Introduction

  1. In August 2018, the Department of Health and Social Care held a consultation on changing regulations to allow the National Institute for Health and Care Excellence (NICE) to charge for technology appraisals (TA).

  2. The new regulations and charges come into effect on 1 April 2019. Those TAs with a formal start date (invitation to participate) after 1 April will be subject to a charge.

Basis

  1. In accordance with UK Statutory Instrument 2018 No.1322, NICE must recover the cost of the TA from the company that expects to market the technology in England. Technologies are selected for appraisal in accordance with the NICE topic selection process.

  2. NICE will appraise the technology in accordance with its published TA process.

  3. Our timelines show more information on charging for TA’s in the context of the guidance development process. NICE will charge for a TA by issuing an invoice for the amount due, in accordance with the pricing table set out below. The charge will be made to the company holding the marketing authorisation for the technology. NICE must receive the payment for the TA within 30 days of the invoice being received.

  4. The relationship between NICE and the company is not contractual and is governed exclusively by NICE's published processes, including this charging process.

  5. NICE expects companies to work proactively with its staff, evidence review groups and independent committees to ensure the appraisal follows the timelines set out in NICE’s process documents. Companies are expected to use all opportunities available to them, to facilitate the appraisal, including commercial and managed access arrangements described in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access.

Pricing

Charges for technology appraisals
ProductCharge 2019/20
Single technology appraisals (STA) £126,000
Fast track appraisals (FTA) £88,000
Cancer Drugs Fund reviews (CDF-R) £88,000
Rapid reviews (RR) £88,000
Multiple technology appraisals (MTA) - standard (covers up to 3 technologies)
Charges are split between participating companies and the 75% discount applies to any participating small companies.
£188,000
Multiple technology appraisals (MTA) - complex (covers more than 3 technologies)
Charges are split between participating companies and the 75% discount applies to any participating small companies.
£251,000
  1. NICE will request a unique reference number from the company approximately 3 months before the invitation to participate (ITP) is issued. The unique reference number identifies the TA in the company’s finance systems and enables payment for the full charge to NICE. The company is required to submit the unique reference number by the deadline that NICE provides. If the company issues a purchase order as the unique number, any terms and conditions attached to the purchase order will not apply and no contract will be created (see UK Statutory Instrument 2018 No.1322 for the legal basis of this charge).

  2. NICE reserves the right not to start the appraisal until this unique number has been received.

  3. NICE reserves the right to pause the appraisal if payment is not received in full by the deadline for evidence submission.

  4. Where an assessment requires substantially different resource to that of a standard assessment, alternative cost models may be explored by NICE using a methodology consistent with Managing Public Money.

  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.

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. The table below shows how much NICE will charge small companies for technology appraisals.
Charges for small companies - technology appraisals
ProductCharge 2019/20
Single technology appraisals (STA) £31,500
Fast track appraisals (FTA) £22,000
Cancer Drugs Fund reviews (CDF-R) £22,000
Rapid reviews (RR) £22,000
Multiple technology appraisals (MTA) – standard (covers up to three technologies)

See the pricing table in paragraph 7

Multiple technology appraisals (MTA) – complex (covers more than three technologies)

See the pricing table in paragraph 7
  1. Small companies have the option to pay the charge in 3 instalments:
    • an initial 40% (forty percent) of the charge on receiving the invoice from NICE
    • a further 50% (fifty percent) of the charge before the first committee meeting at which the technology is to be discussed
    • the final 10% (ten percent) of the charge before publication of the final appraisal document (FAD).

  2. Companies will declare whether they are a small company as part of their response to the charging notice.

  3. If the company pays an initial instalment of the charge under paragraph 16, the company will provide written evidence to validate its status as a small company when asked by NICE. If NICE does not accept the evidence provided (at its sole discretion), the company will immediately pay the remaining balance of the charge in full.

  4. Companies that declare themselves as small will be asked to confirm that they have not reached the limit on the amount of state aid that companies can receive (that is, €200,000 over a 3-year period, in line with the UK Government’s guidance on state aid).

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 appraisal if:
    • A single technology appraisal (STA) is converted into a fast track appraisal (FTA). In this case, NICE will refund the difference in charge.
    • In the sole opinion of NICE, NICE is unable to complete the appraisal after it has started (for example, if the technology does not receive a marketing authorisation or the company withdraws an application from the relevant regulatory authority). NICE will refund the amount paid less any costs incurred during the appraisal process up to that point (including fair allowance for overheads and other similar costs).

March 2019