Breast cancer drug Perjeta launched for early use – but UK access uncertain

Roche’s Perjeta has been launched today in the UK for use in women with HER2-positive breast cancer before surgery – but, as with many new cancer drugs, access to treatment is uncertain.

Trials of the drug show it can help clear all signs of breast cancer from more women with early stage disease, when added to Herceptin and chemotherapy.  But its high price will undoubtedly be a barrier to access on the NHS.

Cancer charity Breast Cancer Now is pessimistic about the chances of the drug being made available in this setting any time soon. It has reiterated its call for the government and the pharmaceutical industry to work out a new approach to pricing and appraising new cancer drugs.

Perjeta (pertuzumab) is already available for use in HER-2 positive patients with metastatic breast cancer when combined with Herceptin and docetaxel, but is only available through the Cancer Drugs Fund (CDF) in England.

Health technology assessment body NICE halted its appraisal in June 2014 because it hit a brick wall in its cost-effectiveness modelling: even if Perjeta were absolutely free, NICE said it still could not judge it to be value for money. This was because Perjeta added to Herceptin and chemotherapy creates a very high combined cost. In these patients, Perjeta alone costs around £43,000 a year.

In addition, a Herceptin and chemotherapy combination is already effective in delaying the cancer’s progression, making Perjeta’s task in reaching NICE’s cost-effectiveness threshold much more difficult.

Nevertheless, the Perjeta regimen has shown strong evidence in its NEOSPHERE trial: it nearly doubled the number of women (39.3 vs 21.5 per cent) whose tumours were eradicated compared with current treatment. This is measured by pathological complete response (pCR), the absence of invasive tumour tissue at the time of surgery in the affected breast and lymph nodes.

Roche says patients were also 40 per cent more likely to be disease-free after three years versus current Herceptin + chemotherapy treatment. The Perjeta regimen is the first neo-adjuvant breast cancer treatment authorised in the EU based on the benefit in achieving pCR.

Roche says over 1,800 women per year in the UK could benefit from Perjeta as a targeted neo-adjuvant (pre-surgery) treatment for HER2-positive, locally advanced, inflammatory or early-stage breast cancer at high risk of recurrence.

Access

Roche says it will work with NHS England, NICE and the Scottish Medicines Consortium (SMC) to ensure clinicians can prescribe Perjeta routinely through the NHS. But the prospects of the drug gaining NICE approval any time soon look slim, not least because of the unresolved question of Perjeta’s use in metastatic disease.

Perjeta in neo-adjuvant patients could be added to the CDF list in a shorter time frame, but this also looks highly unlikely: the Fund is currently undergoing major reform, and a second round of ‘de-listing’ has just been made to cut its overspend.

Sally Greenbrook, Policy Manager at Breast Cancer Now, said: “It is very promising that a new indication for Perjeta has been licensed for use, following the findings that patients with HER2+ early breast cancer who had undergone this treatment pre-surgery were more likely to be disease-free after three years than those on standard treatment.”

Breast Cancer Now has been critical of the government and pharmaceutical companies for not having arrived at a workable model for approving drugs for NHS use. Unlike many other cancer charities, Breast Cancer Now has called on pharma directly to play its part by lowering its prices.

Sally Greenbrook said: “A licence does not guarantee access for patients. Perjeta is given in combination with the effective yet expensive Herceptin, and whilst its availability is currently being considered by NICE and the SMC, at the current price it is highly unlikely that anyone will be able to access it for this particular indication any time soon.

“Preventing early breast cancer from returning or spreading would be a major step towards finally stopping women dying from the disease, but under our current drug pricing system we continue to risk letting encouraging findings such as this go to waste.”

NHS England’s proposed new system for the CDF would turn it into a ‘Managed Access Fund’ managed by NICE. This would see cancer drugs, which are promising but with insufficient evidence, given rapid provisional market access. The drug would then be reviewed when more mature data – including the NHS’ own real-world data – is available, with drugs either given full NICE approval or removed from the CDF entirely.

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