Charging procedure: technology appraisal and highly specialised technologies evaluations

Introduction

  1. In accordance with UK Statutory Instrument 2018 No.1322, NICE must recover its costs for producing Technology Appraisals (TA) or Highly Specialised Technologies (HST) guidance from the company that expects to market the technology in England.
  2. Technologies are selected for evaluation in accordance with the NICE health technology evaluation topic selection: the manual and evaluated following the NICE health technology evaluations: the manual.
  3. The timelines describe charging in the context of the guidance development process. NICE will initiate the charging process by requesting a Unique Reference Number (URN) from the company.
  4. Upon receipt of URN, NICE will issue an invoice for the amount due and the charges will be made to the company who holds or expects to hold the marketing authorisation (MA). NICE payment terms are 30 days from the date the invoice is issued. 
  5. The relationship between NICE and the company is not contractual and is governed exclusively by NICE's published processes, including this charging process.
  6. NICE expects companies to work proactively with its staff, evidence review groups and independent committees to ensure the evaluation follows the timelines set out in NICE's process documents. Companies are expected to use all opportunities available to them, to facilitate the evaluation, including commercial and managed access arrangements described in the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth [PDF].

Charging procedure

  1. NICE will request a commitment to pay via a Unique Reference Number (URN) from the company approximately 6 months before the Invitation To Participate (ITP) date. The URN identifies the TA or HST evaluation in the company's finance systems and enables payment for the full charge to NICE. The company is required to submit the URN by the deadline that NICE provides.  
  2. If the company issues a purchase order as the URN, any terms and conditions attached to the purchase order will not apply and a contract will not be created (see UK Statutory Instrument 2018 No.1322 for the legal basis of this charge).
  3. NICE reserves the right not to start the scope consultation until the URN has been received.
  4. NICE reserves the right to pause the evaluation if payment is not received in full before the ITP is issued, and the agreed timeline may be at risk.
  5. The charge is exclusive of UK VAT which shall be payable by the company, where applicable, in addition to the charge. All invoices are subject to the relevant VAT rate at the time of invoice, where applicable.
  6. The company will be responsible for any applicable sales, value-added, use and similar taxes, together with all customs and import duties, and similar levies and impositions (“Taxes”) payable with respect to its payment of the charge. Unless expressly specified otherwise in this procedure, all charges exclude Taxes. If the company has tax-exempt status, then it must provide written evidence of this when asked by NICE. 
  7. If the company is required to withhold taxes which may be imposed on NICE for any payment under this procedure by virtue of the statutes, laws, codes, or governmental regulations of a country, then the company will make these payments on behalf of NICE by deducting them from the payment due to NICE and remitting such taxes to the proper authorities on a timely basis. In this case, NICE will adjust the charges upwards or issue another invoice so that it receives the full amount of the charge as specified in the tables above. The company will provide NICE with official documentation or tax receipts on any withholdings and related payments supporting such taxes and related payments, that NICE may need for its tax records as soon as reasonably possible after payment to the applicable tax authority, and no later than when required by applicable law.
  8. As per section 8c of the National Institute for Health and Care Excellence (Miscellaneous Amendments) Regulations 2018 NICE regularly reviews its policies and procedures and may revise them where appropriate.

Amendments to processes

  1. From 1 April 2024, a divergent fee will apply to evaluations where standard processes have been amended.
  2. Cost recovery will be based on the standard fees and the key milestone weightings. NICE will explore a fee based on the evaluation resource effort, relevant indirect costs and overheads using a methodology consistent with HM Treasury’s guidance, Managing Public Money (MPM). The divergent fee would accurately reflect the resource and unit capacity utilised by an evaluation.
  3. In exceptional cases, it may be necessary to deviate from the standard fees to reflect the unit capacity utilised. It is not expected that any fees will exceed the maximum fee in the fee table.

Change fee

  1. A change fee will apply if NICE receives a request from the company to amend the timeline in the four calendar months prior to the ITP date. A change fee can be applied to an evaluation more than once. 
  2. The change fee is set at £9,305.
  3. Payment is required as per NICE payment terms, within 30 days of the invoice being issued.
  4. A change fee will not apply if:
    • An ITP has been issued. In this case, the refund process will be followed.
    • The company is engaged in a Multiple Technology Appraisal (MTA)
    • NICE initiates the change to timelines. 

Small companies

  1. The definition of a small company for the purposes of this process is section 382(3) (qualification of a company small) of the Companies Act 2006.
  2. Companies will be asked to declare whether they are a small company as part of their response to the charging notice and request for the URN.
  3. Companies are required to provide the latest available independently audited financial statements and written evidence to validate their status as a small company. If it is not possible to provide audited financial statements by the deadline provided, the company will be asked to advise when this information will be available. Evidence must be received before the ITP is issued. If NICE does not accept the evidence provided (at its sole discretion) or evidence is not submitted before the ITP is issued, NICE will invoice the company the standard large fee.
  4. Small companies have the option to pay the charge in 3 instalments: 
    • 40% on receiving the invoice from NICE 
    • 50% before the first committee meeting at which the technology is to be discussed 
    • 10% before publication of the final draft guidance (FDG). 

Late payment

  1. NICE has the right to claim interest, compensation, administrative fees and reasonable costs under the Late Payment of Commercial Debts (Interest) Act 1998 and it is agreed that the term implied by that Act shall apply after any judgment as well as before. If for any reason the Late Payment of Commercial Debts (Interest) Act 1998 does not apply, interest shall be payable on overdue amounts at 8% over the Bank of England base rate together with compensation at the rate of £100 per invoice on amounts unpaid by the company on their due date and the costs of claiming these amounts in the event of late payment.

Refunds

  1. NICE will fully or partially refund the charge of the evaluation if: 
    • A single technology appraisal (STA) is converted into a cost comparison (CC). In this case, NICE will refund the difference in charge. See 5.8.27 NICE health technology evaluations: the manual for further details. 
    • A single technology appraisal (STA) follows the streamlined decision-making process. In this case, NICE will issue a proportionate refund.  
    • There are amendments to process, or divergent fees are applied to a pilot evaluation.  
    • If in the sole opinion of NICE, the evaluation cannot be completed after the evaluation has started (for example, if the technology does not receive regulatory approval or the company withdraws an application from the relevant regulatory authority), a proportionate refund will apply for the amount paid less any costs incurred during the evaluation process up to that point (including fair allowance for overheads and other similar costs). 
    • If the ITP has been issued and the timelines for the evaluation are rescheduled over 4 months later, then NICE will provide a proportionate refund considering the milestones met and formally recharge at the appropriate rate and time. This ensures that NICE manages public monies appropriately, acts in line with financial regulations and aligns with published and monitored start dates for the evaluation process for each topic. 
  2.  The key milestones are used as a baseline for refund calculations. The exact refund owed may differ if additional resources and overheads are utilised: 

    TA-HST cost recovery percentage effort at key milestones
    Key milestonesWeighting (%)
    ITP
    includes pre ITP resource such as topic selection, scoping and scheduling.    		 18%
    Evidence submission 7%
    Evidence Assessment Report (EAR) deadline 7%
    Appraisal committee meeing 1 - preparation 12%
    Appraisal committee meeting 1 21%
    Appraisal committee meeting 2 - preparation 8%
    Appraisal committee meeting 2 17%
    Guidance Publication 10%
  3. Refunds are not applicable when an evaluation has started or passed the preparation stage for the first committee meeting (“Appraisal committee meeting 1 – preparation” milestone in the table above).

Updated: March 2024