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Cautious Optimism for Growth In Alzheimer’s Disease Treatments
Alzheimer’s disease (AD), the most common form of dementia, is a progressive neurodegenerative condition that alters cognition, behavior, and functional status.1 AD has devastating effects not only for patients but also for caregivers, who often endure physical and emotional consequences as a result of their efforts.
As of 2014, approximately 5.2 million Americans had AD, which was the sixth leading cause of death in the U.S. 2 Most AD cases occur in people older than 65 years of age. 1 As the proportion of Americans falling into this group continues to increase, the focus on AD and its treatments is also growing.
Available pharmacological options include small-molecule medications in two drug classes known as cholinesterase inhibitors and n-methyl-d-aspartate receptor antagonists. These therapies, with results that vary from person to person, are used only for symptomatic improvement—they cannot cure the disease or halt its progression.1 Estimated U.S. sales of marketed treatments totaled $2.4 billion in 2013, a figure that is expected to more than triple to $7.6 billion in 2023 with the addition of new medications.3
Unmet needs in the competitive landscape of AD treatment leave significant room for future disease-modifying therapies, many of which are biologic medications.4 Along with a promising AD pipeline, there remains an urgent need for continued research to identify curative and preventive therapies. This has become increasingly apparent as support for federal research funding grows. In addition, manufacturers, advocacy groups, and academic institutions have formed a rare partnership to evaluate upcoming AD therapies.5,6 Such unique partnerships and increased support will facilitate the development of disease-modifying therapies for AD.
|Status||Regimen Information||Pivotal Studies||Expected Approval||Anticipated Peak Year Sales/Pricing|
|TRx-0237 (leucomethyl-thioninum chloride)
|Phase 3||75, 100, or 125 mg orally twice daily||NCT01689246
|2016||$178.8M in 2023; expected to be priced at 20–30% premium to marketed therapies but lower than mAb therapies|
|Phase 3||30 or 60 mg orally once daily||STAR studies||2016||$338.5M by 2023; expected to be priced higher than medications now available|
|Phase 3||8 mg orally once daily||NILVAD||2017||$1.0M in 2023; expected to be priced higher than marketed therapies but lower than mAb therapies|
|Phase 3||5 mg orally once daily||NCT02080364||2017||$260.8M in 2023; expected to be priced at 30–40% premium to marketed therapies and in reference to MS, stroke, and ALS medications|
|Phase 3||Orally once daily; low and high dose being evaluated||NCT01969123
|2017||$137.1M by 2023; expected to be priced higher than medications now available|
|Albutein 20% + Flebogamma 5%
|Phase 2/3||High-dose and low-dose IV infusion is being studied||AMBAR||2017||$31.4M by 2023; expected to be priced in reference to Flebogamma and Albutein|
|Phase 3||3 or 4.5 mg/kg per day orally||NCT01872598||2017||$88.6M by 2023; expected to be priced at 30–40% premium to marketed AD treatments|
|Phase 3||12, 40, or 60 mg orally once daily||EPOCH: mild/moderate
APECS: amnestic mild cognitive impairment
|2018||$947.7M in 2023; expected to be priced at 50–60% premium to marketed medications and to use ALS medications as reference|
|Phase 3||SC injection every 4 weeks||Marguerite RoAD||2019||$502.2M in 2023; expected to be priced at 1–2% discount to Eli Lilly’s solanezumab and in reference to IV biologic MS medications|
|Phase 3||400 mg IV infusion every 4 weeks||EXPEDITION||2019||$2.2 billion in 2023; as a potential first-in-class agent, not expected to be discounted|
|Phase 2/3||20 or 50 mg orally once daily||AMARANTH||2019||$687.7M by 2023; expected to be priced at a 1–4% premium to Merck’s MK-8931 and medications used in MS and ALS|
|Phase 3||Sustained release 0.8 mg orally once daily||TOMMORROW||2020||$14.9M in 2023; expected to be priced in reference to Actos|
ALS = amyotrophic lateral sclerosis; B = billions; IV = intravenous; mAb = monoclonal antibody; M = millions; MS = multiple sclerosis; SC = subcutaneous
Sources: FDA; GlobalData; manufacturers’ websites;
||Cost of Course of Therapy per Year|
|Combination Cholinesterase Inhibitor and N-methyl-d-aspartate Receptor Antagonist|
|Namzaric (memantine/donepezil) Actavis||December 23, 2014||AD||28 mg/10 mg (memantine/donepezil) orally once daily||Not available|
|Exelon Patch (rivastigmine transdermal system) Novartis||July 6, 2007||AD||9.5 mg patch/24 hours||$5,487|
|Razadyne ER (galantamine), Janssen||December 22, 2004||AD||24 mg orally once daily||$4,254|
|Razadyne (galantamine), Janssen||February 28, 2001||AD||12 mg orally twice daily||$2,127|
|Exelon (rivastigmine) Novartis||April 21, 2000||AD, PD||6 mg orally twice daily||$5,021|
|Aricept (donepezil), Eisai||November 25, 1996||AD||10 mg orally once daily||$6,723|
|N-methyl-d-aspartate Receptor Antagonist|
|Namenda XR (memantine), Forest/Actavis||June 21, 2010||AD||28 mg orally once daily||$4,334|
|Namenda (memantine), Forest/Actavis||October 16, 2003||AD||10 mg orally twice daily||$4,562|
aThis list is not all-inclusive; additional therapies may be available for this disease state.
bAbbreviated indication provided; for full indication, please refer to prescribing information.
cRegimens based on the recommended dosage and maintenance phases from prescribing information; typical doses and titration schedules may vary based on patient-specific requirements.
dCosts calculated using average wholesale price and regimen provided and rounded to the nearest dollar.
Sources: Red Book; Drugs@FDA; and prescribing information for all medications
AD = Alzheimer’s disease; ER = extended release; PD = Parkinson’s disease
- DiPiro J, Talbert RL, Yee G, et al. Alzheimer’s disease. Pharmacotherapy: A Pathophysiologic Approach
9th edNew York, New York: McGraw-Hill. 2014;817–833.
- Alzheimer’s Association. 2014 Alzheimer’s disease facts and figures. Alzheimers Dement 2014;10;(2):e47–e92.
- GlobalData. Alzheimers Disease—Global Drug Forecast and Market Analysis to 2023 February 2015;
- National Institute on Aging. Developing new treatments for Alzheimer’s disease. Available at: https://www.nia.nih.gov/alzheimers/publication/2011-2012-alzheimers-disease-progress-report/developing-new-treatments. Accessed March 6, 2015
- Strobel G. DIAN trial picks gantenerumab, solanezumab, maybe BACE inhibitor. Alzforum October
102012;Available at: https://www.alzforum.org/news/conference-coverage/dian-trial-picks-gantenerumab-solanezumab-maybe-bace-inhibitor. Accessed March 12, 2015
- Alzheimer’s Association, Alzheimer’s Advocates Center. Public policy victories. Available at: http://www.alz.org/advocacy/victories.asp. Accessed March 12, 2015