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NICE rejects funding Benlysta, the first new lupus drug in 40 years


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NICE draft guidance provisionally denies funding for lupus treatment Benlysta on the NHS

Posted 05.10.2011

Draft guidance issued last Friday by the National Institute for Health and Clinical Excellence (NICE) does not recommend

Benlysta (belimumab) for patients with active autoantibody positive systemic lupus erythematosus (SLE) in England and Wales because it does not consider it to be a cost-effective use of National Health Service (NHS) resources.

Belimumab was granted marketing authorisation by the European Commission in July 2011 in adult patients with SLE, with a high degree of disease activity, despite standard therapy. It is the first new treatment to be specifically developed and licensed for use in these patients for several decades and is reflective of GSK's commitment to researching and developing innovative medicines in diseases of high unmet need.

Simon Jose, General Manager, GlaxoSmithKline UK, commented: "Today's initial decision is very disappointing for patients living with lupus who currently have very limited treatment options and we will do everything we can to change NICE's mind in an effort to ensure they get access to

Benlysta on the NHS."

"NICE's current methodology means that it is difficult to meet their cost-effectiveness threshold given the nature of the disease and the comparison with unlicensed or cheap generic medicines. We had hoped that our offer of a patient access scheme would help overcome these challenges."

"It is critically important that the current limitations are addressed quickly so patients in England and Wales can get access to the best medicines for their conditions," he added.

The draft guidance in the NICE Appraisal Consultation Document (ACD) is open to comment from interested parties, including physicians and the general public, on the NICE website (

www.nice.org.ukBG_external-link.gif) until 21 October 2011, when the consultation period ends.

Benlysta is a registered trademark owned by Human Genome Sciences, Inc., used under license by the GlaxoSmithKline group of companies.


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In the National Institute for Health and Clinical Excellence - NICE - the regulatory body of reimbursements/acceptance of treatments in UK - has decided that Benlysta is not be included for reimbursement unless as last resort (when other treatments have failed). A decision most likely to be followed by the most other regulatory bodies in Europe!

The Petition

To: Worldwide Lupus Patient Organizations

From: Lupus Europe, Lupus Foundation of America, and St. Thomas’ Lupus Trust, UK

Date: October 13, 2011

Dear Members of the International Lupus Family,

We need your help! Recently, the United Kingdom's (UK) National Institute for Health and Clinical Excellence (NICE) released its preliminary recommendation to NOT cover the cost of Benlysta through their National Health Service. As you know, Benlysta is the first drug developed and approved for use in people with lupus in more than 50 years.

NICE's preliminary recommendation could have a worldwide negative impact on the use of this potentially life-saving treatment for lupus. The decision could be a catalyst for various payers and governments across the world to deny coverage of this important treatment. Furthermore if the preliminary recommendation is allowed to stand, it may have a chilling effect on global industry only now beginning to invest in research and the development of new treatments for lupus, denying physicians and patients appropriate options to treat this complex and underserved disease. Today, we ask you to band together to protect patient access to new drugs like Benlysta and to protect the development of future drugs treating lupus. Please join the Lupus Europe, Lupus Foundation of America, and St. Thomas’ Lupus Trust, UK in urging NICE to recommend Benlysta for coverage through the UK’s National Health Service.

Lupus Europe, Lupus Foundation of America, and St. Thomas’ Lupus Trust, UK encourage you to take action on two items.

  1. Sign your organization on to the following letter requesting NICE recommend Benlysta® for coverage; Please contact Kim Cantor with the Lupus Foundation of America at cantor@lupus.org to sign your organization on to the letter. Also include the exact title and spelling of your group. Deadline for signing on to the letter is Wednesday, 19 October.

  2. Sign and share widely our online petition addressed to NICE with your membership, advocates and other constituents; Click here or visit http://www.thepetitionsite.com/1/cover-Benlysta to access the petition. We are hopeful to garner 5,000 signatures in just one week by 20 October!

We can’t accomplish our goals alone. We must work together to protect the future of people with lupus worldwide. If you have any questions on this effort, please contact me at (202) 349-1150 or at cantor@lupus.org.

Thank you,

Kim Cantor

Kimberly Cantor

Senior Director, Public Policy and Government Relations

Lupus Foundation of America

2000 L Street, NW Suite 410

Washington, DC 20036

Tel. (202) 349-1150 (direct)

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