This online briefing for the medicines sector on 28th August, raising funds for the healthandcare.scot news service, heard from three speakers at the centre of delivering medicines policy on behalf the Scottish government and NHS Scotland. Each was asked to reflect on the year so far and the impact of the COVID-19 pandemic, and then to look ahead to what the rest of the year might hold.

Alison Strath

Principal Pharmaceutical Officer, Scottish Government

Here is a summary of the main points that Alison made:

COVID-19

• The four nations’ Governments, the NHS and the pharmaceutical industry have worked closely together throughout the period of the COVID-19 pandemic since March; this has included supporting new healthcare delivery models.
• The NHS Pharmaceutical Specials Service based at NHS Tayside supported COVID assessment centres and hubs as well as in/out of hours services, providing pre-packaged and pre-labelled medicines to support people’s discharge from hospital and end of life care at home.
• The work over recent years planning for EU Exit-related shortages had a positive impact on understanding the pharmaceutical supply chain and has informed the steps needed to strengthen the resilience of the supply chain. National Procurement played a central role in ensuring the NHS did not run out of critical care medicines at the peak of the first COVID wave.
• The Scottish Government and NHS have been working alongside UK counterparts to ensure a UK-wide approach to areas such as the repurposing of certain medicines, use of the Early Access to Medicines Scheme and rapid assimilation, dissemination and implementation of research evidence into evolving practice. This includes exploring new treatments for COVID-19, the extension of the flu vaccination programme to a broader population and ensuring arrangements for the temporary or rapid licensing of new COVID treatments and future vaccines.

Remobilising the NHS

• Key priorities to support remobilisation of the health service include maintaining core public health functions, ensuring preventative and reactive care, and delivering integrated scheduled and unscheduled care.
• There is a desire to learn the lessons from how the NHS responded to the COVID-19 pandemic and hold onto new ways of delivering services where possible.

Priorities in medicines policy

• Baroness Cumberlege’s review, published during the pandemic, on the safety of medicines and medical devices, makes a series of recommendations on how to improve safety aspects. Although its focus is on England and some of the recommendations relate to reserved areas, there will be implications for Scotland that Scottish Ministers will want to deliver on.
• The UK Early Access to Medicines scheme has played a part during COVID-19 in terms of allowing access to medicines, such as remdesivir, prior to licensing.
• There is a willingness within government to continue to explore innovative options to improve access to new medicines; however, this needs to be seen against the priorities for the NHS over the next six months.
• The NICE process review may have implications for Scotland and Scottish Government officials will consider this with the Scottish Medicines Consortium.
• The Scottish Government continues to take forward the Montgomery review recommendations with a particular focus on the use of data to track the use and effectiveness of medicines. This includes considering how data might inform future models for payment. Effective use of data will be particularly important in how advanced therapies and treatments are evaluated and reimbursed.

Future challenges

• The focus remains on planning to manage any future COVID-19 outbreaks, as well as planning for the winter period and remobilising services. The priorities will be seasonal flu and COVID-19 vaccination programmes and strengthening public health resources to respond to contact tracing and testing.
• This year’s Programme for Government will look very different and aim to respond to the impact of the pandemic.
• Planning for the end of the EU transition period on 31^st December remains a priority. The Scottish Government is aware that pharmaceutical companies have been asked to increase their stockholdings of medicines within the UK and ministers realise the challenges that companies are already facing at a global level in terms of maintaining access and meeting demand for medicines.
• The Scottish Government is working very closely with the MHRA and the UK Department of Health and Social Care around the future licensing arrangements for medicines, including any potential impact of the changing role of MHRA on the health technology appraisal of new medicines, and post-EU transition period supply chain resilience including the implications of the Northern Ireland protocol.
• Maintaining strong working relationships between the Scottish Government and stakeholders, including the pharmaceutical industry, will be very important in the way that Scotland responds to, and maintains safe and effective access to medicines in the face of the range of challenges in the forthcoming months.

Jan Jones

Senior Pharmacist, Scottish Medicines Consortium

Here’s a summary of the main points that Jan made:

SMC before COVID

• During the first months of 2020, SMC had just appointed a new chair, Dr Mark MacGregor who is the Medical Director at the Golden Jubilee National Hospital, and also appointed a new Chair of the New Drugs Committee, Dr Scott Muir who is a Consultant Clinical Pharmacologist with NHS Greater Glasgow and Clyde.
• The organisation was undertaking a continuing strategic review of its methodology: building on previous Scottish Government reviews and the Montgomery recommendations and the introduction of the UK-wide VPAS scheme; looking at the likely implications of the NICE review including the move to NICE covering all medicines; exploring how to deal with uncertainty better; and examining how best to use broader datasets such as real-world data.

SMC during the height of the pandemic

• When the NHS in Scotland was put on an emergency footing, SMC clinical staff were redeployed to frontline clinical duties, to direct response teams within Health Boards and the Scottish Government. Meanwhile, SMC members had to prioritise their ‘day job’ in their home boards.
• SMC was closed to all new submissions from companies, and all meetings were suspended. However, the EMA continued its licensing activity throughout.
• A small team continued to work on assessment of the more than 30 existing submissions.
• SMC continues to be part of the UK-wide multiagency initiative RAPID-C19 (Research to Access Pathway for Investigational Drugs for COVID-19) supporting rapid introduction of treatments shown to be effective for patients with COVID-19.

