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I also found this leaflet …
https://www.ouh.nhs.uk/patient-guide/leaflets/files/12048Punlicensed.pdf
Which explains it.
I suppose a variant is the patient access program for US patients needing surufatinib while it is assessed by the FDA.
Nothing illegal about it at all. Happens all the time across the world (and not just China) as doctors look to ascertain what publicly available drugs might work best for their individual patients, some of whom might have cancers so rare that even Phase I trials are never conducted.
Meanwhile if you are an ambitious salesman worth your salt working for Astra Zeneca and speaking to a hospital, surely you are going to want to mention that while Orpathys has been licensed for NSCLC with somewhat rare MET exon 14 skipping alterations, the drug also has completed a (wildly?) successful Phase 11 trial with Tagrisso for the much more common advantage metastatic EGFR mutation positive NSCLC with MET amplification. And confidence is so high that an exceptionally expensive global phase III trial is now underway.
And then of course as a third line patient with the latter and assuming you can afford the non-NRDL treatment price, you almost certainly would want your doctor to consider prescribing the drug. The alternative of waiting for the global Phase III trial results might not prove ideal if that means you are dead by then.
So while Hutch Med awaits further Phase III trials on its three publicly available drugs within China, the market will be watching for just how successfully the sales teams start the process of persuading the medical industry to utilise Elunate, Sulanda and Opathys across as many scenarios and to as many cancer patients as possible.
Are off label sales legal? Sounds a bit dodgy to me and not something HCM would want to do with its clean regulatory record.
……and the one other area to focus on at the next set off results and beyond, will be how successful the much grown China based sales team has been in securing off-label sales.
Those sales teams already have considerable bodies of evidence to hand (ahead of the various Phase III trials over the next 2-3 years) to show potential patients how the now three licensed drugs can assist in different cancer types.
Off-label sales have always been a significant feature of the most successful Chinese drug companies. HCM has to prove it can do it too.
There was also some market concern prior to this that pricing pressure by the regulator this year might have been so extreme that the company was prepared to take the likes of Elunate off the NRDL. That agreement has been reached between the two, even if details of the new pricing do not yet seem to have been released, has to be good news.
The messaging around Orpathys in the NRDL has been non committal. In the end it probably comes down to numbers….with a relatively small market without alternatives they have chosen to keep a higher list price plus some charitable patient access program as preferable to a significant discount. Maybe AZ think they can the sales they want to establish the product and they will not go for NRDL when there is more volume in combination therapies in a couple of years. Savo is owned by AZ after all with HCM a junior partner.
I am sure the inclusion of sulanda is a good move both politically and commercially….let’s. Hope the terms are reasonable and pave the way for future therapies to come to market with the support of the Chinese regulators.
Nice news today that SULANDA® (surufatinib) has been included in the NRDL and ELUNATE® (fruquintinib) will continue to be on the list. However, I'm puzzled about ORPATHYS® (savolitinib) as the updates states " It was also included in the 2021 negotiations with the NHSA, however HUTCHMED and AstraZeneca, its partner on ORPATHYS®, declined inclusion in the NRDL for 2022." Does that mean Hutchmed and AZ declined or were declined by the NHSA... A moot point given the niche target patient population for Exon14 but it would be interesting to know.