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July 19

Harrowing reality and stress of Alzeimer's (long, Vox)

https://www.vox.com/policy-and-politics/22577776/alzheimers-disease-dementia-symptoms-aduhelm-drug

Endpoints on "Slick disease awareness campaign"

https://endpts.com/biogen-wasted-no-time-in-rolling-out-a-disease-awareness-campaign-for-alzheimers-as-an-rd-marathon-turns-into-a-sprint-a-top-analyst-awards-gold-silver-and-bronze/

July 15

ADU Debated at ICER

https://www.managedhealthcareexecutive.com/view/aduhelm-pros-and-cons-debated-at-icer-meeting

https://www.fiercepharma.com/pharma/despite-biogen-s-sharp-rebuke-cost-watchdog-experts-unanimously-refute-aduhelm-s-benefits

https://endpts.com/as-investigations-mount-and-controversy-swirls-biogen-fights-back-against-icer-and-then-faces-another-unanimous-slapdown/

Radhakrishnan vilified the ICER report as “inappropriate” and “fundamentally flawed.” Radhakrishnan particularly objected to ICER’s “blending” of the two Phase III trials in its analysis, leading to its flaws.

ADU, AMY PET, META-ANALYSIS

Ackley et al, ...Glymour....Reductions in amyloid [and] cognitive change...

https://www.bmj.com/content/bmj/372/bmj.n156.full.pdf

July 14

Private insurers nix ADU coverage

https://endpts.com/private-insurers-decline-to-cover-biogens-new-alzheimers-drug-in-escalating-standoff-report/

(subsc) https://www.bostonglobe.com/2021/07/13/business/this-is-unprecedented-several-private-insurers-wont-cover-biogens-alzheimers-drug/

Kaiser: We may never know if ADU works

https://khn.org/news/article/commentary-aduhelm-alzheimers-drug-effectiveness/

JAMA

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2782120

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2782118

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2782122

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2782119

July 7

Rep. Porter, OIG to investigate FDA-Biogen close ties

https://endpts.com/rep-porter-calls-on-hhs-inspector-general-to-investigate-fda-biogen-ties-ahead-of-aduhelm-approval/

July 6

Endpoints on Disapproval of Off-Label Use

https://endpts.com/if-you-thought-the-fdas-approval-of-aduhelm-for-alzheimers-was-controversial-you-should-hear-the-experts-thoughts-on-off-label-use/

Underlying Lancet Article to Endpoints Article (open access)

https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(21)00213-1/fulltext#%20

July 5

ADU approval, questions about AMY Hypothesis

https://www.washingtonpost.com/health/2021/07/05/aduhelm-new-alzheimers-drug-amyloid/

Off-Label ADU _ Amyloid Angiopathy

https://endpts.com/if-you-thought-the-fdas-approval-of-aduhelm-for-alzheimers-was-controversial-you-should-hear-the-experts-thoughts-on-off-label-use/

Acumen Raises $160M for AMY Drugs

https://medcitynews.com/2021/07/all-in-on-amyloid-acumen-pharmas-ipo-raises-160m-for-alzheimers-drug-rd/

Is Alz Assoc serious about ADU pricing?

https://www.statnews.com/2021/07/06/alzheimers-association-pushing-biogen-or-lip-service/

July 2

Class of Molecules, ADU, New Lease on Life

https://endpts.com/the-class-of-molecules-behind-one-of-biotechs-biggest-alzheimers-failures-get-a-new-lease-on-life/

Duke, FDA, Private Meeting with Payers and Stakeholders

https://endpts.com/duke-to-host-private-meeting-with-payers-and-biopharma-on-how-to-pay-for-alzheimers-drugs/

June 30

Medicare "CED" for ADU?

https://www.healthaffairs.org/do/10.1377/hblog20210625.284997/full/

Poll, Most Docs Doubtful re ADU Data

https://www.statnews.com/pharmalot/2021/06/30/biogen-alzheimers-fda-neurologists-primary-care/

ICER on ADU Pricing

At BiopharmaDive

https://www.biopharmadive.com/news/icer-aduhelm-cost-label-revise-biogen/602641/

At Endpoints

https://endpts.com/icer-finds-biogens-new-exorbitantly-priced-alzheimers-drug-doesnt-match-even-an-optimistic-view-of-potential-clinical-benefits/

