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Published on 20 September 2010

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Managed introduction of new cancer drugs – a Scottish perspective

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The Scottish Medicines Consortium approves new cancer medicines and a treatment protocol is established. National, regional and local systems cooperate to ensure clinical and financial governance

Fiona M Maclean
MSc MRPharmS
Lead Clinical Pharmacist (Cancer/Neurosciences)
New Victoria Hospital
NHS Greater Glasgow & Clyde
UK

Expenditure in Scotland on medicines is about £1.22 billion per year, for a population of around 5million. This is a significant amount and equates to almost 10% of the NHS budget. Financial governance is an essential component of hospital pharmacy practice in the UK and most senior pharmacists are expected to provide advice on the managed introduction of new drugs and information on subsequent uptake and expenditure. Access to new and innovative medicines must be equitable, demonstrate clinical benefit to patient care and offer value for money.
The Scottish Medicines Consortium (SMC) was set up in 2001 to provide advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland concerning the status of newly licensed medicines, new formulations of existing medicines and new indications for established products. It was introduced to avoid duplication of new medicines assessment by individual ADTCs, to avoid geographical inequity in decision making and to make the best use of expertise available across Scotland. SMC advice is available as soon as practical after product launch, usually within 12 weeks. When a new product is licensed, the pharmaceutical company is expected to provide evidence about the medicine to the SMC who will assess its clinical and cost effectiveness for use in the NHS in Scotland. The advice is published on the SMC website and, where a medicine is accepted for use in Scotland, NHS Boards are expected to make it available where appropriate.
In March 2010 new guidance was published which sets out the policy framework with regard to the introduction and availability of newly licensed medicines in the NHS in Scotland.[1]

Horizon scanning
The SMC also performs national horizon scanning whereby early intelligence on new medicines in development is provided in strict confidence to key personnel in the Scottish Health Boards in the form of an annual report. This aids financial and service planning and supports individual Boards and cancer networks performing a similar exercise applied to local incidence data.
Horizon scanning for new cancer medicines within the individual West of Scotland (WoS) NHS Boards is well established and will typically involve pharmacists, clinicians, service managers and representatives from finance and planning. To enable financial planning the Board teams use:

  • SMC horizon scanning reports.
  • Industry-produced advanced medicines notifications.
  • National information on epidemiology and cancer incidence.
  • Clinical expert knowledge, current protocols and predicted uptake.

Individual Boards and cancer networks produce a spreadsheet detailing the high cost items, their predicted cost over the financial year and the allocated budget. It is noted if the new medicine is a direct replacement for an existing therapy or an ‘add-on’. In addition, it is essential to understand the service implications too as capacity planning for pharmacy, medical and nursing capability of delivering new treatments must be considered, or if additional scans or critical tests are required, there will be additional pressure on laboratories and imaging services.

Exceptional cases
The SMC does not ‘accept for use’ all medicines submitted and not all new medicines are formally submitted by the industry. For those medicines which are not accepted for use, including those not recommended due to a non-submission, the national advice is that they should not routinely be prescribed by NHS Boards. These medicines will not be added to local Formularies. However, Boards are expected to have policies in place describing their arrangements for consideration of individual patient treatment or exceptional prescribing requests. Full details can be found in CEL 17 (2010).[1]
As part of NHS Boards’ written policy on systems and processes for the managed entry of newly licensed medicines, they will be expected to describe the arrangements in place to consider requests for medicines not recommended by the SMC or NHS Quality Improvement Scotland.
The route for dealing with such requests is on a ‘case by case’ basis via the Individual Patient Treatment Request (IPTR) route. This route should only be pursued where the clinician responsible for the patient for whom the medicine is being sought, is of the view that their clinical circumstances merit such consideration. In pursuing IPTRs, clinicians will be required to exercise their professional judgement on the basis of clinical need in individual cases and in accordance with the NHS Board’s policy.
Cancer care pharmacists are often called upon for advice, cost and availability of such medicines. Boards are expected to have a formal committee whose remit is to quantify, evaluate and report back on the use of non-formulary medicines. Such information is very useful if asked to examine prescribing practices.

