NICE does not recommend inavolisib combination for advanced breast cancer in final draft guidance

NICE does not recommend inavolisib with palbociclib and fulvestrant for a type of advanced breast cancer, in final draft guidance published today.   

Inavolisib (also called Itovebi and made by Roche) becomes the only breast cancer drug NICE has been unable to recommend since April 2018, during which time 26 have been made available for routine use on the NHS. 

 NHS England and the company were unable to agree a price that would make the treatment cost effective.  

Clinical trial evidence showed that adding inavolisib to palbociclib and fulvestrant increased the time before the cancer worsened and increased overall survival to around 34 months compared with 27 months for palbociclib and fulvestrant alone. However, the committee was uncertain whether NHS patients would experience the same level of benefit as those in the clinical trial. 

Even after considering the severity of advanced breast cancer and its effect on people's quality and length of life, the committee concluded that the benefits seen in the evidence did not justify the cost to the NHS. 

Helen Knight, director of medicines evaluation at NICE, said: We know that people with advanced breast cancer and their families need effective treatments that can give them more time before their cancer gets worse, so we understand this decision will be disappointing. 

The evidence shows that inavolisib can benefit patients. However, at its current price, the additional benefit it provides is not enough to make it a cost-effective use of NHS resources. 

We stand ready to review the guidance rapidly if the commercial position changes. 

Usual NHS treatment for people with this type of breast cancer is a CDK4/6 inhibitor, either abemaciclib, palbociclib or ribociclib, given with fulvestrant.  

The final draft guidance is now subject to NICE's appeal process.

Notes to editors 

1.  Link to final draft guidance 
2. Inavolisib, also known by the brand name Itovebi, is a targeted treatment that is used with palbociclib and fulvestrant. Its marketing authorisation covers adults with PIK3CA-mutated, oestrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence during, or within 12 months of completing, adjuvant endocrine treatment. Patients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence.  
3. PIK3CA mutations occur in around 30% to 40% of oestrogen receptor-positive, HER2-negative breast cancers and are associated with a poorer prognosis.  
4. The clinical evidence came from INAVO120, a phase 3, multicentre, double-blind randomised controlled trial involving 325 people. The trial compared inavolisib with palbociclib and fulvestrant against placebo with palbociclib and fulvestrant.  
5. The trial found statistically significant improvements in progression-free and overall survival with the inavolisib combination. The committee identified uncertainty about the generalisability of these results to NHS practice. 
6. Inavolisib has a list price of £10,836 for a 28-pack of 9 mg tablets, excluding VAT. Commercial arrangements for inavolisib and palbociclib are confidential. 
7. Around 315 in England people would have been eligible for inavolisib with palbociclib and fulvestrant if NICE had recommended its use.