The introduction of clinical commissioning groups (CCGs) in England in 2013 saw much of the decision making and budget powers that previously sat at a national level devolved to the newly set up CCGs. This in turn created a new group of regional payers of importance to the pharmaceutical and medical device industry.
CCGs are, among other things, responsible for developing and maintaining regional formularies. These are either managed by an individual CCG’s formulary group or, in some instances, by a joint formulary group working across two or more CCGs and/or acute trusts. A drug that has received a positive technology appraisal (TA) by NICE should automatically be included in CCG formularies within three months of NICE’s decision. However, CCGs can conduct their own appraisals of drugs that have not undergone a TA and that are considered relevant to the local population. As such, CCG formulary groups function as gatekeepers to the uptake of drugs that have not undergone a national level assessment.
How should they operate?
NICE’s guidelines for how CCGs should manage regional formularies recommends that regional formulary groups involve a mix of locally relevant stakeholders in their decisions. Stakeholders that NICE recommends including are clinical networks, patient groups, local people and communities and relevant manufacturers. If CCGs conduct local appraisals and evidence synthesis, the guidelines further state that CCGs should ensure there are individuals with the specialist skills necessary to undertake these activities available. Such specialist skills include literature searching, critical appraisal and interpreting and contextualising evidence.
What did we do?
We wanted to find out how local formulary groups actually work, what stakeholders they involve in their formulary decisions and what data they consider and prioritise during decision making. To this end, we surveyed 32 selected commissioners from across England.
What did commissioners tell us?
- Clinical groups are part of (97%), or consulted by (84%), almost all CCGs’ formulary groups. Conversely, patients and patient representative groups, who NICE guidelinesrecommend are included in decision making, are only part of, or consulted by, a minority of local formulary groups (22% to 41%)
- Most CCGs (73%) require both budget impact (BI) and cost-effectiveness (CE) data when evaluating drugs for inclusion on the local formulary. Overall, CCGs are more likely to require CE estimates that are based on national, than on CCG specific, data (75% versus 50% of CCGs). An opposite trend is seen for BI estimates, for which local formulary groups are more likely to request estimates based on CCG specific (58%), rather than national data (33%), data
- Most formulary groups conduct an in-house critical appraisal of clinical data in submissions (75%) and over half conduct their own BI or CE estimates (58%)
- Most CCGs have at least one member on their formulary group with formal training in how to conduct a critical appraisal of clinical data (83%). Conversely, despite the importance of health-economic data to formulary decisions, only 25% of CCGs surveyed had a member of the formulary group with formal training in how to appraise such data.
What does this mean?
- There is demand for CCG specific data in submissions. Most CCGs require both BI and CE data in formulary submissions and, when BI estimates are requested, CCGs prefer for these to be based on local data. If assisting a local champion with preparing a formulary submission, manufacturers and consultancies working with them should ensure they clearly state the economic impact that uptake of the product would have on local services
- CCGs may require support in developing in-house expertise. Despite the importance of health-economic data for formulary submissions two-fifths of surveyed CCGs do not conduct their own CE or BI analyses and only one one-quarter has a person on their formulary group with expertise in how to appraise such data. To ensure funding decisions are made to the highest standards, CCGs may therefore require further support from NHS England in developing and retaining professionals with the necessary skills to conduct a critical appraisal of formulary submissions
- Patients may be underrepresented in formulary decision making. Despite recommendations to involve patients and patient representatives when developing and reviewing local formularies, these groups are only included or consulted by between one-fifth and two-fifths (22% to 41%) of surveyed CCGs’ formulary groups. As a result, important user views could be missed during decision making