Euro Roundup: NICE seeks feedback on how it develops health technology guidance

The UK National Institute for Health and Care Excellence (NICE) is seeking feedback on its proposals to create a simplified, single process for all technology evaluations and gain the flexibility to assess new and emerging health technologies. Feedback is being accepted until 15 April.
 
“To continue to support the needs and aspirations of all parts of the healthcare and life sciences ecosystem, NICE must ensure that its processes of health technology evaluation maintain and improve upon key objectives regarding quality, dependability, speed, flexibility and cost,” said Meindert Boysen, deputy chief executive at NICE. “These proposals present an important opportunity to achieve these objectives.”
 
NICE grouped its proposals into four themes.
 

• Align current guidance development processes. Specific proposals include the development of a single simplified process for all Centre for Health Technology Evaluation (CHTE) programs. NICE sees the single process as a response to the different terminology and approaches to scoping, stakeholder involvement and consultation that arose due to the independent evolution of CHTE programs.
• Create new process improvements and ways of working. Specifically, the agency seeks to develop a process to rapidly review guidance as a result of the introduction of biosimilars and an option to stop guidance development when a company puts forward a base-case incremental cost-effectiveness ratio that is well above the standard threshold.
• Improve commercial and managed access processes. Proposals include asking companies to share a summary of data gaps to enable exploratory discussions about managed access and the exploring of opportunities to route promising technologies directly into managed access, without requiring a full health technology evaluation.
• Reaffirm the vision and principles for highly specialized technologies. NICE set up the highly specialized technologies program in 2013 to support the evaluation of drugs and other products targeting rare and very rare diseases. The agency now wants to confirm the program’s vision and underlying principles to further develop the criteria for topic selection and routing.

 
NICE officials will discuss its consultation and answer attendee questions at a webinar on 25 February.
 
Press Release, Consultation Documents
 
Nitrosamine risk drives EU regulators to ask manufacturers to test rifampicin
 
European regulators are requesting marketing authorization holders to test rifampicin-containing medicines for contamination with nitrosamines before releasing them onto the market. The request follows the discovery of a nitrosamine impurity, 1-nitroso-4-methyl piperazine, in some batches of rifampicin medicines.
 
European Medicines Agency (EMA) described the testing request as a precautionary step. Regulators will monitor the responses and act accordingly.
 
The Finnish Medicines Agency (Fimea) is among the regulators to issue statements about the need for testing. Fimea is advising patients and healthcare professionals to continue taking and prescribing rifampicin as before as the risks of not taking the drug outweigh the danger posed by the impurity.
 
EMA issued its notice around the time that the World Health Organization (WHO) published updated critical concentrations for susceptibility testing to rifampicin. WHO lowered the critical concentration for culture-based phenotypic drug susceptibility testing after identifying a flaw in its approach to the detection of rifampicin resistance.
 
EMA Update, Fimea Notice (Finnish), WHO Statement
 
MHRA publishes opinions on potential conflicts of interest in COVID-19 projects
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released its annual report on conflicts of interest. The report details multiple COVID-19 projects that were ultimately deemed to have a public health justification by a subgroup of MHRA’s corporate executive team.
 
MHRA describes seven potential conflicts of interest in the report. Most of the possible issues stem from the relationship between MHRA and the National Institute of Biological Standards and Control (NIBSC) and Clinical Practice Research Datalink (CPRD), which may perform work on products that are later reviewed by the UK regulator.
 
For example, NIBSC was asked to test a SARS-CoV-2 product. The resulting efficacy data could then be used in a regulatory submission to MHRA. The subgroup permitted the work to take place if the samples were sent to NIBSC with minimal information and other mitigating measures were taken.
 
Two of the non-COVID-19 related conflict of interest assessments involved CPRD’s role in Phase 4 clinical effectiveness assessments. CPRD is a real-world research service and as part of MHRA can be asked to work on products that present a potential conflict of interest. The subgroup cleared CPRD to perform the work but asked MHRA to task the Irish regulatory agency to inspect the studies.
 
The annual report is the first covering events since MHRA updated its conflict-of-interest policy early in 2020. MHRA is next due to review the policy early in 2023 but could act sooner if it identifies a need to change its approach.
 
Annual Report, More
 
EMA clarifies GMPs for plants and herbal extracts used as active substances
 
EMA has shared details of the good manufacturing practice (GMP) requirements for non-transgenic comminuted plants and herbal extracts used as active substances.
 
In the statement, EMA identifies the GMP documents that apply to plants and herbal extracts. As one of the referenced documents explains, “comminution and initial extraction steps in the manufacture of non-transgenic comminuted plants and herbal extracts used as active substances should be carried out in compliance with the requirements of EU GMP Part II.”
 
In some exceptional circumstances “it is acceptable that the early manufacturing steps such as expression from plants and distillation are performed in the field,” according to the statement. For that to be permissible, the plants must be cultivated in compliance with good agricultural and collection practice. “Appropriate documentation, control and validation according to the GMP principles should be assured” as part of supplier qualification, EMA added.
 
EMA Statement
 
Other News:
 
MHRA has released the expression of interest form for the New Active Substance Work Sharing Initiative. The form covers the information companies need to submit to benefit from coordinated regulatory review by MHRA and other members of the Access Consortium, namely the regulatory agencies in Australia, Canada, Singapore and Switzerland. MHRA Update
 
The European Parliament and Council have agreed to reforms of the EU Civil Protection Mechanism (UCPM). The reforms are intended to improve prevention, preparedness and response to disasters. The EU set up UCPM in 2013 and identified certain shortcomings when the pandemic coronavirus first arrived in the region. Press Release