery system could cause a problem with a child who is doing well on one type of delivery system who gets a different type the following month. The drug releases into the body at a different rate, so the drug is distributed differently throughout the day. This can be insignificant for some people, but can cause significant issues in others. I have heard that some children's medicine wears off much earlier (before the end of the school day) and much faster (leading to emotional and behavioral problems) with different delivery systems.

It is important that whatever delivery system a child does well on continues to be used. They are not interchangeable. Talk with your pharmacist every time you fill the prescription to be sure it is the same manufacturer, or in the case of Concerta, one of the manufacturers that makes the name brand or authorized generic.

Problem #2: Shortages

Since pharmacists can no longer use two of the three brands of generics to fill Concerta prescriptions, there is now a nationwide shortage of Concerta and the one generic that uses the OROS technology. The shortages are expected to last through the second quarter of 2015.

Problem #3: Formularies

To top it off, many insurance companies dropped Concerta and the authorized generic from their 2015 formularies. This means that if you buy the OROS methylphenidate medicine, it is not covered at all by insurance. You must pay cash and it does not count toward your deductible. This makes it out of reach for many most families. I am happy to see that some companies are adding it back to their formularies already -- I suspect there have been a lot of complaints. If it is not on your formulary and it is the medicine that works best for your family member, start complaining.

You will most likely need to try another medicine - or several other medicines - to make a good argument. If a formulary medicine also works, simply use it instead. Save yourself the trouble of going through the hoops to get the OROS methylphenidate. It is only if there is not a well tolerated and effective other option that you should fight for the OROS methylphenidate.

How do you fight the fight? Talk to your HR representative who deals with the insurance company. Call your insurance company directly. Send them e-mails and snail mail. Ask your physician to write a letter on your behalf. State why your family member needs the OROS technology. Give examples of how it works better than the other extended release methylphenidates and why the amphetamine class of medication failed. People were able to get the FDA to look into the issue and they agreed that there are significant differences, so insurance companies cannot pretend that it is an equal substitution.

Finding the right medicine


Due to the formulary changes and the shortage of OROS methylphenidate, I have heard that pharmacists are telling patients that they cannot fill a prescription because it cannot say "Concerta" and that they doctor must re-write the prescription as "methylphenidate ER" for them to be able to fill it. This means that they will fill it with the non-authorized generic formulation. If your child has done well on a non-OROS medicine in the past, great! If not, you must find out if it is a formulary issue or if the pharmacy is out of stock of one of the brands, since the remedy is different for different issues.

You will need to check on your formulary, usually available on your insurance company website, for the amount in milligrams that is allowable. It might be that another generic formulation of methylphenidate, not one for Concerta, is on formulary. Concerta comes in very odd sizes (18mg, 27mg, 36 mg, 54mg) and most others come in multiples of 5s or 10s. So if your formulary has only methylphenidates in multiples of 5s or 10s, you know that your child will not be getting the OROS formulation. It is more tricky if the odd sizes are available on the formulary, because unless the prescription says "Concerta", the pharmacist can pick which one to use.  All the pills with the OROS technology say "ALZA" on the pill. Look at the pills before finalizing the purchase and keep your child's medicine the same from month to month unless there are problems on it.

If a prescription is written "methylphenidate ER __ mg" instead of "Concerta __ mg" a pharmacist can fill with any of the long acting methylphenidate medicines that are the same strength, regardless of it is is OROS technology or another form of long acting medicine. The problem is that the same strength of the same active ingredient does not become usable at the same rate due to the delivery system of the pill, so try to keep your child on the same brand if he does well on it. If he doesn't do well on it, it might be better to simply try a different brand with a different delivery system, if allowable by your insurance and available at the pharmacy.

Since the prescription can no longer say "Concerta" if you want to try the other formulation, it might take a few trips between the doctor's office and the pharmacy to find a prescription to match the medicine available at the pharmacy that is covered on your formulary. Each might require a prior authorization before being able to finalize the purchase, so anticipate a few days to weeks before you will be able to take home the medicine.

It will be difficult to deal with drug shortages once the formulary issue is resolved. If your insurance allows 90 day prescriptions, this might be a good option once the dose is optimized. (This is not a good option for the first few months of a new medicine because dose changes might be needed.) Be sure to fill a new prescription as soon as possible to give time for the pharmacy to order in the drug if needed and to have any required prior authorizations completed by your doctor.

Take a deep breath. Slowly exhale. This will all pass in time, but it will be a rocky road for a bit.