Restarting SMC

• The high number of assessments already in the system combined with a backlog of those that would have been submitted in the period from March until now, has led the SMC to temporarily change its standard processes to support effective recovery.
• New Drugs Committee and PACE meetings resumed in June and July respectively, using an online platform, and the full SMC met virtually for the first time in August.
• All the committees are currently operating at maximum capacity
• SMC will prioritise and manage submissions for medicines where there is the greatest clinical need. At the same time, it will seek to minimise delay in access as a result of the pandemic.
  • Of the medicines licensed during the period when SMC was suspended, priority will be given to those that, in the view of clinicians, deliver the greatest clinical benefit.
  • It remains up to companies when they choose to submit a medicine following licensing. SMC is aware that companies themselves have been disrupted by the pandemic.
  • A fast track route has been introduced to give prompt advice for a small number of medicines, following review by the SMC Executive, where there is a high level of confidence in their clinical and cost effectiveness.

Looking ahead

• Throughout its entire history, the SMC has adapted its processes, generally in one direction: to become more complex. This has been entirely appropriate and is likely to continue. However, there is also a case for companies choosing a simpler approach for some medicines, and a shared desire from all parties to try to avoid the need for resubmissions.
• SMC will seek to adapt HTA to deal with the increasing number of complex medicines such as new oncology combinations, advanced therapy medicinal products, medicines with histology-independent indications and products with complex commercial arrangements.

Lindsay McClure

Associate Director, Medicines Pricing and Supply at NHS National Services Scotland

Here is a summary of the main points that Lindsay made:

National Procurement (NP)

• NP is part of National Services Scotland and includes a dedicated pharmacy procurement team made up of pharmacists and procurement specialists.
• The team is involved in every stage of the product lifecycle: it hosts the Patient Access Scheme Assessment Group, tenders for the supply of generic and biosimilar medicines and supports their use, and runs tenders in areas of therapeutic competition. A major tender in rheumatology, dermatology and gastroenterology biologics is planned for 2021.
• The team leads the procurement of medical gas cylinders and liquid gas delivery systems which was a critical area of the COVID-19 response with Health Boards reconfiguring theatres and wards into temporary ICUs, and the need to install a system for bulk storage of liquid oxygen at the NHS Louisa Jordan Hospital, with oxygen piped to every bedside. In addition, there was a surge in demand for cylinder oxygen to support transfers of very unwell people into hospitals from community assessment centres.
• NP works closely with the NHS Pharmaceutical Specials Service in Tayside which produced over-labelled TTO (“to take out”) packs to give to people with COVID-19 to allow them to go home from assessment centres. The network of NHS pharmaceutical manufacturing units also supported sourcing active pharmaceutical ingredients (APIs) to use to produce pre-filled syringes.
• The team supports homecare – services have adapted in a number of ways including contactless handover of medicines on the patient’s doorstep and a move to deliver nurse training via video consulting tools including the NHS Near Me platform used in NHS Scotland.
• NP supports the delivery of flu vaccines in primary care and is also responsible for pandemic flu medicines stockpiles.

The impact of the pandemic

• There was an unprecedented increase in demand for intensive care unit medicines and palliative care medicines – in the case of propofol, IQVIA estimated that demand increased by almost 500% in early April 2020 compared to the same time period in the year before. There was also a surge in repeat prescription requests in primary care in March with patients seeking to pick up their prescriptions early and there was evidence of some prescribers issuing prescriptions for a longer period of time. All this put strain on supply.
• In some therapy areas, there was a move to change treatment choices to reduce the need for people to go into hospital, such as a moving from intravenous medicines to those suitable for subcutaneous administration.
• The demand created by trials of medicines with a potential to be useful in COVID-19 had to be managed in such a way that it did not affect their availability for people already prescribed them.
• Supply was also affected by temporary suspensions of manufacturing, export bans by other countries and staff absences in UK wholesalers.
• The response of governments, NHS, manufacturers and suppliers demonstrated “absolutely extraordinary teamwork” at one of the most challenging and worrying times imaginable.
• The NHS in Scotland did not run out of stock.

Looking forward

• Monitoring arrangements were put in place at UK level to collect data from all major wholesalers, manufacturers of affected products and NHS teams to identify shortages and allocate medicines or ensure supplies of therapeutic alternatives. Now a new reporting solution is being implemented for the first time at a Scotland level to allow access to real-time information on medicines use and stocks, which will be a great asset in managing shortages in the future.
• Work is being coordinated across the UK to build a strategic stockpile of intensive care unit medicines, palliative care medicines and antibiotics.
• NP is looking at the feasibility of standardising the choice of critical care medicines. Before COVID, different health boards were making different choices in terms of the formulation of medicines for use in intensive and critical care settings making it difficult to plan and procure.
• Where previously consideration of supply chains in the medicines procurement process has often been limited to the number of wholesalers supplying the product, there will be a need to consider whether there are changes that could support greater diversification of supply lines, for example the number of sources of active pharmaceutical ingredients used by a supplier.
• Consideration is being given at UK-level, in the light of the impact of export bans by other countries, to the need for re-shoring of the manufacturing of some strategically important medicines.