|Eli Lilly Disappointed in Medicare's Decision on Beta-Amyloid Imaging Agents; Ampio Announces Positive Results for Ampion(TM)|
|By Mary Davila|
|Monday, 30 September 2013 19:47|
Eli Lilly and Company (NYSE: LLY) is disappointed that the Centers for Medicare & Medicaid Services (CMS) has denied patient access to beta-amyloid imaging agents, such as Amyvid™ (Florbetapir F 18 Injection). This final decision is not only contrary to expert opinion and published Appropriate Use Criteria previously recommended by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging, but contradicts the statutory authority CMS has over coverage determinations for diagnostics. Denying appropriate patient access is also in conflict with the administration's National Alzheimer's Project Act.1 CMS participated in creating this plan aimed at developing new and innovative ways to diagnose, support and treat patients suffering from Alzheimer's Disease1—yet the same agency is challenging the value of the only technology approved by the Food and Drug Administration (FDA) for estimating beta-amyloid neuritic plaque density in the living brain, which can aid in helping doctors make a more informed diagnosis.2
Amyvid is a beta-amyloid imaging agent for use in adults with thinking or memory problems who are being assessed for Alzheimer's Disease or other causes of these symptoms. Amyvid is used by doctors in combination with other tests. A positive Amyvid scan does not diagnose Alzheimer's Disease or other thinking or memory disorders. Amyvid is not approved to predict the development of dementia or other brain conditions in the future or for monitoring the effectiveness of treatments. Amyvid for intravenous use is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F 18.2
"Coverage with Evidence Development as proposed by CMS does not provide patients appropriate access to these amyloid imaging brain scans. Instead, it creates additional complexity for the broader community in determining the best path forward for patients," said Eric Dozier, senior director, Alzheimer's Business Division, Eli Lilly and Company. "As we continue to review the final decision memo, we will be evaluating all available options to ensure patients and physicians can gain access to this innovative diagnostic tool as soon as possible."
Ampio Pharmaceuticals (NYSE: AMPE) announced additional positive results from the SPRING study (clinicaltrials.gov NCT01839331) of Ampion™ for the treatment of osteoarthritis of the knee (OAK). In this study of 329 patients, patients treated with a single intra-articular injection of Ampion™ achieved a clinically meaningful reduction in pain. Ampio announced on August 14, 2013 that the SPRING study met its primary and key secondary endpoints.
Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, explained "The previously reported achievement of primary end point efficacy for pain (WOMAC A, p=0.0038), function (WOMAC C, p=0.04) and Patient Global Assessment (PGA, p=0.01) at 12 weeks following a single intra-articular injection is now augmented by significant results from secondary end points. The newly announced positive results include:
The reduction in pain compared to the vehicle control (saline) was also significant across/over the whole twelve-week period and not just at the 12 weeks end point (p=0.01). This study demonstrated that a single intra-articular (IA) injection of Ampion™ resulted in a clinically and statistically significant reduction in pain, with an estimated difference from control at the study endpoint of -0.25 on the WOMAC A scale (95% CI: -0.41 to -0.08, p=0.004), corresponding to a 42.3% improvement in pain at 12 weeks in patients treated with Ampion™. Note: In contrast, despite recommendations against their use, Hylan G-F 20 is the current treatment of choice in patients who cannot be managed with analgesics. In the pivotal trial of a single IA injection of 6 ml Hylan G-F 20, a borderline statistically significant reduction in pain was demonstrated, with an estimated difference from control of -0.15 (95% CI: -0.30 to -0.002, p = 0.047), corresponding to a 31.3% improvement in pain over 26 weeks in patients treated with Hylan G-F20.
Note: The accepted threshold for a Minimum Clinically Important Improvement (MCII), defined as the smallest change in a measurement that signifies important improvement in a patient's symptom, is -40.8% [Ann Rheum Dis. 2005;64:29-33 Tubach F, Ravaud P, Baron G, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement] in WOMAC A pain change from baseline with knee OA, which only Ampion exceeded as an intra-articular injection.
The Ampion™ SPRING study included "all comers", including Kellgren-Lawrence IV patients that make up a significant portion of the "real world" osteoarthritis patients (19% in the SPRING study). Ampion™ was not only effective overall (p=0.004) as previously reported, but was specifically effective in the subset of patients with severe osteoarthritis (Kellgren-Lawrence IV, p=0.017) who currently face a severe unmet medical need. Note: In contrast pivotal trials for the approved hyaluronic acid and derivatives, which commonly exclude patients with severe osteoarthritis (Kellgren-Lawrence IV stage of disease), these patients are sometimes considered "intractable" due to lack of efficacy of any approved therapy (NSAIDS, hyaluronic acid and steroids). The only accepted therapy is joint replacement, which is not only a significant patient burden but also has significant morbidity associated with it and is contraindicated in many patients with comorbidities.
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