Principal unmet needs still outstanding for Alzheimer’s patients
By Mia Burns (email@example.com)
In the world of treating mild to moderate Alzheimer’s disease, the drugs offering a greater effect on cognition and function compared with current treatments remain the top unmet needs, according to surveyed U.S. and European neurologists. Research and advisory firm Decision Resources says that the current available therapies alleviate some cognitive and functional symptoms associated with Alzheimer’s disease during the short-term, but do not slow disease progression, thus underscoring the remaining unmet need for more efficacious alternatives, which could be either symptomatic or disease-modifying.
The DecisionBase report Alzheimer’s Disease (Mild to Moderate): In an Increasingly Generic Market, What Attributes Can Differentiate Novel Brands in the Minds of Physicians and Payers? also finds that, based on a product profile presented, surveyed U.S. neurologists would prescribe Eli Lilly’s emerging anti-beta-amyloid monoclonal antibody solanezumab to a median 15 percent of their mild to moderate Alzheimer’s disease patients. Interviewed thought leaders are encouraged by a slowing of cognitive decline observed in solanezumab-treated mild Alzheimer’s disease patients, pooled across two completed, placebo-controlled, Phase III studies, in addition to the drug’s safety profile, particularly with regard to a low risk of amyloid-related imaging abnormalities.
“We expect Eli Lilly’s solanezumab to launch beginning in 2018 and to attain blockbuster status in 2019,” says Decision Resources Senior Analyst Georgiana Kuhlmann. “We anticipate the drug will attain sales of nearly $5.5 billion in 2022, the last year of our current forecast period, across the United States, France, Germany, Italy, Spain, United Kingdom, and Japan.”
Decision Resources analysts say that the report also includes insights from a survey of U.S. managed care organization pharmacy directors. Two-thirds of those surveyed indicated they would reimburse a new disease-modifying therapy for the treatment of mild to moderate Alzheimer’s disease that was priced at a significant premium to current brands ($25/day), if such an agent offered a 200 percent improvement on cognitive decline compared to donepezil, which is also known as Eisai/Pfizer’s Aricept, other brands, and generics. Payers expecting not to cover such a therapy mostly cite insufficient benefits as the reason, suggesting that—for some payers—greater therapeutic gains would be needed to justify the value of a drug offered at such a considerable cost.
Kuhlmann told Med Ad News Daily, “In terms of the dynamic between donepezil and solanezumab, we do not foresee solanezumab displacing donepezil’s position within the Alzheimer’s disease market. In fact, we anticipate that current symptomatic therapies (acetylcholinesterase inhibitors [AChEIs], such as donepezil, and the NMDA receptor memantine [Forest’s Namenda/Namenda XR]), will largely be immune from competition with solanezumab because the drugs are targeting two separate components of the disease: solanezumab is aimed at slowing the underlying disease progression by targeting the disease pathology, while AChEIs and memantine are aimed at addressing patients’ cognitive complaints. The experts we interview tell us that they anticipate using solanezumab and AChEIs and/or memantine in combination in many patients in order to achieve maximal clinical benefit—solanezumab to slow the disease progression and an AChEI/memantine to provide a ‘cognitive boost’. Because the AChEIs are now largely generic, with the exception of Novartis’s Exelon Patch, and Namenda will be generic by 2015 in the United States, we do not anticipate reimbursement hurdles to such combination use. We also anticipate that solanezumab, as a disease-modifying therapy, will see use in the earliest stages of the disease, when symptomatic therapies may not offer benefit, and thus will not be directly competing with donepezil and other current therapies. Furthermore, we expect many patients (e.g., those with substantial comorbidities, those in the later stages of Alzheimer’s disease) will not be candidates for treatment with emerging biological agents and will thus receive treatment with AChEIs and memantine instead.”
The analysts also discuss delivery burden in the report. “With respect to delivery burden, that phrase encompasses a number of factors—dosage formulation (e.g., oral pill, transdermal patch, intravenous infusion), dosing frequency, monitoring requirements (e.g., routine blood work, MRI monitoring, etc.), treatment setting (e.g., home, hospital), and need for titration,” Kuhlmann told Med Ad News Daily. “Solanezumab has an advantage over donepezil in dosing frequency (monthly vs. daily), and need for titration; however, donepezil can be taken at home and does not require a lengthy infusion or a trip to a hospital or infusion center. For a younger, more active, and more cognitively-intact patient, solanezumab’s infrequent dosing may outweigh the need for an IV infusion away from home, whereas for an older, frailer patient with more severe cognitive impairments, the ease of an at-home therapy, even a daily one, may be a better choice.”
Posted: September 2013