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FDA Approves Radicava, First New ALS1 Therapy in 22 Years

alsnewstoday.com

11–20 of 32 posts

Re: FDA Approves Radicava, First New ALS1 Therapy in 22 Years

#11
According to the ALS Association, the treatment’s list price is $1,000 per infusion, or about $146,000 annually, and it is expected to be available for use by August

A whole new class of drugs is reaching these prices. "The insurance" doesn't really pay; those xx% increases every year in premiums do.

Re: FDA Approves Radicava, First New ALS1 Therapy in 22 Years

#12
> According to the ALS Association, the treatment’s list price is $1,000 per infusion, or about $146,000 annually, and it is expected to be available for use by August.

$146k/year for being able to live a better life, or maybe at all. right up there with cancer treatments according to my ethical standards.

Re: FDA Approves Radicava, First New ALS1 Therapy in 22 Years

#13
post #4

Earlier quoted context omitted.

Private insurance, unless you're on Medicare.

Medicaid may cover it and the company is providing it at no charge to people that are uninsured and meet some other requirements ( http://web.alsa.org/site/PageNavigator/alsa_radicava_faq.htm... )

How much paperwork does it take to prove you meet those requirements and what is the cognitive/time cost of that paperwork?

Gentoo is free-as-in-speech, but way way too expensive for most people. Given that the US healthcare system is bewildering even to middle-class people who have relatives that work in healthcare, the cognitive costs of something like this might be considerable.

Re: FDA Approves Radicava, First New ALS1 Therapy in 22 Years

#14

According to the ALS Association, the treatment’s list price is $1,000 per infusion, or about $146,000 annually, and it is expected to be available for use by August A whole new class of drugs is reaching these prices. "The insurance" doesn't really pay; those xx% increases every year in premiums do.

Yeah. Other countries generally solve this by not covering these treatments; for example there's no way this would be available on the NHS at this price. Somehow I suspect this would be a political non-starter in the US through.

Re: FDA Approves Radicava, First New ALS1 Therapy in 22 Years

#15
post #9
post #8

> Results from the six-month Japanese clinical trial — in which 137 patients were randomized to receive either Radicava or placebo Giving placebo to ALS patients? How is that allowed ? They should be able to tell already what is the course of a typical ALS patient without using such methods. For cancer drugs there are no placebo used since there is extensive survival data available to prove whether or not a drug actu…

You have to get rid of placebo effect. It can be pretty strong in an (supposedly) advanced drug tests. >For cancer drugs there are no placebo used since there is extensive survival data available to prove whether or not a drug actually makes any difference. Source, please?

Are you kidding me ? Are you assuming I don't know what I am commenting about ?

http://www.cancer.net/navigating-cancer-care/how-cancer-trea...

"In past years, it was generally not necessary or possible to use placebos in cancer clinical trials."

Re: FDA Approves Radicava, First New ALS1 Therapy in 22 Years

#16
post #12

> According to the ALS Association, the treatment’s list price is $1,000 per infusion, or about $146,000 annually, and it is expected to be available for use by August. $146k/year for being able to live a better life, or maybe at all. right up there with cancer treatments according to my ethical standards.

I don't claim to understand this aspect of healthcare very well. But I've definitely observed that the list price of medications keeps on going up, insurance keeps on paying for it, and we keep on having higher premiums. Who wins? Who loses?

Re: FDA Approves Radicava, First New ALS1 Therapy in 22 Years

#18
I have some problem to understand why this is presented as a therapy (may be I do not understand what it implies) when the paper (or I may have found the wrong paper) states:

"Edaravone showed efficacy in a small subset of people with ALS who met criteria identified in post-hoc analysis of a previous phase 3 study, showing a significantly smaller decline of ALSFRS-R score compared with placebo. There is no indication that edaravone might be effective in a wider population of patients with ALS who do not meet the criteria"

Another paper is quite skeptical:

"Edaravone: a new treatment for ALS on the horizon? Orla Hardiman, , Leonard H van den Berg"

Re: FDA Approves Radicava, First New ALS1 Therapy in 22 Years

#19

Earlier quoted context omitted.

Medicaid may cover it and the company is providing it at no charge to people that are uninsured and meet some other requirements ( http://web.alsa.org/site/PageNavigator/alsa_radicava_faq.htm... )

How much paperwork does it take to prove you meet those requirements and what is the cognitive/time cost of that paperwork? Gentoo is free-as-in-speech, but way way too expensive for most people. Given that the US healthcare system is bewildering even to middle-class people who have relatives that work in healthcare, the cognitive costs of something like this might be considerable.

So what's your point?

I was speaking to there being other potential mechanisms to obtain the drug, not glorifying the US health system.

Re: FDA Approves Radicava, First New ALS1 Therapy in 22 Years

#20
post #14

According to the ALS Association, the treatment’s list price is $1,000 per infusion, or about $146,000 annually, and it is expected to be available for use by August A whole new class of drugs is reaching these prices. "The insurance" doesn't really pay; those xx% increases every year in premiums do.

Yeah. Other countries generally solve this by not covering these treatments; for example there's no way this would be available on the NHS at this price. Somehow I suspect this would be a political non-starter in the US through.

No, a huge portion of the US is on board with the idea that the government shouldn't be covering any medical care.

Apparently they don't even want the federal government having standards for acceptable insurance plans (but they want a federal law saying that the standards set by any state can be used to market plans in all states).

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