“The interesting study below shows that you can give natalizumab intravenously, subcutaneously and intramuscularly and they do the job almost as well as the intravenous route. This study refers to actual levels of natalizumab in the blood. What an innovation this would be to allow pwMS to administer their own natalizumab to themselves? It would free them up from their monthly infusion visits and free up all those staff in the infusion units across the world to do other things. A subcutaneous or intramuscular preparation of natalizumab would be so much more cost-effective and this would almost certainly feed through the system increasing access for many more pwMS in need of a high efficacy therapy. In other words it would improve healthcare efficiency. From my perspective it would make it much easier to use natalizumab in resource poor environments as well.”
“However, every decision that is made has some repercussions. For example, I recall an email I received from a desperate person with MS from a few years ago. He was living in San Antonio, Texas. He was unemployed, and uninsured, and had highly active MS. Biogen had kindly agreed to give him natalizumab free, as part of their drug-access scheme. However, he couldn’t find any infusion unit in San Antonio to give him the infusions at price he could afford to pay. His local unit wanted to charge him $1200 an infusion. Unfortunately, he was unable to start natalizumab. My heart goes out this man. At this moment I have two visions of him. Firstly, of him sitting in a wheelchair doubly incontinent the victim of uncontrolled active MS. Then a more pleasant second vision, of him self-injecting with a new formulation of natalizumab on the first Monday of each month before he leaves his home and walks to work. Since starting subcutaneous natalizumab 3 years ago he has no evident disease activity and has noticed a marked improvement in all his symptoms and disabilities. In fact he improved so much that he was able to get a job and return to full-time employment. There is little doubt that natalizumab is a transformational drug it is a great pity that it is only the privileged few who have access to it. I sincerely hope Biogen reconsider their decision not to develop a new self-administered formulation of natalizumab; who is really more important, pwMS who need access to highly effective therapies or the business people who prescribe natalizumab to keep their infusion units running smoothly and profitably?”
Epub: Plavina et al. A Randomized Trial Evaluating Various Administration Routes of Natalizumab in Multiple Sclerosis. J Clin Pharmacol. 2016 Feb 2. doi: 10.1002/jcph.707.
Background & Objectives: The primary objective was to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of single subcutaneous (SC) or intramuscular (IM) 300-mg doses of natalizumab with IV 300-mg doses of natalizumab in patients with multiple sclerosis (MS). Secondary objectives included investigation of the safety, tolerability, and immunogenicity of repeated SC and IM natalizumab doses.