Biosimilar Herceptin helps Roche gain new Perjeta recommendation

NICE has a history of rowing with Roche over its breast cancer drugs, but peace has broken out in recent times - and now recommendation of a new use for Perjeta will make the NHS an early adopter.

The breakthrough is thanks to a Roche discount on Perjeta – but most especially because of the arrival of cheaper Herceptin (trastuzumab) biosimilars, which have brought down the cost of combination treatment considerably.

The cost effectiveness watchdog has today recommended Roche’s newer breast cancer treatment Perjeta (pertuzumab) in people with early HER2-positive breast cancer whose disease has spread to their lymph nodes, in combination with trastuzumab and chemotherapy.

The recommendation is for people who have had surgery for their breast cancer and whose cancer has already spread to their lymph nodes (node-positive disease).

An estimated 2,700 people in this subgroup in England and Wales have a higher risk of their cancer returning, but will be eligible for treatment once the guidance is finalised in March.

As is now standard procedure, Roche has had to offer an improved discount to the price of Perjeta, helping it to reverse NICE’s initial rejection of the use in June last year.

NICE agrees that clinical trial data shows that adding Perjeta to the standard therapy of Roche’s older drug Herceptin and chemotherapy after surgery (adjuvant use) increased the proportion of people whose disease didn’t spread. However, the lack of evidence on overall survival was a sticking point, but this has now been resolved by Roche’s (confidential) pricing offer.

NICE has rejected Roche’s second generation breast cancer drugs Kadcyla and Perjeta numerous times since their EU launch in 2013, though steep price discounts have helped them gain traction with NICE in more recent times.

But an even bigger factor in helping the new Perjeta and Herceptin combination reach NICE’s cost effectiveness threshold was the arrival last year of Herceptin (trastuzumab) biosimilars for intravenous administration.

The NICE document indicates this means the combination is well below its cost effectiveness threshold: “If the commercial discount to the price of pertuzumab, together with a weighted discount for biosimilar intravenous trastuzumab are taken into consideration, the cost-effectiveness estimate is comfortably below £20,000 per QALY gained.”

NICE already recommends Perjeta, given with trastuzumab and chemotherapy, for treating early HER2-positive breast cancer before surgery, and in metastatic or locally recurrent unresectable HER2-positive breast cancer.

Roche says NICE’s decision to offer Perjeta to patients whose early HER2-positive breast cancer has spread to their lymph nodes puts the NHS at the forefront of adoption in this new use.

Richard Erwin, Roche UK's general manager (pictured) said: “Roche has worked closely with NICE and other health stakeholders to help make Perjeta available as quickly as possible. So we’re delighted that England and Wales are amongst the first countries in the world in which these patients can get routine access to Perjeta in the adjuvant setting.”

Herceptin sales reached $6.94bn last year, but declined 16% in Europe due to biosimilar competition. Meanwhile Perjeta’s revenues reached $2.77bn, with Europe contributing 15% growth. Roche is continuing to support the growth of Perjeta and Kadclya with more trials exploring their use in earlier settings.