Available
breast cancer medications
Ø Who
decides whether to use novel cancer medications on the NHS?
The National Institute
for Health and Care Excellence (NICE) is the organisation in England that
decides which new medications will be made available through the National
Health Service. Normally, Wales and Northern Ireland adhere to NICE rulings.
The Scottish Medicines Consortium (SMC) in Scotland decides which new
medications will be made available through the Scottish National Health Service
(NHS). For every new breast cancer medicine, Breast Cancer Now provides input
into both processes to make sure the patient voice is heard clearly at every
turn.
What
medicines have already received approval for 2022?
Trastuzumab
and capecitabine, tucatinib (Tukysa)
Both NICE and the SMC
approved the use of the targeted medication tucatinib in combination with
trastuzumab and capecitabine at the start of this year. It can be used after
two or more additional therapies for HER2-positive breast cancer. This
treatment is for HER2 positive, locally progressed, or secondary breast cancer.
It represents a significant improvement in treatment options, especially for
eligible individuals whose breast cancer has progressed to the brain.
Chemotherapy combined with pembrolizumab
(Keytruda)
In May, we celebrated
Pembrolizumab's NICE approval as a chemotherapy and immunotherapy combo drug
(paclitaxel or nab-paclitaxel). It is appropriate for patients with locally
advanced or secondary breast cancer that is triple negative, has an elevated
level of the protein PD-L1, and who have not previously undergone chemotherapy
for their secondary or locally advanced breast cancer.
This treatment, in which
we are participating, is currently being evaluated by the SMC. In the fall of
2022, a decision is anticipated.
Abemaciclib, the primary treatment for
breast cancer (Verzenios)
For select patients with hormone-receptor-positive,
HER2 negative primary breast cancer, whose breast cancer is lymph node-positive,
NICE authorised abemaciclib for routine use on the NHS alongside hormone
therapy after surgery. An estimated 4,000 people will be qualified for this
treatment per year. We are awaiting the dates for the SMC's appraisal after it
was submitted.
If you have used this
treatment and would be willing to share your experience with us in order to
inform our efforts to ensure that it is also accepted for use on the Scottish
National Health Service, please do so.
What
is scheduled for the remainder of 2022?
Here, we focus on a few
of the medications that are presently being evaluated, and we anticipate that
decisions about their application to the NHS will be made later this year. The
NICE and SMC schedules may include new medications, and the timings are only
estimates.
Ø Secondary breast
cancer medications
Saquinuzumab emtansine (Trodelvy)
We appreciate your
support of the Time For Trodelvy initiative. In March 2022, the SMC approved
the use of sacituzumab govitecan for the Scottish National Health Service.
Tragically, NICE rejected it provisionally in April 2022. To guarantee that
this decision is overturned, we have been working hard with our patient
advocates and supporters. We'll keep you updated as we anticipate announcing
the final decision in July.
In the interim, we have
confirmation from the pharmaceutical industry that they will continue to
welcome new qualified patients into their pre-reimbursement access programme.
We advise patients to discuss this with their treatment team as a healthcare
professional must submit any requests to Gilead.
Combined alpelisib (Piqray) and
fulvestrant
Following a provisional
denial in April, we anticipate NICE will make a definitive determination
regarding the use of alpelisib with fulvestrant in July. This is the first
specific therapy for some patients with PIK3CA mutations, which are thought to
occur in 30–40% of oestrogen receptor-positive, HER2-negative breast tumours.
We're expecting the SMC's timeframe for when it will be evaluated.
Deruxtecan trastuzumab (Enhertu)
For HER2-positive breast
cancer that cannot be surgically removed or secondary breast cancer after two
or more prior treatments for HER2-positive breast cancer, trastuzumab
deruxtecan is already accessible on the NHS. In a recent clinical trial, the
medication was compared to trastuzumab emtansine (Kadcyla) in order to
determine if it should be used earlier in the course of the disease or after
one or more prior therapies for HER2 positivity. Timelines for the SMC will be
set after the decision, which is anticipated around the end of this year.
Lbrance (palbociclib) with fulvestrant
NICE approved the use of
palbociclib with fulvestrant under the Cancer Drugs Fund in 2019. (CDF). While
more information is gathered, the CDF permits NICE to provisionally approve
promising medicines. After this period of data gathering, NICE reviews the
treatment and decides whether or not to utilise it on the NHS. This has
previously happened for related drugs like ribociclib (Kisqali) and abemaciclib
(Verzenios), and a new review is being done to see whether palbociclib with
fulvestrant can be made regularly accessible. A decision is anticipated in the
fall of 2022.
Ø Primary
Breast cancer drugs
Olaparib (Lynparza)
After surgery and
chemotherapy, olaparib is being evaluated by NICE as an adjuvant therapy for
high-risk, HER2 negative, BRCA positive primary breast cancer. A choice is
anticipated before the year is over.
For eligible patients,
AstraZeneca has launched an early access programme for olaparib, and we advise
patients to discuss this with their treatment team as any requests to
AstraZeneca must be made by a healthcare professional.
Pembrolizumab (Keytruda)
In some patients with
primary triple-negative breast cancer, pembrolizumab is now being evaluated by
NICE in combination with chemotherapy prior to surgery and again after surgery
on its own. This year's choice is anticipated to be made public in the fall.