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Media Release

Alcon receives positive recommendation for reimbursement of Jetrea® in Sweden for the treatment of patients with vitreomacular traction with no epiretinal membrane

  • Jetrea® (ocriplasmin) is the first and only approved pharmacological treatment for vitreomacular traction in Europe
  • Vitreomacular traction with macular hole is a progressive age-related eye disease that can cause irreversible vision loss and thus reduced quality of life

Stockholm, January 15, 2015 – Alcon, the global leader in eye care, and the second largest division of Novartis, is pleased to announce that the Swedish Dental and Pharmaceutical Benefits Agency (Tandvårds- och läkemedelsförmånsverket –TLV) recommends Jetrea®(ocriplasmin) as a clinically proven and cost-effective treatment option for patients in Sweden suffering from vitreomacular traction (VMT) including when associated with macular hole (MH) of less than or equal to 400 microns, with no epiretinal membrane (ERM).1

This recommendation from TLV follows previous positive evaluations in Europe from the National Institute for Health and Care Excellence (NICE) in England, the Federal Joint Committee (Gemeinsame Bundesausschuss- G-BA) in Germany and the Scottish Medicines Consortium (SMC) in Scotland.2,3,4

TLV concluded its assessment based on health economic analysis showing that Jetrea® is cost-effective for the treatment of VMT patients, with and without macular hole of less than or equal to 400 microns, with no ERM. Therefore Jetrea® should not be reimbursed for patients who have VMT and ERM.

“It is important that a cost-effective medicine like Jetrea® is funded by the local authorities", said Faustino Vidal Aroca, Head of Medical Affairs, Alcon Nordics. “With modern OCT imaging technology, we have gained greater understanding of VMT and the possibility to reach early diagnosis. A medicine like Jetrea® delivered as a single injection in appropriate patients, may avoid the need for vitrectomy and allow for earlier intervention that can safely halt VMT progression and restore vision. It also represents an important step forward for those patients who are not suitable for or not willing to have surgery, and can now be treated before their condition deteriorates.”

VMT and MH are age-related, sight-threatening conditions that can gradually lead to irreversible vision loss and blindness. People living with VMT have difficulties performing normal daily activities such as reading watching TV, driving and recognizing faces. So far, the treatment of VMT has been to ‘watch and wait’ which means that patients undergo a period of observation before they become eligible for eye surgery because of the worsening of their condition. Because of the potential risks and complications, surgery is usually indicated to patients who are strongly affected by the symptoms of VMT. These patients are usually at a later stage of the disease, often with MH, when the vision loss may never be recovered.5,6,7,8

Jetrea® was approved in March 2013 by the European Medicine Agency (EMA) for the treatment of VMT in adults, including when associated with MH with a diameter of less than or equal to 400 microns.9

Alcon acquired the rights to commercialize Jetrea® outside the United States from the Belgian biopharmaceutical company ThromboGenics, which retains the right to commercialize Jetrea® in the United States. In October 2012 Jetrea® was approved in the US for the treatment of patients with symptomatic vitreomacular adhesion (VMA). Jetrea® is a trademark of ThromboGenics, and licensed to Alcon.

 

About VMT, including macular hole

As people get older, the vitreous, a gel-like substance at the back of the eye that helps it maintain its round shape, naturally detaches from the retina (the light-sensitive layer of tissue located at the back of the eyeball). However, in some cases, the vitreous remains attached to areas of the retina, particularly at the macula (the area of the retina responsible for central vision needed for everyday tasks, such as driving, reading and recognizing faces). This is known as vitreomacular adhesion. These areas of vitreomacular adhesion can exert a ‘pulling force’ on the macula, a condition known as vitreomacular traction (VMT). VMT may eventually lead to the formation of a hole in the macula. VMT is often responsible for progressive sight-threatening symptoms and irreversible vision loss.

 

References

  1. TLV decision http://www.tlv.se/beslut/sok/lakemedel/?itemno=555572&st=DecisionHistory..., last accessed January 13, 2015
  2. NICE. Ocriplasmin for treating vitreomacular traction. NICE technology appraisal guidance 297. Oct 2013,https://www.nice.org.uk/guidance/ta297, last accessed January 12, 2015
  3. Gemeinsame Bundesausschuss, des Gemeinsamen Bundesausschusses über eine Änderung der Arzneimittel-Richtlinie (AM-RL): Anlage XII - Beschlüsse über die Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a SGB V – Ocriplasmin, Dec 2013, https://www.g-ba.de/downloads/39-261-1834/2013-10-17_AM-RL-XII_Ocriplasm..., last accessed January 12, 2015
  4. Scottish Medicine Consortium, Ocriplasmin (Jetrea), Aug 2014, https://www.scottishmedicines.org.uk/medicines-advice/ocriplasmin-jetrea-resubmission-89213/, last accessed January 2015
  5. Carpineto P, Di Antonio L, Aharrh-Gnama A, et al. Diagnosing and Treating Vitreomacular Adhesion. Retina 2011 69-73.
  6. Hikichi T, Yoshida A, Trempe C. Course of vitreomacular traction syndrome. Am J Ophthalmol. 1995;119(1):55-61.
  7. Bottós, Juliana, et al. Vitreomacular Traction Syndrome. Journal of Opthalmalic and Vision Research. 2012;7(2):148-161.
  8. Johnson MW. Perifoveal vitreous detachment and its macular complications. Trans Am Ophthalmol Soc. 2005;103:537-567
  9. Jetrea® Summary of Products Characteristics. ThromboGenics NV. Belgium; March 2013, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Info..., last accessed January 12, 2015

About Alcon

Alcon, the global leader in eye care, provides innovative products that enhance quality of life by helping people worldwide see better. The three Alcon businesses - Surgical, Pharmaceutical and Vision Care - offer the widest spectrum of eye care products in the world. Alcon is the second largest division of the Novartis Group, with pro-forma sales of USD 10.5 billion in 2013. Headquartered in Fort Worth, Texas, USA, Alcon has more than 25,000 employees worldwide, operations in 75 countries and products available in 180 markets. For more information, visit www.alcon.com.

Alcon Media Relations

Irina Ferluga

Alcon Communications Europe, Middle East and Africa
Telephone: +41 58 91 120 44

[email protected]