New Medicines Reviews 2013

Reports on the role of SMC & Review of IPTR & ADTC

4 Discussion

CMO(2012)1 has introduced a common framework for NHS boards to adopt that should allow NHS boards to apply common principles and processes in the introduction of newly licensed medicines to facilitate consistency of approach to local decision-making.

4.1 The decision taken for each medicine by each NHS board

The majority (74%) of SMC accepted medicines were included in NHS board formularies. Of those not included, the most common reason given by ADTCs is category 4: "clinicians did not support formulary inclusion". For this decision category, 50% of the boards confirmed that clinicians did not support formulary inclusion because an "equivalent"[2] was available, those medicines were not required in their board area because they do not have the applicable specialist clinics or those medicines are only used by specialist clinicians and are therefore not applicable to the general formulary. The remaining 50% of boards that used category 4 did not provide a rationale for why clinicians did not support inclusion on to their boards' formularies.

Some of the variation between board ADTCs about which medicines are included on their formularies is explained by the differing local needs (for example, specialist paediatric medicines are only required in tertiary centres). When a medicine is not included by more than one board's ADTC, there is variation in the reasons given for why the medicine has not being included. This variation needs to be further explored with the boards as it may reflect different local service provision or inconsistent use of the decision categories.

The previous data collection exercise in 2012 was undertaken before the introduction of the CMO guidance. This prevented us from being able to comment on uptake of SMC accepted medicines across the boards, due to the variability of their data. The categories from CMO(2012)1 have since provided the boards with a consistent framework to report their ADTC decisions and subsequently helped us to determine the spread of uptake of medicines across the boards. The CMO guidance has also helped boards to describe the implementation of SMC advice in their board area.

Appendix 4 details the breakdown of each medicine and which ADTC decision category they were given by the boards.

4.2 Decisions made within 90 day target

Of the 23 medicines audited, all except three (exenatide, fidaxomicin, colecalciferol) are considered highly specialised medicines. The highly specialised nature of these medicines and the service provision required could account for the delay in most boards not making all of their ADTC decisions within 90 days, as specialised expertise input would be required. For example, of the above three medicines, fidaxomicin, a non specialized medicine, was included on to the formularies of 10 out of the 12 boards and ADTC decisions were made on this drug within 90 days by all of the 12 boards.

The five medicines that did not make the 90 day target were all related to advice from SMC in April and May, immediately after the guidance was issued. The time taken for the boards to create and update local processes to facilitate compliance with the CEL may explain this delay.

Also, there may be differences in the frequency of ADTC meetings, which could cause decisions on specialist medicines to be delayed significantly if specialist input is not available.

4.3 Decision was published on the NHS board website

The audit found that most boards were relatively timely in adding their ADTC decisions to their websites. With the exception of three boards (and one board that did not provide dates of publication), the boards published at least 70% (16 out of 23) of their decisions within 14 days of their ADTC decisions being made.

This is a marked improvement on the data provided by the boards for the baseline data collection exercise in 2012, which highlighted that prior to the introduction of the CMO guidance, there was no requirement for the boards to present this information on their websites.

4.4 Transparency of decision making

From the audit on all 14 NHS boards, we can conclude that ADTC decisions are largely being made transparent, with only four boards failing to provide sufficient access to the board formularies or a note of ADTC decisions on their websites. Of the seven boards that had excellent access to view ADTC decisions and the board formularies, three published their ADTC decisions in a format consistent with the CMO(2012)1 guidance (see Appendix 6).

However, for patients and the public, the search terms required to access this information may not be intuitive and, therefore, the accessibility of the published information may be more challenging.



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