German G-BA starting Kymriah’s appraisal

A few days after Novartis announced Kymriah’s list price in Germany – i.e. 320’000 € – the G-BA has started the procedure to review the CAR-T for treating forms of child (ALL) and adult (DLBCL) leukemias. The G-BA review, that will be finalized in mid-December 2018,  will feed into price negotiations between Novartis and the German health insurances that will take place in 2019.

German G-BA positive on Takeda’s Darvadstrocel

The German G-BA just published the added-benefit assessment for Takeda/Tigenix’ Darvadstrocel, link to the G-BA webpage here: G-BA Darvadstrocel

Darvadstrocel has orphan drag status in Europe and therefore it is assumed by G-BA to bring some kind of benefit to patients. A consultation process will be held until the end of September and the final G-BA resolution with be published end of November 2018.

G-BA have assessed Darvadstrocel added benefit based on the pivotal trial ADMIRE-CD with the strongest evidence of effect coming from time-to-remission data both at 24 and 52 weeks.

UK NICE says draft No to Yescarta

Just the day after the good news of EMA marketing authorisation to Yescarta and Kymriah, NICE posted the Yescarta Draft Guidance for consultation, and it is a No. Here the link to the draft recommendation: NICE draft guidance

These news come as a surprise and apparently in contradiction with previous NICE work on CAR-Ts, the so-called CAR-T mock appraisal.

The NICE committee motivates this initial no with the lack of comparative data vs. chemotherapy and therefore on the uncertainty about size of benefit. Here below the excerpt from the NICE document:

“Evidence from a small, single-arm study suggests that people having axicabtagene ciloleucel have good response rates, overall survival and progression-free survival. But, there are no direct data comparing axicabtagene ciloleucel with salvage chemotherapy (referred to as best supportive care by the company). This means that the exact size of the benefit of axicabtagene ciloleucel compared with salvage chemotherapy is unknown.”

 

And now what?  – Yescarta’s draft guidance is currently undergoing a consultation process, and Gilead/Kite will have the opportunity to complement the submission with more relevant chemotherapy data. NICE has suggested to use subpopulation data from the ORCHARRD study or from the UK Haematological Malignancy Research Network. The NICE Committee will meet again on September 27th and a final decision is expected for December 17th.

Our guess: at NICE, an initial no does not mean no. There are good reasons to think that Gilead/Kite have the opportunity to turn it into a yes for Yescarta.

Negative draft NICE guidance for Biogen’s Nusinersen for SMA

The UK NICE has issued a negative draft guidance on Nusinersen. NICE motivates its current position mainly on the grounds of the high acquisition cost of Nusinersen and the uncertainty on long term effect. This is not a final decision and a second NICE Appraisal Committee meeting is expected for October 2018. NICE’s language makes think that a further confidential price discount may change the guidance to positive. The NICE press release can be read clicking the link below:

NICE negative draft guidance on Nusinersen

 

THE WAY FORWARD FOR HTA COOPERATION – THE VIEWS OF STAKEHOLDERS

Could a more coordinated EU HTA improve access to new healthcare technologies, favour development of EU-wide evidence development infrastructure and reduce fragmentation? These and other related topics will be discussed on July 9th in Brussels in a meeting organised by the EU Commission and that will involve relevant stakeholders. Here below a link to the meeting webpage:

meeting programme