by Natalie Morrison
LONDON, 14 Dec (APM) - NICE would expect to remain part of the EUnetHTA parallel advice process if the current Brexit deal is approved, the UK health assessor’s director of scientific advice Jeanette Kusel told APM.
However, if the UK leaves the EU without a deal, “it is currently unclear whether we would be able to continue to participate as we are,” she said in a Thursday afternoon email.
“If there are any ongoing parallel projects at this stage, we would continue to provide the companies with a separate advice meeting and report from NICE in the event that we are unable to participate in the parallel process.”
The current Brexit withdrawal agreement (APMHE 60598
) presented to European and UK MPs is on shaky ground. UK Prime Minister Theresa May faced a vote of no confidence in Parliament earlier this week, winning the right to stay in office by what many commenters have branded an uncomfortably close margin.
MPs who voted against May are unhappy with the current deal, particularly with the ‘backstop’ agreement, which would keep the UK in the EU trading union indefinitely if an agreement cannot be made to prevent a hard border between the North and the Republic of Ireland.
However, on Friday, the BBC reported that European Union leaders say the agreement is “not open for renegotiation”, despite May’s warnings that it is “at risk” if UK MP concerns cannot be addressed.
Can joint advice only ever be high-level?
Kusel’s comments follow her participation in a panel session at EBE’s seventh annual regulatory conference on advanced therapies in London earlier this month, where she spoke about joint health technology assessment (HTA) and European Medicines Agency (EMA) activities through the European network of HTA bodies (EUnetHTA).
She told the audience that joint early scientific advice is usually at a high level, and that if companies want more specific advice they may need to approach NICE directly.
Speaking to APM about these comments, Kusel said: “It is the company’s decision in each individual case on whether they would like to request NICE scientific advice directly or whether they would like NICE to be part of the EUnetHTA-EMA parallel process.
“In our standard national advice, we can go into a broader range of topics in more depth and we involve a health economics expert, a senior HTA expert from the UK and a UK patient expert, as well as a UK clinical expert who is involved in either the national or EUnetHTA-EMA process.”
APM asked whether joint early scientific advice can only ever be on a high level as national reimbursement procedures are so different.
Kusel replied: “As there are a number of stakeholders involved in the parallel process it often means that there is not time to go into a wide range of individual topics in great detail. If there are certain topics that the company feels they would like to explore in depth with all parties, then this is possible, but it may limit the number of topics that the company is able to cover.
“These parallel meetings also do not include external health economics experts, and therefore detailed discussions on modelling methods are often better had via the national NICE scientific advice process.”
Others at the conference said that early HTA-EMA dialogue tends to lack detail because sponsor companies do not provide it. Specifically, they were referring to the information presented on post-launch evidence generation (PLEG) (APMHE 60940
In particular, they stressed the importance of early discussions over PLEG with developers of advanced therapy medicinal products (ATMPs), since these products tend to have high price tags but curative benefits (APMHE 60922
, APMHE 60928