Kathleen Lynch (Cork North Central, Labour)

The priorities for the NCCP under its medical oncology programme are development of national multidisciplinary clinical practice guidelines which are under way for breast, lung, gastrointestinal, prostate and gynaecological cancer; a review of medical oncology services from a quality assurance and safety perspective, commencing in September 2012; continual assessment of new drugs and related predictive laboratory tests through a health technology review committee in order that these may be presented to the HSE management team for approval; recruitment of a pharmacist to lead, in conjunction with Irish medical oncologists and nurses, the development of more than 300 national treatment protocols and to advise on drug utilisation costs and pharmacy ICT - this recruitment is nearing completion; development of national protocols for drug usage and standardisation of practice nationally, based on best clinical evidence; assisting in the development of mechanisms for the management of the cancer budget within the HSE's community drug scheme. With regard to the latter, the new melanoma drug, Ipilumimab, or IPI, is the first intravenous drug administered in hospitals in respect of which reimbursement is available under the primary care reimbursement scheme on a demand-led basis. This is an example of money following the patient.

The HSE examines a range of important inputs, including input from clinicians before making a recommendation regarding funding approval for a particular drug, including oncology drugs. Pharmaceutical companies make applications to the HSE seeking pricing and reimbursement of new medicines. The HSE considers a range of factors prior to making an initial recommendation on pricing and reimbursement. These factors include but are not limited to clinical effectiveness, cost-effectiveness, unmet needs, availability of other treatments, sub-group response and budget impacts. Recommendations from these processes are forwarded to the HSE drugs group which has been tasked by the HSE with prioritising those medicines which should be processed first. In addition, the group also considers how any prioritised medicine might best be introduced in the HSE clinical care pathways.

The HSE seeks to provide the best access possible to new services and new technologies within its resources. In any health system with a fixed budget, each decision to fund a new service and technology has implications in relation to availability of resources for other services or technologies. Unfortunately, that is a challenge faced by all health systems, even in a good economic climate.

In the specific area of pharmaceuticals, individual pharmaceutical companies hold patents for a new medicine and are the sole supplier of such medicine to health services, that is, they are monopoly suppliers. These companies decide the initial price at which they seek to provide medicines, but the health systems do not have access to an alternative supplier of the medicine. There is always a danger that monopoly suppliers might seek to achieve the highest possible price. If health systems do not challenge such demands, pharmaceutical costs could rise exponentially.

The Secretary General of the Department of Health has requested the HSE to examine further the approval system for new drugs to ensure the robust system is put in place to support decision-making in relation to drugs and to promote and drive evidence-based prescribing. This should help to create capacity on a sustainable basis to provide for necessary new drugs when there is evidence to support their use.

Internationally, the cost of cancer drugs has risen by 15% year on year, of which 5% is related to the rising incidence of cancer and the prevalence of patents remaining on ongoing treatment. Some 10% of growth is related to the cost of new drugs. Drug costs reported from the acute hospitals for 2011 and the most up-to-date figures on cancer expenditure from the primary care reimbursement scheme indicate that the annualised expenditure on oncology drugs is currently in the region of €150 million. There are now more than 700 new drugs in clinical trials around the world and the nature of cancer treatment is being transformed with the discovery of targeted molecular therapies and immunotherapies.

In the wider context within the national cancer control programme, NCCP, a range of initiatives have been introduced to support the ongoing growth in demand for medical oncology services. This includes the establishment of the NCCP technology review committee which is responsible for reviewing proposals received from industry or expert groups in Ireland for funding of new cancer drugs or expanded indications for existing cancer drugs or related predictive laboratory tests. The NCCP technology review committee takes account of national clinical practice guidelines from the Irish Society of Medical Oncology, the Irish Haematology Association and other relevant bodies.

The aim of the NCCP medical oncology patient safety and quality review is to conduct the baseline assessment of medical oncology services from a quality assurance and safety perspective across 25 hospitals. The review will enable the NCCP to establish a broad understanding of existing medical oncology policies and practices nationally. These data will help to develop national quality and safety guidelines for the safe handling of cytotoxic biological and immune therapy drugs.

It is not necessary to legislate for optimum access and treatment for cancer patients. Indeed, to do so would be inequitable for other patients in need of effective treatments and would introduce risks for patients in this era of increasing complex treatments.

The NCCP is developing a comprehensive oncology drug management system comprising evidence-based treatment protocols, technology review and a national oncology drugs budget, including a national register of patients. Money will follow the patient when the system is implemented in 2013. The overarching plan will ensure access to effective drugs and best value for investment of very scarce resources and the means to ensure compliance with national standards of care.