E-Bulletin October 2015

Evidence and economics: Scotland-wide use of new therapies

New national guidance on the treatment of Hepatitis C virus (HCV) has been released in Scotland, following a review of clinical evidence by expert stakeholders. The content of this guidance has been determined by a systematic review, expert consensus and national contract pricing for the products.

The new guidance advises Sofosbuvir-based regimens as the first-line prescribing choice for treating the majority of patients with genotypes 1, 2 and 3. Where no contraindication exists, the recommended first-line regimen should be selected for prescribing in Scotland.


The development of the national guidance has been a collaboration between Scotland’s clinical leads in viral hepatitis, National Services Scotland and Healthcare Improvement Scotland. Regimens have been considered for inclusion in the guidance where at least one clinical trial has demonstrated a Sustained Viral Response (SVR) of at least 90% and the medicines have been accepted for use by the Scottish Medicines Consortium; the relative place in treatment for regimens meeting these criteria has been determined by cost.  First-line treatment options are shown within the guideline in bold font. 


Leon Wylie, Lead Officer of Hepatitis Scotland said, "It’s up to health systems to band together to help drive down the price of these medicines in order to deliver the highest number of cures possible, within current funding constraints".

“It would be good to see this system of regular reviewing of evidence and price repeated on a European-wide basis, so as to get greater economies of scale.”


2015-2020 update for Sexual Health and BBV Framework launched


On the first day of the World Hepatitis Summit, the Scottish Government has released an update to the Sexual Health and Bloodborne Virus Framework that will extend it from 2015-2020.

The framework is aimed as a natural progression, rather than a reworking, of the Hepatitis C Action plans and SHBBV Framework 2011-15. Significant developments have occurred in the field of treatment for Hepatitis C in recent years and the Framework update seeks to incorporate the likely changes in delivery into practice. For those affected by Hepatitis C, a key highlight was the commitment to the elimination of hepatitis C as a public health concern in Scotland.


Key points include:

  • The Third Sector remains a critical partner supporting the implementation of the Framework, working with people on broader, holistic prevention and support issues beyond clinical care.
  • In many cases Third Sector support is vital to individuals remaining on, and adhering to, treatment. Unless there are particular reasons not to involve Third Sector organisations they should be involved in local multi-disciplinary discussions about individual patients, assuming the necessary information governance approvals are in place.
  • The Scottish Government will host a meeting with the Third Sector and NHS representatives to consider further what more can be done to ensure appropriate information sharing between the NHS and the Third Sector in the best interests of integrated patient care.
  • Emerging issues in the field of substance misuse, including new psychoactive substances (NPS) and ‘chemsex’, reflect the fact that this is a continually evolving field. A related, important issue is the use of injectable performance and image enhancing drugs (PIEDs). There are recognised issues in some parts of Scotland relating to the injecting of NPS, and the use of NPS is recognised as a potential driver of risky behaviours, both in relation to injecting and sexual behaviour. It is also important to recognise that NPS users may present different usage patterns and different cohorts to those traditionally dealt with by drug services.
  • Hepatitis Scotland and SDF have actively highlighted the ways welfare reforms have affected those affected by viral hepatitis and substance use. The Smith Commission report on the further devolution of powers to the Scottish Parliament made recommendations about the further devolution of powers relating to welfare and benefits. The Scottish Government will give careful consideration as to how best to ensure that new powers are appropriate for the Scottish context, tailored to the needs of individuals and will do what it can to make the system fairer and simpler. Until these powers are devolved the Scottish Government will oppose all further cuts to the welfare budget and reforms which undermine the provision of care and support for vulnerable people.
  • This update to the Framework restates the importance of prevention of viral hepatitis, particularly because it is vital that the developments in treatment do not distract us from this work. Prevention remains a priority for all blood borne viruses and all NHS Boards and partners should ensure efforts continue to prevent infections.
  • The Scottish Government will provide funding to support a review and update of the IEP Guidelines, working with the Scottish Prevention Leads network. The review should take account of the NICE guidance in relation to young people to reflect any issues in relation to those under-16 who may be particularly vulnerable.
  • All hepatitis C infected individuals are eligible for treatment with optimal SMC accepted regimens. However, in view of the current high cost of these regimens and the high number of individuals infected in Scotland, priority, in terms of the timing of treatment, should be initially given to those patients with the highest need. This means, as a minimum:

-          patients with F3/F4 hepatic fibrosis;

-          and/or patients with severe extra-hepatic manifestations of hepatitis C;

-          and/or patients with significant psychosocial morbidity as a consequence of hepatitis C.

Because the availability of new treatments and their pricing is changing rapidly, the above recommendations will be reviewed on an on-going basis.

  • Scotland should aim to deliver hepatitis C therapy for most infected people in community settings (including prisons); such an approach must be overseen by the NHS Board Managed Care Network responsible for hepatitis C
  • Three priority areas of research for hepatitis C have been identified:

-          The cost, effectiveness and cost-effectiveness of different models of diagnosing, assessing and delivering of therapy to hepatitis C infected people

-          Assessing the drivers and impact of alcohol consumption on hepatitis C case management and evaluating interventions to address the adverse impact of such consumption

-          Evaluating the concept of the administration of antiviral treatment to people who actively inject drugs to prevent onward transmission of infection.


Chemsex in Scotland: starting the conversation

‘Chemsex’ is currently used to describe a diverse range of behaviours in which a wide variety of men who have sex with men use a range of drugs, sometimes with complex consequences.