Role of the Scottish Regional Cancer Networks
There are three Regional Cancer Networks in Scotland – the West of Scotland Network, the South East of Scotland Network and the North of Scotland Network. The remainder of this article will focus on cancer services within the West of Scotland Cancer Network.
The network is a collaborative group of healthcare professionals from primary, secondary and tertiary care working in co-ordination to ensure equitable provision of high quality clinically effective services.
The West of Scotland serves a population of approximately 2.5 million and includes four Health Boards. The largest is Greater Glasgow and Clyde which hosts the Beatson West of Scotland Cancer Centre. Patients with the more common cancers and haemato-oncological cancers are treated close to their home in their own health board. However, anticancer agents for rare solid tumours types, bone marrow transplant and treatments with concurrent radiotherapy are given in the Cancer Centre in Glasgow. The population estimate by Board is given in
Table 1.

[[HPE52.53]]

National standards for cancer chemotherapy quality and safety were published in 2005 and with that came the requirement for Networks or Boards to have in place approved Clinical Management Guidelines with supporting chemotherapy protocols.[2] Clearly it is advantageous if all the Network Health Boards are given the same advice and, to ensure consistency of advice to ADTCs, a WoS Prescribing Advisory Subgroup (PASG) was established. The group is chaired by the WoS Regional Cancer Pharmacist with representation from the WoS Boards and tumour site specific teams. The PASG manages the processes by which advice is given to the WoS ADTCs and is a central source of advice on new or new uses of cancer medicines.
Once a new medicine is approved for use by the SMC, a treatment protocol and guidance on budget and service impact are written, usually by the Lead Pharmacist for that tumour type. These are submitted to the Tumour Lead Clinician for approval and then submitted to PASG for consideration for use across the Network.
The WoS Cancer Network has standard templates to ensure uniformity of documentation.
The budget and service guidance includes:

  • Medicine name, formulation and indication.
  • Treatment details – eg, dose, frequency, number of cycles.
  • Summary of national guidance eg, SMC decision with detail of restrictions if any.
  • Proposed place in therapy in the WoS eg, 1st line, replacement of another therapy or ‘add on’.
  • Anticipated patient numbers per annum
  • Service impact eg, extra hospital visits, additional scans or critical tests.
  • Budget impact for the WoS – taking into account any existing therapies this replaces, additional supportive medicines.

The WoS systemic anti-cancer treatment protocols provide the clinical details for prescribers (see Table 2). Where there is limited evidence on, for example, a dose modification, expert opinion or consensus is sought.
The chemotherapy protocols are widely used and were welcomed by the cancer care teams. It has been found found very helpful to file a copy of the treatment protocol in the patient’s case notes. This ensures that there is detailed information available to healthcare professionals should their patient be admitted as an emergency, perhaps with an oncological emergency or a treatment-related toxicity.

[[HPE52.54]]

Protocol evaluation and review
The cancer centre has a dedicated clinical effectiveness pharmacist who leads or supports ongoing Board and network wide clinical effectiveness audits of cancer treatments. Recent audits include 1st line chemotherapy for non-small cell lung cancer, rituximab and a breast cancer audit. These audits are extremely valuable tools for evaluating adherence to protocols, uptake of new drugs, and for assessing toxicity associated with chemotherapy and effectiveness of new therapies in the local population.
The systemic anticancer treatment protocols have a ‘review by’ date and many are under review at present. The update process involves:

  • Checking the Summary of Product Characteristics for changes.
  • Discussion with tumour-specific teams.
  • Checking if there are updates to supportive care guidelines.

There is a Chemotherapy Protocol Change Request Form which must be completed before any changes can be made to a protocol. The form requests the following:

  • Protocol name and reference.
  • Details of the requested change and reasons.
  • Will the change have an impact on chemotherapy service delivery – if yes, this must be approved through wider governance processes.

There is an established system of document control and each protocol has a reference number and version number. Approved protocols are made available for use by the multidisciplinary team in individual health boards. Future plans include implementation of a WoS intranet so that regionally approved cancer protocols will be stored on one single website accessible to all cancer healthcare professionals across the WoS.
These national, regional and local systems dovetail to ensure robust clinical and financial governance of cancer care practice. Many of these systems are driven by the cancer care pharmacists and their collective input facilitates equity of access to new cancer medicines underpinned by standards for safety and quality.

References
1. Introduction and availability of newly licensed medicines in the NHS in Scotland, CEL 17(2010). Available online at: www.scottishmedicines.org.uk/smc/files/CEL2010_17.pdf
2. Scottish Executive. Guidance for the safe use of cytotoxic chemotherapy HDL (2005)29, Edinburgh 2005.



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