Are the Newest Anti-Alzheimer’s Medicines Being Evaluated Under Outdated Pricing Paradigms?

Main Article Content

Charles S. Wilcox, Ph.D., M.P.A., M.B.A.

Abstract

The 2021 approval of aducanumab in the United States, was not followed by approvals in Europe, Canada, Australia or elsewhere; nonetheless, the initial pricing of $56,00.00/year created a firestorm of controversy. The 2023 Food and Drug Administration approval of lecanemab has been followed by approvals in Japan and China. The current (2024) costs are $26,500 in USA, $20,438 (National Health Insurance) in Japan and $28,180 (private market) in China. In Europe, a health technology assessment will drive coverage decisions and set single-payer prices for each health system for lecanemab and subsequently approved new treatments. For comparison, 2024 average pricing for the top five selling drugs for cancer [$198,273], arthritis [$83,666], hepatitis C [$75,118] and multiple sclerosis [$86,765] far exceed lecanemab’s annual cost. Could there be an anti-brain-health bias?


The International Consortium for Health Outcomes Measurement notes that patient-centered outcome measures represent the ultimate measure of quality and they are always multi-dimensional. Quality-adjusted life-years (QALY) seem to be absent from the computation of pricing for anti-dementia treatments. Although global consensus on QALY calculations remains elusive, currently extant data are compelling. The QALY calculation is the change in utility value induced by the treatment, which is then multiplied by the duration of treatment effect to provide the number of QALYs gained. QALY ranges differ quite significantly, even amongst the most industrialized nations. Value-based pricing from double-blind, placebo-controlled trial results, demonstrating statistically significant beneficial effects on cognition and/or global function, would reward manufacturers for innovation whilst also enabling payer systems to remain solvent.


Now that the first truly disease-modifying treatment for Alzheimer’s (lecanemab) has been approved, a second disease-modifying treatment (donanemab) appears to be heading for regulatory approval as well. The full value of these newest anti-dementia treatments may be understated when quantified under older pricing models and, hence, could unwittingly be a disincentive to further innovation. We now have disease-modifying and symptomatic relief treatments for Alzheimer’s disease to be included within the treating clinicians’ armamentarium and, when priced appropriately, access should be widely available whilst also encouraging further innovative anti-Alzheimer’s clinical research.

Keywords: Alzheimer’s Disease; AD, dementia; Quality-Adjusted Life-Years; QALYs; Disease-Modifying Treatment; DMT; aducanumab; lecanemab; donanemab; value-based pricing; Pharmacy Benefits Managers; PBMs; pricing paradigms; cost-benefit analysis; risk-benefit analysis; health technology assessment; HTA; patient-centered outcome measures.

Article Details

How to Cite
WILCOX, Charles S.. Are the Newest Anti-Alzheimer’s Medicines Being Evaluated Under Outdated Pricing Paradigms?. Medical Research Archives, [S.l.], v. 12, n. 4, apr. 2024. ISSN 2375-1924. Available at: <https://esmed.org/MRA/mra/article/view/5360>. Date accessed: 27 may 2024. doi: https://doi.org/10.18103/mra.v12i4.5360.
Section
Editorial

References

1. Saad L. Retail, Pharmaceutical Industries Slip in Public Esteem. September 13, 2023. Accessed February 27, 2024. https://news.gallup.com/poll/510641/retail-pharmaceutical-industries-slip-public-esteem.aspx

2. Manalac T. Orchard Sets $4.25M US Price for Gene Therapy Lenmeldy on Heels of Approval. March 20, 2024. Accessed March 21,2024. https://www.biospace.com/article/orchard-sets-4-25m-us-price-for-gene-therapy-lenmeldy-on-heels-of-approval/

3. Cummings JL, Morstorf T, Zhong, K. Alzheimer’s disease drug development pipeline: few candidates, frequent failures. Alz Res Therapy 6, (37) .2014. https://doi.org/10.1186/alzrt269

4. Cross R. Failure, faith and $8 billion: How Lilly’s amyloid conviction brought it to the brink of Alzheimer’s approval. February 26, 2024. ENDPOINTS in FOCUS.

5. Alzheimer’s Association 2024 Alzheimer’s Disease Facts and Figures. Special Report. https://www.alz.org/media/Documents/alzheimers-facts-and-figures.pdf

6. Chappell B. 3 Experts Have Resigned From an FDA Committee Over Alzheimer’s Drug Approval. NPR Medical Treatments. June 11, 2021. Accessed March 1, 2024.
https://www.npr.org/2021/06/11/1005567149/3-experts-have-resigned-from-an-fda-committee-over-alzheimers-drug-approval#-:-.text=

7. Hassanein N. Controversial Alzheimer’s drug, explained: What to know about Aduhelm, FDA and scathing report. USA Today. December 30, 2022. Accessed March 4, 2024. https://www.usatoday.com/story/news/health/2022/12/30/fda-approval-alzheimers-drug-aduhelm-report/10970324002/

8. ICER, Institute for Clinical and Economic Review. Lecanemab for Early Alzheimer’s Disease; Final Policy Recommendations. April 17, 2023. Accessed March 4, 2024. https://icer.org/wp-content/uploads/2023/04/ICER_Alzheimers-Disease_Policy-Recommendations_04172023.pdf

9. Janakievski N, Nagowski C. Pricing Strategy For New Anti-Alzheimer’s Drug Puts Access Community On The Defensive. Life Science Leader. January 25, 2023.

