Guide to the processes of technology appraisal

4.3 A patient access scheme is a scheme proposed by a company that is a member of the 2014 PPRS. Up to January 2018, these were approved by the Department of Health and Social Care, but from January 2018 onwards they are approved by NHS England. Patient access schemes allow patients to have a technology when NICE's assessment of value, on the current evidence base, is unlikely to support the list price.

4.4 Flexible pricing recognises that the initial launch price of a technology may not fully reflect its longer-term value to patients in the NHS. It therefore allows a company to propose an initial price for a technology that reflects value that can be demonstrated at launch, while retaining the freedom to apply to increase or decrease this original list price either as further evidence or as new indications emerge and change the effective value that the technology offers to NHS patients.

4.5 A commercial access agreement between a company and NHS England supports use of a technology for which at least 1 indication is currently, or has been, considered as part of the Cancer Drugs Fund.

4.6 NICE can only consider patient access scheme proposals, flexible pricing proposals and commercial access agreements after NHS England has formally approved them (see figure 6).

4.7 The Commercial and Managed Access Programme at NICE will provide companies with opportunities to engage in commercial and managed access conversations with both NICE and NHS England. The relevant stages for commercial dialogue are:

4.8 The 2014 PPRS identifies 2 types of patient access scheme (see chapter 5 of the 2014 PPRS for more details):

4.9 The Patient Access Scheme Liaison Unit (PASLU) at NICE advises NHS England on the feasibility of implementing patient access scheme proposals. When assessing a patient access scheme proposal, the PASLU considers the key principles for implementing patient access schemes in England as outlined in the 2014 PPRS. The PASLU process is not part of the appraisal process. Changes could be made to a patient access scheme proposal after NHS England has referred it to NICE, however, these must be discussed and agreed with NHS England.

4.10 The appraisal committee considers the effect of a patient access scheme proposal on the clinical and cost effectiveness of the technology and clarifies relevant points with the company (see section 3.3). The ERG or the NICE team assesses the impact of the proposed scheme on clinical and cost effectiveness.

4.11 The process for reviewing the impact of a patient access scheme proposal on the cost effectiveness of a technology depends on when the proposal is submitted to NICE. When companies wish to propose a patient access scheme in the context of a NICE technology appraisal, they should follow these rules:

4.12 If the appraisal committee recommends a technology with an outcomes-based patient access scheme or commercial access agreement, it is essential that arrangements are in place to collect and analyse the relevant outcomes. If the actual outcomes differ significantly from those assumed during the original appraisal, NICE may decide to bring forward a review of the recommendations.

4.13 For fast track appraisals (this is an exception to the statement in section 4.11) a patient access scheme proposal must be included in the company evidence submission.

4.14 Any significant new proposals for, or structural changes to, a patient access scheme or commercial access agreement after release of the final appraisal document (FAD) will not be accepted, but minor changes to an agreed commercial arrangement, such as a change in the level of discount could be accepted. At this point an update to the guidance will only be considered in a rapid review of the guidance. See sections 4.21–4.25 for further details.

4.26 The 2014 PPRS identifies 2 circumstances in which flexible pricing may be relevant:

4.27 Requests to consider a flexible pricing proposal for an existing indication of a technology must be linked to new evidence emerging. The company therefore needs time to gather the additional evidence necessary to justify a price change. NICE will consider reviewing the guidance only in the light of significant new evidence that is likely to have an impact on the clinical or cost effectiveness of the technology. This could include: new clinical trial evidence, new evidence on identified subgroups of patients, or significant new evidence supporting additional benefits previously unaccounted for (for example, long-term outcomes). New evidence does not include new analyses of existing data. Flexible pricing proposals that are not supported by new evidence will not be considered.

4.28 For technologies launched after 1 January 2009, if NICE receives a flexible pricing proposal for an existing indication within 12 months of guidance publication, NICE will consider the impact of the new evidence and the flexible pricing proposal on the clinical and cost effectiveness of the technology. NICE will clarify relevant points with the company before the ERG reviews the proposal. The appraisal committee will then consider the proposal together with the ERG's independent review.

4.29 NICE considers flexible pricing proposals for an existing indication submitted more than 12 months after guidance publication by the standard review process (see section 6).

4.30 All flexible pricing proposals for technologies launched before 1 January 2009 are considered through the standard review process (see section 6).

4.31 When the appraisal committee considers a flexible pricing proposal for an existing indication, the committee will review the original guidance in light of the new evidence and the proposed new price. The committee's assessment of cost effectiveness will be consistent with that used in the original appraisal.

4.32 Although NICE includes flexible pricing proposals under consideration on the relevant committee meeting agenda, NICE makes no public announcement about the specific topics. NICE considers it essential that such proposals can be received and considered in confidence. NICE also understands that companies may suffer commercial and other harm if information on the proposals were to be made public at this point. Therefore, NICE treats all flexible pricing proposals for existing indications as confidential and will not normally release any information about these schemes under the Freedom of Information Act, or for any other purpose at this stage (including during the public part of appraisal committee meetings), unless the company has agreed to this.

4.33 When the appraisal committee has reviewed the existing guidance on the technology in the light of the new evidence and flexible pricing proposal, an ACD will be published for consultation (see section 3.5.26 onwards). Detailed information will be released as part of the ACD consultation so that the proposed new price and its impact on the clinical effectiveness, cost effectiveness and the recommendations can be understood. As with the normal appraisal process, the appraisal committee will review consultation responses on the ACD and develop a FAD. NICE will issue the FAD to consultees, along with the consultation response to the ACD, for appeal. Appeals will be accepted only on points relating to the flexible pricing proposal. They will not consider points previously raised or points that could have been raised at an earlier appeal. Subject to any appeal by consultees, the FAD forms NICE's updated guidance on the use of the technology.

4.34 Flexible pricing proposals for new indications of existing technologies are also covered in the 2014 PPRS. New indications are potential new appraisals. Consideration of their suitability for technology appraisal is therefore covered under topic selection (see section 2).