Wonder drugs and health cuts
The decision by Minister for Health James Reilly to make the cystic fibrosis drug ivacaftor (Kalydeco) available to patients has been uniformly welcomed. For the 10 per cent of patients with a particular form of the disease who may now look forward to a significantly greater life span by taking the new drug, the argument for ivacaftor’s approval was never in doubt. The €20 million cost of this one drug represents about one-third of the entire budget for new drugs this year. While acknowledging the right of the 120 people who will benefit to receive this breakthrough treatment, it is nonetheless reasonable to question how decisions to allocate scarce resources are being made by Government.
The speed of Dr Reilly’s decision surprised many observers. He may have succeeded in reducing the original cost per patient following negotiations with the manufacturer, but the terms of the deal remain secret. What is not in doubt is that even at reduced cost, the decision to approve ivacaftor for use in the public health system contradicts the advice of the body charged with making a formal health technology assessment of new drugs and medical treatments. The National Centre for Pharmacoeconomics ruled ivacaftor should not be approved for reimbursement “at the submitted price of €234,804 per patient per annum”. It did suggest the new drug could be reimbursed if there was either a significant price cut or a scheme whereby the manufacturer would only be reimbursed in cases where it had proved effective.
With the country still in the grip of recession and health budgets suffering perennial cutbacks, decisions such as those posed by the cystic fibrosis drug are emblematic of broader economic challenges facing the health service. We are moving from a period of cost -containment to one of effective healthcare rationing. A fundamental principle of medicine is to treat patients in need. In theory rationing follows the same principle but this is rarely the case in practice. “Need” is a term that lacks precision in healthcare; it may be obvious in medical emergencies or in the treatment of life-threatening conditions but is far less apparent in the management of chronic disease. The danger is that the need to ration overcomes the patient’s need, which becomes subservient to financial constraint. This can be the beginning of a slippery slope to rationing on the basis of age, lifestyle or even place of residence.
In the absence of transparency from the Minister, it is not possible to judge whether his negotiations around the approval of ivacaftor achieved a cost -effective resolution. In times of effective healthcare rationing such opacity is unacceptable. And Dr Reilly will not have endeared himself to the troika, who following last year’s cost overruns will be monitoring health spending even more closely in 2013.