How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Consultation

    a. Has all of the relevant evidence been taken into account?

  • Question on Consultation

    b. Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    c. Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Consultation

    d. Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?

Draft guidance consultation

Open for comments Open until   Request commenting lead permission

We have updated this service so that members of the same organisation can now collaborate on a joint online response.

Read our blog to learn more.

1 Recommendations

1.1

Inavolisib plus palbociclib and fulvestrant should not be used to treat oestrogen receptor-positive, HER2-negative, PIK3CA-mutated locally advanced or metastatic breast cancer in adults when:

  • the cancer has recurred during adjuvant endocrine treatment or within 12 months of completing it, and

  • if neoadjuvant or adjuvant treatment included a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, the cancer has recurred 12 months or more after stopping the CDK 4 and 6 inhibitor.

1.2

This recommendation is not intended to affect treatment with inavolisib plus palbociclib and fulvestrant that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.

What this means in practice

These are NICE's draft recommendations. If these recommendations become final, inavolisib plus palbociclib and fulvestrant would not be required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because the available evidence does not suggest that inavolisib plus palbociclib and fulvestrant is value for money in this population.

Why the committee made these recommendations

Oestrogen receptor-positive, HER2-negative, PIK3CA-mutated, locally advanced or metastatic breast cancer can recur (come back) after adjuvant endocrine treatment with or without a neoadjuvant or adjuvant CDK 4 and 6 inhibitor. After recurrence, usual treatment is a CDK 4 and 6 inhibitor (abemaciclib, palbociclib or ribociclib) plus fulvestrant.

Clinical trial evidence suggests that inavolisib plus palbociclib and fulvestrant increases how long people have before their condition gets worse compared with palbociclib plus fulvestrant. But this is uncertain because the trial population differs from the NHS population.

Even when considering the condition's severity, and its effect on quality and length of life, the most likely cost-effectiveness estimates are above the range that NICE considers an acceptable use of NHS resources. So, inavolisib plus palbociclib and fulvestrant should not be used.