According to a story from BioPortfolio, the company Novocure has recently announced that Medicare has released final local coverage determinations for its product Optune. Optune is used to treat patients with newly diagnosed glioblastoma, an aggressive and rare form of brain cancer. The local coverage determinations will officially go into effect on September 1st, 2019. These final determinations have removed many prior proposed restrictions that will make it easier for Medicare patients with this cancer to be treated with Optune.
Glioblastoma is a rare brain cancer. It is also the most aggressive cancer to originate in the brain. It is characterized by its rapid progression and poor response to most treatments. In most cases, the cause of glioblastoma is not known. A small number of cases evolve from another type of tumor called an astrocytoma. Risk factors for glioblastoma include genetic disorders such as Turcot syndrome and neurofibromatosis, exposure to pesticides, smoking, and a career in petroleum refining or rubber manufacture. Symptoms of glioblastoma include personality changes, headaches, memory loss, seizures, vomiting, and nausea; patients may lose consciousness in late stages. Treatment approaches include anticonvulsants, steroids, chemotherapy, radiation, and surgery. While a small number of patients can survive for several years, treatment is often ineffective, with the tumor relapsing quickly. Five year survival rate is only three percent. To learn more about glioblastoma, click here.
The criteria for local coverage are more less in line with the company’s own criteria for commercial usage of Optune. These criteria are as follows:
- The patient must have a newly confirmed and completely diagnosed case of glioblastoma that is considered supratentorial;
- The recipient must also have received prior treatment in the form of debulking surgery (procedure to remove as much tumor mass as possible) followed by radiation therapy and chemotherapy;
- Optune must be administered within seven weeks following the final dose of radiation or chemotherapy;
- The glioblastoma patient shows no signs of progression based on Response Assessment in Neuro-Oncology measures;
- The patient scores at least 70 in Karnofsky Performance Score;
- The recipient must be able to adhere to 18 hours/day of treatment with Optune.
Optune is an alternative form of therapy for patients after radiation and surgical treatments have been exhausted.