We recap which breast cancer drugs have been approved for use on the NHS so far this year and share an update on which breast cancer drugs are currently being assessed for use.

dozens of pills of all shapes and sizes spread out on a counter

Recap: who makes decisions on the use of new cancer drugs on the NHS?

In England, the National Institute for Health and Care Excellence (NICE) is the body that makes decisions on which new medicines will be available on the NHS. Wales and Northern Ireland normally follow NICE decisions. In Scotland, the Scottish Medicines Consortium (SMC) makes decisions on which new medicines will be available on the NHS in Scotland. At Breast Cancer Now we input into both processes for every new breast cancer drug to ensure the patient voice is heard loud and clear, at every single step.

What drugs have been approved in 2022 so far?

Secondary breast cancer drugs

Tucatinib (Tukysa) with trastuzumab and capecitabine

At the beginning of this year, targeted drug tucatinib in combination with trastuzumab and capecitabine was approved for use by both NICE and the SMC. This is a treatment for HER2 positive, locally advanced or secondary breast cancer and can be used following two or more other treatments for HER2 positive breast cancer. It’s a huge step forward in the treatment options available, particularly for eligible patients whose breast cancer has spread to the brain.

Pembrolizumab (Keytruda) with chemotherapy

In May, we welcomed the NICE approval of pembrolizumab, an immunotherapy given in combination with chemotherapy (paclitaxel or nab-paclitaxel). It’s suitable for people who have triple negative, locally advanced or secondary breast cancer that has a higher than normal level of a protein called PD-L1 and who have not received previous chemotherapy treatment for their locally advanced or secondary breast cancer.

The SMC is currently assessing this treatment which we are participating in. A decision is expected in autumn 2022.

Primary breast cancer drugs

Abemaciclib (Verzenios)

In June, NICE approved abemaciclib for routine use on the NHS with hormone therapy following surgery for certain people with hormone-receptor positive, HER2 negative primary breast cancer, whose breast cancer is lymph node positive. It is estimated that around 4,000 patients will be eligible per year for this treatment. It has been submitted to the SMC for appraisal and we are awaiting the timelines for this.

If you have experience of this treatment and would be happy to share your experience with us to inform our work to help ensure it is also approved for use on the NHS in Scotland, please get in touch with policy@breastcancernow.org 

What’s coming up for the rest of 2022?

Here, we highlight some of the drugs which are currently being assessed and which we expect decisions on their use on the NHS to be made later this year. Timings are an estimate and there may also be new drugs added to the NICE and SMC schedules.

Secondary breast cancer drugs

Sacituzumab govitecan (Trodelvy)

Thank you to everyone who has supported our Time For Trodelvy campaign. Sacituzumab govitecan was approved by the SMC for use on the NHS in Scotland in March 2022. Devastatingly, it was provisionally rejected by NICE in April 2022. We’ve been working hard with our patient advocates and supporters to ensure this decision is reversed. We are expecting a final decision to be announced in July and so will keep you posted.

In the meantime, we have received confirmation from the drug company that they will keep their pre-reimbursement access scheme open to new eligible patients. We’d recommend patients speak to their treatment team about this as any requests to Gilead need to be made by a healthcare professional.

Update: on 14th July, we received the fantastic news that Trodelvy was approved by NICE for routine use on the NHS. More information can be found here 

Alpelisib (Piqray) with fulvestrant

We are expecting a final decision by NICE on the use of alpelisib with fulvestrant in July following a provisional rejection in April. This is the first targeted treatment for certain patients with a PIK3CA mutation, which is estimated to be found in around 30-40% of oestrogen receptor positive, HER2 negative breast cancers. It is due to be assessed by the SMC and we are awaiting timelines for this.

Update: on 14th July, this treatment was approved by NICE for routine use on the NHS. Our reaction to this news can be found here 

Trastuzumab deruxtecan (Enhertu)

Trastuzumab deruxtecan is already available on the NHS for treating HER2 positive breast cancer that can’t be removed by surgery or secondary breast cancer after two or more other treatments for HER2 positive breast cancer. The treatment is now being assessed for use earlier in the disease, after one or more prior HER2 positive treatments and has been compared to trastuzumab emtansine (Kadcyla) in a new clinical trial. We are expecting a decision towards the end of this year and timelines for the SMC will follow.

Palbociclib (Ibrance) with fulvestrant

In 2019, palbociclib with fulvestrant was approved by NICE for use on the Cancer Drugs Fund (CDF). The CDF enables NICE to conditionally approve promising treatments while more data is collected. Following this period of data collection, NICE reconsiders the treatment and makes a final decision on its use on the NHS. This has already happened for similar treatments abemaciclib (Verzenios) and ribociclib (Kisqali) and now palbociclib with fulvestrant is being reassessed to see whether it can be made routinely available. A decision is expected in autumn 2022.

Primary breast cancer drugs

Olaparib (Lynparza)

NICE is currently assessing olaparib for the adjuvant treatment of high-risk HER2 negative, BRCA positive primary breast cancer after surgery and chemotherapy. A decision is expected towards the end of this year.

AstraZeneca has introduced an early access programme for olaparib for eligible patients and we recommend that patients speak to their treatment team about this as any requests to AstraZeneca need to be made by a healthcare professional.

Pembrolizumab (Keytruda)

Pembrolizumab is currently being assessed by NICE in combination with chemotherapy before surgery, and then again on its own after surgery in certain patients with primary triple negative breast cancer. We expect a decision to be announced in autumn this year.

 

Anyone with questions about their breast cancer treatment can call our free Helpline on 0808 800 6000 to speak to one of our nurses. 

 

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