What is UK PharmaScan?
The database, UK PharmaScan, is intended to contain in one place the type of information currently provided by companies to the seven horizon scanning bodies across the UK. Companies are requested to populate it with information on medicines in development from up to three years before launch or start of Phase III clinical development (whichever is the earlier). It has been developed and will be hosted by NICE (NHS Evidence).
Who owns UK PharmaScan?
The Department of Health owns the database. The content of the database relating to individual products remains the respective companies' property
Why is UK PharmaScan needed?
The purpose of UK PharmaScan is to support better NHS planning for the introduction of new medicines. It is known that better planning results in earlier and more effective decision-making and faster uptake in patients who need the medicines.
There are seven horizon scanning organisations across the UK, which fulfil a variety of NHS and Government needs and which are collecting information on products in development. They all require the same information and companies are dedicating resource to delivering information to each of them. This is inefficient.
There is a need to improve the quality, timeliness and consistency of the horizon scanning information used by the NHS to enable better forward planning and faster uptake of new medicines.
How was UK PharmaScan conceived?
In 2007, the Ministerial Industry Strategy Group, a joint forum of Ministers and senior industry executives, agreed that a more streamlined horizon scanning system was needed. All the UK horizon scanning bodies, industry, the ABPI and Department of Health then agreed that the best means to do this was to create a single, unified horizon scanning database that captured the information companies were currently providing to horizon scanning bodies. This agreement was then formalised in Lord Darzi's Next Stage Review of the NHS in 2008 and in the 2009 PPRS.
What are the benefits for the industry?
- Uptake of new medicines should be enhanced as the NHS will receive more consistent, timely and comprehensive information on pre-launch products through the outputs of the horizon scanning agencies and selected NHS subscribers to the database (see below).
- Time and resource will be saved by reducing company activity to provide the same information to multiple agencies
- The comprehensiveness and quality of the information the NHS receives will be enhanced because of the consistent standards set by UK PharmaScan.
- Provision of information by companies should be much easier – simply keying in the information from their offices, rather than multiple visits and ad hoc contact.
- Future contact between horizon scanning agencies and companies will be more productively focused on discussion of the interpretation of product information, rather than on seeking/providing basic facts, thus making optimal use of limited company and horizon scanning agency resources.
What are the benefits for the horizon scanning bodies?
Instead of searching for a lot of information in the public domain and contacting individual companies, horizon scanning bodies will now be able to go direct to the database for information about products in development, that it is comprehensive and up to date. Contact with companies will be more productively focused on discussion of the interpretation of product information, rather than on seeking basic facts, thus making optimal use of limited horizon scanning agency resources.
What information does the database contain?
UK PharmaScan is a repository for the type of information that is currently being provided to horizon scanning organisations by companies. It contains information on medicines in development from up to three years before launch or start of Phase III clinical development (whichever is the earlier). As the time moves closer to launch, it will be possible to populate an increasing number of fields.
- Technology information, with one record per indication, including usual items such as mode of action, route of administration, formulation, dose, BNF class, likely comparators and whether the product has been selected for Health Technology Appraisal.
- Clinical Trial information, also with one record per study, including patient population, study design, primary objectives and outcomes.
- Regulatory information such as regulatory procedure and status, date of submission, estimated licence date, estimated UK availability.
- Costs and budget impact, including proposed average dose, estimated length of treatment, drug cost range per patient per year/per episode, budget impact.
How is the database being managed?
An Oversight and Governance Committee is responsible for governance and will report to the Ministerial Industry Strategy Group, with membership including representatives from the horizon scanning organisations, companies, ABPI, NHS, Department of Health, and a lay representative.
Why was NICE chosen to develop and host the database?
The Horizon Scanning Project Board set out criteria for the organisation it would like to develop and host the database. One of these was that the database should be hosted by an organisation within the 'NHS family'. It then approached organisations who met these criteria who had a potential interest. NICE, which had launched NHS Evidence and therefore had significant IT expertise, expressed an interest and was the strongest candidate organisation. The Project Board therefore recommended to the MISG Partnership Working Group that NICE develop and host the database. This was accepted by the MISG and the ABPI Board of Management approved the choice in July 2009. Following approval by the NICE Board in September 2009, a programme management team was set up using the expertise and experience of the NHS Evidence team.
When was UK PharmaScan made available?
The database was made available to companies for data entry purposes in May 2010. The database was made available to horizon scanning bodies and NHS users from Summer 2010.
Who has access to it?
