Replies to post #574428 on NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Per a Bristol Myers spokesperson, Opdualag won’t be marketed in Germany “for the foreseeable future,” as the country’s drug pricing law from 2010 makes it so that the pharma giant “sees no possibility to achieve a benefit rating from the G-BA [Gemeinsamer Bundesausschuss] for Opdualag.”

Not including that benefit rating from the G-BA means the price regulator does not think Opdualag has any additional benefit over its appropriate comparator (“preferably a therapy for which endpoint studies are available and which has proved beneficial in practical use,” the German regulator’s English website says), so the drug’s yearly treatment costs cannot be higher than what it is being compared to.

Part of the reason is due to BMS’ use of progression-free survival (PFS) in measuring Opdualag’s efficacy. A BMS spokesperson said that while the combo drug demonstrated statistically-significant PFS over anti-PD-1 monotherapy in patients with advanced melanoma, the AMNOG law does not consider PFS a “patient-relevant endpoint.”

https://endpts.com/bristol-myers-axes-german-launch-of-new-cancer-drug-citing-pricing-hurdles/?u=200286d9-a154-4450-a266-8f0bf8cf7980&s=email&c=524130ce-075cfa5f-9398dfde&utm_medium=email&utm_campaign=274%20-%20BMS%20decides%20not%20to%20launch%20new%20cancer%20drug%20in%20Germany%20California%20looks%20to%20cut%20ties%20with%20Walgreens%20Basic&utm_content=274%20-%20BMS%20decides%20not%20to%20launch%20new%20cancer%20drug%20in%20Germany%20California%20looks%20to%20cut%20ties%20with%20Walgreens%20Basic+CID_ff054bb167e8a1077705bb9cb3849dd2&utm_source=ENDPOINTS%20emails&utm_term=Bristol%20Myers%20axes%20German%20launch%20of%20new%20cancer%20drug%20citing%20pricing%20hurdles

[space~farm]

I personally think it’s bearish. FDA is the most lenient with pricing so I really hope they prioritize BLA. That being said GBM has less treatment options and I think there is a better use case for DC-Vax.

But remember it’s only been a couple months since MHRA approved Kite’s Yescarta so I dunno it definitely is a little bit of a gamble going for MHRA first.

[ilovetech]

Germany's reimbursement guidelines are brutal. I wouldn't take anything for granted with their system. While believing that the company blew the lid off the meeting with efficacy and cost effectiveness data, you may find your jaw on the ground, when an inappropriate comparator is used to reject the pricing model. Vascepa was expected to earn a 70% margin on a $170.00 spread. No combination therapy has ever improved the RRR of having a cardiac event by 25% on top of the 25% provided when on statins alone. Germamy chose cheaper Fibrates as a comparator despite all recent literature showing no additional benefit. Keep in mind, an once of prevention is far cheaper than the cost of hospitalization, and the cost of future aftercare, and the cost of reducing taxable labor income that supports the system.

Go figure that one out.

ILT