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 publish its final guidance on the Vimizim treatment.
Answered by George Freeman
The National Institute for Health and Care Excellence currently expects to publish its final guidance on elosulfase alfa (Vimizim) for mucopolysaccharidosis (type IVA) or Morquio Syndrome in December 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, what steps he is taking to ensure that NHS England funds homecare costs for patients currently in receipt of the Vimizim drug from BioMarin.
Answered by George Freeman
NHS England can confirm that it does and will continue to reimburse costs incurred by National Health Service trusts for providing homecare for patients currently in receipt of Vimizim.
NHS England remains committed to supporting any additional costs associated with the delivery of Vimizim to individuals who are continuing treatment following on from the clinical trial.
This message was communicated in a letter from the Director of Specialised Commissioning, Richard Jeavons, to the Chief Executive of the Society for Mucopolysaccharide Diseases (The MPS Society), Christine Lavery, on 17 August.
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The National Institute for Health and Care Excellence (NICE) published further draft guidance on 2 September 2015 which recommends elosulphase alfa (Vimizim) for the treatment of mucopolysaccharidosis (type IVA)/Morquio syndrome, subject to certain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.
Asked by: Stella Creasy (Labour (Co-op) - Walthamstow)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, when the NHS will make a decision on the funding for Translarna; if he will make funding available to ensure that the people who may benefit from Translarna have long-term access to that drug; what steps he is taking to ensure that emerging treatments for Duchenne muscular dystrophy are fully funded by the NHS; and if he will make a statement.
Answered by George Freeman
We understand that a draft clinical commissioning policy to cover the use of ataluren (Translarna) for the treatment of Duchenne muscular dystrophy is currently going through NHS England's standard development and decision making processes.
NHS England has advised that a meeting of its Clinical Priorities Advisory Group has been delayed whilst further work is undertaken to refine the overall decision making process. NHS England remains committed however, to ensuring that a timely decision is made about a range of investment proposals that have been put forward for the 2015-16 financial year.
NHS England continues to keep the range of services and treatments available to patients under review as new evidence and expert guidance becomes available.
On 9 December 2014, I met with the hon. Member for Leeds North West (Greg Mulholland), representatives from the Society for Mucopolysaccharide Diseases and Muscular Dystrophy Campaign, as well as the parents of three children who suffer with Morquio syndrome and Duchenne muscular dystrophy, to hear their concerns about the continued provision of innovative drugs for these conditions which have been greatly benefiting their children.