This one has a reasonably settled answer, so here it is. Denials are usually procedural rather than clinical, and the order that works reflects that. Get the denial reason in writing, because it names the criterion you failed. Then supply the documentation that criterion asks for — usually documented BMI with a comorbidity, or a failed prior therapy. Then appeal, and ask for a peer-to-peer review, because a prescriber talking to a reviewing clinician resolves a large fraction of denials that written appeals do not. Manufacturer copay assistance is separate and applies mainly to commercial insurance, and patient assistance programmes are means-tested rather than a discount.
Reading the phase 2 write-up next to the injectable trials, and the comparison people keep making does not survive putting the two protocols side by side.
Phase 2: about 14.7% at 36 weeks on 45mg, GI adverse events broadly in line with the injectables, no food-timing requirement.
The question I want answered is whether a non-peptide oral agonist can match injectable exposure in practice, or whether the convenience is bought with a lower ceiling.
Happy to be told the question itself is wrong.
mike.trainer_LA said:Denials are usually procedural rather than clinical, and the order that works reflects that.
Agreeing with mike.trainer_LA, and the qualification matters more than the agreement. The manufacturing argument is the underrated one. Peptide synthesis capacity has been the binding constraint on this entire class, and a small molecule is made in ordinary chemical plants. If it holds up in phase 3, the supply and price picture changes more than the efficacy picture does.
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Browse GL BiochemDr.CardioMD said:Reading the phase 2 write-up next to the injectable trials, and the comparison people keep making does not survive putting the two protocols side by…
Agreed, and coverage criteria are plan-specific rather than insurer-specific. Two people with the same insurer and different employers have different rules, which is why "my insurer covers it" is not transferable information.
If somebody has the primary source to hand I would rather cite it than paraphrase it.
From the other side of the consultation, briefly. The distinction that resolves most of these threads is between what is true on average and what is true for one person. Both are real; they answer different questions and get quoted as if they were the same one.