Dr Rick Greville, Director, ABPI Wales Cymru & Distribution Supply Chain and Association of the British Pharmaceutical Industry -Supplementary written evidence (HMS0009)

At the Committee’s evidence session on Wednesday21 June, I undertook to provide further information in response to the following question: 

• Please briefly outline the contractual arrangements for homecare medicines services. Which bodies commission services; where does the money come from; and how is that money routed?
• This question seeks clarity on commissioning arrangements. It should help the Committee draw up an accurate flow chart of funding. 

Specifically, I promised to share additional written feedback (a step-by-step descriptor) of how Marketing Authorisation Holders (MAH) contract for Homecare Services to be offered to the NHS. I have provided this below in the Annex to this correspondence.

We hope this illustrates the complexity, governance and due diligence required of multiple individual and organisational stakeholders to establish, let alone deliver effective and efficient Homecare Services.

As the question also references financial flows, it is perhaps useful to also note that there may be a real risk to the future of MAH funded homecare services due to the recent commencement of negotiations on the UK pricing of branded medicines between the ABPI and DHSC.

As the committee heard at the evidence session on 21 June, approximately 80 per cent. of all homecare services are sponsored by Marketing Authorisation Holders, with the vast majority of medicines delivered by homecare falling under the Voluntary Pricing and Access Scheme (VPAS).

VPAS was recently debated by the House of Lords following a Motion of Regret tabled by Lord Hunt of Kingsheath (25 May 2023) and that debate described well the consequences of the current pricing environment for branded medicines in the UK – where VPAS repayment levels have jumped from around 5 per cent. of net sales in 2018-19 to 26.5 per cent. in 2023, and future risks.

Increasingly the NHS is negotiating/tendering to achieve the best net price for medicines, and the cost to the MAH of offering a homecare service for those medicines would be in addition to the discount offered under a tender and the significant VPAS repayment. In these circumstances, and if similar repayment rates are imposed under a future pricing scheme, the MAH will inevitably need to consider the viability of continuing to offer any homecare service.

Where the MAH considers the continued offer of homecare services to be un-viable, the NHS would need to fill the gap either via direct funding of homecare services, or return patients to hospital pharmacy dispensing and in-hospital services such as patient education, nurse care etc (with all the added challenges that would create for workforce and estate planning) which may further delay patient access to new and established medicines.

We would therefore ask the Committee to recognise and consider the potential unintended consequences of the current VPAS negotiations on the future provision of MAH homecare services as a part of this inquiry.

We would of course be happy to provide further evidence to the Committee as the Inquiry progresses, and please do let us know if the Committee needs any further information or clarification from us.

23 June 2023

ANNEX

A ‘step-by-step’ guide to the contracting of Marketing Authorisation Holder (MAH) funded Homecare Services offered to the NHS (Based on the ABPI Good Practice Guide to Homecare Medicines Service)

• MAH decides whether to offer a ‘homecare service’ as part of its offering to the NHS (perceived obligation/expectation) and sometimes driven/required by tender specifications from the NHS (i.e., medicine only, medicine and homecare package).
• MAH designs service offering in line with compliance/regulatory obligations e.g. additional patient support programmes - administration training, blood/stool tests, nurse training, virtual patient review (avoiding visit to hospital), patient education etc.
• MAH submits ‘NHMC Homecare Service Proposal’ (HSP) form to NHS for approval/sign-off.
• NHS scrutiny/review and amends to NHMC HSP.
• MAH sources and contracts with suitable Homecare Provider(s) (HcP) (note: this may proceed (at risk to MAH and HcP) in parallel with sign-off of NHMC HSP).  This may present limited options as not all HcP vendors are suitable/available to contract.
• NHMC shares approved NHMC HSP with Regional Homecare Medicines Pharmacists (if employed), to disseminate to Trust Homecare Pharmacists
• MAH offers service to Trust via Clinical Referral Centre (medicine available with or without homecare service).
• Clinical Referral Centre engages with Trust Homecare Pharmacist to agree preferred Homecare Service Provider, including ability to deliver to NHS SLA (which is an important stage for on-going governance).
• Trust accepts service; manages transfer of prescription to preferred HcP, including compliance of HcP delivery with the NHS Homecare Service Level Agreement; then gains patient consent for means of distribution; and reviews provision of service to patients.
• MAH manages and funds homecare service contract with HcP, aligned with NHS/NHMC standards including;

• Arrangements for supply of medicines
• Delivery of contracted core service specifications
• Monitoring of KPI’s, as contracted
• Compliance with MAH regulatory obligations to pharmacovigilance and patient safety e.g. Post marketing commitments (Annex 2), HcP reporting of safety information to MAH

• NHS holds regular meetings with HcP to manage performance and progress escalation (if need identified)