1. Pink Sheet
  2. >>Market Access

Enhertu Snub From England’s NICE Not ‘In Line’ With Other Countries

 
• By Eliza Slawther

England’s NICE has “misclassified” HER2-low metastatic breast cancer as a medium severity disease, say AstraZeneca and Daiichi Sankyo, the co-developers of Enhertu. NICE said it would consider a rapid re-appraisal if the companies offered a “fair price” for the drug.

Outlier
NICE's decision on Enhertu is different from that of many other countries • Source: Shutterstock

Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate drug used to treat certain types of breast cancer, has been turned down for English funding in a new indication after the country’s health technology assessment (HTA) body NICE said its co-developers were “unwilling” to offer the drug at a lower price.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Market Access

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.

US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
• By Sue Sutter

The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.

Raising Drug Prices In The EU Could Take Years, Even If Pharma Effort Succeeds

 
• By Cathy Kelly

Manufacturers are engaging the European Commission and individual countries to allocate more health care spending to innovative medicines and align prices more closely to those in the US.

Non-Submissions To England’s NICE Surge Across All Disease Areas

 
• By Leela Barham

Blood cancer therapies were most proportionately impacted by the failure of pharmaceutical companies to submit evidence on their cancer therapies to England’s health technology appraisal body, shows analysis by the Pink Sheet.

More from Pink Sheet

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
• By Joseph Haas

During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

What MAHA Means For US FDA: Prevention Is Not What You Think

 
• By Michael McCaughan

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.