Introduction:In an Increasingly Generic Market, What Attributes Can
Differentiate Novel Brands in the Minds of Physicians and Payers?
In 2011, Alzheimer’s disease (AD) affected more than 7
million people in the seven major pharmaceutical markets under study, and this
patient population is poised to expand rapidly. No available therapies can
prevent, stop, or even modify the progression of AD; they can only address the
symptoms of the disease over the short term. The growing patient population,
coupled with the high unmet need for treatments that have a long-term effect on
the underlying cause of the disease, represents large untapped commercial
opportunity. Although several therapies are in late-stage trials for mild to
moderate AD, they have yet to meet the efficacy and/or safety requirements that
surveyed neurologists expect of a therapy that they would consider a major
improvement over currently available agents. Thus, considerable opportunity
exists for therapies that can modify the underlying course of AD and/or are
more effective than current symptomatic therapies while offering a safety and
tolerability profile on par with that of current agents.
Questions Answered in This Report:
An AD drug’s performance on certain key efficacy end points,
including the mean change from baseline on the Alzheimer’s Disease Assessment
Scale-cognitive subscale (ADAS-cog) at 6 and 18 months, is important for drug
approval and physician prescribing. What are the key primary and secondary
clinical trial end points with which new AD therapies—both symptomatic and
disease-modifying—are evaluated? How do U.S. and European neurologists surveyed
weight efficacy measures and other drug attributes in their prescribing
decisions for mild to moderate AD?
Donepezil (Eisai/Pfizer’s Aricept, other brands, generics) was
the 2011 major-market sales leader in AD. On which clinical and
cost-related attributes are surveyed neurologists and managed care organization
pharmacy directors (MCO PDs) most satisfied with this therapy? Despite the
strengths of donepezil, what unmet needs remain in the treatment of mild to
moderate AD according to the insights of surveyed neurologists and MCO PDs?
An agent’s effect on cognition and effect on functional decline
are key drivers of physicians’ prescribing decisions and/or are the focus of
drug development for new mild to moderate AD therapies. What trade-offs
across these and other clinical attributes are U.S. neurologists willing to
make when considering the use of emerging therapies for mild to moderate AD?
Based on the trade-offs in price and performance across key drug attributes
that U.S. neurologists are willing to make, how do physician preference and
prescribing likelihood vary across different target product profiles for mild
to moderate AD?
Based on its clinical profile, the combination of memantine
(Merz Pharmaceuticals/Grünenthal’s Axura, Lundbeck’s Ebixa, Forest
Laboratories’ Namenda/Namenda XR, Daiichi Sankyo’s Memary, generics) and an
acetylcholinesterase inhibitor (AChEI) is the current clinical gold standard in
our Drug Comparator Model. What attributes do thought leaders believe
differentiate this combination from competing current therapies and emerging
therapies? Will any therapies in development challenge memantine plus an AChEI
as the future gold standard in 2016 or 2021?
Attributes included in our conjoint analysis-based
assessment of target product profiles for mild to moderate AD:
- Effect on cognition.
- Effect on functional decline.
- Effect on brain beta-amyloid (Aβ) load.
- Effect on cerebrospinal fluid (CSF) biomarkers.
- Rate of gastrointestinal (GI) side effects.
- Delivery burden.
Attributes included in assessment of U.S. payers’
receptivity to new therapies for mild to moderate AD:
- Effect on cognitive decline—symptomatic therapies.
- Effect on cognitive decline—disease-modifying therapies.
- Rate of serious adverse events.
- Delivery burden.
Physicians surveyed: 60 U.S. and 36 European
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and
- Donepezil (Eisai/Pfizer’s Aricept, other brands, generics)
- Galantamine extended-release (ER; Shire
Pharmaceuticals/Janssen/Takeda’s Reminyl/Reminyl LP/Razadyne/Razadyne ER,
- Rivastigmine patch (Novartis’s Exelon Patch, Ono
Pharmaceutical/Novartis Pharma KK’s Rivastach Patch)
- Memantine (Merz Pharmaceuticals/Grünenthal’s Axura; Lundbeck’s
Ebixa, generics; Forest Laboratories’ Namenda/Namenda XR; Daiichi Sankyo’s
- Solanezumab (Eli Lilly)
- IVIG (Baxter’s Gammagard/Kiovig)
- MK-8931 (Merck)
- EVP-6124 (EnVivo Pharmaceuticals/Mitsubishi
- Lu-AE58054 (Lundbeck)