LONDON (Agence de Presse Medicale for Reuters Health), Jun 12 - Roche's Herceptin (trastuzumab) gained simultaneous recommendations on Friday from the England and Wales cost-effectiveness watchdog, NICE, as well as the Scottish Medicines Consortium (SMC), for women with early-stage HER2-positive breast cancer.
NICE issued its positive draft guidance in record time but said it was not recommending the drug in cases where there were concerns about a patient's cardiac function and limited Herceptin therapy to one year.
It said in a statement that final guidance is expected to be issued at the beginning of July.
The recommendation follows last month's announcement that the drug, which costs about 20,000 pounds (29,000 euros) a year, in the U.K. had received EU marketing authorization for use in women with early-stage breast cancer.
That EU approval was one of the fastest ever -- less than one month after the CHMP announced its positive opinion on April 28.
NICE Chief Executive Andrew Dillon said in a statement its guidance was good news for women with HER2 positive breast cancer.
"Herceptin for these women is clinically and cost effective in the early stage of the disease, and we look forward to being able to issue final guidance, subject to any appeal against our recommendations in a few weeks' time."
The draft recommendations state:
Trastuzumab, given at three-week intervals for one year or until disease recurrence (whichever is the shorter period), is recommended as a treatment option for women with early-stage HER2-positive breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant), and radiotherapy (if applicable).
Cardiac function should be assessed before therapy is started, and trastuzumab treatment should not be offered to women who have a left ventricular ejection fraction (LVEF) of 55% or less, or who have any of the following:
- a history of documented congestive heart failure
- high-risk uncontrolled arrhythmias
- angina pectoris requiring medication
- clinically significant valvular disease
- evidence of transmural infarction on electrocardiograph (ECG)
- poorly controlled hypertension.
Cardiac functional assessments should be repeated every three months during trastuzumab treatment.
If the LVEF drops by 10% from baseline and to below 50%, then trastuzumab treatment should be suspended.
A decision to resume trastuzumab therapy should be based on a further cardiac assessment and a fully informed discussion of the risks and benefits between the individual patient and their clinician.
The Scottish Medicines Consortium (SMC) said Herceptin will be accepted for use in the treatment of HER2-positive early breast cancer following surgery, chemotherapy and, if applicable, radiotherapy.
"To ensure the highest quality of care, trastuzumab should only be prescribed by a breast cancer specialist," the SMC added.
It estimates about 300 patients a year will be prescribed Herceptin in Scotland at an estimated recurring annual cost of 7.7 million pounds (11.2 million euros).
It added that there is a requirement to monitor cardiac function before, during, and after treatment.
Good news but don't raise false hope for women
Herceptin in early cancer has been at the centre of a media, political and legal furore and the unprecedented speed at which it has gone from clinical trials to positive NICE guidance may be seen as a good example of patient power in the U.K.
Charities welcomed the news and called for the same speed to be applied to other possible life-saving new generation cancer therapies as well as extra funding.
Kate Law, head of clinical trials at charity, Cancer Research U.K. in a statement welcomed the decisions but cautioned: "We must remember that Herceptin is only suitable in about one in five cases of breast cancer. So it's essential not to create a climate of false hope for women, where Herceptin is seen as a miracle cure suitable for everyone with breast cancer.
"NICE appraised Herceptin in record time and we hope it will be able to apply the same processes to other important drugs that are in the pipeline."
Innovations fund to pay for herceptin-like treatments
Charity cancer patient support group Cancerbackup also voiced approval for the recommendations.
Its Chief Executive Joanne Rule said in a statement: "Women with early breast cancer who are HER2 positive will feel immense relief after today's decision to approve Herceptin.
"We hope this means that no woman will be forced to fight for treatment to help save her live. We urge Primary Care Trusts (PCTs -- local health bodies) to implement this guidance today by funding the treatment to patients when clinicians recommend it.
"The Department of Health should help PCTs by announcing an Innovations Fund to assist local areas absorb the costs of new treatments," she added.
Last Updated: 2006-06-09 12:11:09 -0400 (Reuters Health)
Copyright © 2006 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.