What are the new requirements?
Following concerns over the effectiveness of flu immunisation over the past two years, particularly in elderly people, the JCVI updated guidance towards the end of last year to recommend a quadrivalent flu vaccine for the 18- to under-65s at risk, and an adjuvanted trivalent vaccine for those aged 65 and over.
This is because the immunogenicity of the old trivalent vaccine was insufficient to provide adequate cover for the elderly (particularly over-75s), and the quadrivalent vaccine is more cost effective in under-65s at risk than the previous trivalent vaccine, providing wider protection against influenza B – more of a problem in younger patients.
When do we start?
The current advice is quite clear and should be used by all practices in England and Wales who order vaccine for the 2018/2019 flu immunisation programme starting in September this year. GP practices in Scotland and Northern Ireland where vaccine is centrally procured will be provided with the new vaccines.
Specifically it is recommended that all patients under 18, whether at risk or in the immunised age cohorts, should get either the existing intranasal vaccine (which is quadrivalent), or the new quadrivalent injectable vaccine.
At-risk 18–64-year-olds should also receive the new quadrivalent injection, and those 65 and over should all receive the adjuvanted trivalent vaccine.
What if we’ve already ordered our vaccines?
Trivalent, unadjuvanted vaccines should not be used in next season’s programme. Practices who ordered early should be able to cancel orders and get refunded. NHS England has advised that refund requests will be honoured, and we understand this will be the case in Wales.
Would we face sanctions if we used the ‘old’ vaccines?
There wouldn’t be explicit contractual sanctions for using the old unadjuvanted trivalent flu vaccines, but if a practice failed to follow clear advice on a vaccination campaign, and followed a path shown scientifically not to be in patients’ interests, they could find it very difficult to defend a claim that they were acting unprofessionally – and potentially attract the attention of the GMC. CCGs and health boards could also take the view that the practice was prescribing in an unsafe manner and misleading patients, which would potentially be a breach of contract. In short, it would be extremely unwise to do this.
Practices may of course choose not to engage in the flu vaccination programme at all, for workload reasons, in which case responsibility for providing access to flu vaccination reverting to the CCG or health board.
Are there sufficient stocks of the new vaccines to order?
NHS England has confirmed with the single adjuvanted trivalent manufacturer and the various companies that manufacture the quadrivalent vaccine that they have capacity to meet all orders placed by March 29th.
Obviously, the need for two vaccines will present logistical problems for practices, although there is currently only one adjuvanted vaccine supplier.
How do we calculate how much of each vaccine we need?
Practices will need to assess likely demand in the two groups. In general, previous years are a fair guide to future uptake, particularly if a small sale or return cushion can be agreed with suppliers.
Practices should therefore calculate the number of vaccines needed according to the uptake in their 65+ cohort last year.
It will be more tricky to calculate the number for under-65s at risk, but practices should again go on last year’s uptake and any update in their at-risk cohort from their disease registers.
What if we over-order?
Practices should consider buying groups with their LMCs and try to negotiate sale and return deals to mitigate costs of unused stock. Many LMCs run buying groups to get economies of scale; with each order both practices and buying groups should try to negotiate a percentage of their order as sale or return. This depends on the relationship with the company and size of order, and will be more difficult with the new adjuvant vaccine as one manufacturer has the monopoly this year, while three companies are offering quadrivalent. In all cases, however, competition will increase so companies will want to build relationships.
How are we reimbursed?
The new vaccine costs are slightly higher than previous vaccines, and governments have committed to cover reimbursement. The regulations provide that all vaccines personally administered should be reimbursed by CCGs and health boards, who cannot mandate either particular brands or suppliers.
All vaccines for under-18s will be centrally procured in England, as they will in Wales, although Welsh practices should source their own quadrivalent injections for under-18s at risk.
Payments under the DES will be uplifted as per the final contractual settlements in the two countries, and also in Scotland and Northern Ireland where all vaccines are centrally procured.
What if we get calculations wrong and under-order?
In the event of running short of vaccines, practices should endeavour to re-order, although as in previous years that won’t always be possible – in that event, under-65s and 65–75s may still get some protection from the ‘wrong’ vaccine.
For under-65s, the adjuvanted trivalent would still give protection (just less against the B strain) so would be better than nothing, but not as good as quadrivalent.
For the 65+ group, the quadrivalent vaccine is less immunogenic, so although covering a wider range of flu viruses, the adequacy of the immune response reduces over age 65, and seems to be minimal over 75. The drop off in protection will be on a gradient rather a step change, so it is likely that those closer to 65 with better general health and stronger immune systems will get relatively more benefit from the quadrivalent jab than older, less fit individuals. There would appear little justification for administering the unadjuvanted quadrivalent vaccine over age 75, in the absence of the adjuvant vaccine.
Will community nursing staff be prepared for vaccinating the housebound?
PGDs from Health boards and CCGs will all be updated so we can rely on community nursing colleagues to be clear on vaccine usage.
Is the guidance likely to change next year?
It seems highly likely that the new advice on an age-related split will stay in place, although development of adjuvanted quadrivalent vaccines is likely in the near future, which will no doubt trigger a further re-evaluation.
With item of service increases, opportunities for buying profit and QOF points together with the intangible but real opportunity benefits of reducing flu incidence on the health of patients and the workload of practices, the flu programme remains hugely worthwhile even with the pending changes.
Dr David Bailey is a GP in Gwent, Wales GPC deputy chair and GPC dispensing and pharmacy policy lead
1. NHS England. Vaccine ordering for 2018-19 influenza season.