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Angst over Amyvid: is CMS being short-sighted?

by Lisa Chamoff, Contributing Reporter | June 19, 2014
Alzheimers/Neurology
From the June 2014 issue of HealthCare Business News magazine


“The new concept of personalized medicine with companion diagnostic linked to therapeutics seems to become a nicely opened door for nuclear medicine,” wrote Zimmermann in a 2012 article published in the journal Nuclear Medicine and Biology. “However it has already triggered new discussions about the reimbursement ratios between diagnostics and therapeutics as more patients will be diagnosed than treated. This is another new question mark for investors thinking of investing in diagnostics.”

Zimmermann says that particularly when there is lots of competition, with three Alzheimer’s PET agents already on the market, big pharmaceutical companies need to look at developing therapies as well as the tracers.

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According to a recent market research report by the European research firm MEDraysintell, diagnostic radiopharmaceuticals will experience an average limited growth of about 5 percent per year, mainly driven by volume. The report noted that radiodiagnostics and radiotherapeutics will continue to grow, but the growth will largely rely on the interest of investors, who are being impacted by the politics of different health care systems.

Successful therapies
Aside from imaging, radiopharmaceuticals have been shown to be effective cancer therapies.

Last May, the FDA approved a unique alpha emitter designed to treat men with advanced prostate cancer. An alpha particle- emitting agent can be administered at a higher dose to the site where it’s being delivered and reduces damage to surrounding tissue, with no more than flu-like side effects.

The drug, radium Ra 223 dichloride, is marketed by Bayer as Xofigo. FDA approval for the drug was based on the results of a single clinical trial that evaluated 809 men with symptomatic castration-resistant prostate cancer that spread to their bones but not to other organs. Results showed that it prolonged the patients’ lives by a median of 14 months, compared to a median of 11.2 months for men receiving the placebo.

Beyond the overall survival benefit that the therapy demonstrated in clinical trials, Xofigo also delayed the first skeletal-related event in patients by a median increase of 5.8 months compared to the placebo, and it also reduced pain and opioid use among patients.

The company recently initiated a Phase 3 combination study with abiraterone, another FDA-approved treatment for metastatic castration-resistant prostate cancer with a different mechanism of action, in asymptomatic or minimally symptomatic patients with CRPC. Bayer is also planning to study using the therapy in breast cancer.

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