Microsoft word - for cert_nice dmo release_27_12_2012.doc

Novartis Pharmaceuticals UK Ltd
Novartis Communications UK
Frimley Business Park
Frimley Camberley
http://www.novartis.co.uk
FOR CONSUMER AND MEDICAL MEDIA
MEDIA RELEASE • MEDIA RELEASE • MEDIA RELEASE
EMBARGOED UNTIL 00:01 HOURS, Friday 4th January
NICE says Lucentis (ranibizumab) from Novartis should be available
on the NHS for some patients with diabetes related eye condition

 Visual impairment due to diabetic macular oedema (VI-DMO) is the leading cause of blindness in the working age population1  Approval of ranibizumab would be the most significant development in the treatment of the diabetes related eye condition in 25 years  Now some patients with VI-DMO could soon be eligible for a treatment with more likelihood to not only preserve but improve vision, compared with laser therapy, the current standard of care 2,3,4
Frimley, January 02 2013 – The National Institute for Health and Clinical Excellence
(NICE) has issued a Final Appraisal Determination (FAD) recommending ranibizumab be
approved for use within the National Health Service (NHS) to treat people with visual
impairment due to diabetic macular oedema (VI-DMO) who have more extensive swelling
of the retina, specifically those with VI-DMO with a retinal thickness in the eye of 400
micrometres or more at the start of treatment2.
The announcement by NICE today represents an important and long awaited step
forward in improving the standard of care for people with VI-DMO. An estimated 25,0003,4
people with the condition could now soon be eligible for treatment with ranibizumab,
which has more likelihood to not only preserve but improve vision compared with laser
therapy, the current standard of care3,4.
Until now many people with VI-DMO have had to face the possibility of irreversible sight
loss as for 25 years available treatment has been limited to laser therapy. Laser therapy
is not suitable for all people, due to the nature of their condition and has only been shown
to stabilise vision on average5,6,7.
The decision by NICE to recommend ranibizumab for some people with VI-DMO on the
NHS is likely to be welcomed by the clinical community and patient groups alike, who
have called for NICE to make it available since early 2011.
 Date of Preparation: December 2012      Job bag number:  LUC12‐C236a  Mr Ben Burton, Consultant Ophthalmologist at the James Paget University Hospital
supports the decision from NICE and the clinical benefits of ranibizumab for patients with
VI-DMO: “Granting access to ranibizumab for patients with VI-DMO, who face the very
real prospect of permanently losing their vision, is great news. Up until now, most
patients could only receive laser treatment on the NHS, which usually just stops their
vision worsening but does not necessarily improve it. We have been able to use
ranibizumab to treat people with wet Age-related macular degeneration (AMD) since
2007 and have seen good patient outcomes in this disease. Now that ranibizumab has
been approved for VI-DMO I look forward to seeing improved outcomes for people with
this condition.”
Ranibizumab, which is given by injection into the eye is an innovative medicine
administered according to individual need, so patients can gain or maintain vision, while
reducing the risk associated with over or under-treatment8. In its review of key clinical
data, NICE acknowledged the superior clinical effectiveness of ranibizumab over laser
therapy within its decision, recognising that ranibizumab can improve visual acuity over 2
years when compared to laser photocoagulation alone2.
Novartis has worked closely with NICE to ensure people with VI-DMO have the
opportunity to access this important treatment. A new Patient Access Scheme (PAS) has
helped ensure ranibizumab is a cost effective option for the treatment of VI-DMO, the
details of the PAS are commercial in confidence. Following publication of final guidance
the implementation of the new PAS will mean the NHS will benefit from immediate and
significant savings in drug cost across all current and future licensed indications for
ranibizumab, including wet AMD and visual impairment due to macular oedema
secondary to retinal vein occlusion. Novartis looks forward to the publication of the
institute’s final guidance on ranibizumab for the treatment of VI-DMO in the coming
months.

