Asked by: Matt Vickers (Conservative - Stockton South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps her Department is taking to help reduce the time taken for clinically-proven drugs to be considered for use on the NHS once they are off-patent.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines Repurposing Programme was established in March 2021 by the Department, NHS England, the National Institute for Health Research and the National Institute for Health and Care Excellence (NICE). This seeks to identify new uses for medicines that are outside of the scope of the existing licence for the medicine. This typically involves taking an existing medicine that already has a marketing authorisation or licence for human use for a particular condition, and then using it to treat another condition. It provides a tailored package of support to priority repurposed medicines, potentially including support for research, licensing and implementation.
NICE makes recommendations on whether the benefits of licensed medicines justify their costs and maintains surveillance of new developments that may affect its published guidance, including the latest evidence and any significant changes in the prices of medicines. NICE would consult on proposed changes to its guidance with stakeholders if significant new evidence relating to the clinical- and cost-effectiveness of a medicine were to emerge.
Asked by: John Spellar (Labour - Warley)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps is his Department taking to prevent the NHS being overcharged for off-patent drugs.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
The costs of branded medicines, whether they have patents on them or not, are controlled by the 2019 Voluntary Scheme for Branded Medicines Pricing and Access and the statutory scheme for branded medicines.
For unbranded generic medicines the Department relies on competition to keep prices down. This has led to some of the lowest prices in Europe and allows prices to react to the market. In an international market this ensures that when demand is high and supply is low, prices in the United Kingdom can increase to help secure the availability of medicines for UK patients. Concerns about potential drug pricing abuses are a matter for the Competition and Markets Authority (CMA). Where it has concern about the price of a generic medicines, the Department asks the CMA to investigate that price. The CMA has several ongoing investigations into excessive prices of generic medicines.
Asked by: Karen Lee (Labour - Lincoln)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department is taking to facilitate patient access to off-patent drugs.
Answered by Steve Brine
Off patent drugs are widely used every day in the National Health Service, and there are no barriers to their use.
Asked by: Lord Sharkey (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government whether they intend to review how they can incentivise manufacturers of generic medicines to ensure off-patent medicines can be repurposed and made available to patients.
Answered by Lord O'Shaughnessy
The Association of Medical Research Charities (AMRC) has led a group of stakeholders which has produced a framework to facilitate the adoption of off-patent repurposed drugs into National Health Service clinical practice where there is robust evidence to support it and where this would benefit patients. This, alongside some recommendations which will further support drug repurposing, was published in their report last year, Facilitating adoption of off-patent, repurposed medicines into NHS clinical practice. A copy is attached.
The Department has supported this work and is playing its part in implementing the recommendations which fall within its area of responsibility. We have no plans to further review how generic manufacturers can be incentivised. The AMRC’s report includes two recommendations which relate to incentives for generic manufacturers which are for a range of other stakeholders to drive forward. However, we took an important step forward in incentivising medicines manufacturers to repurpose drugs in ensuring that the Accelerated Access Pathway announced last November is open to repurposed drugs.
Asked by: Lord Sharkey (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what plans they have to facilitate the adoption of off-patent, repurposed drugs into NHS clinical practice where these would benefit patients.
Answered by Lord O'Shaughnessy
The Association of Medical Research Charities (AMRC) has led a group of stakeholders which has produced a framework to facilitate the adoption of off-patent repurposed drugs into National Health Service clinical practice where there is robust evidence to support it and where this would benefit patients. This, alongside some recommendations which will further support drug repurposing, was published in their report last year, Facilitating adoption of off-patent, repurposed medicines into NHS clinical practice. A copy is attached.
The Department has supported this work and is playing its part in implementing the recommendations which fall within its area of responsibility. We have no plans to further review how generic manufacturers can be incentivised. The AMRC’s report includes two recommendations which relate to incentives for generic manufacturers which are for a range of other stakeholders to drive forward. However, we took an important step forward in incentivising medicines manufacturers to repurpose drugs in ensuring that the Accelerated Access Pathway announced last November is open to repurposed drugs.
Asked by: Chris Ruane (Labour - Vale of Clwyd)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, which prescription drugs had the highest increase in price to the NHS in the last 10 years for which data is available.
Answered by Steve Brine
The table below shows the top five individual medicines that have shown the highest increase in cost over the last 10 years for Net Ingredient Cost (NIC) per prescription item . Prescription medicines have only been included where there was prescribing in both 2006 and 2016.
For any medicine listed, it does not necessarily mean that the price has increased. For example, the cost per prescription item will be higher if the quantity being prescribed per prescription item has increased.
