The UKMi ‘Information on New Products’ Portfolio

UKMi produces a range of information on new products, covering early horizon scanning intelligence on drugs in clinical development through to evaluations of medicines once marketed.

The information is intended to support the managed entry of new drugs into the NHS, to assist organisations in developing medicines management policies and to inform prescribing decisions when a product has been launched.

All elements of UKMi’s new product portfolio are available on the UKMi website at http://www.ukmi.nhs.uk/Med_info/NewProd.asp and are classified under three headings;

• information for early horizon scanning,
• information for planning
• information for prescribing

Resources falling into the first two categories are confidential to NHS staff with budget setting, prescribing planning and medicines management responsibilities and are password protected. Passwords are available to eligible personnel via their regional medicines information centre. A Work in Progress database informs NHS staff of UKMi new product work currently in production.

Information for early horizon scanning

Information for early horizon scanning is available through access to UKMi’s New Drugs Online database.

New Drugs Online (NDO) contains information about drugs in clinical development through to launch, as well as on licence extensions to existing products. Drugs are included in NDO if they fulfil the following criteria:

• Likely to reach the UK market
• In late phase 2 trials if they are being fast tracked
• Otherwise, are in phase 3 clinical trials
• A major licence extension is anticipated

Some new medical devices are also included in the database.

The database is updated daily by a number of medicines information pharmacists from regional MI centres across the UK. Information sources include Scrip, NewDrugFile daily news, InPharma and Biospace news. Two MI centres ( London – Northwick Park and Trent) have ongoing regular liaisons with major pharmaceutical companies to provide an additional source of horizon scanning data.

Drugs are continually tracked on the database up to the time of launch and then for some time afterwards. The database links drug entries to available UKMi ‘Information on New Product’ reviews: New Drugs in Clinical Development and On the Horizon (produced in collaboration with the National Prescribing Centre), and New Medicines Profile monographs.

In addition, each NDO drug entry links to data from a commercial, independent database, NewDrugFile online (NDF), which contains clinical, pharmacological and marketing information. NDF, via NDFInform also links to information about phase 3 products provided by the pharmaceutical industry.

NDO can be searched in two ways:

• Using the ‘SEARCH’ box to search for an individual drug or disease
• Using the ‘REPORT’ function to search for drugs using specified criteria, e.g. within a BNF category, according to development phase, by pharmaceutical company or by predicted launch date.

Individual registration to the database is required to access to the report function. NDFinform is only available to those who have individually registered.

Information for planning

Information for planning is provided in two broad forms; as the publication Prescribing Outlook and as monographs containing more detailed evaluations of drugs in development published under the titles Drugs in Clinical Development and On the Horizon.

The Prescribing Outlook Series is intended to assist NHS budget holders and those involved in prescribing planning assess the potential impact of new drugs and national guidance on the local health economy. It is available in three parts.

Prescribing Outlook A includes information on drugs with launches planned over the next 12 to 18 months and on marketed drugs with new major indications. It contains brief clinical and therapeutic data plus information on predicted launch date, potential target population and estimated impact on service delivery and cost. Prescribing Outlook A is produced in collaboration with the National Prescribing Centre (NPC) and the National Horizon Scanning Centre.

Prescribing Outlook B c ontains information on existing and forthcoming NICE guidance,NSFs, the GMS contract and other national targets that may have budgetary implications over the next 12 to 18 months. Is intended to facilitate the implementation of national targets and guidelines and to calculate the cost of such implementation.

Prescribing Outlook C is an excel spreadsheet based on the content of Prescribing OutlookA and B. It allows crude calculations of potential costs of prescribing changes for a local population.

New Drugs in Clinical Development are monographs for significant new medicines armarked for appraisal by NICE at, or around, the time of their anticipated market launch. These monographs are published some 12 months before launch.

On the Horizon – Future Medicines are bulletins for new medicines either not to be covered by NICE or, if covered, to be appraised at least four to six months after launch. These bulletins are issued around six months pre-anticipated launch. If, after publication, significant additional information emerges, an On the Horizon – Rapid Review will be produced around two months after launch to update the Future Medicines bulletin.he content of both Drugs in Clinical Development and On the Horizon takes the form of critically appraised, balanced information, rather than guidance. They are produced by a number of UKMi regional MI centres working in collaboration with the NPC.

The target audience for the horizon scanning and planning information include:

Information for prescribing

New Medicines Profiles are post-launch new product evaluations produced by UKMi. They have replaced the New Medicines on the Market Monographs (stage 4) monographs which were published up to mid-2003.

New Medicines Profiles are produced on newly launched medicines that

• are new chemical entities e.g. aripiprazole
• are anticipated to have significant budgetary impact in primary care including combination products e.g. Tramacet
• have major licence extensions e.g. palivizumab

Monographs are allocated at the time of EMEA approval, where possible, and published shortly after launch

New Medicines Profiles focus on evaluating large published studies, are brief (two pages with an option for appendices if required) and cover risk management issues as well as clinical efficacy and adverse effects. The LNDG contribute to the production of New Medicines Profiles, linking these evaluations with their own, more detailed assessments.

Therapeutic Class Summaries are more detailed documents than New Medicines Profiles and examine the clinical efficacy, adverse effects and licensed indications of a group of related drugs, such as the statins.

The target audience for New Medicines Profiles and Therapeutic Class Summaries is:

Work in Progress database

The Work in Progress database lists new product monographs currently in preparation by UKMi both nationally and regionally, together with those being produced in collaboration with the NPC, and by the LNDG. The database gives details of the estimated time of publication, the prime author of the work and the format in which the monograph will be published. It is intended that this information will facilitate the planning of work to support prescribing committees etc. Working together in this way helps ensure that UKMi, the NPC and the LNDG provide NHS healthcare professionals and managers with a wide range of information on new medicines with minimum duplication.

See flow diagram (document ) which explains how new products work is carried out on a regional and national basis.