“Quality of Life” is not a phrase in the Constitution like the “pursuit of happiness,” but in the face of incurable illness and decline, both concepts loom large. Whether the new drug Aduhelm improves quality (or prolongs duration) of life in Alzheimer’s patients seems unclear…and this being the US, at what cost?
Context before exploring the “rational…response”: Aduhelm (aducanumab) was granted US marketing rights by FDA leadership on June 7, over a solid vote against approval by its own selected panel of experts. Some panel wrote of their objections for the public, mainly about determination of clinical efficacy, and some resigned. Others are more supportive of the drug.
In press releases that same day, Pharma partners Biogen / Eisai announced the decision and a wholesale price of $56,000. The price was based on an average patient weight, about $4,000/ dose. They also announced ways that patients might seek help paying for it.
That wholesale price does not include the doctor / hospital fees, IV administration fees, necessary scans to monitor side effects, and “markup.” The wholesale price/gram of Aduhelm is about 100X the price of gold.
To paraphrase a JAMA Viewpoint estimate from July, if 10% of US Alzheimer’s patients receive Aduhelm, Medicare’s drug budget would then increase by $32B; in contrast NASA’s entire 2021 Budget is $23B. It even suggests how a direct tax increase might look!
Those authors describe some of the Medicare agency’s issues in dealing with the cost of Aduhelm. Two NEJM papers last week discuss other aspects, one pointing out “irrational insurance problems” in the US environment of drug pricing, calling the price a “rational manufacturer response”; the other describes how state Medicaid programs might be impacted. The latter calls for Congressional action.
An independent non-profit health economics group, Institute for Clinical and Economic Review, suggests that Aduhelm’s evidence is “insufficient to show a net health benefit” and is over-priced by 10-fold, suggesting ~ 90% discount. It also suggests a closer followup than the nine year post-marketing assessment period granted by the FDA, and other policy changes.
Besides treatment with Aduhelm, if you had to pay out of pocket, what does $56K (~salary of a HS teacher in our state) get you in 2021? How about a new Lexus ES-300h sedan, or an upscale 180-night world cruise (single fare, balcony)? Or as a gift, five wishes for kids with life-limiting conditions at Make-A-Wish? Those might be more tangible quality or happiness goals.
But who pays out of pocket for the whole cost of their medications these days? COVID-19 vaccines are said to cost the US government about $15-20/dose, free to the public, but retail HPV vaccines might cost >$200 without insurance. The most expensive drug in the US costs $2.1 million, a viral-mediated gene replacement one-time therapy, Zolgensma. The top ten most expensive drugs are all for very rare conditions, many >$500K/year.
Drug pricing reform seems….well, you know! So, instead …. Have a Happy Holiday Season (damn the budget, full speed ahead on the spending!)