This is based on Prescription Cost Analysis (PCA) data. PCA data is based on analysis of all prescriptions dispensed in the community i.e. by community pharmacists and appliance contractors, dispensing doctors, and prescriptions submitted by prescribing doctors for items personally administered in England. PCA data do not cover drugs dispensed in hospitals, including mental health trusts, or private prescriptions.
Costs vary over time due to numerous factors including medicines going off patent and becoming available generically, unlicensed medicines becoming licensed medicines, shortages, the level of competition for generic medicines, as well as centrally agreed pricing schemes such as the Pharmaceutical Price Regulation Scheme.
The Department is working closely with the Competition and Markets Authority on a number of investigations into unwarranted price rises of unbranded generic medicines. Where companies have breached competition law, we will seek damages and invest that money back into the National Health Service.
The top five medicines with the highest increase in Net Ingredient1 Cost per prescription item2 | |||
Drug Name | 2006 | 2016 | Increase |
Orfadin_Cap 10mg | £5,436.74 | £20,030.86 | £14,594.12 |
Cerezyme_I/V Inf 400u Vl (Dry) | £18,143.17 | £30,397.85 | £12,254.68 |
Chenodeoxycholic Acid_Cap 250mg | £88.57 | £9,580.10 | £9,491.54 |
Trientine Dihydroch_Cap 300mg (Old) | £218.58 | £5,488.22 | £5,269.64 |
Sod Benz_Liq Spec 400mg/5ml | £361.95 | £4,352.92 | £3,990.96 |
Source: Prescription Cost Analysis
Notes:
1NIC is the basic cost of a drug. It does not take account of discounts, dispensing costs, fees or prescription charges income, so the amount the NHS spent will be slightly different.
2Prescriptions are written on a prescription form known as an FP10. Each single item written on the form is counted as a prescription item.
Asked by: Nick Thomas-Symonds (Labour - Torfaen)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what progress his Department has made on ensuring that repurposed, off-patent drugs are consistently available to NHS patients where evidence supports their use.
Answered by Baroness Blackwood of North Oxford
Current prescribing arrangements already allow off-patent drugs that are found to have new uses to be prescribed to patients.
The Government and medical research charities are working together to ensure that robust evidence showing new uses for existing drugs can be brought more systematically into clinical practice to benefit patients.
Asked by: Ian Blackford (Scottish National Party - Ross, Skye and Lochaber)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what discussions his Department has had with the General Medical Council on amending guidance related to the prescription of off-label drugs and subsequent personal liability.
Answered by George Freeman
The Government has made no such assessment and has not had discussions with the General Medical Council (GMC) on amending their guidance related to the prescription of off-label drugs and subsequent personal liability. The GMC is responsible for the assessment of its national guidance and this is kept under review as part of GMC’s normal internal governance arrangements.
As part of its response to the Off-Patent Drugs Bill, the Government has discussed a range of issues around off-label prescribing with a wide range of stakeholders, including the GMC. Working with the Department of Health, the GMC has recently published a Hot Topic on ‘Prescribing unlicensed medicines.’ This on-line tool explains GMC’s prescribing guidance and assures doctors of the clinical appropriateness of unlicensed and off-label prescribing. A copy of this is available at:
http://www.gmc-uk.org/guidance/28349.asp
Asked by: Ian Blackford (Scottish National Party - Ross, Skye and Lochaber)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what assessment he has made of the effect of guidance from the General Medical Council on the personal liability taken on by medical professionals when prescribing off-label on the rate of off-label prescribing.
Answered by George Freeman
The Government has made no such assessment and has not had discussions with the General Medical Council (GMC) on amending their guidance related to the prescription of off-label drugs and subsequent personal liability. The GMC is responsible for the assessment of its national guidance and this is kept under review as part of GMC’s normal internal governance arrangements.
As part of its response to the Off-Patent Drugs Bill, the Government has discussed a range of issues around off-label prescribing with a wide range of stakeholders, including the GMC. Working with the Department of Health, the GMC has recently published a Hot Topic on ‘Prescribing unlicensed medicines.’ This on-line tool explains GMC’s prescribing guidance and assures doctors of the clinical appropriateness of unlicensed and off-label prescribing. A copy of this is available at:
http://www.gmc-uk.org/guidance/28349.asp
Asked by: Carol Monaghan (Scottish National Party - Glasgow North West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what research his Department has conducted on the disincentives to prescribing off-patent repurposed drugs.
Answered by George Freeman
The Department has conducted no such research. Current arrangements already allow off-patent drugs to be prescribed for new purposes where this is the most appropriate clinical treatment course for a patient. Prescribing decisions are a matter for the clinical judgement of the prescriber concerned.