The last decade has seen huge advances in medicine and illnesses which once had a poor prognosis can be treated with highly evolved pharmaceutical products with patient outcomes dramatically improved as a result.
But each advance comes at a cost and sometimes that cost is staggering. The State’s High Tech Drug Scheme cost €20 million in 1997, but in less than 12 years it has reached almost €400m as drug companies continue to make breakthroughs.
One such breakthrough was made earlier this year when Kalydeco, a drug used to treat Cystic Fibrosis was given the green light by the European Medicines Agency. When it gained regulatory approval last summer, it was hailed by the Cystic Fibrosis Association of Ireland as “an exciting development” and it is not hard to see why.
Described by Dr Michael Barry of the National Centre for Pharmacoeconomics (NCPE) yesterday as a “game changer”, the drug appears perfect for the Irish market and could extend the life expectancy of some patients by many years. It does not come cheap however, and it has been estimated that it will cost each patient over €234,000 a year.
The reason why it is so important in an Irish context is that it is used to treat people with a type of Cystic Fibrosis which is caused by what is commonly known as the Celtic Gene. Because of its link to the G551d mutation, to give the Celtic gene its scientific name, it is estimated that 10 per cent of the Irish CF population – or around 120 people – will be able to benefit from it as opposed to four per cent of the Cystic Fibrosis population in the rest of the world.
But the localised element is just one reason why the availability of the drug matters. Many treatments have to be administered over many hours in hospitals – which by their very nature are not safe places for Cystic Fibrosis patients to be – but Kalydeco is taken in tablet form at home. It can improve lung function, increase a patient’s body weight, makes their quality of life better and reduces relapses requiring hospitalisation by more than 50 per cent.
While the drug is a major breakthrough, its timing could scarcely be worse. The Troika has been exerting heavy pressure on the Government to rein in health spending and Department of Health is cutting the State’s drugs bill by hundreds of millions of euro so there is little appetite in the Department to add the total annual cost of around €28 million for the drug.
If it was given the green light by the HSE’s accountants it would make up around 40 per cent of the State’s annual spend on new drugs this year.
All is not lost, however. Dr Barry said yesterday the NCPE wanted all patients who could benefit from this drug to have access to it and he said he was “very confident that the HSE and will be able to come up with a compromise” on cost.
The NCPE is suggesting a number of steps which should be taken in order to reach this compromise. First the HSE needs to negotiate with Vertex which makes the drug. If successful it could see the price fall by up to 25 per cent, a move which would save the State over €3m while still allowing the company benefit from its new drug.
The NCPE has also called on the company to risk-share the scheme. This would see the company take a hit on the medicine costs if the drug does not work. This is a well-established precedent across the EU and given the efficacy it claims for its drug the company should be in a position to stand over its drug financially as well as medically.