June 29

Aduhelm Back Channels at FDA; Stat Plus

https://www.statnews.com/2021/06/29/biogen-fda-alzheimers-drug-approval-aduhelm-project-onyx/

June 28

WSJ Dubious on High ADU Costs; Quoting Tunis, Bach

https://www.wsj.com/articles/costly-new-alzheimers-drug-could-force-medicare-to-restrict-access-11624872601

Update at Biopharma Dive

https://www.biopharmadive.com/news/congress-pressure-alzheimers-aduhelm-biogen-fda/602502/

June 27

Summary to date; FDA "hornet's nest," House hearing

https://endpts.com/the-fda-has-now-poked-a-hornets-nest-of-controversy-in-the-house-and-that-could-sting-biogens-mega-blockbuster-quest-in-alzheimers/

June 22

New Drug Costs Equal NASA (NYT)

https://www.nytimes.com/2021/06/22/upshot/alzheimers-aduhelm-medicare-cost.html?referringSource=articleShare

Many Experts Say Limit ADU (NYT)

https://www.nytimes.com/2021/06/21/health/aduhelm-alzheimers-drug.html?searchResultPosition=2

ADU Triggers Cry for Price Reform (Endpoints)

https://endpts.com/biogens-new-alzheimers-drug-serves-as-a-rallying-cry-for-drug-pricing-reforms/

Janet Woodcock Defends ADU Accel Approval

https://endpts.com/woodcock-defends-biogens-new-alzheimers-drug-says-it-has-more-supportive-data-than-many-past-accelerated-approvals/

FDA Releases Approval Meeting Documents

https://www.statnews.com/2021/06/22/documents-reveal-fda-unprecedented-aduhelm-decision/

FDA web page (see "Application Review Files")

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761178_Orig1s000TOC.cfm

Detailed Footnoted Articles at ALZFORUM (Madolyn Bowman Rogers)

https://www.alzforum.org/news/research-news/aducanumab-approval-sparks-backlash

https://www.alzforum.org/news/research-news/new-era-alzheimers-treatment

June 21

Harvard's Kesselheim Slams ADU decision

https://www.cbsnews.com/news/fda-adviser-alzheimers-drug-aduhelm/?ftag=CNM-00-10aac3a

June 20

Leroy Hood; Wife with Alzheimer's; Son with ApoE4/E4; Exercise FINGERS trial

https://www.latimes.com/opinion/story/2021-06-20/alzheimers-treatment-research-genetics-health

June 17

WaPo: Furor Rages over FDA approval

https://www.washingtonpost.com/health/2021/06/17/alzheimers-drug-controversy/

"Another complication is that the PET scans used to detect amyloid clumps — critical to diagnosing Alzheimer’s — can cost thousands of dollars and are not covered by Medicare. Nor are the multiple follow-up scans needed to check for tiny brain bleeds sometimes caused by the drug."

LATimes: Alzheimer approval looks bad (Hitzik)

https://www.latimes.com/business/story/2021-06-17/fda-alzheimers-drug-looks-worse-than-ever

Links to report by ALTARUM consultants "raise national health spending 1%" (dateline June 16)

https://altarum.org/news/new-alzheimer-s-drug-projected-increase-national-health-expenditures-more-one-percent

June 16

CMS Needs to do FDA job, Limit population

https://endpts.com/opinion-cms-needs-to-do-fdas-job-and-limit-the-use-of-biogens-pricy-new-alzheimers-drug/

Alz Assoc: Stop Discussing the Decision

https://www.statnews.com/2021/06/16/qa-ceo-alzheimers-association-on-aduhelm/

Public Citizen calls on Officials to Resign

https://www.citizen.org/article/letter-to-the-hhs-secretary-calling-for-the-resignations-of-acting-fda-commissioner-other-top-officials-responsible-for-indefensible-approval-of-the-alzheimers-disease-drug-aducanumab/

June 15

Politico: "Devastating costs," review, incl. PET issues

https://www.politico.com/news/2021/06/15/fda-alzheimers-drug-aduhelm-costs-494546

NYT: Op Ed: "Worst Decision, New Low"

https://www.nytimes.com/2021/06/15/opinion/alzheimers-drug-aducanumab-fda.html?searchResultPosition=2

Woodcock defends at BioCentury (subsc)

https://www.biocentury.com/article/637248/acting-fda-commissioner-woodcock-defends-aducanumab-approval