All of the horizon scanning bodies across the UK have access to UK PharmaScan (National Horizon Scanning Centre, National Prescribing Centre, UKMi, NICE, SMC, AWMSG, Northern Ireland). In addition, a limited number of local NHS organisations (not individuals) which have a specific role in supporting the managed introduction of new medicines, and which have arrangements in place with their local NHS (e.g. a Service Level Agreement or Commissioning Agreement) to provide information on new medicines, are allowed to apply for access to some of the information available.
All organisations granted access are required to sign a User Agreement which sets out roles and responsibilities, including strict adherence to commercial confidentiality and commitment to pay the subscription fee.
Which NHS groups can apply for access to the database?
We are aware that there are a number of groups that provide information on products in the pipeline to assist other local NHS organisations to plan for their introduction. These groups can apply for access to the database via a process which will be set out on the website. They have to apply to their SHA for permission to access the database and the SHA is responsible for ensuring that they meet the specified criteria.
- They have a legitimate and clearly stated purpose for evaluating medicines
- Their group is responsible for providing the NHS (or parts of the NHS) with information on new medicines
- A proven track record in critically evaluating new medicines
- Evidence synthesis skills and the ability to synthesise information into a fair, accurate and balanced summary
- A proven track record in presenting data in a user friendly format
- Multidisciplinary expertise within the group, or as a minimum outputs which are subject to multidisciplinary peer review with incorporation of appropriate comments
- Policies and processes in place for liaising with manufacturers during compilation of their evaluations
- Processes in place whereby manufacturers are invited to review draft outputs and comment on factual inaccuracies, when appropriate.
How can NHS Organisations Subscribe?
Access to the database will be granted following a formal application process. All applications will be signed off at SHA level (or equivalent in the Devolved Administrations). Where there is a disagreement between the SHA and the NHS organisation about the appropriateness of the application that cannot be resolved, or where SHA has identified that there may be a conflict of interest, or where the SHA is in doubt about the appropriateness of the application and needs advice, decisions on the application will reside with the UK PharmaScan Oversight and Governance Committee in consultation with the SHA.
The process will be as follows:
- A nominated champion user should be identified within the NHS organisation to complete the registration process. The champion user should fill out the Register your company / organisation form on the UK PharmaScan website and select NHS Organisation from the Company type drop down list. Once the champion user has completed and submitted the form, NICE will receive an email requesting approval of the company and champion user.
- On receipt of the email, NICE will complete some preliminary checks to assess if the application should proceed. If the application can proceed then NICE will email the champion user a more detailed application form and Data Accessor Agreement (see example Data Accessor Agreement).
- The champion user should complete the application form and send to the relevant SHA Prescribing Lead for approval. If the SHA Prescribing Lead approves the application she/he should sign the form where indicated and return to the champion user at the NHS organisation. The champion user should then arrange for the Data Accessor Agreement to be completed. It is expected that the signatory to the agreement must hold a sufficiently senior position to provide the authority to act on behalf of the NHS organisation and bind the NHS organisation to the terms of the Data Accessor Agreement. The champion user should then return the completed application form and signed Data Accessor Agreement to NICE.
- On receipt of the documents NICE will send an email to the champion user containing a link to download the client certificate and activate their UK PharmaScan account.
New applications will be invited on a rolling basis between 1st July 2010 and 30th June 2011. Thereafter applications will be accepted on a six-monthly basis with 30th June and 31st December deadlines. In the event an applicant misses a deadline their application will not be considered until the next submission date.
When can NHS users gain access to specific data on UK PharmaScan?
To prevent duplication between the work of these organisations and the horizon scanning bodies, these organisations will have access to information on medicines for which a marketing authorisation has been requested (i.e. about 12 months prior to market entry).
Is UK PharmaScan secure?
The database can only be accessible to pharmaceutical companies, the seven national horizon scanning bodies and those NHS groups that demonstrate that they have met the criteria outlined above. Access is protected by the use of SSL certificates (SSL stands for Secure Sockets Layer). In addition, companies can only view their own technologies and not those from other companies. All users have to sign up to a "user agreement" which sets out their responsibilities in maintaining the security of the information on the database.
Is participation from the pharmaceutical industry mandatory?
Participation in UK PharmaScan is voluntary. In time, it will become the primary route for the NHS to access up-to-date horizon scanning information needed to plan for the introduction of new medicines. As such, companies choosing not to participate will find their products disadvantaged in terms of NHS planning.
Participation is a 2009 PPRS commitment. ABPI therefore advises all pharmaceutical companies with products in the pipeline to participate.
Have all the national horizon scanning bodies committed to using the database?
All national horizon scanning organisations have committed to using the database. It is anticipated that for a period they will use parallel systems while UK PharmaScan is being fully populated by industry. It is in everyone's interests that population takes place as rapidly as possible.
