Pharmaceutical Market Europe • April 2022 • 8-9

NEWS

NICE recommends GSK’s Zejula for ovarian cancer

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NICE, the National Institute for Health and Care Excellence, has recommended the use of GlaxoSmithKline’s (GSK) Zejula (niraparib) on the NHS. Zejula is recommended as a therapy option for treating epithelial ovarian, fallopian tube or primary peritoneal cancer in adults.

The drug is used as a maintenance therapy, which helps to slow the cancer’s return/progression. In the UK, it is estimated that at least 41,000 women are living with ovarian cancer. Of those whose cancer has advanced, around 22% will need second-line therapy.

Jack Harris, vice president of Oncology, UK and Ireland at GSK, said: “Recurrent advanced ovarian cancer remains challenging to treat and having access to options that may help slow the progression of this disease is key to maximising outcomes for those affected.”

The recommendation is only for those who have a germline BRCA mutation and have already had two courses of chemotherapy, or for those who do not have a germline BRCA mutation and have had two or more courses of platinum-based chemotherapy.

NICE’s decision marks the first time it has recommended that a PARP inhibitor should be made available outside the CDF for ovarian cancer patients, regardless of whether they carry a BRCA gene mutation.


NICE recommends Seagen’s Tukysa for breast cancer

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NICE, the National Institute for Health and Care Excellence, has recommended Seagen UK’s Tukysa (tucatinib) as a combination treatment for patients with breast cancer.

Specifically, the combination treatment is recommended for patients with HER2-positive unresectable locally advanced or metastatic breast cancer who have already had two or more anti-HER2 treatments.

The combination treatment of Tukysa and an intravenous infusion of trastuzumab and capecitabine is now available for routine funding on the NHS in England and Wales, with around 400 patients set to benefit from the treatment annually.

The decision was based on a pivotal HER2CLIMB trial which found that the combination treatment improved survival rates by 34% and decreased rates of disease progression or death by 46%.

This was compared with when trastuzumab and capecitabine were used alone. The study also showed that overall survival increased by 4.5 months.

In patients diagnosed with brain metastases, the combination treatment significantly reduced disease progression and risk of death by 52%, extending overall survival by six months.

NICE’s decision follows the Scottish Medicines Consortium (SMC) acceptance of tucatinib combination treatment, for use in NHS Scotland on 17 January.
Peter Martin, country medical director, UK and Ireland at Seagen, said: “The positive decision from NICE, making the tucatinib combination available for baseline NHS commissioning, is a real step-change for HER2-positive metastatic breast cancer patients.”


NICE recommends Amgen’s Lumykras for lung cancer

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NICE, the National Institute for Health and Care Excellence, has recommended Amgen’s Lumykras (sotorasib) for use within the Cancer Drugs Fund. The therapy will be used for adult patients with non-small-cell lung cancer (NSCLC).

Lumykras – an oral targeted therapy – is Amgen’s first-in-class drug and was the first new medicine to receive a Conditional Marketing Authorisation (CMA) from the Medicines and Healthcare products Regulatory Agency (MHRA) for use across England, Scotland and Wales as part of Project Orbis.

The treatment will be available to eligible patients in England through the Cancer Drugs Fund, and will address an unmet need for previously treated NSCLC patients who have a specific mutation that was previously thought to be ‘undruggable’.

NICE’s decision to grant a recommendation for Lumykras for use in the Cancer Drugs Fund follows a deal between Amgen and NHS England that has already given over 100 patients access to the treatment following its authorisation by the MHRA through Project Orbis.

The authorisation for Lumykras is based on clinical evidence from the phase 2 CodeBreaK 100 trial which evaluated the drug in 126 patients with advanced NSCLC.

Dr Tony Patrikios, executive medical director at Amgen UK and Ireland, said: “Sotorasib provides a new treatment option [for lung cancer patients]. More than half of NSCLC patients have advanced or metastatic disease at diagnosis and outcomes across the UK remain poor.”


IMC outlines need to combat antibiotic resistant infections

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The Infection Management Coalition (IMC) has launched a White Paper, in a first-of-its-kind call to action, outlining the need to improve the way infection is detected, monitored, prevented and managed by the NHS and other healthcare systems.

Established in January 2021, the IMC is focused on holistic management and pandemic preparedness, following the impact of COVID-19.

The IMC includes leading healthcare professionals, the scientific community and industry who, along with the government, are working together to implement a more cohesive approach to infection management.

The IMC partners are Antibiotic Research UK, the Association of British HealthTech Industries (ABHI), the Association of the British Pharmaceutical Industry (ABPI), BD, bioMérieux, the British In Vitro Diagnostics Association (BIVDA), the British Society for Antimicrobial Chemotherapy (BSAC), Menarini UK, Pfizer UK, Roche Diagnostics UK, Thermo Fisher Scientific and the UK Sepsis Trust.

The Infection Management Coalition White Paper calls for the creation of a healthcare system that is resilient in the face of outbreak and pandemic preparedness, infection prevention, rapid treatment of time-critical viral and bacterial infection, with the aim of delivering effective antimicrobial stewardship. It builds on the findings published in The Lancet’s worldwide report on the burden of AMR, and underscores the ways society must collectively commit to delivering transformational change.


UK health secretary sets NHS target for electronic patient records

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UK Health Secretary Sajid Javid has revealed plans for an accelerated roll out of electronic patient records (EPRs) in the NHS, aiming for 90% of NHS Trusts to have implemented the use of EPRs by the end of 2023.

Javid announced the proposals in a speech at the HSJ Digital Transformation Summit, where he stated that current estimates indicate that one in five NHS Trusts still do not have the electronic patient records that are “the essential prerequisite for a modern, digital NHS”.

The 90% take-up target is the main focus, but Javid also wants the remaining 10% of Trusts to be in the process of implementing them by the end of next year.

Javid’s announcement comes in light of the government’s plans to merge NHSX and NHS Digital into NHS England as part of a larger restructuring of the UK’s digital health system.

The review of the NHS’ digital strategy was led by former chief executive of Tesco’s online division, Laura Wade-Gery, who added that structural changes were necessary to put digital transformation at the core of the NHS.

Javid said that he had received a copy of the Goldacre Report, led by researcher, physician and clinical data transparency campaigner Dr Ben Goldacre and that this report would be published soon.


Pandemic Antiviral Discovery initiative launched

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The Novo Nordisk Foundation, Open Philanthropy and the Bill & Melinda Gates Foundation have joined together to create a programme called Pandemic Antiviral Discovery (PAD).

Initial funding of up to $90m has been announced for the PAD initiative, which has been set up to aid the discovery and early development of antiviral medicines for future pandemics.

One of the key principles of PAD is equitable access and the founding partners of the initiative have pledged to ensure that discoveries and innovations supported by PAD are made accessible to people living in low- and middle-income countries.

PAD will support researchers globally to identify and develop phase 2-ready antiviral drugs to target pandemic threat viruses, including coronaviruses and two other viruses that have the highest potential to cause a future pandemic.

Mads Krogsgaard Thomsen, CEO, Novo Nordisk Foundation, said: “The duration of the COVID-19 pandemic serves as a reminder that the world needs to invest in next-generation tools to combat emerging threats.”

PAD will focus on small molecule drugs that can be taken orally and are cheaper and easier for patients to access than biologic drugs. By doing this, PAD hopes to be able to quickly develop and equitably distribute effective, accessible antiviral treatments in the event of a future pandemic.