Anecdotal and recent survey evidence in some Scottish regions suggests a rise in sexualized drug use amongst MSM which is also possibly linked to the greater use of social and sexual networking apps.


These planned events, brought together by a range of voluntary and statutory organisations, seek to highlight key learning and adapt them to a Scottish context. They are aimed at enabling services to enhance their accessibility through exploring practical steps workers can use to engage with this group of MSM effectively. They will highlight core consistent messages/nuts and bolts facts/questions to ask/ common terminology and explore health behavior change approaches.

These events would be of interest to those who provide services to all men who have sex with men. This includes GPs, harm reduction teams, social work, mental health, prison staff, public health, sexual health, ADPs, voluntary sector addiction and LGBT services and Scottish Government.


The events are initially being held in Aberdeen, Dundee, Edinburgh and Glasgow with more planned for other areas in the near future. For more information or to book onto the professionals events please click here. Please note the Glasgow event now has a waiting list.


Crown Use provisions of Section 55 of the UK Patents Act 1977 Propose a  forward ­looking model for addressing the challenges of ensuring universal access to medically important drugs, without putting patients at risk. We propose an approach that addresses the effects of a drug’s monopoly, when prices are unreasonable and/or unaffordable as a result, and which creates a more sustainable model for innovation and access going forward, as the population of the UK ages, and medical science provides new hope for treating disease.


Scottish National Research Framework for Problem Drug Use and Recovery

The Scottish Government, in collaboration with leading academics in the drugs field, nationally commissioned organisations, NHS Health Scotland and ISD Scotland have developed this research framework document. Its aim is to further progress research into problem drug use, the common comorbidities encountered with it and how individuals can recover from problem drug use, while also addressing the associated wider issues.


Access to treatment, now not then

The MS Society have recently published an early treatment consensus statement from MS charities, health professionals and people with MS . We believe that everyone with relapsing remitting MS should be offered disease modifying treatment as close to diagnosis as possible. There is a growing body of evidence that early treatment improves long-term health and wellbeing by slowing down the build-up of irreversible damage and reducing the number of relapses people experience.


Recent evidence is also giving us new understanding about the impact of the underlying progressive disease process of HCV. With the price of new Hepatitis C medications making it currently unaffordable for health care systems to treat all with HCV it is necessary to think more innovatively about access to treatment for  those with Hepatitis C at all stages of the illness. attempts to manage HCVrelated costs by delaying treatment with the new regimens until patients develop advanced disease will result in a period of infectiousness that persists for an average of three to four decades







Pan European HIV and Hepatitis Testing week

It is estimated that just under half of those with Hepatitis C in Scotland are unaware they have the illness. It is likely that a significant number have had significant progression of liver disease and even though new treatments are available to stop or even reverse this, if unaware of the illness it can’t be treated. To reduce severe liver related outcomes nationally, it is vital that we look at enhancing thwe numbers who are tested.

The inaugural European HIV- Hepatitis testing week, from 20-27 November is targeted at individuals who should be getting tested, as well as those who could be offering HIV and/or hepatitis tests. It also aims to increase awareness of the benefits of testing, so that more people are aware of their status.


Last year, more than 709 organisations from 56 countries signed up to participate in the European HIV Testing Week in 2014. It is an initiative being led by HIV in Europe in collaboration with an expert working group comprising civil society representatives, healthcare professionals and policy makers from across Europe. Due to the success of the week in 2014 it has been expanded to also take in viral hepatitis testing. By signing up here you gain access to materials that can help organisations and NHS boards organise ways of increasing testing. 

Just saying......

A recent Chinese analysis of 320 blood donors posited that using a profile of commonly administered blood tests  (RBC, MCHC, PLT, P-LCR, and MONO) gave an ROC of 0.822 (specificity = 0.768; sensitivity = 0.757), which confirmed that this subset may be a significant predictor of HCV.


World Hepatitis Summit

Patients, policy-makers and experts from around the world gathered in Glasgow to discuss global efforts to tackle viral hepatitis. The World Hepatitis Summit was a World Hepatitis Alliance and World Health Organisation event hosted by the Scottish Government and supported by Health Protection Scotland and Glasgow Caledonian University.

Patient groups, Government Ministers, policy-makers and public health experts attended the inaugural meeting, a first response to last year’s WHO health assembly calling for concerted action to reverse the ever-rising death toll from viral hepatitis. Global Burden of Disease data presented at the event showed, for the first time, the five year incremental increase in global deaths from viral hepatitis. Viral hepatitis now kills more people than HIV/AIDS, TB and malaria and has become the seventh biggest annual killer globally.


The Scottish Government’s updated Sexual Health and Blood Borne Virus Framework was launched, along with a consultation draft of  WHO Global Health Sector Strategy on Viral Hepatitis was also launched .

Health Secretary Shona Robison said:

“I am delighted that Scotland is once again opening its doors to the world to host the first ever World Hepatitis Summit. I can think of no better location than a country which has been recognised as a world leader in our approach to tackling hepatitis C.

“The innovation of new therapies for hepatitis C is a watershed moment for viral hepatitis.... We must also not lose focus on the vital issue of prevention of disease. Scotland will continue to invest in prevention initiatives and this must be a central part of any national and international plan.

Director of the WHO Department of HIV/AIDS and Global Hepatitis Programme, Dr. Gottfried Hirnschall said:

“We have seen from the global response to HIV what can be achieved when governments, civil society, international organizations and the private sector work together to provide prevention and treatment services to those who need them.