Key documents

Update on access to ivacaftor/tezacaftor/elexacaftor (Kaftrio®) for children aged 2-5yrs (November 2023)

John Stewart, National Director for Specialised Commissioning at NHS England said: “Following the MHRA approval of ivacaftor/tezacaftor/elexacaftor (Kaftrio®) for children aged 2 – 5 yrs, children as young as two years old with cystic fibrosis will now be eligible to receive the triple therapy if determined to be suitable by their treating clinician.

“We anticipate that as many as 600 children could benefit from this approval under the terms of the existing commercial agreement, and NHS England will publish an updated policy confirming this expansion in access and funding to coincide with stock arriving in England, which is anticipated in a few weeks.

“Patients, families and carers should be assured that NHS CF centres across the country have plans in place to ensure that all eligible children can be initiated on treatment while the NICE review of the CFTR modulators remains ongoing – meaning that all children eligible today can be confident about their long term access to these life-changing treatments”.

Update on evaluation of cystic fibrosis transmembrane conductance regulator modulator therapies and continued patient access (November 2023)

Responding to the National Institute for Health and Care Excellence (NICE) publication of a draft guidance consultation as part of its appraisal of cystic fibrosis transmembrane conductance regulator modulator treatmentsJohn Stewart, National Director for Specialised Commissioning at NHS England said: “Since 2019, thousands of people with cystic fibrosis have been able to benefit from licensed treatments – firstly Orkambi® and Symkevi® and then Kaftrio®, following its marketing authorisation in 2020. Access to these treatments is provided under the terms of a commercial agreement reached between Vertex and NHS England, with the full support of NICE.

“Within the agreement between NHS England and Vertex there is a flexible commercial mechanism to ensure continued access for patients already receiving any of the licensed treatments following the conclusion of a full NICE evaluation.

“Today’s draft publication is an initial step in the review of these medicines and does not affect patients’ continued access to these drugs on the NHS in any way. Eligible children and adults with cystic fibrosis can continue to receive ongoing treatment and be initiated onto treatment with these drugs, as clinically appropriate.

“NHS England remains committed to ensuring that these life-changing cystic fibrosis medicines are available to everyone who may benefit, now and in the future, and will continue to work with Vertex and NICE through the next stages of the appraisal process to make this possible in a way that is fair to patients, and fair to taxpayers”.

Roadmap for integrating specialised services within integrated care systems

NHS England and NHS Improvement have issued a letter to the system which sets out the next steps for the delegation of NHS England direct commissioning functions for April 2023, including a roadmap about integrating specialised services within Integrated Care Systems.

Specialised clinical commissioning document library

Our Specialised Clinical Commissioning document library includes:

  • non routinely commissioned policies
  • routinely commissioned policies
  • policy statements/urgent policy statements
  • service specifications.

Service development policy and methods

This service development policy sets out NHS England’s approach for making decisions about which new treatments and interventions to routinely commission, and the approach used for updating existing service specifications, or creating new ones.

It is intended to ensure that funding is allocated fairly and appropriately, with due regard to the competing demands on NHS England’s available funding.

The service development process has three phases:

  1. Clinical build: This phase is where new or amended clinical commissioning policies and new or amended service specifications are proposed and developed. Policy propositions are will need to be underpinned by a clinical evidence review.  NHS England’s specialised services Clinical Panel challenges and confirms whether the proposition has a sound evidence base. Service specifications do not normally require an evidence review and therefore are not normally considered by the Clinical Panel.
  2. Impact analysis: This stage identifies the financial and operational impacts of moving from current pathways of care to the pathways proposed in the draft policy proposition or service specification proposition. The proposed policy or service specifications then are also subject to stakeholder testing, and public consultation.
  3. Decision: For policy propositions and service specification propositions which are cost-neutral or cost-saving, the decision on whether to approve is based on an assessment of its clinical benefit. For propositions which require additional investment and where there is not sufficient funding available to cover all interventions being proposed, the policy propositions are assessed on their likely relative clinical benefit and relative value for money. Using this information, NHS England carry out twice a year a relative prioritisation process to determine which services will be routinely commissioned.

NHS England can rapidly assess policy propositions, for example where there is an urgent clinical case and it would not be appropriate to wait for a decision to be made through the full service development process.  In these circumstances a policy statement can be put in place to provide an interim commissioning position which allows interim access to the service, or to make it clear that there is no access to the service until a full assessment has been carried out. The policy may then be considered in full through the normal service development process.

The service development policy document, and supporting methods documents set out the policy and process for these in more detail.

In the event of non-submission of data to the National Institute of Health and Care Excellence (NICE), NHS England’s procedure is outlined in the document below:

View details of the current service specification and clinical commissioning policy work programmes.

Individual Funding Requests

Individual funding requests (or IFRs) are made to NHS England by clinicians when they believe that a patient’s clinical circumstances are exceptional and because of this, they would benefit from a treatment that isn’t usually available on the NHS. Applications are considered by an independent panel made up of doctors, nurses, public health experts, pharmacists, NHS England representatives and lay members. To find out more about what an IFR is, watch our short animation.

More detailed information about IFRs and how decisions are made is available in our patient guide and process map.

NHS England’s policy and standard operating procedure, which are used for decision making in the case of IFRs, are below.

These documents were consulted on with the public, and a range of other stakeholders, between October 2016 and March 2017. The aim of the revised IFR documents is to make sure there is a timely and consistent approach to managing requests.

You can read the detailed consultation response, which provides a summary of the key themes identified and how these have shaped the new policy and supporting documentation.

Online application form: The IFR team has been developing an online application form. Trusts can now register with the online portal and create IFR applications. The IFR Team will no longer accept a Word application from 1 December 2021. Following this date all submissions must be via the Apollo portal.

Please go to to register with the Apollo portal. A user guide is also available on the Future NHS platform.

Terms of Reference for the Specialised Commissioning Oversight Group (SCOG)

SCOG is a decision-making group within NHS England, established in order to deliver the key priority of creating sustainable, clinically effective and affordable specialised services. It has operational oversight of specialised commissioning and holds to account the national and regional specialised commissioning teams in NHS England in delivering high quality specialised services within budget. SCOG also receives recommendations from the Clinical Priorities Advisory Group (CPAG) on the introduction of new clinical commissioning policies  and other service developments.

The Manual

The Manual is a technical document describing the 150 prescribed specialised services. It describes the rationale and which elements of specialised services are directly commissioned by NHS England and which are commissioned by integrated care boards. This document now combines the Manual and the Identification Rules Handbook and replaces all previous versions.

Virtual clinics in Highly Specialised Services (HSS): guidance for services supporting patients with rare and complex and multi-system disorders

This guidance document for services supporting patients with rare and complex multi-system disorders provides acute hospital teams with support for setting up or improving the safety and efficiency of digital/virtual and phone clinics. It contains guiding principles alongside worked examples from clinical lessons learned during the Covid-19 pandemic.

Identification Rules

The Identification Rules (IR) is a mechanism by which healthcare activities can be identified as specialised. The data flows used to support the commissioning process consist of both standard and non-standard flows of various quality and content. It is therefore not possible to have one single identification method for prescribed activity. There are two products that exist and are required to be used in tandem in order to identify specialised service activity:

Other NHS England Commissioning Policies

Specialised commissioning is supported by a range of NHS England generic commissioning (listed below) policies that are to be applied consistently and cover a range of areas.