DecisionBase

September 2013

Alzheimer’s Disease (Mild to Moderate)

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?

Scope:

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.

- Price.

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 neurologists.

Payers surveyed: 20 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Donepezil (Eisai/Pfizer’s Aricept, other brands, generics)

- Galantamine extended-release (ER; Shire Pharmaceuticals/Janssen/Takeda’s Reminyl/Reminyl LP/Razadyne/Razadyne ER, generics)

- 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 Memary)

Emerging Therapies

- Solanezumab (Eli Lilly)

- IVIG (Baxter’s Gammagard/Kiovig)

- MK-8931 (Merck)

- EVP-6124 (EnVivo Pharmaceuticals/Mitsubishi Tanabe Pharma)

- Lu-AE58054 (Lundbeck)


Search Reports

Mentioned in this report:

  • - Almirall
  • - Astellas Pharma
  • - AstraZeneca
  • - Baxter International
  • - Daiichi Sankyo
  • - Dainippon Sumitomo Pharma
  • - Eisai
  • - Eli Lilly
  • - EnVivo Pharmaceuticals
  • - Forest Laboratories
  • - Grünenthal
  • - Gruppo Bracco
  • - Janssen
  • - Janssen Alzheimer Immunotherapy
  • - Janssen-Cilag
  • - Johnson & Johnson
  • - Lundbeck
  • - Merck
  • - Merz Pharmaceuticals
  • - Mitsubishi Tanabe Pharma
  • - Mochida Pharmaceuticals
  • - Novartis
  • - Ono Pharmaceutical
  • - Ortho-McNeil
  • - Ortho-McNeil Neurologics
  • - Pfizer
  • - Recordati
  • - Shire
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