Aurinia Pharmaceuticals Inc (AUPH)

[moosedogger]

What this country needs is a good de-ICER

ICER final report (Lupkynis vs. Benlysta) is out and Aurina got royally shafted (as anticipated).

https://34eyj51jerf417itp82ufdoe-wpengine.netdna-ssl.com/wp-content/uploads/2020/11/ICER_Lupus-Nephritis_Final-Evidence-Report_041621.pdf

Can't really say enough bad things about these ICER bums- dishonest, disingenuous, incompetent, etc.

The report is 166 pages, so thoroughly digesting it will be time-consuming.

Here are a just a few gag-worthy gems I've found fairly quickly; I'm sure there are many more:

With these uncertainties in view, our modeling suggests that belimumab’s estimated net price aligns well with its’ estimated long-term added benefits for patients. These findings do not include
consideration of potential broader benefits of belimumab on health for patients with LN. For voclosporin, its estimated net price produces a cost-effectiveness result at the upper end of commonly accepted ranges.
(p. 10 of 166 pgs.)

Finally, the majority of the Council judged belimumab to©Institute for Clinical and Economic Review, 2021 Page ES4 Evidence Report – Belimumab and Voclosporin for Lupus Nephritis provide a “high” long-term value for money and voclosporin to provide an “intermediate” longterm value for money, at current pricing.
(p. 10-11 of 166 pgs.)

At their net prices, approximately 80% (belimumab) and 35% (voclosporin) of eligible patients with LN could be treated in a given year before crossing the ICER potential budget impact threshold of $819 million per year. Testimony from clinical experts at the public meeting suggested that the uptake of these drugs would include the chance for nearly every patient to be on one drug or the other. Given that efforts to reach this clinical target would create a short-term potential budget impact that exceeds the threshold, ICER is issuing an access and affordability alert.
(pg. 11)

Manufacturers should not seek to use common sense dosing algorithms as a tool to gain prolongation of their patents, thereby adding to future health care affordability concerns and reducing the headroom for future innovative therapies.
(p.11)

There are several other important differences between the trials. The primary outcome for the AURORA trial was “complete response” (CR) at one year, while the primary outcome in the BLISS-LN trial was “primary efficacy renal response” (PERR) at two years. Apart from the time of assessment, the two outcomes differed in the degree of allowable proteinuria (CR UPCR ≤ 0.5; PERR UCPR ≤ 0.7) and CR required sustained, low dose or no corticosteroid use. Since the differences are small, it is reasonable to compare them at similar time points. There were also slight differences in the definitions used for complete response and partial response in the two trials (Supplement Section A1 describes the specifics for each definition). Lastly, the AURORA trial required a rapid taper of corticosteroids, which was not required in the BLISS-LN trial
(p. 16)


They never said it would be easy!

Cheers anyway