Scotland backs Pfizer’s Ibrance for breast cancer


Pfizer’s Ibrance has been approved for use by the NHS in Scotland as a second-line treatment for advanced breast cancer after hormonal therapy.

The Scottish Medicines Consortium (SMC) said Ibrance – a CDK4/6 inhibitor – can increase the time before the condition progresses and delay the need for chemotherapy in people with hormone receptor-positive, HER2-negative advanced breast cancer.

Pfizer’s drug was backed for use alongside anti-oestrogen drug fulvestrant for these patients under the SMC’s Patient and Clinician Engagement (PACE) process, which is used for medicines to treat end of life and very rare conditions.

It is estimated that around 400 women could be eligible for treatment with the drug each year in Scotland. South of the border in England, the National Institute for Health and Care Excellence (NICE) is still deliberating on this use for Ibrance with a decision due before the end of the year.

At a PACE meeting to discuss Ibrance, patient groups and clinicians said that this stage of breast cancer is incurable and treatment options are limited.

 “We know that this approval from the SMC will be meaningful for the many patients and families who are affected by this type of advanced breast cancer,” said Pfizer UK’s oncology medical director Dr Olivia Ashman. “We hope the same outcome will be reached by NICE later this year.”

In the PALOMA-3 trial, Ibrance was shown to increase the time before the condition progresses, allowing patients additional months of life, and could also delay the need for chemotherapy with its associated side effects.

Ibrance has been approved for NHS use in Scotland since December 2017, when the SMC gave the green light for restricted prescribing of the drug in first-line HR+/HER2- breast cancer in combination with aromatase inhibitor drugs.

First-line use of the drug south of the border was rejected by NICE earlier that year but given the nod after Pfizer agreed a price reduction. Two other CDK4/6 inhibitors – Novartis’ Kisqali (ribociclib) and Eli Lilly’s Verzenios (abemaciclib) have also been approved by the SMC and NICE for first-line use.

Both are also trying to get the okay for second-line use with fulvestrant. Kisqali was turned down by NICE for this use in April and is still under review by the SMC with a verdict due later this year. Verzenios meanwhile has been approved in England for previously-treated patients, but only via the Cancer Drugs Fund.

Ibrance was the first CDK4/6 inhibitor to reach the market and is already a blockbuster with sales of around $4 billion last year. It is predicted to swell to $6 billion by 2022, staying well ahead of its rivals although both Novartis and Lilly’s drugs are expected to compete closely for second place in the market.

Earlier estimates by EvaluatePharma give Kisqali the edge over Lilly’s drug with predicted sales of $1.6 billion in 2022, with Verzenios not expected to be far behind.