Mentions:
1: Kate Hollern (LAB - Blackburn) My constituent Enola Halleron-Clarke, who is 11 years old, suffers from Morquio syndrome. - Speech Link
2: David Cameron (CON - Witney) dialogue with the drug companies, because of the vast prices that are being charged for some of these drugs - Speech Link
Asked by: Greg Mulholland (Liberal Democrat - Leeds North West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, when he expects NICE to announce its decision on approving the Vimizim form of elosulfase alfa.
Answered by George Freeman
The National Institute for Health and Care Excellence (NICE) published further draft guidance on 2 September 2015 which recommends elosulphase alfa (Vimizim) for the treatment of mucopolysaccharidosis (type IVA)/Morquio syndrome, subject to certain conditions. Interested parties now have until 23 September to comment on NICE’s draft recommendation.
NICE now expects to publish its final guidance in January 2016.
Asked by: Greg Mulholland (Liberal Democrat - Leeds North West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what assessment he has made of the compatibility with paragraph 9 of Article 3 of the EU directive on the transparency of measures regulating the prices of medicinal products for human use of NHS England's decision not to respond to BioMarin's pricing offer for Vimizim in October 2014.
Answered by George Freeman
The Department is responsible for determining the price of medicinal products. The Department’s procedures for determining price comply with the requirements of the EU Directive on the transparency of measures regulating the prices of medicinal products. The Biomarin product Vimizim (elosulfase alfa) is currently being evaluated by the National Institute for Health and Care Excellence as part of its Highly Specialised Technologies programme. In the meantime, NHS England has defined a draft commissioning policy for elosulfase alpha for Mucopolysaccharidosis IV Type A on the basis of the clinical evidence of its effectiveness. No final funding decision has been made.
Asked by: Greg Mulholland (Liberal Democrat - Leeds North West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what assessment he has made of the compatibility of NHS England's announcement on 2 July 2015 on a final funding decision on Vimizim with the EU directive on transparency of measures regulating the prices of medicinal products for human use.
Answered by George Freeman
The Department is responsible for determining the price of medicinal products. The Department’s procedures for determining price comply with the requirements of the EU Directive on the transparency of measures regulating the prices of medicinal products. The Biomarin product Vimizim (elosulfase alfa) is currently being evaluated by the National Institute for Health and Care Excellence as part of its Highly Specialised Technologies programme. In the meantime, NHS England has defined a draft commissioning policy for elosulfase alpha for Mucopolysaccharidosis IV Type A on the basis of the clinical evidence of its effectiveness. No final funding decision has been made.
Asked by: Gregory Campbell (Democratic Unionist Party - East Londonderry)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, if he will approve the use of Vimzin as an enzyme replacement therapy for Morquio on an interim basis until NICE makes a final decision in October 2015.
Answered by George Freeman
My Rt. hon. Friend the Secretary of State does not make decisions on the approval of drugs for treatment on the National Health Service.
NHS England has recently made the decision to await the National Institute for Health and Care Excellence (NICE) final guidance for the use of Vimizim for Morquio. This decision has been made by clinicians, and we await the outcome of the NICE guidance expected in October 2015.
Asked by: Greg Mulholland (Liberal Democrat - Leeds North West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, for what reasons NHS England's announcement on whether it will grant interim funding for the Vimizim drug has been rescheduled from 25 to 30 June 2015.
Answered by George Freeman
The decision on the interim funding of Vimizim (elosulfase alfa) will be made by NHS England by the end of June 2015. NHS England has not scheduled a date for the announcement of this decision.
Clinical commissioning policies setting out NHS England’s position on investing in a number of specific specialised services and treatments will be published on the NHS England website as soon as possible following final decisions being taken.
In addition to publishing clinical commissioning policies on its website, NHS England will be engaging with stakeholder groups with particular interest in specific policies to ensure that they are aware of NHS England’s decisions and their implications for patients and service users. A communications plan is currently in development.
Mentions:
1: Greg Mulholland (LDEM - Leeds North West) In 2009, when Sam was 16 months old, he was diagnosed with Morquio syndrome, an ultra-rare disease that - Speech Link
2: Mark Tami (LAB - Alyn and Deeside) Gentleman, I have been involved in the issue of Morquio. - Speech Link
3: Caroline Nokes (CON - Romsey and Southampton North) I also pay tribute to him for the enormous amount of work he has done on Morquio syndrome, which he has - Speech Link
4: Philippa Whitford (SNP - Central Ayrshire) People with Morquio already have the changes. - Speech Link
Mentions:
1: None therapy to treat Morquio syndrome is unlikely to be approved due to cost saving; and further that the - Speech Link
2: None in England for rarer conditions like Elosulfase alpha (Vimizim) for the treatment of Morquio syndrome - Speech Link
3: None receiving Elosulfase alpha have every chance of continuity of treatment, provided the supplier of the drugs - Speech Link
Mentions:
1: Greg Mulholland (LDEM - Leeds North West) I urge him to intervene in the campaign to get the drugs that are needed for those with Morquio syndrome - Speech Link
2: Nick Clegg (LDEM - Sheffield, Hallam) children and their families who are—quite understandably—concerned about the continued provision of these drugs - Speech Link