Interim acceptance decisions

The Scottish Government’s Review of access to new medicines (2016) recommended that SMC should have the option to accept a medicine for use subject to ongoing evaluation and future reassessment. This process, known as interim acceptance, was introduced in 2018 and has been extended in autumn 2021.

Further details on this decision option can be found in the Q&A below.

What decisions can SMC make on a medicine?

SMC can make the following decisions on a medicine:

  • accepted
  • accepted with a restriction(s) (for example, the medicine can only be accepted in a particular group of patients with the condition. This typically occurs because the company has requested this explicitly in the submission)
  • accepted on an interim basis, or
  • not recommended

What is the “interim acceptance” decision option?

SMC can decide to accept some medicines on an interim basis. This means that the medicine can be accepted for use subject to ongoing evaluation and reassessment once further evidence is available

SMC may issue interim accepted advice if the committee considers the medicine may provide value for money and additional evidence is expected that may address the key uncertainties in the evidence presented by the submitting company.

Which medicines will it apply to?

It applies to medicines that:

Guidance for companies making submissions for medicines eligible for the interim acceptance decision option

Why is it only for certain medicines?

The interim acceptance decision option aims to align the SMC assessment with MHRA early regulatory access pathways and support early access to innovative medicines. These medicines are expected to address an unmet need, however, there is often considerable uncertainty about the potential benefits they will bring to patients in NHSScotland. This approach will support increased access while using an established process to assess ongoing clinical effectiveness. At the time of reassessment companies will provide updated information from clinical studies and can also provide additional data gathered in a ‘real-world’ setting if this is available.

Why was it introduced?

The Scottish Government published a review of access to new medicines in 2016 which included a recommendation that SMC should have an additional decision option of accepting a medicine for use subject to ongoing evaluation and future reassessment.

Read the 2016 review

What difference will it make?

This approach will allow earlier patient access to promising new medicines which address an important unmet medical need, with the reassurance that a final decision on the use of the medicine in NHSScotland will be made once further data on clinical outcomes are available.

When should the company resubmit?

For medicines with a conditional marketing authorisation, the marketing authorisation holder (the pharmaceutical company) is required by the regulator (the MHRA) to provide more data on the medicine within the specific obligations imposed. At this stage, the MHRA will generally convert the conditional marketing authorisation into a standard (full) marketing authorisation. The company must then provide an updated submission to allow reassessment of the medicine by SMC. The SMC executive will consider any requests for a delay to reassessment due to data availability on a case-by-case basis.

For medicines included in EAMS and ILAP, SMC will liaise with the company to agree on further regular points of contact about the clinical evidence, to ensure a practical and mutually acceptable date can be set with the company for submission for reassessment.

What happens if the company doesn't provide an updated submission for reassessment?

If the company chooses not to provide an updated submission, SMC will issue not recommended advice.

What process is followed for an updated submission?

An updated submission must be provided in line with standard SMC Guidance to submitting companies including the relevant comparator(s) and within the context of the current treatment pathway in NHSScotland at the time of reassessment.

What happens if a medicine initially accepted on an interim basis is not recommended on reassessment?

Where the patient continues to derive clinical benefit, it is expected that they should remain on the treatment until the patient and clinician consider it appropriate to stop, as per current guidance and best practice.