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

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

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

  • Question on Consultation

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

  • Question on Consultation

    Are there any equality issues that need special consideration and are not covered in the medical technology consultation document?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Draft guidance consultation

Closed for comments This consultation ended on at   Request commenting lead permission

1 Recommendations

1.1

Ribociclib with an aromatase inhibitor can be used as an option for the adjuvant treatment of hormone receptor-positive, HER2-negative, early breast cancer at high risk of recurrence in adults. It can only be used if the cancer is lymph-node positive and present in:

  • at least 4 axillary lymph nodes, or

  • 1 to 3 axillary lymph nodes and the cancer:

    • is grade 3, defined as at least 8 points on the modified Bloom–Richardson grading system or equivalent, or

  • has a primary tumour size of at least 5 cm.

It is recommended only if the company provides it according to the commercial arrangement (see section 2).

1.2

For women in pre- or perimenopause, and men, combine the aromatase inhibitor with a luteinising hormone-releasing hormone (LHRH) agonist

1.3

This recommendation is not intended to affect treatment with ribociclib with an aromatase inhibitor 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

Ribociclib with an aromatase inhibitor must be funded in the NHS in England for the adjuvant treatment of hormone receptor-positive, HER2-negative, early breast cancer at high risk of recurrence in adults, only if the cancer is lymph node positive and present in:

  • at least 4 axillary lymph nodes, or

  • 1 to 3 axillary lymph nodes and the cancer:

    • is grade 3, defined as at least 8 points on the modified Bloom–Richardson grading system or equivalent, or

    • has a primary tumour size of at least 5 cm.

It must be funded in England within 90 days of final publication of this guidance.

There is enough evidence to show that ribociclib with an aromatase inhibitor provides benefits and value for money, so it can be used routinely across the NHS in this population.

Why the committee made these recommendations

Adjuvant treatment aims to reduce the risk of cancer returning after surgery. Usual treatment for hormone receptor-positive, HER2-negative, early breast cancer at high risk of recurrence includes adjuvant endocrine treatment, such as aromatase inhibitors. Abemaciclib plus endocrine treatment is also an option if the cancer meets the criteria in section 1.1.

Results from a clinical trial suggest that, compared with an aromatase inhibitor alone, ribociclib plus an aromatase inhibitor may increase how long people have before their cancer returns. But this is uncertain. It is also unclear whether ribociclib plus an aromatase inhibitor increases how long people live, because the trial is ongoing.

Ribociclib plus an aromatase inhibitor has not been directly compared in a clinical trial with abemaciclib plus endocrine treatment. But results from an indirect comparison suggest that they work as well as each other.

When abemaciclib plus endocrine treatment is not an option, there is not enough evidence to show cost effectiveness of ribociclib plus an aromatase inhibitor compared with endocrine treatment alone. This is because there is no long-term evidence and there are uncertainties about some assumptions used in the economic model. So, ribociclib plus an aromatase inhibitor should not be used in this population.

When abemaciclib plus endocrine treatment is an option, the evidence shows ribociclib plus an aromatase inhibitor is a cost-effective use of NHS resources, compared with abemaciclib plus endocrine treatment or endocrine treatment alone. So ribociclib plus an aromatase inhibitor can be used in this population.