I read with interest the letter from Charles Gore of The Hepatitis C Trust asking why NHS England is treating people living with hepatitis C as exceptional cases and has capped the access to medicines that can eradicate the infection in most cases.
The NHS England early access scheme allowed us to treat the sickest hepatitis C patients before National Institute for Health and Clinical Excellence (NICE) approval. This showed the commitment NHS England had in introducing these direct-acting antivirals (DAAs) early and in a managed way. The Expanded Access Progamme created the operational delivery networks (ODNs) with a hub-and-spoke model, which has proved to be successful in driving the development of viral hepatitis services across England.
In view of the excessive cost of the drug, NHS England tried to manage NHS resources in a responsible way in an unfavourable financial climate. It is debatable whether the negotiations were conducted in the most appropriate or effective way but this will be used as a case study to learn from for future negotiations. By imposing the use of the cheapest option, costs have been kept low but it has clashed with clinical opinion when discussing patients at weekly multidisciplinary team meetings.
The imposed numbers allowed to treat for each ODN has undoubtedly resulted in delays in the availability of treatment for the non-urgent patient groups and are difficult to accept but indisputably resulted in an increase in identification of patients with advanced disease. Gore estimates that only 15,000 patients per year would seek treatment but does not acknowledge that the current commissioning document has encouraged services to actively find and include difficult to treat patients. The reservoir of undetected and untreated hepatitis C in our population is great enough to be of concern as shown by Gore’s figures and needs to be addressed as a priority.
In addition, NICE has provided clear guidance in the effectiveness of the treatments and a way will have to be found to implement the guidance in the next few months. As a recent article in The BMJ (2016;354:i4117) points out, NICE looks at long-term budget impact and NHS England has to manage budget impact now. The DAAs save transplant procedures and prevent early deaths in the future but the cost is today. With finite financial resources, the eternal question remains — what are we not going to provide if we pay for DAAs?
The commissioning of the services by NHS England has allowed ODNs to access resources that would, in the current financial climate in the NHS, not be available otherwise. Commissioning for Quality and Innovation money (enables commissioners to reward excellence) has pushed ODNs to extend services by establishing viral hepatitis clinics in neighbouring non-specialist hospitals, in substance misuse units and in prisons to reach difficult to treat patients.
Pharmacy services have, for the first time, been actively included in commissioning specifications and we have been able to create specialist roles and an effective national pharmacists’ network to support these developments. The DAAs have high interaction potential, which needs a multidisciplinary approach when treating complex patients. The real-life data collection imposed by NHS England has been vital to understand the therapies better and to support hepatitis C virus research.
Overall, out of a not ideal situation and a difficult commissioning process, many positive service developments have emerged. The now established ODN hub-and-spoke structure and a wealth of real-life data will be of great benefit to viral hepatitis patients in the future.
Anja St. Clair Jones
Consultant pharmacist gastroenterology
Brighton and Sussex University Hospitals NHS Trust
