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Written Question
Drugs
Tuesday 11th September 2018

Asked by: Mark Tami (Labour - Alyn and Deeside)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what proportion of the funding allocated for 2018-19 for products approved by the relative prioritisation process was allocated to products approved for use in the (a) November 2017 and (b) May 2018 commissioning rounds.

Answered by Steve Brine

The level of funding for products undergoing review by NHS England will be determined during the 2019/20 planning process.

In 2016/17 and 2017/18, £25 million was set aside for discretionary investment in new specialised services. This was determined by NHS England, who considered it an appropriate level of investment in the context of NHS England’s Specialised Commissioning functioning having to achieve overall efficiency savings of approximately 2.5% and 2.7% in 2016/17 and 2017/18 respectively in order to meet the financial pressures resulting from demographic growth and the legal requirement to fund all positive National Institute for Health and Care Excellence technology appraisals.

The split in the overall funding available between the November and May prioritisation rounds is not fixed but determined each year based on the number and estimated cost of treatments being considered by the independently chaired Clinical Priorities Advisory Group (CPAG) in each round. Revealing the split risks revealing commercial in confidence information around pricing. Anything that is not prioritised in the November round has the opportunity to be considered at the May round therefore ensuring consideration against the full funding envelope for the financial year.

Where manufacturers have requested the cover sheets of the policy propositions, they have received the CPAG summary report as presented at the May 2018 meeting from NHS England.

The full scoring methodology that is used at all prioritisation meetings is published on the NHS England website. This can be found at the following link:

https://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2016/06/prioritisation-method-cons-response.pdf

The outcome of the May 2018 prioritisation process through use of this methodology has been published as a ranked list of five prioritisation Levels. This can be found at the following link:

https://www.england.nhs.uk/2017/12/nhs-england-announces-new-specialised-treatments-for-patients/

The impact assessments for all the treatments include a narrative about the estimated forecast financial implications for each item, based on the list price. These are published as part of the public consultation pack. The detailed costings are not shared as in many cases these are based on discount prices provided on a commercial in confidence basis.

The methodology for relative prioritisation has been subject to legal advice as part of its development and implementation, and NHS England believes it complies with equalities legislation, the NHS Constitution and human rights legislation.

NHS England routinely publishes the stakeholder engagement response report as part of consultation through policy development, but does not routinely publish any responses that arise as a result of public consultation.

NHS England has no plans to introduce a revised decision-making process for ultra-orphan medicines as introduced in Scotland following the Montgomery Review. NHS England will continue to use the methodology for prioritisation that has previously been publicly consulted on.


Written Question
Drugs
Tuesday 11th September 2018

Asked by: Mark Tami (Labour - Alyn and Deeside)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what funding his Department plans to allocate to products undergoing review by the NHS England relative prioritisation process in 2019-20.

Answered by Steve Brine

The level of funding for products undergoing review by NHS England will be determined during the 2019/20 planning process.

In 2016/17 and 2017/18, £25 million was set aside for discretionary investment in new specialised services. This was determined by NHS England, who considered it an appropriate level of investment in the context of NHS England’s Specialised Commissioning functioning having to achieve overall efficiency savings of approximately 2.5% and 2.7% in 2016/17 and 2017/18 respectively in order to meet the financial pressures resulting from demographic growth and the legal requirement to fund all positive National Institute for Health and Care Excellence technology appraisals.

The split in the overall funding available between the November and May prioritisation rounds is not fixed but determined each year based on the number and estimated cost of treatments being considered by the independently chaired Clinical Priorities Advisory Group (CPAG) in each round. Revealing the split risks revealing commercial in confidence information around pricing. Anything that is not prioritised in the November round has the opportunity to be considered at the May round therefore ensuring consideration against the full funding envelope for the financial year.

Where manufacturers have requested the cover sheets of the policy propositions, they have received the CPAG summary report as presented at the May 2018 meeting from NHS England.

The full scoring methodology that is used at all prioritisation meetings is published on the NHS England website. This can be found at the following link:

https://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2016/06/prioritisation-method-cons-response.pdf

The outcome of the May 2018 prioritisation process through use of this methodology has been published as a ranked list of five prioritisation Levels. This can be found at the following link:

https://www.england.nhs.uk/2017/12/nhs-england-announces-new-specialised-treatments-for-patients/

The impact assessments for all the treatments include a narrative about the estimated forecast financial implications for each item, based on the list price. These are published as part of the public consultation pack. The detailed costings are not shared as in many cases these are based on discount prices provided on a commercial in confidence basis.

