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Exkivity Wins HTA Thumbs Up In England For Rare & Aggressive NSCLC

NICE Also Confirms Spravato Rejection

 
• By Neena Brizmohun

The budget-neutral deal under which Takeda’s Exkivity was previously made available via the National Health Service is ending and being replaced by commercial supply at a confidential price.

Exkivity is being made available via the NHS at a discounted price • Source: Alamy

Exkivity (mobocertinib), Takeda’s treatment for a rare and aggressive type of lung cancer, will continue to be made available in England via the National Health Service after health technology assessment (HTA) institute NICE said that the cost-effectiveness estimates for the drug it called “ground-breaking” were acceptable.

The treatment, for EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer (NSCLC), was previously made available in England in May on a budget-neutral basis under a deal the NHS brokered

More from United Kingdom

Managed Access Agreement Fails To Help BioMarin’s Brineura Secure Routine Reimbursement In England

 
• By Francesca Bruce

BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
• By Eliza Slawther

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

Industry On Making England’s HTA Innovation Lab A Success

 
• By Eliza Slawther

England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.

More from Europe

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
• By Eliza Slawther

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

Few Takers For EMA’s OPEN Pathway Prompts Rethink

 
• By Vibha Sharma

While drug companies say they support the European Medicines Agency’s expanded OPEN framework for the collaborative assessment of marketing applications with non-EU authorities, they are reluctant to participate in the initiative for a number of reasons.

EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 
• By Eliza Slawther

The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.