Getting smarter

Is getting smarter, getting better?

RebiSmart™ is the new autoinjector developed for Rebif, interferon beta-1a subcutaneous (s.c.) made by Merck KGaA and EMD Serono.

This revolutionary autoinjector is unlike anything you have ever seen or even imagined.

Let’s start with standard autoinjectors: They are available for the three subcutaneous (s.c.) MS disease modifying agents (Betaseron, Copaxone, Rebif and soon, Extavia). Avonex is intramuscular (i.m.) and does not have an autoinjector for technical reasons, but one is in development.

The autoinjectors share a lot in common: the basic shape, you don’t see the needle until the end and a spring loaded system. Patient concerns are also similar: the noise of the injection. There are some differences: patients generally do not like the new Betaject Lite, because: it is harder to push the button, the handle is thicker, you can’t easily change the depth (you need to get different heads for each of the 3 depths) and you have to press it deeper into the skin and the needle seems to go into the muscle.

The new RebiSmart blows away the competition in terms of avoiding seeing the needle, consistency of injection and being able to verify compliance. It is much fancier, heavier and cooler.

Yes, it is the “iPhone” of autoinjectors, but is it really worth it?

It is already available in Europe and Canada and is undergoing testing in the United States in order to seek FDA approval, but can’t we find a better use of these pharmaceutical dollars?

The RebiSmart works as follows:

1. You load a week’s supply of medicine into the machine (it is a machine and not a piece of plastic). The medicine is contained in a non-refrigerated vial (with no needle attached).

2. You push a covered needle system into the unseen vial. You don’t touch or see the needle.

3. You then place the whole rectangular device on the area of the skin you want to inject. You can only inject your skin because there is a special skin sensor.

4. You press a button on top and the needle silently enters your subcutaneous fat (under the skin).

5. Once the light stops flashing, you can take the machine away from your body.

6. You place the cap at the part where the needle is and it is reinserted without you seeing our touching the needle.

The LCD screen takes you through these steps and won’t let you proceed unless you do them correctly. You can even see a calendar with the dates you injected. The problem is that the screen is too small and the colors used in the calendar are black and green and it is hard for people with low contrast sensitivity to make out the difference between these colors. If someone drops the autoinjector (rather, when someone drops it), how will anyone feel comfortable injecting what may contain a broken glass medicine container?

You can set the speed of the needle entering your skin and the speed of the medication going in your body. The whole system is rectangular, as wide as a Blackberry but as tall as a Palm Pilot and the thickness of 2 Palm Treos (is that confusing enough?). It has a nice weight to it and a solid feel. This may be better for people with tremors because there is no narrow fulcrum (there is a wide base) and the weighting might actually be a physical and occupational therapy treatment for the tremors.

If the neurologist is patient enough, she can load the injection information into the computer and verify compliance. This may be useful in discussions on whether this is the right medicine for you. If you are missing a lot of your injections, it doesn’t matter how good the medicine (or the autoinjector) is, it may not be the right one for you. It would be nice to have a beeping reminder if you haven’t injected in 3 or 4 days.

So, how is Novartis going to answer this with their Extavia autoinjector?

Well, Rebif sold against Betaseron its convenience in that there were so few steps. This is definitely not going to be the case anymore. Merck KGaA is coming out with a disposable needle cover for Rebif, so this may be a simpler, if less technologically advanced, option.

So, is hi-tech better?

What do you think?

- Dr. Daniel Kantor, MD BSE
Medical Director
Neurologique

info@neurologique.org
www.neurologique.org