A breast cancer charity is calling for women in the UK to be given access to a drug that could slow the progress of advanced breast cancer by an extra 10 months compared with current treatment but is not yet licensed in Europe despite being used widely in the US.
Pfizer, the company that makes palbociclib, which is sold under the brand name Ibrance, only applied for a European licence last August, even though it was licensed for sale in the US in February 2015 and has been prescribed for 27,000 women.
But the charity Breast Cancer Now has criticised the National Institute for Health and Care Excellence (Nice), expressing concern that women in the UK will not get access to palbociclib any time soon – because even if it is granted a licence it may not be judged cost-effective by Nice.
Palbociclib is used in combination with a cheap off-patent aromatase inhibitor drug called letrozole. Results of a trial in 666 women with advanced breast cancer, presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago, showed the combination increased progression-free survival for a median 24.8 months compared with 14.5 months for letrozole alone.
That may mean women live longer, but there is not yet data to prove it.
However, Breast Cancer Now said it was important for women in the UK to be able to take a drug that could allow them a respite of extra months without their disease progressing. “We’re really concerned about this getting through the Nice appraisal system because what we’ve seen over the last seven years is that new breast cancer drugs are just not getting through the process,” said the charity’s chief executive, Lady Delyth Morgan.
“We’re really concerned that we have this promising new first-in-class drug [one that works in a new way] and yet the anxiety is that it won’t get through to the women who could benefit. That is the majority of women with advanced breast cancer.
“This is a really significant step forward in the management of advanced breast cancer. It could mean seeing the birth of your grandchild, being around long enough to see your children graduate. We’re talking about an average of 10 months but it could be more.”
Pfizer, the manufacturer of palbociclib, only applied for a European licence for it last August. Photograph: Andrew Kelly/Reuters
There are side-effects with palbociclib, including a possible drop in white blood cells, which Morgan said “will need to be carefully managed”.
She claimed Nice was not approving new breast cancer drugs. “Despite it being approved and even fast-tracked by the FDA [Food and Drug Administration] for use in the United States, this drug will face a number of hurdles in the UK,” she said. “We haven’t seen a single example of the current Nice appraisal system working for new breast cancer drugs in the last seven years and, without reform, we’re not any more optimistic for palbociclib.”
She said Nice would compare the new drug to letrozole used on its own, which is the current standard treatment for advanced oestrogen receptor-positive breast cancer – the commonest kind. Letrozole can now be made by any generic drug manufacturer. “It would be near impossible for this new patented drug to show it can be cost-effective,” said Morgan.
A Nice spokesperson said: “Nice understands and supports the ambition that patients and charities have for access to effective cancer medicines.
“Our approach to assessing the value of new cancer drugs has been reviewed on a regular basis since we were set up in 1999 and is already more generous than for other conditions. An appraisal for palbociclib for metastatic breast cancer is proposed, and if this goes ahead it won’t be possible to pre-judge the outcome.
“From April 2016, Nice committees have been able to recommend drugs for use in the Cancer Drugs Fund. We want to ensure the NHS introduces the best of the new innovative cancer treatments while managing its resources carefully. If palbociclib is put forward for the Cancer Drugs Fund then the drug can be considered in this context.”
The first hurdle for the drug, however, is obtaining a licence in Europe, for which Pfizer applied to the European Medicines Agency (EMA) last summer.
A spokeswoman for Pfizer said: “I can confirm the application was validated by the EMA in August 2015. We have previously communicated that we anticipate approval towards the end of 2016.”
Some criticise the EMA for being slower to process licensing applications than the FDA. Dr Harold Burstein, from the Dana-Farber Cancer Institute in Boston, said EU bureaucracy was holding up access to promising drugs. “The FDA has been able to move drugs into the marketplace more quickly. They seem more willing to to act on dramatic results shown in small numbers of patients,” he said.
“I don’t think the EMA is any more rigorous, it’s the levels of committees and discussions that go on with their processes.”
The EMA said in a statement that the task of processing the drug application was taking the normal time, a maximum of 210 days, but that “in the course of the assessment, concerns may be identified with the application that require further information or clarification from the company. In such a case, the clock is stopped to give the company time to reply to the agency.”
In December, the EMA sent Pfizer a list of questions and in February Pfizer asked for more time to answer them. “Since then, the company has submitted additional information and consequently, EMA has restarted the clock for evaluation,” it said.