June 12

Stat Plus: Alz Assoc Condemns Price

https://www.statnews.com/pharmalot/2021/06/12/alzheimers-association-biogen-fda-aduhelm-price/

Stat Plus: Is Woodcock in line of ADU fire?

https://www.statnews.com/pharmalot/2021/06/11/covid19-vaccine-g7-biogen-fda-alzheimers-lilly/

June 10

Biogen hopes quick rollout.

https://endpts.com/with-its-controversial-aducanumab-approval-in-hand-biogen-gears-up-for-a-quick-us-rollout/

Drug Could Break US Healthcare / Bagley

https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-drug-alzheimers-cost-medicare/619169/

Harvard Kesselheim Quits FDA Board

https://www.fiercebiotech.com/biotech/harvard-s-kesselheim-quits-adcomm-over-fda-s-aduhelm-approval

Separately, STAT quotes Kesselheim letter to FDA, "Worst drug decision in recent US history." See his June 15 NYT op ed.

https://www.statnews.com/2021/06/10/third-member-of-fda-expert-committee-resigns-over-controversial-alzheimers-therapy-decision/

Three Quit FDA, NYT

https://www.nytimes.com/2021/06/10/health/aduhelm-fda-resign-alzheimers.html

In an ASCO video, apparently oncologist Richard Pazdur at FDA says he advised ADU team.

https://www.statnews.com/2021/06/09/virtual-event-the-asco-recap-live-2021/

"Thorny issues ahead for ADU" - Stat Plus

https://www.statnews.com/2021/06/10/biogen-aducanumab-aduhelm-payment-infusions/

Implications across stakeholders; Rachel Sachs JD

https://www.healthaffairs.org/do/10.1377/hblog20210609.921363/full/

June 9

FDA Panelist Resigns (Joel Perlmutter)

https://www.statnews.com/2021/06/08/fda-expert-panel-resigns-alzheimers-approval/

Two Doctors Resign (Business Insider) (Subsc.)

https://www.businessinsider.com/doctors-resign-from-fda-panel-after-aducanumab-biogen-approval-2021-6

(It's David Knopman, Mayo)

https://news.yahoo.com/two-members-u-fda-advisory-214345113.html

"Second ad comm members abandons his point." (June 10)

https://endpts.com/a-second-adcomm-member-abandons-his-post-in-aftermath-of-controversial-aducanumab-decision/

Majority Say ADU Disaster

https://endpts.com/what-does-a-clear-majority-of-the-biopharma-industry-think-of-the-fda-approval-of-aducanumab-horrifying-dangerous-confusing-disaster/

Will Biogen Ever Publish ADU??

https://endpts.com/will-biogen-will-ever-publish-the-trial-results-for-its-new-alzheimers-drug/

Bad Drug at High Price

https://www.statnews.com/2021/06/08/aducanumab-lackluster-drug-high-price/

A Drag on Innovation for Years to Come (Op Ed)

https://www.fiercebiotech.com/biotech/editors-corner-fda-s-decision-aducanumab-will-drag-down-innovation-for-years-to-come

June 8

NYT - Bonanza at taxpayer expense; Peter Bach quotes

https://www.nytimes.com/2021/06/08/business/aducanumab-alzheimers-cost.html?action=click&module=Top%20Stories&pgtype=Homepage

LAT - Debated drugs; Benefit 0.39/18, Other AMY lowering drugs didn't work in the past.

https://www.latimes.com/science/story/2021-06-07/us-regulators-ok-alzheimers-drug-against-advice-of-experts

Endpoints - ADU Price, Reactions in Global markets

https://endpts.com/analysts-hound-biogen-with-questions-over-aduhelms-56k-price-point-as-news-of-alzheimers-ok-ripples-through-global-markets/

ADU is $50,000 too much

https://qz.com/2018322/fda-approved-alzheimers-drug-aduhelm-is-50000-too-expensive/#:~:text=According%20to%20ICER%2C%20this%20is,%242%2C500%20to%20%248%2C300%20per%20year.

