Interim acceptance decisions
The Scottish Government’s Review of access to new medicines (2016) recommended that SMC should have the additional decision option of accepting a medicine for use subject to ongoing evaluation and future reassessment. This option, introduced in summer 2018, is known as an interim acceptance.
Further details on this decision option and what it means can be found in the Q&A below.
What decisions can SMC make on a medicine?
SMC can make one of three decisions on a medicine:
- 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), or
- not recommended
For submissions received from August 2018, SMC can also accept some medicines on an interim basis, subject to ongoing evaluation and future reassessment.
What is the new decision option?
Which medicines will it apply to?
It will apply to medicines that have been given a conditional marketing authorisation (licence) by the European Medicines Agency. Before SMC can assess a medicine, it must have a licence. The EMA can grant a conditional marketing authorisation for medicines that address an important unmet medical need, for example a medicine for a condition for which no other treatment is available. As well as being able to accept or not recommend these medicines, SMC may issue interim accepted advice if the committee considers the medicine may provide value for money and the requirements for additional evidence that have been specified by the EMA (known as specific obligations) are expected to address the key uncertainties in the evidence presented by the submitting company.
Why is it only for these medicines?
The new interim acceptance decision option aims to align the SMC assessment with EMA conditional marketing authorisation to support early regulatory access pathways. Although these medicines address an unmet need there is often considerable uncertainty about the expected benefits they will bring to patients in NHSScotland. The new approach will support increased access while using an established process to assess ongoing clinical effectiveness. The submitting company is already responsible for collecting additional clinical for submission to EMA, so an SMC re-assessment at a later date will mean a limited additional workload for the submitting company and NHSScotland . At the time of re-assessment companies can also provide additional data gathered in a ‘real-world’ setting if this is available.
Why is it being introduced?
The Scottish Government published a review of access to new medicines (2016) which assessed the impact of the changes made by SMC following the previous review (2013). One of the recommendations in 2016 was that SMC should have an additional decision option of accepting a medicine for use subject to ongoing evaluation and future reassessment.
What difference will it make?
The new approach will allow earlier patient access to promising new medicines which address an important unmet medical need, with the reassurance that a decision on the use of the medicine in NHSScotland will be revisited once further data on clinical outcomes are available.
How long is the advice valid for?
Interim advice is valid until the licence holder (the pharmaceutical company) is required by the regulator (the EMA) to provide more data on their medicine within the specific obligations imposed. At this stage, the EMA will generally convert the conditional marketing authorisation into a standard (full) marketing authorisation and the company must provide a full updated submission to SMC to allow reassessment of the medicine.
What happens if the company doesn't provide an updated submission for reassessment?
If the company chooses not to provide an updated submission once a standard marketing authorisation is issued by the EMA, SMC will issue not recommended advice.
What process does the medicine follow once it is submitted for reassessment?
An updated submission for a medicine which was initially accepted on an interim basis will follow SMC’s standard assessment process.
What if a medicine 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.