Is the website easy to use?
Fields to be filled within the database appear as a mix of free text, drop down menus, radio buttons etc. to make it as easy and straightforward as possible for the person completing records.
How many users can input into the database per organisation?
The maximum recommended number of active users is five per organisation. A “Champion User” will be the lead person in that organisation for granting access to the Database to up to four active “Standard Users”. NICE monitors the number of users per organisation.
Has there been an opportunity to feed into its development?
A Horizon Scanning Project Board, comprising representatives from all the horizon scanning bodies across the UK, NHS end-users, Department of Health and industry, oversaw the development of UK PharmaScan, including hosting, funding arrangements, principles and standards, oversight, agreement and contracts and NHS access.
Two sub-groups of the Project Board developed the technical specification and proposals for access by a limited number of NHS Users.
User testing sessions involving manufacturers were also held on 6th and 12th April.
Is there any Quality Assurance of the information provided by the companies?
NICE will review the data by verifying that the field and its content correspond. For example, if the field under "stage of disease" contains the name of the company, NICE will contact the company to highlight this error and companies will be able to make corrections.
If horizon scanning or NHS users find inaccuracies in the database, they will notify NICE, and NICE will approach the company for confirmation of any changes required.
How often are companies asked to review their data?
Companies are required to update the information monthly. NICE will send a reminder every month prompting for updates. At certain critical times in the development of the product, companies are expected to update relevant information more often.
What should happen to products that are not taken forward?
If a product fails in the late stages of development or is no longer of interest, the company will be able to move the relevant record(s) to the database archive.
Does the archive remain accessible to horizon scanning bodies?
Yes, the archive is accessible to horizon scanning bodies. Companies can also access their own archived records.
What is the governance of the database?
An Oversight and Governance Committee will be established from June 2010 responsible for:
- Oversight of the effective operation of the database to agreed standards and to the satisfaction of the DH, ABPI, users and data providers
- Ensuring appropriate governance arrangements are in place and applied
- Development of recommendations for evolution and future developments of the database
- Dispute resolution between any parties engaged with the database
Will there be further development of the database?
No technical solution like this one can ever stand still. It is anticipated that user feedback will identify the need for enhancements or changes. The Oversight and Governance Committee will make recommendations to DH and the ABPI on these potential developments.
How is the maintenance and development of the database being funded?
By subscription, Horizon Scanning bodies, ABPI and NHS users each pay an equal annual fee to cover the costs of maintaining the database and any required future developments
Will there still be a need for horizon scanning bodies and companies to talk to each other?
UK PharmaScan only provides factual information on products in the pipeline. Each horizon scanning body has its own purpose, outputs and "customers" and will need to interpret and report on the information in the database in its own way. Queries to companies are still anticipated, therefore, but these should change to a richer dialogue based on interpretation of the information rather than requests for factual information.
There may be instances where horizon scanning bodies require information urgently before it is entered on to the database. In these cases, they should contact the companies directly.
Will companies still be given an opportunity to comment on horizon scanning bodies' reports?
It is not anticipated that the processes used by horizon scanning bodies to produce their outputs will change because of UK PharmaScan. Changes are anticipated in the means used and extent to which these bodies seek and assemble factual information.
Is there any support to help with enquiries and any technical issues?
NICE - NHS Evidence - has established an enquires desk to deal with any questions you have about using this service. Contact details for the enquiries desk are available on the UK PharmaScan website (www.ukpharmascan.org.uk) and are as follows:
E-mail - firstname.lastname@example.org
Telephone - 0845 003 9183
What happens if a company doesn't update their data?
Entry of information on to UK PharmaScan is voluntary. In time, it will become the primary route for the NHS to access up-to-date horizon scanning information needed to plan for the introduction of new medicines. As such, companies choosing not to participate will find their products disadvantaged in terms of NHS planning.
NICE will regularly communicate with the ABPI about any companies that fail to update information held on the database about their products. ABPI will contact companies directly to remind them that updates are due and discuss any potential issues.
Do companies need to register to gain access to the database?
Companies need to sign a user agreement as part of the process before being granted a SSL certificate allowing access to the database.
Who should be alerted to any changes in contacts within companies with responsibilities to update the database?
It is the responsibility of companies to keep NICE and the ABPI informed of changes to primary contacts responsible for input to UK PharmaScan. ABPI will keep an up-to-date list of contacts. If any changes occur, please email the ABPI at: email@example.com.
What does the 2009 PPRS say about the Horizon Scanning Database?
