Euro Roundup: UK’s NICE launches five-year strategy

The UK’s National Institute for Health and Care Excellence (NICE) on Monday announced a five-year strategy to revamp its approach to health technology assessments (HTA) to speed access to new and innovative treatments.
 
“The new strategy sets out a vision for the future where NICE will be more dynamic, work more collaboratively, and continue to build on the excellent foundations of the last 22 years,” said NICE Chief Executive Gillian Leng.
 
The strategy is built around four pillars, which include: rapid, robust and responsive technology evaluation; dynamic, living guideline recommendations; effective guidance uptake to maximize impact; and leadership in data, research and science.
 
NICE says its new approach will enable it to be more responsive to new technologies and allow for more flexible, modular guidance.
 
The strategy has been well-received by the British pharmaceutical industry. Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry (ABPI) said the strategy “sets out a positive vision for the future of NICE; one which will see it evolve with the science that makes these breakthroughs possible and build on its international reputation for producing evidence-based guidance.”
 
Statement, NICE Strategy 2021-2026
 
NICE recommends two drugs for treating cancer
 
The UK’s National Institute for Health and Care Excellence (NICE) on 20 April published draft guidance recommending Enhertu (trastuzumab deruxtecan) for use in the Cancer Drugs Fund (CDF) for treating HER2 positive breast cancer, a type of cancer that cannot be surgically removed or which has spread to other parts of the body.
 
The decision means that it will be the first time Enhertu, which was jointly developed by Daiichi-Sankyo UK and AstraZeneca UK, has been commissioned for use in any European country. The drug was granted conditional authorization in the EU last January and in the UK in February.
 
According to an announcement, up to 400 people will have immediate access to the treatment.
 
Trastuzumab deruxtecan is an anti-HER2 therapy that can be used after two or more anti-HER2 therapies and it works by targeting the changes in HER2 that help the cancer grow, divide and spread.
 
NICE expects to publish final guidance for the drug in May.
 
NICE also recommended on 21 April that AstraZeneca’s Calquence (acalabrutinib) be used to treat adults with untreated chronic lymphocytic leukemia (CLL), England’s most common leukemia. This means that an estimated 2,395 patients will be eligible for treatment with the drug each year.
 
The agency said the “decision means that people with CLL who have high-risk disease or cannot have standard chemotherapy can be offered the monotherapy treatment acalabrutinib which can be taken at home.”
 
There are around 3,800-4,500 new cases of CLL each year, and men are nearly twice as likely to have CLL as women, with more than a third of all cases occurring in people over the age of 75.
 
NICE 1, 2
 
Swissmedic greenlights Roche COVID antibody drug
 
Switzerland’s Swissmedic has given the green light for Roche Pharma to distribute its COVID-19 prevention medicine RegN-Cov2 on an emergency basis.
 
During its session on 14 April, the Federal Council approved the inclusion of the active substances casirivimab and imdevimab, in Annex 5 of the COVID-19 Ordinance 3. This annex lists those active substances that may be used before they are authorized yet are subject to certain preconditions.
 
While the medicine may be distributed, the authorization process is continuing through the rolling procedure.
 
The drug contains an artificial antibody cocktail that was developed to provide resistance to the SARS-Cov-2 coronavirus. In November 2020, the US FDA issued an emergency use authorization for this combination for the treatment of mild to moderate COVID-19 in patients who are at risk of progression to a severe form of the disease.
 
The agency also received an application from CureVac Swiss AG seeking approval for its COVID-19 vaccine candidate CVnCoV.
 
The agency said that CureVac can submit documentation on its vaccine candidates on a rolling basis without having to await the results of clinical trials. The duration of the rolling review will depend on the completeness of the data and the clinical trial results. The company is the fifth to seek approval for a COVID-19 vaccine in Switzerland, and joins Pfizer/BioNTech, AstraZeneca, Moderna and Janssen.
 
Swissmedic 1, 2
 
Swissmedic details national exceptions for nitrosamine rules
 
In an update posted last week, Swissmedic explained some ways in which its requirements for the control of nitrosamine impurities will differ from the EU approach announced in February.
 
While Swissmedic will apply the same deadlines for risk evaluations, confirmatory testing and changes to authorizations as the EU, it will not apply the same requirements to new marketing authorization applications for products containing biological active substances. For already authorized biological products, “Swissmedic only expects in-depth investigations if risk factors arise from the ingredients or as a consequence of the manufacturing conditions.”
 
Contrary to EU requirements, Swissmedic will not require documents to be submitted if no risks are identified in the risk evaluation.
 
The Swiss agency has also adopted the same limits for nitrosamine impurities as the EU, except in the case of metformin preparations. “For metformin preparations, the conditions imposed by Swissmedic continue to apply until further notice in view of the uncertainty surrounding the causes of NDMA contamination.”
 
Swissmedic
 
Other News
 
Netherlands Medicine’s Evaluation Agency’s (MEB) has released its 2020 annual report. As was the case in 2019, the agency took the top spot for the most co-rapporteurships in the European regulatory network with 12% of all co-rapporteurships.
 
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued an Early Access to Medicines Scheme (EAMS) scientific opinion for Sanofi’s avalglucosidase alfa for treating late and infantile-onset Pompe disease for patients who have already received enzyme replacement therapy.