Connecting ALS

This week Jeremy talks to Dr. Stephen Goutman, Director of the Pranger ALS Clinic and Associate Professor of Neurology at the University of Michigan, about ALS risk factors and the burgeoning science of preventing ALS.

Learn more about research being done into preventing ALS at https://www.als.org/research/funding-opportunities/prevention-grants-2022

This episode is brought to you by The ALS Association in partnership with CitizenRacecar.

This week, Jeremy continues his conversation with Dr. Neil Thakur, chief mission officer at The ALS Association, about the latest developments in the fight for approval of and access to AMX0035 and explores the Association’s formal objections to ICER’s draft analysis.

Learn more about efforts to make sure flawed and discriminatory data isn’t used to erect barriers to access at als.org/icer

This episode is brought to you by The ALS Association in partnership with CitizenRacecar.

Given the FDA’s decision to reconvene the Peripheral and Central Nervous System Drugs Advisory Committee to discuss the New Drug Application for AMX0035 for the treatment of amyotrophic lateral sclerosis, Jeremy welcomes back Dr. Neil Thakur, chief mission officer at The ALS Association, for the latest.

To urge the FDA to approve AMX0035 as quickly as possible go to als.org/fda

To read the letter from several dozen ALC clinical experts calling on FDA to make AMX0035 available as a treatment option go to https://www.als.org/stories-news/several-dozen-prominent-als-clinicians-call-fda-approve-amx0035

This episode is brought to you by The ALS Association in partnership with CitizenRacecar.

This week Jeremy is joined by Dr. Sarah Parvanta, director of ALS Focus, and Stuart Obermann, vice president of organizational readiness at The ALS Association, to dig into the challenges people with ALS face accessing equipment they need to address mobility challenges and what can be done to reduce barriers to access.

Learn more about ALS Focus at alsfocus.org

Learn more about ALS and mobility at https://www.als.org/navigating-als/living-with-als/therapies-care/mobility-als

This episode is brought to you by The ALS Association in partnership with CitizenRacecar.

This week Jeremy talks to Mark Schoenbaum about his struggles getting medically necessary care through his Medicare Advantage Program and then turns to Peggy Lighe, a health care advocate who is helping to lead the fight to pass legislation to modernize Medicare Advantage help reduce delays in care for beneficiaries.

Learn more about the Regulatory Relief Coalition’s work to pass the Improving Seniors’ Timely Access to Care Act at regrelief.org

Find the Inspector General’s report on prior authorizations at https://oig.hhs.gov/oei/reports/OEI-09-18-00260.asp

This episode is brought to you by The ALS Association in partnership with CitizenRacecar.

This week, Jeremy provides an update on the fight for approval of AMX0035, including an extended review period at the FDA and how new data and approval in Canada puts more pressure on the FDA to act quickly. He also talks to Dr. David Vequist, director of the Center for Medical Tourism Research at the University of the Incarnate Word, about the history of medical and pharmaceutical tourism around the world.

Learn more about the Center for Medical Tourism Research at https://my.uiw.edu/medical-tourism/index.html

To email the FDA and urge them to approve AMX0035 quickly, go to als.org/fda

Read more about the potential impact on FDA delay at https://www.wsj.com/articles/a-lot-to-figure-out-als-patients-weigh-travel-to-canada-to-get-drug-for-deadly-illness-11655906422?mod=hp_lista_pos2

To read the letter signed by 38 ALS clinical experts urging approval of AMX0035, go to https://www.als.org/stories-news/several-dozen-prominent-als-clinicians-call-fda-approve-amx0035

This episode is brought to you by The ALS Association in partnership with CitizenRacecar.

This week Jeremy talks to Dave Zook, chair of Faegre Drinker Consulting and an advisor for The ALS Association, about the process of getting new drugs covered by Medicare, the VA and insurance companies.

Join the fight to get emerging drugs approved at als.org/fda

Watch a video recording of this episode at https://www.neurologylive.com/view/connecting-als-how-new-drug-coverage-decisions-are-made

This episode is brought to you by The ALS Association in partnership with CitizenRacecar.

This week, Jeremy is joined by Dr. Neil Thakur, chief mission officer at The ALS Association, and Melanie Lendnal, the Association’s senior vice president of policy and advocacy, to get an update on the fight to make AMX0035 available, preview the 2022 ALS Association Advocacy Conference, and dig into the role advocates play in making ALS livable.

Send an email to the FDA telling them to approve AMX0035 as soon as possible at www.als.org/fda

Register for The ALS Association’s 2022 Advocacy Conference at https://www.als.org/advocacy-conference

Learn more about the tofersen trial results at https://www.als.org/stories-news/biogen-announces-promising-findings-tofersen-trial

For the latest on the fight for approval and access to AMX0035, go to https://www.als.org/stories-news/fda-extends-timeline-amx0035-review

This episode is brought to you by The ALS Association in partnership with CitizenRacecar.

This week, Jeremy reflects on the legacy of Lou Gehrig and revisits a conversation with Larry Falivena, a member of The ALS Association’s board of trustees, on the genesis of Lou Gehrig Day.

Learn more about Lou Gehrig Day at https://www.als.org/4ALS

Check out how communities across the country commemorated Lou Gehrig Day in 2021 at https://www.als.org/lou-gehrig-day-photos

For more on MLB’s support of ALS go to https://www.mlb.com/mlb-community/4als

This episode is brought to you by The ALS Association in partnership with CitizenRacecar.

This week Jeremy wraps up ALS Awareness Month by talking to Ellen and Lorenzo Trujillo about living with ALS and taking on life one day at a time.

Read more about Ellen and Lorenzo at https://www.als.org/blog/ellen-and-lorenzo-trujillo-living-als-one-day-time

The opportunity to tell the FDA to approve AMX035, referenced in this episode, can be found at https://www.als.org/blog/ellen-and-lorenzo-trujillo-living-als-one-day-time

To sign up for the 2022 advocacy conference, referenced in this episode, go to https://www.als.org/stories-news/join-us-2022-virtual-advocacy-conference

This episode is brought to you by The ALS Association in partnership with CitizenRacecar.