5.2 The Department will establish a single, unified horizon scanning process to identify new technologies in development by the industry. This process will be developed in co-operation with the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), the All Wales Medicines Strategy Group (AWMSG), the National Prescribing Centre (NPC), UK Medicines Information (UKMi) and the National Horizon Scanning Centre (NHSC). The industry will play a full part in the design and development of a database to capture such new technologies. Uses of the database will include supporting Health Technology Assessment (HTA) topic selection, scoping of appraisals and providing timely information to all NHS organisations for planning and budgeting purposes.
More detail is provided in Annex B of the Scheme :
Current horizon scanning information and processes are fragmented, with duplication of information requests and syntheses and analyses of information being undertaken by numerous different bodies. There is agreement in principle between the Department, NICE, the National Prescribing Centre, UK Medicines Information, the National Horizon Scanning Centre, the Scottish Medicines Consortium and the All Wales Medicines Strategy Group for a single unified horizon scanning database. The Association of the British Pharmaceutical Industry (ABPI) strongly supports this and will play a full part in the design and development of the database, and will encourage companies to populate it. Uses would include supporting NICE topic selection, scoping of appraisals and providing timely information to all NHS organisations for pre-launch planning and budgeting purposes.
We propose that as part of the PPRS agreement:
- The Department and the ABPI will renew their commitment to ensuring the delivery of the single horizon scanning database, with a view to developing specifications; processing change requirements; agreeing funding; going through the tendering process; and developing an implementation plan by April 2009. An implementation plan will be agreed with the successful tenderer with a deadline to complete development of the database covering pharmaceuticals by no later than October 2009, and companies will fully populate it by the end of December 2009.
- As part of the design and development work, an analysis is undertaken to understand how horizon scanning data can be translated into actionable information nationally on drugs bill evolution and locally for the NHS to include in commissioning plans and budgets.
- The ABPI will strongly encourage companies to populate the database and keep it up-to-date with timely horizon scanning product pipeline information.
- A single unified system will provide benefits to those companies that contribute to the database, and as such the ABPI anticipates that pharmaceutical companies will wish to populate the database.
The PPRS agreement will commit members to accept the horizon scanning database as a recognised method by which relevant and timely horizon scanning information that they are willing and able to share, will be exchanged between a scheme member and the NHS.
The Ministerial Industrial Strategy Group (MISG) will work with the Health Innovation Council (HIC) to retain oversight of delivery against agreed milestones for the pharmaceutical aspects of these initiatives.
What has ABPI done to ensure companies' participation in this initiative?
Company representatives have been actively involved in this project since July 2007 and have been members of the Project Board and Technical Sub-group which developed the technical specification.
ABPI has held two briefings in January 2010 and has updated its membership as well as non-members companies through the BIA and EMIG. This was done via weekly newsflash, presentation at various meetings including the HTA taskforce, Smaller Companies Forum, Innovation Imperative Board, Value and Access Imperative Board and expert fora and has prepared an update for PPRS Scheme Members for raising awareness.
During the phase of development, the ABPI made direct contact with company members with responsibility for responding to horizon scanning bodies. This will have ensured that those individuals were aware of the next steps, user test days and training sessions.
- What is UK PharmaScan?
- Who owns UK PharmaScan?
- Why is UK PharmaScan needed?
- How was UK PharmaScan conceived?
- What are the benefits for the industry?
- What are the benefits for the horizon scanning bodies?
- What information does the database contain?
- How is the database being managed?
- Why was NICE chosen to develop and host the database?
- When was UK PharmaScan made available?
- Who has access to it?
- Which NHS groups can apply for access to the database?
- How can NHS Organisations Subscribe?
- When can NHS users gain access to specific data on UK PharmaScan?
- Is it secure?
- Is participation from the pharmaceutical industry mandatory?
- Have all the national horizon scanning bodies committed to using the database?
- Is the website easy to use?
- How many users can input into the database per organisation?
- Has there been an opportunity to feed into its development?
- Is there any Quality Assurance of the information provided by the companies?
- How often are companies asked to review their data?
- What should happen to products that are not taken forward?
- Is the archive remain accessible to horizon scanning bodies?
- What is the governance of the database?
- Will there be further development of the database?
- How is the maintenance and development of the database be funded?
- Will there still be a need for horizon scanning bodies and companies to talk to each other?
- Will companies still be given an opportunity to comment on horizon scanning bodies' reports?
- Is there any support to help with enquiries and any technical issues?
- What happens if a company doesn't update their data?
- Do companies need to register to gain access to the database?
- Who should be alerted to any changes in contacts within companies with responsibilities to update the database?
- What does the 2009 PPRS say about the Horizon Scanning Database?
- What has ABPI done to ensure companies' participation in this initiative?