Tag Archives: NICE

NICE approval granted for iluvien implant

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Finally we are allowed to broadcast the fact that Iluvien implants are now approved by NICE for prevention of relapse in recurrent non-infectious uveitis (NIU-PS) which includes birdshot uveitis. https://t.co/YWx9qxXL2k

As some of you already know BUS played an important part in the appraisal process by providing our expert statement as well as our very own patient expert witness, who, as well as providing written evidence, attended the actual appraisal and we understand spoke eloquently at the hearing about her own experiences. Uveitis consultant Laura Steeples from Manchester Royal Eye Hospital, provided her professional expertise in the assessment process. 

From feedback received, NICE took into account what the professional and patient experts had to say, but of course cost is always critical, so we understand that negotiations on this front were required. 

One more tool for our doctors to use, but we note that the guidance says: ” …if clinically appropriate.” so it is unlikely to be handed out too freely because of the cost considerations and is likely to be offered only to patients who really need it.

Following publication of its Final Appraisal Document, NICE requires that clinical commissioning groups, NHS England, and local authorities comply with its recommendation on ILUVIEN® within 3 months and within 2 months for NHS Wales.

Mr Carlos Pavesio, Specialist Uveitis Consultant Ophthalmologist at Moorfields Eye Hospital, said: “It is welcome news that there is now a long-acting intravitreal steroid available on the NHS for preventing relapse in patients with NIU-PS, as this is a treatment priority for this condition. Preventing vision loss due to relapse has a huge impact on patients’ quality of life.”

Complications resulting from intraocular inflammation can damage the eye, so timely diagnosis and effective management of NIU-PS are imperative to avoid potentially severe vision loss.

36-month data from the PSV-FAI-001 study, presented at The Association for Research in Vision and Ophthalmology (ARVO) annual conference in April 2019, showed that significantly more eyes treated with ILUVIEN®experienced no recurrence* of uveitis over three years compared to those in the treated control group (34.5% of eyes treated with ILUVIEN®versus 2.4% treated control).

The secondary outcomes of the study showed that patients treated with ILUVIEN®had a reduced need of adjunctive systemic or immunosuppressant treatments.

Please find a link to the iluvien.co.uk website for more patient information. NICE

Humira and Ozurdex finally approved for treating non-infectious uveitis in England and Wales

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Finally after months of consultations, NICE has published its guidance and recommendations for adalimumab (Humira) and dexamethasone implants (Ozurdex).

The general information for the public can be found:  https://www.nice.org.uk/guidance/ta460/informationforpublic:

We suggest you may also wish to read Recommendations and then, if you want to know more, turn to the Summary from page 19 onwards and finish by reading the ‘Implementation’, section 5 on page 27.

Please also be aware that the process of obtaining Humira (adalimumab) injection and Ozurdex (dexamethasone intravitreal implant) treatment won’t suddenly speed up in England and Wales because the NICE guidance has been published. However, having NICE guidance should make it much easier to obtain Humira or Ozurdex treatment if your consultant says you need it.

 

https://www.nice.org.uk/guidance/ta460/informationforpublic

NICE – Uveitis (non-infectious) – adalimumab and dexamethasone [ID763]

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It has been a long time coming but at last you can now  access all the committee papers, presentations and the draft NICE guidance for adalimuab injection (Humira®) and dexamethasone implant (Ozurdex®) as all the documents are now available on the NICE website: https://www.nice.org.uk/…/indevelopme…/gid-ta10007/documents

This multiple technology appraisal is a long drawn process and  BUS has been involved in this from the start in June 2015.   Since then we submitted an organisation statement and provided a patient expert to give the patient’s perspective on Humira.    We, along with RNIB and Olivia’s Vision have provided the patient perspective as we feel it is very important that these totally different technologies are available for people with sight threatening posterior uveitis.

There are many pages involved in the committee papers, but below we provide an index to help you find your way around.

As an organisation we will be providing our comments about draft guidance to try and get it improved and as members of the public you are also free to submit comments via the website.  The committee will meet on the 12th April to consider the proposal and the guidance will then be published in July 2017

We have often felt swamped by all the NICE paperwork. Under the webpage heading ‘Appraisal Consultation’ you will see links to the ‘appraisal consultation document’ and to the committee papers.

There are 684 pages of committee papers, but below we provide an index to help you find your way around. The appraisal consultation document contains the draft recommendations for the use of Humira and Ozurdex and this is fortunately considerably shorter. As an organisation, we will be providing our comments about the draft recommendations to try to get them improved. As members of the public, you are also free to submit your comments on the appraisal consultation document via the website.

The NICE appraisal committee will meet again on the 12th April to consider all the comments received on the appraisal consultation document. The NICE guidance will then be published in July 2017 as a ‘final appraisal determination’.

NICE committee papers, March 2017: page index to the 684 pages

 p3: ‘pre-meeting briefing’ done for committee members before February 15th 2017 meeting (includes useful notes linked to the assessment report, eg, p9: a treatment pathway provided by the clinical advisors).

  • p65:’matrix of consultees and commentators’ (issued February 2016).
  • p61: ‘final scope’ (issued June 2016).
  • p69: ‘Assessment Group Report’ (the economic modelling done by Sheffield; issued 30th November 2016).
  • p298: AbbVie’s response to the assessment group report.
  • p318: Allergan’s response to the assessment group report.
  • p326: BUS’s response to the assessment group report.
  • p328: Olivia’s Vision’s response to the assessment group report.
  • p330: RNIB’s response to the assessment group report.
  • p350: Assessment Group response to RNIB comments.
  • p351: Assessment Group response to Olivia’s Vision comments.
  • p352: Assessment Group response to BUS comments.
  • p357: Errata to the Assessment Group Report (all highlighted in red).
  • p431: AbbVie’s submission to NICE (August 19th 2016).
  • p489: Allergan’s submission to NICE (August 19th 2016).
  • p598: BUS’s submission to NICE (summer 2016).
  • p610: Olivia’s Vision’s submission to NICE (summer 2016).
  • p624: RNIB’s submission to NICE (summer 2016).
  • p640: NHS England’s submission to NICE (includes references to sirolimus).
  • p648: Prof Phil Murray’s submission to NICE.
  • p656: Sri Sharma’s submission to NICE.
  • p663: Ali Mapstone’s patient expert statement to NICE.
  • p671: Maxine McCarthy’s patient expert statement to NICE.
  • p681: Nicola Symes’s NHS England statement to NICE.