The Department of Health supports the timely introduction of effective new medicines that allow people in Northern Ireland to benefit from advances in medical treatment.
In April 2022, the Department published DoH Circular HSC(SQSD) 12/22 which sets out the process for the endorsement, implementation, monitoring and assurance of NICE Technology Appraisals in Northern Ireland (NI). The Circular updates and replaces Circular HSC (SQSD) 2/13 (2013). A copy of the circular can be found here.
Following the publication of NICE Technology Appraisals (TAs), the Department reviews the guidance for its applicability to Northern Ireland to check for legal, policy and financial consequences related to its implementation in NI. As a result, the guidance may be endorsed with caveats to advise local HSC organisations of any equivalent legislation/policy or any specific instructions/requirements.
The Department also has arrangements in place to ensure timelier access to those medicines that have an evidence base for efficacy and cost-effectiveness. These arrangements are known as the Process for the Managed Entry of New Medicines or ‘Managed Entry’ and came into effect on 1st April 2014 and updated on 11 February 2019. The Department adopts the decisions made by NICE as policy. In advance of, or in the absence of, a published NICE determination the Department will seek and potentially apply decisions made by other UK Health Technology Appraisal bodies.
Details of the original process can be found here and amendments can be found here.
Following the closure of the Health and Social Care Board (HSCB) and the transfer of its functions to the Department, these processes now represent the Department’s default policy position.
What does this mean for prescribers?
During the process of making new drugs available, prescribers in Northern Ireland are expected to maintain adherence to Managed Entry for a broad range of conditions. Managed Entry will specify either:
- “Accepted for use”: new medicines with limited long-term safety and outcome data, should only be prescribed in the particular circumstances outlined
- “Not accepted for use”: medicines that should not be prescribed in primary or secondary care for the indications specified.
In Northern Ireland, decisions published by NICE in respect of TAs or Highly Specialised Technologies (HSTs) are made available in Northern Ireland. Where NICE have not reviewed the treatment and in the absence of a decision by NICE, the SPPG will consider the adoption of decisions made by the Scottish Medicines Consortium (SMC) or the All Wales Medicines Strategy Group (AWMSG), in that order. Decisions on treatments from other commissioning organisations e.g. NHS England are not included within the extant policy arrangements in Northern Ireland.
The decisions made via Managed Entry can be found here. The Managed Entry Decisions webpage will typically be updated on the final week of each month.
The Managed Entry webpage will specify the criteria by which the treatment is made available including any requirement by a secondary care clinician to submit a Cost-per-Case (CPC) request before use of the treatment.
See also Cost-per-Case and IFR for more information.