"A Disgraceful Decision"

https://arstechnica.com/science/2021/06/a-disgraceful-decision-researchers-blast-fda-for-approving-alzheimers-drug/

USA Today; Reagan's daughter; QOL?

https://www.usatoday.com/story/opinion/voices/2021/06/10/alzheimers-disease-new-drug-aduhelm-reagan-daughter/7621335002/

Biogen, FDA at odds over trial timing

https://www.statnews.com/2021/06/08/biogen-fda-at-odds-over-timing-of-crucial-confirmatory-trial-of-alzheimers-drug/

June 7, 2021

Mathew Herper, Stat, Biogen, FDA "Shifts the rules."

https://www.statnews.com/2021/06/07/by-approving-biogen-alzheimers-drug-fda-is-shifting-its-rules-that-is-a-giant-risk/

Adam Feuerstein, Historic approval.

https://www.statnews.com/2021/06/07/fda-grants-historic-approval-to-alzheimers-drug-designed-to-slow-cognitive-decline/

Andrew Joseph, "No limits" on patient pool.

FDA said on phone call, it might work later patients.

https://www.statnews.com/2021/06/07/twist-fda-alzheimers-decision-no-limits-on-patients/

Damian Garde, The most lucrative drug in pharma history?

https://www.statnews.com/2021/06/07/why-biogen-may-be-sitting-on-the-most-lucrative-product-in-pharmaceutical-history/

Ed Silverman, "The price is bewildering." "Payers may erect roadblocks." (See Joshua Cohen, below.)

https://www.statnews.com/pharmalot/2021/06/07/biogen-fda-alzheimers-medicare-cms/

Endpoints, "Sadly Misguided"

https://endpts.com/just-how-sadly-misguided-is-the-fda-on-aducanumab/

FDA Bent the rules, and that's bad. Zachary Brennan.

https://endpts.com/opinion-how-the-fda-bent-its-rules-for-biogens-alzheimers-drug-and-why-thats-bad-for-the-entire-biopharma-industry/

FDA approval "sets stage for Medicare coverage battle." Joshua Cohen, Forbes.

https://www.forbes.com/sites/joshuacohen/2021/06/07/controversial-fda-approval-of-alzheimers-drug-aducanumab-sets-stage-for-possible-medicare-coverage-battle/?sh=4b318da919dc

FDA Phase IV Trial Letter (9pp)

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761178Orig1s000ltr.pdf

Health Affairs - Limit Coverage (CED)

https://www.healthaffairs.org/do/10.1377/hblog20210604.489197/full/

AND:

Fierce Healthcare - CMS Should Act Quickly on NCD; Minemyer

https://www.fiercehealthcare.com/payer/experts-cms-should-act-quickly-a-national-coverage-decision-for-biogen-s-newly-approved

>> Discussion of Dickson, Killelea, RG Frank in HA.

ICER First Day Formal Statement

https://icer.org/news-insights/press-releases/icer-issues-statement-on-the-fdas-approval-of-aducanumab-for-alzheimers-disease/

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Other News

One Medical, Iora, another huge merger in the mixed provider/payor space

https://www.statnews.com/2021/06/07/one-medical-iora-health-acquisition/

Harvard Pilgrim and Tufts Health Plan Announce Plans to Hire 'Director of Precision Medicine' to Help Develop Risk-Sharing Agreements Paving the Way for Personalized Medicine

PMC Board Member Michael Sherman, M.D., serves as the Chief Medical Officer of Harvard Pilgrim Health Care and Tufts Health Plan, which finalized a merger in January.

After finalizing their merger with a broad-based commitment to exploring "pace-setting innovations that bring together wide-ranging partners and perspectives to solve health care's challenges," the newly combined Harvard Pilgrim Health Care and Tufts Health Plan are recruiting a Director of Precision Medicine who will focus on spearheading the combined company's efforts to explore innovative solutions in this evolving area of health care. Harvard Pilgrim and Tufts Health Plan's Head of Clinical Innovation, Kate Wallis, said the new hire will be the point person for developing all of the health insurance company's programs in personalized medicine, including a growing portfolio of risk-sharing agreements with the developers of groundbreaking diagnostics and treatments. Harvard Pilgrim's previous risk-sharing agreements, which are designed to base payment rates for certain products and services on how well they work for its patients, have helped speed the advancement of personalized medicine by demonstrating how payers can facilitate access to promising innovations such as genomic sequencing and gene therapies while generating important data about personalized medicine's clinical and economic utility.

"As the entity whose policies may influence access to personalized medicine diagnostics and treatments, health plans have a unique opportunity to facilitate access to these important advancements and to do so in a way that balances access and affordability," said PMC Board Member Michael Sherman, M.D., who serves as the Chief Medical Officer of Harvard Pilgrim and Tufts Health Plan.

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