Amid Substantial Unmet Need, What Clinical Improvements Do Neurologists and Payers Expect of Novel Symptomatic and First-to-Market Disease-Modifying Therapies?

Alzheimer’s disease (AD) will pose a considerable healthcare strain on the seven major pharmaceutical markets under study, where the population will surpass 10 million prevalent cases by 2023. Currently available symptomatic therapies offer only modest, short-term benefits, and none can prevent, stop, or even modify the progression of AD. The rapidly growing AD patient population and the high unmet need for bona fide disease-modifying therapies (DMTs) that can deliver long-term benefits support a considerable and largely untapped commercial opportunity. Despite repeated failures among investigational DMTs, the race to unlock this opportunity in AD continues to attract pharmaceutical companies to develop the first DMTs for the treatment of mild, mild to moderate, or early AD, of which several are in late-stage trials. However, surveyed neurologists and interviewed thought leaders also remain eager for superior clinical benefits from emerging symptomatic therapies—an opportunity that may be more realistically fulfilled in the near term. Ultimately, any novel therapy that demonstrates efficacy in AD patients would be a welcome addition to the treatment algorithm.

Questions Answered in This Report:

  • Mean change from baseline on the Alzheimer’s Disease Assessment Scale-cognition (ADAS-cog)—a standard measure of a therapy’s effect on cognition—assessed at either 6 or 18 months, is a key goal in the treatment of mild to moderate AD. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European neurologists weight specific efficacy end points and other drug attributes in their prescribing decisions for mild to moderate AD?

  • Greater effect on cognition and function are key areas of unmet need for mild to moderate AD according to the insights of surveyed U.S. and European neurologists. Which therapies in development for mild to moderate AD are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome in order to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. MCO PDs seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?

  • An agent’s effect on cognition and function 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, memantine (Merz Pharmaceuticals/Grünenthal’s Axura, generics; Lundbeck’s Ebixa, generics; Actavis’s Namenda/Namenda XR; Daiichi Sankyo’s Memary) plus an acetylcholinesterase inhibitor (AChEI) is the current clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe differentiate this therapy from competing current therapies and emerging therapies? Will any therapies in development challenge memantine + an AChEI as the future gold standard in 2018 or 2023?

Scope:

Attributes included in conjoint analysis based assessment of target product profiles for mild to moderate AD:

- Improvement over placebo on ADAS-cog score.

- Improvement over placebo on the Alzheimer’s Disease Cooperative Study of Activities of Daily Living (ADCS-ADL) score.

- Improvement over placebo on Neuropsychiatric Inventory (NPI) score.

- Rate of serious side effects (% of patients).

- Rate of minor side effects (% of patients).

- Delivery profile.

- Price/day.

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.

- Delivery profile.

- Effect on agitation.

Physicians surveyed: 60 U.S. and 32 European neurologists.

Payers surveyed: 22 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/Janssen/Takeda Pharmaceutical’s Reminyl/Reminyl LP/Razadyne/Razadyne ER, generics)

- Rivastigmine patch (Novartis’s Exelon Patch, generics; Ono Pharmaceutical/Novartis Pharma KK’s Rivastach Patch)

- Memantine (Merz Pharmaceuticals/Grünenthal’s Axura, generics; Lundbeck’s Ebixa, generics; Actavis’s Namenda/Namenda XR; Daiichi Sankyo’s Memary)

Emerging Therapies

- Solanezumab (Eli Lilly)

- MK-8931 (Merck & Co.)

- LMTX (TauRx Therapeutics)

- Encenicline (previously EVP-6124; Forum Pharmaceuticals/Mitsubishi Tanabe Pharma)

- Idalopirdine (previously Lu-AE58054; Lundbeck/Otsuka Pharmaceutical)


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