About Lucentis® (ranibizumab)
Ranibizumab is an anti-vascular endothelial growth factor (anti-VEGF) licensed for the
treatment of visual impairment due to macular oedema secondary to Retinal Vein
Occlusion (RVO) (central and branch), VI-DMO and wet AMD. Lucentis is approved by
the National Institute for Health and Clinical Excellence (NICE) for the treatment of wet
AMD and by the Scottish Medicines Consortium (SMC) for wet AMD, VI-DMO and the
treatment of visual impairment due to macular oedema secondary to Central Retinal Vein
Occlusion (CRVO). Ranibizumab was developed by Genentech and Novartis. Genentech
has the commercial rights in the US, while Novartis has exclusive rights in the rest of the
world.
About visual impairment due to diabetic macular oedema
Diabetic macular oedema (DMO) is an ophthalmic complication of diabetes. It is a type of
diabetic retinopathy that can cause visual impairment. DMO is caused by the leaking of
fluid from the small blood vessels in the eye. The build-up of fluid causes swelling and
thickening at the macula (the centre of the eye), reducing vision. The early stages of
DMO are often asymptomatic however later blurred vision may occur. If left untreated,
permanent damage or even blindness may occur. Visual impairment due to DMO occurs
more commonly when a person’s diabetes has been poorly controlled. All people with
diabetes are at risk of developing visual impairment due to DMO but only a small
                                           Job bag number:  LUC12‐C236a  proportion (approximately 1-3%) will develop it, which equates to 50,000 people in the
UK living with the condition9,10. In the UK, we estimate that around 5,000 new patients
will be affected by the condition each year9,10.

About Novartis
Novartis provides healthcare solutions that address the evolving needs of patients and
societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best
meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals,
consumer health products, preventive vaccines and diagnostic tools. Novartis is the only
company with leading positions in these areas. In 2011, the Group achieved net sales of
USD 58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding
impairment and amortization charges) was invested in R&D throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ approximately
121,000 full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit http://www.novartis.com.

Novartis UK Press Office
Meera Surendran, Weber Shandwick
1. World Health Organisation report of a WHO consultation on Prevention of Blindness from Diabetes Mellitus in Geneva, Switzerland, 9 ‐11 November 2005.   2. NICE FAD ‐ Ranibizumab for treating diabetic macular oedema (rapid review of technology appraisal guidance 237) 3. Mitchell P et al. The RESTORE Study: Ranibizumab Monotherapy or Combined with Laser versus Laser Monotherapy for Diabetic Macular Edema. Ophthalmology 2011, 118: 615‐625 4. DRCR.NET. Randomized Trial Evaluating Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular Edema. Ophthalmology. 2010 June ; 117(6): 1064–1077 5. Furlani BA et al. Emerging pharmacotherapies for diabetic macular oedema. Expert Opin Emerg Drugs 2007; 12:591‐603 6. The Royal College of Ophthalmologists. Guidelines for Diabetic Retinopathy 2012. http://www.rcophth.ac.uk/page.asp?section=451&sectionTitle=Clinical+Guidelines. Accessed December 2012 7. American Academy of Ophthalmology Retina Panel. San Francisco: AAO, 2008 8. Lucentis SmPC – http://www.medicines.org.uk/emc/medicine/19409/SPC/Lucentis+10+mg+ml+solution+for+injection. Updated 30 August 2012. Accessed December 2012 9. Minassian DC, Owens DR, Reidy A. Prevalence of diabetic macular oedema and related health and social care resource use in England. Br J Ophthalmol. 2012; 96: 345‐349. 10. Diabetes in the UK 2012. Key statistics on diabetes: http://www.diabetes.org.uk/Documents/Reports/Diabetes‐in‐the‐UK‐2012.Pdf. Accessed December 2012                                             Job bag number:  LUC12‐C236a 

Source: http://www.visionary.org.uk/uploads/2013/CERTIFIED_NICE%20FAD%20Release.pdf