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Whether or not “people who could benefit have access” is not relevant to the FDA’s mandate. The intent of the FDA is to regulate the safety and efficacy of medicines - not access, not price.
Once supply was addressed, the FDA’s regulatory objectives were complete
Every country arranges their payment mechanism slightly differently- the US is worse than pretty much all of them but they are all slightly different- but every form of insurance has to be able to walk away in the negotiations, or else the monopoly producer will hike the price up.
I imagine if you forced insurance to cover but also removed patent protection and allowed generics immediately... drug companies would be even more unhappy than the insurance companies would if you forced them to cover GLP-1's.
Insurance companies have to pay $100k+ per month for medicine for anemic people, and many other much higher cost medicines. Why is a couple hundred dollars to fix THE single biggest cause of future healthcare expenses (diabetes, high blood pressure, and cholesterol) not covered?
https://www.desmoinesregister.com/story/news/health/2017/05/...
Insurers routinely pay for $1M+ NICU babies, $100k+ heart surgeries, yada yada, but the US government draws the line at medicine that costs $200 per month that prevents hundreds of thousands of dollars in future spend?
I can’t make it make sense, unless the junk food/alcohol/restaurant/sugar caffeine drink lobby has their tentacles deep in the government.
I think the easiest answer is found by looking towards religion. Gluttony being one of the seven deadly sins. Obesity is seen as a moral problem by a lot of people, so paying for its treatment would be broadly unpopular. People who cannot control their appetite need to suffer.
That means that every healthy person is also paying $670 per month just so that the 2/3 of the country can get this drug. But current medical loss ratios are at least 85% and if we did nothing but pay $670 we’d be at 100% loss ratio and the drug paid for.
Boy the economics for the average person look pretty bad, considering they can just get it off the internet for a fraction. I have 240 mg of retatrutide in my fridge for about a dollar a mg in comparison.
For decades now, every single healthcare study seems to say overconsumption is the root cause, and now that there is a way to combat it, the government is saying the fix to overconsumption at a few hundred dollars per month is not worth it?
PS - And, yes, compound versions are $100/month, but insurance doesn't cover those.
For people making how much? Low income people are jumping through the hoops to get SNAP. $100 for them is a lot, and which they might just not have. And for insurance it would be cheaper long-run than dealing with diabetes, etc.
Anyway, why a such "submarine" attack on the $100 GLP-1 sources and why now? Well, one way of thinking would be that Trump RX just went online and there, thanks to the well known Trump's care about people's needs, the GLP-1 is $350, so one has to remove the $100 competitors.
It’s a case of trying to get so many consumers buying that regulators are scared to touch you due to blowback. Much like Uber did.
Insurance companies are allowed to limit access to more expensive therapies unless cheaper therapies have been tried and have failed.
Medicare Part D (outpatient drugs) has wide latitude on what medicines they cover - it's actually smart for patients to shop their Part D plans if they are taking an expensive, chronic medication.
The only classes of drugs that Part D plans must included are:
Part D sponsor formularies must include all or substantially all drugs in the immunosuppressant (for prophylaxis of organ transplant rejection), antidepressant, antipsychotic, anticonvulsant, antiretroviral, and antineoplastic classes. (Page 28)
https://www.cms.gov/medicare/prescription-drug-coverage/pres...
If I were Trump for a day I'd force Lilly to sell the tirzepatide patent to the federal government (I'd even pay them a fair amount) and then make it a generic. Maybe a subsidized generic, even. Then in a decade or so the citizenry might actually be okay naming things after me. Though it might require dialing back some other activities, but whatever.