No randomized controlled trials have established superiority of blood brain barrier disruption (BBBD) techniques over the use of chemotherapy. Although these techniques have been used for over twenty years, their efficacy has not been established. Chemotherapy with BBBD has been associated with a higher risk of complications that include seizures, focal neurologic deficits, obtundation, cerebral herniation, stroke and death. These complications are then multiplied by the side-effects related to the chemotherapy itself. The Centers for Medicare and Medicaid (CMS) issued a National Coverage Determination that states that the use of osmotic BBBD is not reasonable and necessary when it is used as a part of a treatment regimen for brain tumors.
A search of the literature was completed through MEDLINE database through November 2008. There is limited scientific data to permit conclusions regarding the use of direct brain infusion catheter(s) in the brain for delivery of therapeutic agent(s), and for the treatment of brain tumors, Parkinson disease, epilepsy or other disorders of the brain. Although the ongoing clinical trial data is promising, further study is needed to demonstrate whether the use of this therapy leads to improved outcomes.
A search of peer reviewed literature was performed through November 2011. The following is a summary of the key literature to date.
Bruce, J.N., et al. carried out a prospective, dose-escalation phase 1b study to assess the safety profile of convection-enhanced delivery of the chemotherapeutic agent, topotecan, for the management of recurrent malignant gliomas, as well as evaluate radiographic response and survival. The reported results indicated “Significant antitumor activity as described by radiographic changes and prolonged overall survival with minimal drug-associated toxicity was demonstrated.” The study established the maximum tolerated dose for future phase II studies. “The potential for use of this therapy as a generally effective treatment option for malignant gliomas will be tested in subsequent phase II and III trials” was noted by the authors.
Although the study is promising, further studies are needed. This update failed to identify any additional information that would change the coverage position of this medical policy.
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