ACSMA: Anti Coagulation Self Monitoring Alliance

‘Healthy Lives, Healthy People’ workshop

Health policy: Financial incentives in the new NHS

Health Policy: Making sense of the Cancer Drugs Fund

Implementing new NICE guidance

The Rheumatology Futures Project

Health Technology Appraisals Project Management

Young People with Arthritis Event

Supporting Health Technology Appraisals through Public Affairs

There are more than 1.2 million people in the UK on warfarin, but fewer than two per cent of them benefit from self-monitoring. People on long-term warfarin need to have regular blood tests to check their internationalised normal ratio (INR), or the level of clotting tendency. These blood tests affect patient’s personal and professional lives making them regularly dependent on attending a hospital, GP surgery or anticoagulation clinic for a simple test.

In October 2012, the Anti Coagulation Self Monitoring Alliance (ACSMA) (comprised of four of the UK’s leading charities and patient groups) launched itself as an alliance with an objective.

“To ensure INR self-monitoring technology is available, accessible and on prescription through the NHS for eligible patients.”

Over the past five months HJCL has driven forward ACSMA’s concerns surrounding self-monitoring technology bringing them to the attention of healthcare professionals, policy makers and Government via a concerted public affairs, parliamentary and media campaign. To date 444 individuals and organisations have pledged support. These include Little Hearts Matter, ISMAAP (International Self Monitoring Association of Oral Anticoagulated patients) the British Heart Foundation and the NHS Alliance.

Campaign achievements so far include:

• 1:1 meetings with Dr Archie Prentice – Royal College of Pathologists, Professor Richard Thompson – Royal College of Physicians, Baroness Gardner, Lord Colwyn and Baroness Masham
• Support from Secretary of State for Health Rt Hon Jeremy Hunt and Parliamentary Under Secretary of State Rt Hon Earl Howe
• A parliamentary reception hosted by Virendra Sharma MP with speakers: Shadow Health Minister Andrew Gwynne, Stephen Johnson (Department of Health lead on 3 million lives)
• An Early Day Motion tabled in the House of Commons with 51 signatures to date

At the end of 2010, the Coalition Government published its flagship public health strategy: ‘Healthy Lives, Healthy People’. The White Paper signalled a radical shift in public health provision, aiming to give it parity with mainstream health services and place primary responsibility for delivery with Local Authorities and Directors of Public Health.

HJCL worked closely with the Royal Society for Public Health to design, deliver and facilitate a full day workshop involving a small number of voluntary sector and professional organisations. The workshop was intended to share and discuss the implications of the Public Health White Paper and the (at the time unpublished) Health and Social Care Bill; to identify potential opportunities and threats with particular reference to the immunisation and vaccines agenda; and to explore possible avenues to effectively engage with key decision-makers in the new public health world Held at the Royal Society of Public Health head office with Chief Executive, Professor Richard Parish, as keynote speaker, the workshop was chaired and facilitated by HJCL. The workshop content included:

• an overview of public health policy landscape, a ‘top tips’ guide to responding to government consultations and small group break-out sessions

By the summer of 2011, it had become apparent that one aspect of the ongoing healthcare reforms – the use of financial incentives to drive behaviour in the NHS – was starting to emerge as a particular topic of concern. HJCL organised a parliamentary event using a debate format with panellists speaking for and against a motion that the use of financial incentives in the NHS would have a beneficial impact on the quality of care and patient outcomes. HJCL:

• Devised the debate subject-matter around the use of financial incentives in the NHS, identified potential speakers and discussion points;.
• Secured a high-quality panel of speakers including Nick de Bois MP (Chair), Professor Paul Corrigan, Professor Andy McKeon, Andrew Haldenby (Director of Reform), Dr Daniel Poulter MP and Debbie Abrahams MP;.
• Used the event to position the client as a thought-leader in the health reform debate as well as supporters of open, serious and balanced discussion on topical issues; and
• Attracted a high calibre list of attendees, including parliamentarians and several senior figures from the Royal College of GPs, the National Institute for Health and Clinical Excellence, Diabetes UK and the Royal College of Nursing.

The introduction of the Cancer Drugs Fund in England in 2011 attracted support, interest and criticism in equal measure; not only from the cancer community, but from politicians, the devolved nations, healthcare professionals, the life sciences industry and organisations representing patients with conditions other than cancer.

HJCL was commissioned to undertake a variety of projects to monitor the evolution of the Cancer Drugs Fund throughout 2011 and 2012, tracking its implementation and delivery on the ground.

To date, HJCL has successfully:

• Monitored and tracked parliamentary, patient, industry and clinical comment on the design, principles and operation of the Cancer Drugs Fund and interim fund.
• Undertaken a comparative analysis of the different funding processes and procedures adopted by each of (the then) Strategic Health Authority regions.
• Advised upon and helped draft responses to relevant Government consultations.
• Researched and produced a report detailing the history of access to oncology medicines in the UK over the last ten years, including an analysis of pertinent recommendations by NICE and media reaction to those recommendations.
• Designed, planned and facilitated a half-day client workshop on the use of patient access schemes in England and Scotland.