The methodology for relative prioritisation has been subject to legal advice as part of its development and implementation, and NHS England believes it complies with equalities legislation, the NHS Constitution and human rights legislation.

NHS England routinely publishes the stakeholder engagement response report as part of consultation through policy development, but does not routinely publish any responses that arise as a result of public consultation.

NHS England has no plans to introduce a revised decision-making process for ultra-orphan medicines as introduced in Scotland following the Montgomery Review. NHS England will continue to use the methodology for prioritisation that has previously been publicly consulted on.


Written Question
Rare Diseases: Drugs
Tuesday 11th September 2018

Asked by: Mark Tami (Labour - Alyn and Deeside)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the sustainability of the NICE process for rare disease medicines that do not meet the Highly Specialised Technology criteria.

Answered by Steve Brine

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for developing authoritative, evidence-based guidance for the National Health Service on whether drugs and other treatments represent an effective use of NHS resources.

NICE’s methods and processes for the assessment of drugs have been carefully developed over time and are internationally respected. NICE continues to keep its procedures under periodic review to ensure that they remain fit for purpose.

All topics, including drugs for rare diseases, are considered through a rigorous topic selection process before formal referral to NICE to ensure that NICE guidance is appropriate and will add value. NICE assesses most significant new drugs through its technology appraisal programme and has been able to recommend a number of drugs licenced for the treatment of rare diseases for routine use on the NHS.


Written Question
Rare Diseases: Drugs
Tuesday 11th September 2018

Asked by: Mark Tami (Labour - Alyn and Deeside)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps the Government has taken to enable access agreements for rare disease medicines that do not meet the Highly Specialised Technology criteria.

Answered by Steve Brine

Drug companies have been able to propose patient access schemes, and more recently other commercial arrangements, for products undergoing the National Institute for Health and Care Excellence (NICE) appraisal for a number of years. Such arrangements have enabled NICE to recommend many products for use on the National Health Service that it may not otherwise have been able to recommend.


Written Question
Clinical Priorities Advisory Group
Wednesday 11th July 2018

Asked by: Mark Tami (Labour - Alyn and Deeside)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 27 March to Question 134482 on the Clinical Priorities Advisory Group, when NHS England plans to communicate the results of the Specialised Services Commissioning Committee meeting held on 19 June 2018.

Answered by Steve Brine

The outcome of NHS England’s latest Specialised Commissioning prioritisation round was published on 7 July 2018. Further details can be found on NHS England’s website and accessed via the following link:

https://www.england.nhs.uk/2018/07/thousands-of-patients-to-benefit-from-innovative-new-treatments-on-the-nhs/


Written Question
Clinical Priorities Advisory Group
Thursday 17th May 2018

Asked by: Mark Tami (Labour - Alyn and Deeside)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 4 April 2018 to Question 134482 on Clinical Priorities Advisory Group, what plans NHS England has to review the budget available for products undergoing review by the relative prioritisation process to take account of (a) inflation and (b) any forecasted increase in clinical demand for new products.

Answered by Steve Brine

The budget available for discretionary investment in new drugs and treatments not considered by the National Institute for Health and Care Excellence (NICE) is determined annually and is set in the context of the overall affordability challenges facing the specialised commissioning portfolio. This assessment factors in pressures arising from demographic growth, the legal requirement to fund all NICE approved treatments and other delivery priorities set by the Government via the Mandate to NHS England.

In 2016/17 and again in 2017/18, £25 million of additional investment was set aside to support the specialised commissioning relative prioritisation process. This was assessed as being an appropriate and affordable level of spend in the context of NHS England’s Specialised Commissioning function having to achieve overall efficiency savings of approximately 2.7% in 2016/17 and 2.5% in 2017/18.

Detailed activity and associated costing forecasts are undertaken for all treatments that go through the relative prioritisation process and these take into account any anticipated changes in patient demand, or changes in the clinical or treatment pathway. The assumptions that underpin these forecasts are developed in collaboration with expert clinicians, public health specialists, patient and carer representatives, and industry partners and are tested through stakeholder engagement and formal public consultation before activity and cost estimates are completed for the prioritisation process.

In 2018/19 NHS England will be piloting a new assurance process to assess whether new treatments that are prioritised for funding are being equitably provided to patients across England and to test actual costs against estimates developed as part of the prioritisation process.