10. Comer B. No Playbook For Leqembi: Eisai’s Long Game in Alzheimer’s Disease. Life Science Leader. February 16, 2024.

11. Brennan Z. FTC’s Lina Kahn and Mark Cuban headline White House listening session to rail against PBMs. March 4, 2024. ENDPOINTS NEWS.

12. Jarvis LM. Tough Times For Neuroscience R & D. Chemical and Engineering News. March 19, 2012. Volume 90, Issue 12. Accessed March 5, 2024. https://cen.acs.org/articles/90/i12/Tough-Times-Neuroscience-RD.html

13. Tyer D. BMS exits hep C, diabetes and neuroscience drug discovery. PMLive. November 11, 2013. Accessed March 5, 2024. https://pmlive.com/pharma_news/bms_exits_hep_c_diabetes_and_neuroscience_research_517119/?SQ_DESIGN_NAME=2

14. Mullard A. Pfizer exits neuroscience. Nat Rev Drug Discov. 17, 86 (2018). Accessed March 5, 2024.
https://doi.org/10.1038/nrd.2018.16

15. Six drug pricing models have emerged to improve product access and affordability. September 23, 2019. Accessed March 6, 2024. https://www.pwc.com/us/en/industries/health-industries/library/6-drug-pricing-models.html

16. Morris JC. Clinical Dementia Rating: A Reliable and Valid Diagnostic and Staging Measure for Dementia of the Alzheimer’s Type. International Psychogeriatrics. 1997;9 (S1):173-176. Accessed March 6, 2024. doi:10.1017/S1041610297004870

17. Mulcahy AW, Whaley CM, Gizaw M, Schwam D, Edenfield N, Becerra-Ornelas AU. International Prescription Drug Price Comparisons: Current Empirical Estimates and Comparisons with Previous Studies. 2021 RAND Corporation. https://www.rand.org/pubs/research_reports/RR2956.html

18. Schoonveld E. Assessing Drug Pricing in Europe. Pharmaceutical Commerce. April 2023 Vol. 18, Issue 2. Accessed March 6, 2024. https://www.pharmaceuticalcommerce.com/view/assessing-drug-pricing-in-europe

19. Eisai presents full results of Lecanemab Phase 3 Confirmatory CLARITY AD Study for early Alzheimer’s Disease at Clinical Trials on Alzheimer’s Disease (CTAD) Conference. PR Newswire. Eisai Inc. November 29, 2022. https://www.prnewswire.com/news-releases/eisai-presents-full-results-of-lecanemab-phase-3-confirmatory-clarity-ad-study-for-early-alzheimers-disease-at-clinical-trials-on-alzheimers-disease-ctad-conference-301689627.html

20. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in Early Alzheimer’s Disease. N Engl J Med. 2023; 388:9-21. January 5, 2023. Accessed March 19, 2024.
DOI:10.1056/NEJMoa2212948. https://www.nejm.org/doi/10.1056/NEJMoa2212948

21. Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer’s Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA 2023;330 (6):512-527. Accessed March 19, 2024. doi:10.1001/jama.2023.13239.

22. Beck P. FDA Delays Action on Closely Watched Alzheimer’s Drug. The New York Times. March 8, 2024. Accessed March 21, 2023. https://www.nytimes.com/2024/03/08/health/alzheimers-drug-

23. Meijer E, Casanova M, Kim H, Llena-Nozal A, Lee J. Economic costs of dementia in 11 countries in Europe: Estimates from nationally representative cohorts of a panel study. The Lancet Regional Health Europe, June 24, 2022. Accessed March 9, 2024. DOI: https://doi.org/10.1016/j.lanepe.2022.100445

24. Jonsson L, Tate A, Frisell O, Wimo A. The Costs of Dementia in Europe: An Updated Review and Meta-analysis. Pharmacoeconomics. 2023 Jan;41(1):59-75. Epub November 15, 2022. Accessed March 19, 2024.
https://pubmed.ncbi.nlm.nih.gov/36376775/

25. Stopford A. “Realistic” cost of dementia care in Australia released. Aged Care Guide, January 25, 2018.

26. Genworth Cost of Care Survey 2023, Summary and Methodology. Genworth Financial, Inc. Accessed March 19, 2024. pro.genworth.com/riiproweb/productinfo/pdf/131168.pdf.

27. Mahoney R, Regan, C, Katona, C, Livingston G. Anxiety and depression in family caregivers of people with Alzheimer disease: the LASER-AD study. Am J Geriatr Psychiatry. 2005 Sep; 13(9): 795-801 https://pubmed.ncbi.nlm.nih.gov/16166409/ Accessed March 27, 2024.

28. Ferrara M, Langiano E, Di Brango T, Di Cioccio L, Bauco C, De Vito E. Prevalence of stress, anxiety and depression Prevalence of stress, anxiety and depression in with Alzheimer caregivers. Health Qual Life Outcomes. 2008 Nov.6:6:93 https://pubmed.ncbi.nlm.nih.gov/18990207/ Accessed March 27, 2024.

29. Lsik A, Soysal P, Solmi M, Veronese N. Bidirectional relationship between caregiver burden and neuropsychiatric symptoms in patients with Alzheimer’s disease: A narrative review. Int J Geriatr Psychiatry 2019 Sep; 34(9):1326-1334. https://doi.org/10.1002/gps.4965 Accessed March 27, 2024.

30. Huang S. Depression among caregivers of patients with dementia: Associative factors and management approaches. World J Psychiatry 2022 Jan 19; 12(1):59-76
https://ncbi.nlm.nih.gov/pmc/articles/PMC8783169/ Accessed March 27, 2024.