Patients with certain forms of breast cancer should be able to get routine NHS access to Roche's Perjeta in England and Wales in the next three months following a recent final nod from cost regulators.
The National Institute for Health and Care Excellence has published final guidance endorsing the use of Perjeta (pertuzumab), in combination with trastuzumab and chemotherapy, as an option for the neoadjuvant treatment of adults with human epidermal growth factor receptor 2 (HER2)‑positive breast cancer; that is, in patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer at high risk of recurrence.
However, the recommendation only stands as long as Roche provides the drug with the discount agreed in the patient access scheme.
The decision marks a turnaround from draft guidelines published back in May, which rejected Perjeta because of uncertainties with the economic data presented and over the drug's long-term benefit, largely because of limited trial evidence.
Roche subsequently offered a confidential price discount on Perjeta to increase its cost-effective for the NHS, even when taking the uncertainties highlighted by the committee into account.
Around 1,400 people in England and Wales will be eligible for treatment with Perjeta annually, but patients in Scotland will be unable to access the drug via the NHS after the Scottish Medicines Consortium said mid December it would not endorse its use because of concerns over the evidence around the long term survival benefits of the medicine.
At the time, Richard Erwin, general manager of Roche UK, called the decision "a devastating blow to women in Scotland with this very aggressive form of breast cancer".
In a further blow to UK breast cancer patients, guidance on the use of the firm's Kadcyla (trastuzumab-emtansine) ruled that the drug is too costly for routine use on the NHS in England and Wales.
Kadcyla is intended to treat HER2-positive breast cancer which has spread to other parts of the body that cannot be surgically removed and has stopped responding to initial treatment, but it costs around £90,000 per patient at its full list price.
Breast Cancer Now is now petitioning NICE chief executive Sir Andrew Dillon and Richard Erwin to find a solution that will overturn the decision.
"This disastrous decision is a huge setback for the treatment of advanced breast cancer. Kadcyla offers significant and precious extra time for women with incurable cancer in great need of hope, and we mustn't let it slip away," said Baroness Delyth Morgan, the charity's chief executive.
"NICE and Roche's inability to find a compromise is seeing secondary breast cancer patients left abandoned. Responsibility lies on both sides, and such reckless brinkmanship is unfortunately about to rip away one of the best breast cancer drugs in years from patients in desperate need of a lifeline."
"We welcome that Roche have offered a substantial discount, but they must now lower their price even further. However, NICE's decision to use a comparator drug to calculate the cost-effectiveness of Kadcyla that is not even available to patients is wholly inappropriate and must be reconsidered. We believe that, had an appropriate comparator drug been selected, the discounted price may have seen Kadcyla fall within the cost-effectiveness threshold."
The drug is available in many other countries, including France, Germany, Australia and Canada, "and it is nowhere near good enough that women in England will be denied such an effective option," she stressed.