Written Question
Clinical Priorities Advisory Group
Thursday 17th May 2018

Asked by: Mark Tami (Labour - Alyn and Deeside)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 4 April 2018 to Question 134482 on Clinical Priorities Advisory Group, on what basis £25m per year is assumed to be an appropriate level of funding when actual spending is not separately monitored.

Answered by Steve Brine

The budget available for discretionary investment in new drugs and treatments not considered by the National Institute for Health and Care Excellence (NICE) is determined annually and is set in the context of the overall affordability challenges facing the specialised commissioning portfolio. This assessment factors in pressures arising from demographic growth, the legal requirement to fund all NICE approved treatments and other delivery priorities set by the Government via the Mandate to NHS England.

In 2016/17 and again in 2017/18, £25 million of additional investment was set aside to support the specialised commissioning relative prioritisation process. This was assessed as being an appropriate and affordable level of spend in the context of NHS England’s Specialised Commissioning function having to achieve overall efficiency savings of approximately 2.7% in 2016/17 and 2.5% in 2017/18.

Detailed activity and associated costing forecasts are undertaken for all treatments that go through the relative prioritisation process and these take into account any anticipated changes in patient demand, or changes in the clinical or treatment pathway. The assumptions that underpin these forecasts are developed in collaboration with expert clinicians, public health specialists, patient and carer representatives, and industry partners and are tested through stakeholder engagement and formal public consultation before activity and cost estimates are completed for the prioritisation process.

In 2018/19 NHS England will be piloting a new assurance process to assess whether new treatments that are prioritised for funding are being equitably provided to patients across England and to test actual costs against estimates developed as part of the prioritisation process.


Written Question
Clinical Priorities Advisory Group
Thursday 17th May 2018

Asked by: Mark Tami (Labour - Alyn and Deeside)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 4 April 2018 to Question 134482 on Clinical Priorities Advisory Group, what budget forecasting assumptions were used to determine that £25m per year would be an appropriate level of investment for funding products through the relative prioritisation process.

Answered by Steve Brine

The budget available for discretionary investment in new drugs and treatments not considered by the National Institute for Health and Care Excellence (NICE) is determined annually and is set in the context of the overall affordability challenges facing the specialised commissioning portfolio. This assessment factors in pressures arising from demographic growth, the legal requirement to fund all NICE approved treatments and other delivery priorities set by the Government via the Mandate to NHS England.

In 2016/17 and again in 2017/18, £25 million of additional investment was set aside to support the specialised commissioning relative prioritisation process. This was assessed as being an appropriate and affordable level of spend in the context of NHS England’s Specialised Commissioning function having to achieve overall efficiency savings of approximately 2.7% in 2016/17 and 2.5% in 2017/18.

Detailed activity and associated costing forecasts are undertaken for all treatments that go through the relative prioritisation process and these take into account any anticipated changes in patient demand, or changes in the clinical or treatment pathway. The assumptions that underpin these forecasts are developed in collaboration with expert clinicians, public health specialists, patient and carer representatives, and industry partners and are tested through stakeholder engagement and formal public consultation before activity and cost estimates are completed for the prioritisation process.

In 2018/19 NHS England will be piloting a new assurance process to assess whether new treatments that are prioritised for funding are being equitably provided to patients across England and to test actual costs against estimates developed as part of the prioritisation process.


Written Question
NHS: Drugs
Thursday 17th May 2018

Asked by: Mark Tami (Labour - Alyn and Deeside)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what estimate he has made of the proportion of NHS England's specialised commissioning budget for medicines which is committed to products approved through the relative prioritisation process.

Answered by Steve Brine

NHS England has advised that it does not hold a separate specialised budget for medicines. Spend is not monitored once the drugs have been through the prioritisation process.


Written Question
Leukaemia
Monday 14th May 2018

Asked by: Mark Tami (Labour - Alyn and Deeside)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of (a) the availability of current options for treatment on the NHS for patients with acute myeloid leukaemia and (b) the need for new options for treatment to be made available on the NHS in that area of disease.

Answered by Steve Brine

In England there is a well-established framework for enabling access to cost effective new cancer medicines. All new licensed cancer medicines are referred to the National Institute for Health and Care Excellence (NICE) for inclusion within the Technology Appraisal Programme, this referral is irrespective of the clinical indication concerned. Where cancer medicines are approved by NICE for use in England, NHS England makes these available immediately. NICE now also has the ability to refer licensed medicines demonstrating promising, but not yet certain, benefits for inclusion within the Cancer Drugs Fund.