(Bloomberg) -- AstraZeneca Plc and Daiichi Sankyo Co Ltd have once again failed to reach an agreement with England’s drug pricing regulator on the cost of a breast cancer medicine.
The breakdown of negotiations over the price of Enhertu has become a flashpoint in a wider dispute over changes to the regulator’s assessment of the value of new medicines.
Enhertu is a blockbuster cancer drug developed jointly by Britain’s Astra and Daiichi of Japan. It’s already approved for several indications including certain breast and gastric cancers.
The National Institute for Health and Care Excellence and NHS England provided “as much flexibility as possible,” and it’s Astra and Daiichi that need to offer “a fair price,” Samantha Roberts, NICE’s chief executive officer said in a statement Tuesday.
The drugmakers contest that 19 other European countries have reached agreements to enable routine access to Enhertu for women with low levels of a protein called HER2 in their breast tumors. At least 1,000 women in England could potentially need treatment, NICE estimates.
The stance taken by the country’s regulator means patients who need drugs for advanced cancer are losing out, Astra and Daiichi said.
NICE now uses an algorithm that ranks the severity of a patient’s condition as high, medium, or none, with the higher rankings increasing the chance of a positive recommendation. The type of breast cancer that Enhertu treats is given a medium ranking under the changed rules. Previously, only drugs for extending the life of terminal patients were allowed to be more expensive and still be recommended.
Astra and Daiichi want NICE to change the way it assesses new treatments so that patients in England have access in line with other countries, the drugmakers said in a statement.
The pharma companies have been engaged in negotiations with the regulator and the NHS for months. Optimism had increased in recent weeks that a deal would be reached after an intervention by Health Secretary Wes Streeting.
NICE disputes that any change to its assessment model is needed, pointing to other cancer drugs that have been approved since the changes were implemented. The regulator is currently carrying out a two year research project to assess society’s preferences around the value it places on disease severity.
Meanwhile, recent research published by the Office of Health Economics that was commissioned by the Association for British Pharmaceutical Industry gives an early indication that members of the public believe priority should be given at a substantially lower severity threshold than current rules.
©2024 Bloomberg L.P.