For pharmaceutical manufacturers, patients and professionals alike, receiving a positive recommendation from the National Institute for Health and Clinical Excellence (NICE) about the use of a new medicine represents the culmination of two or more years of evidence-gathering, submission-writing and appearances before the NICE Appraisal Committee. However, receiving positive NICE guidance is only the start of the process; the guidance then needs to be implemented by the NHS. Healthcare professionals are required to take NICE guidance “fully into account” when exercising their clinical judgement. Primary Care Trusts have certain mandatory obligations to fund positive guidance and local NHS organisations and commissioners also have a duty to implement NICE guidance.

HJCL was commissioned by one pharmaceutical company to work with its market access team to develop a series of presentations and meeting materials to help educate and inform its sales and marketing teams, as well as a variety of external audiences about the status of the NICE recommendation and the implications for its implementation.

The Rheumatology Futures Group (RFG) – a coalition of patient and professional organisations representing the entire rheumatology community and the pharmaceutical industry – commissioned the King’s Fund to carry out research exploring the impact of NHS structural reconfiguration and service redesign on people with rheumatoid arthritis (RA) and rheumatology health professionals. The resulting report, “Perceptions of Rheumatology Patients and Professionals”, concluded that patients were experiencing “alarming and unacceptably wide variations” in levels and quality of care, with Government policies having unintended knock-on consequences for patients and professionals alike.

HJCL worked with the RFG to develop and implement a comprehensive communications and stakeholder engagement campaign, so that the RFG could use the King’s research to identify areas where the service was failing patients and professionals, propose possible solutions and make the case for change to ministers, policy-makers and the NHS.

For the pharmaceutical sector, successfully bringing a new medicine to the UK market demands careful navigation of national market access requirements – and, specifically, a detailed review of the clinical evidence and health economic case by at least one (and often all three!) of the HTA bodies in the UK: The National Institute for Health and Care Excellence, the Scottish Medicines Consortium and the All Wales Medicines Strategy Group.

HTAs need careful planning, preparation and execution – ideally, the strategic planning process should start well in advance of the CHMP opinion. You need an HTA strategy, which should form a core part of the overall market access plan for the medicine concerned. What type of economic approach is most appropriate? How and when do you plan to engage the patient and clinical communities in the HTA process? Where are the data gaps? And how are you going to plug those gaps? Do you plan to submit a patient access scheme? In short, HTAs necessitate dedicated and experienced project management resource, often on an ongoing basis.

Over the last 12 years, HJCL has provided an expert project management service, strategic counsel, communications and training support to 15 pharmaceutical, biotech and patient group clients on more than 50 HTA projects. The projects include 21 NICE technology appraisals and span 10 different therapy areas: cardiovascular disease, oncology, respiratory, ophthalmology, metabolic diseases, musculo-skeletal, neuro-psychiatric disorders and anti-infectives.

Our services range from writing HTA submissions and preparing attendees for committee meetings, to advising on procedural aspects, patient and clinical engagement and project managing the entire appraisal process.

In 2006, HJCL organised several parliamentary events on behalf of the National Rheumatoid Arthritis Society (NRAS), which provides secretariat support to the All Party Parliamentary Inflammatory Arthritis Group (APPIAG).

In December, a parliamentary reception focused on raising awareness of the treatment and care needs of young people with Juvenile Idiopathic Arthritis (JIA). JIA affects between 10,000 and 15,000 children under 16 in the UK.

15 young people with JIA – ranging from 4 years old to 22 years old – were invited from every region of the UK to a tour and afternoon tea in the Palace of Westminster. The young people had been nominated by their health professionals, all of whom accompanied the young people and their parents on the trip. The event was particularly successful as a result of the attendance of over 20 MPs and Peers, keen to meet their young constituents and find out more about living with JIA. The event generated a large amount of media coverage (including interviews on several television stations and GMTV), a mention in the Christmas adjournment debate and important opportunities to follow-up with key politicians on areas of concern.

HJCL played a key role in organising the parliamentary event, from drafting invitation cards and information packs, to organising the photographer and the Christmas crackers!

With Health Technology Appraisals by the Scottish Medicines Consortium (SMC) and National Institute for Health and Clinical Excellence (NICE) imminent, HJCL has been working closely with another leading communications consultancy to support a leading pharmaceutical company in the market access of a new medicine in the UK. The project has required us to demonstrate our understanding of the mechanisms and processes of both HTA bodies, supporting the manufacturer’s submissions with a sensitive, timely and effective public affairs campaign.

Although decision-making on the clinical and cost effectiveness of medicines is undertaken by independent bodies, external stakeholders with an interest in the outcome can be important and influential allies and advocates. We designed a parliamentary contact programme that built on and expanded our client’s relationships with parliamentarians in Edinburgh and Westminster in order to raise awareness of this exciting new technology and also to generate support for access to it for patients with this particular neurological condition. Through close working with the key patient groups, the development of briefing materials, letter writing and a series of face-to-face meetings, the contact programme has delivered good results at the key stages of the appraisals.

In Scotland, a surprise negative recommendation by the SMC was met with outrage from MSPs – three parliamentary motions highlighted the negative impact of the decision on patients in Scotland and a Parliamentary debate covered the issues (and – crucially – the client’s key messages) in additional detail. This recommendation and subsequent parliamentary activity also received media coverage in Scotland’s leading press, which cumulatively ensured that the environment for another negative decision following resubmission would certainly not be amenable.

In Westminster, a similar contact programme is being undertaken with key MPs with an interest in these issues to support NICE’s Single Technology Appraisal of this product. An Early Day Motion welcoming the appraisal and the advances the therapy would offer patients received over 50 cross-party signatories.