I have some of my doctors asking me about Pitolisant because they feel it will be safer with similar efficacy. What about you guys?
The anti-cataplectic effects in both studies were not consistent. The Harmony I study showed a significant reduction in the cataplexy rate from baseline to final visit (baseline >0.6 cataplectic episodes versus final visit <0.2 episodes in the pitolisant group; RR=0.38, 95% CI [0.16 to 0.93]; p=0.034), whereas Harmony Ibis showed an increasing trend (0.84 episodes from baseline compared with 1.69 episodes at the final visit in the pitolisant group with no statistically significant difference versus placebo p=0.077).
If they had gotten cataplexy they would have been a real threat, but no cataplexy + no data on MWT + some CYP 3A4, 2D6 liability not to mention renal and hepatic dosing limitations will likely limit enthusiasm even for an unscheduled drug.
Wakix has been approved and successfully used in cataplexy for years in Europe. It will be a quick study and approval, along with a patent extension for Wakix. Drs will still use it for narcolepsy with cataplexy because it's the most safe and effective option.
Yep and the fact it's unscheduled can be downplayed but in many parts of the country, any opportunity to use a non controlled substance is HUGE.
Efficacy matters - and trumps scheduling. Thats been proven already. And with regard to a "quick study" to demonstrate efficacy in cataplexy - ever hear of Avidel - still recruiting their study for the last two years. it will not be a quick study. pitolisant is just another modafanil - and that WAS proven in a study.- good luck with payers. You are as effective as a generic.
is anyone running into these reps? My docs like the idea of what Harmony has but they are not sure it will be affordable to use as a combo therapy. Anyone else hearing anything?
Wakix is a WPA - period. Thats it. Only with less impressive data and no objective endpoints - plus a drug drug interaction profile that create of problem with pts on polypharmacy. And oh yeah - they will charge over a $100K per year for a drug that did not beat modafinil in EDS?? Payers will be saying WTF. Use Sunosi for EDS. Payers will not cover W in cataplexy - without an indication. BTW - did you ever wonder why the FDA did not allow the indication? - cause their cataplexy data stinks.
I’m on Wakix. Got a call from the pharmacy to refill today. Over $15,500 a month billed to insurance. I’m going to look to see what they actually paid.
You will never know - your PBM/insurer signed a contract for a discount on the drug in return for formulary placement. That discount is likely in the 30-50% range - so the PBM/insurer pockets the difference between list price and their contracted discount price.
