Nine drugs denied to Irish patients due to price pressures

Irish patients are being denied access to nine drugs that are widely available across Europe, largely on cost grounds. A new bulletin published by the Irish Pharmaceutical Healthcare Association (IPHA) has found that nine medicines currently in the Irish reimbursement system are already available in 12 other western European countries on average.

Cancer and cardiovascular care are the main areas where Ireland is lagging behind, according to the IPHA. This initial report says that seven new therapies have been approved by the State so far this year.

They include MSD’s cancer drug Keytruda and GlaxoSmithKline’s Nucala, which treats severe asthma. Among the drugs still waiting for approval are Pfizer’s breast cancer drug ibrance and Spinraza, a Biogen drug for the rare genetic disease, spinal muscular atrophy. Apart from Spinraza, six of the drugs on the list are cancer therapies and two are designed to treat cholesterol.

Among the other companies with drugs on the list are cancer drug heavyweights Roche and Bristol Myers Squibb, as well as biotech group Amgen and Sanofi, which is understood to have two of its drugs awaiting approval.

The IPHA also reports latest EFPIA research which shows that Ireland is currently 18th out of 26 European countries in the availability of new medicines. The IPHA has said it will now regularly monitor and report on the availability in other EU countries of new medicines that are awaiting reimbursement in our system.

Specifically, they report their availability in the 14 EU Member States which are used to calculate the price in Ireland under the current Framework Agreement with the State (2016-20). These are Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the UK.

Two of the drugs stuck in the Irish process waiting for approval on payment by the HSE are already available in all of the other 14 states against which prices in the Irish market are set. All but two are available in 10 or more of the price basket countries and the remaining two are available in nine.

That basket was extended in the most recent drug pricing agreement to include more low-cost countries for medicines.

By monitoring access compared to the 14 nominated EU Member States, IPHA will show the therapies that should be routinely available to clinicians to prescribe for patients in Ireland.

Their research showed that as of April 1st:

  • Nine IPHA medicines which have undergone a Health Technology Assessment and are not yet on the reimbursement list;


  • These nine medicines are available, on average, in 12 of the 14 EU countries, but are not routinely available and reimbursed for Irish patients;


  • These medicines are for cardiovascular disease (2), musculoskeletal treatment (1) and oncology (6);


  • These nine medicines have been in the reimbursement process for over two years on average;

In this context, there is also some welcome progress, given that since the start of the year, seven new IPHA medicines have been approved for reimbursement (up to April 9th).

IPHA Chief Executive OIiver O’Connor said: “It is not good enough that patients in Ireland should be among the last in western Europe to have access to these new medicines.

“In some cases, these medicines are available in other EU Members States beyond the EU-14. With prices now limited to the average of 14 European countries under the Agreement, patients in Ireland should not have to wait longer than patients in comparable European countries for new medicines.

“IPHA members are delivering the promised savings under the Agreement. Its promise to patients of being ‘at the forefront of its European peers in terms of early access’ should also be met by State policy.

“Improved processes, collaborative working with industry and reasonable increases in Exchequer funding will deliver better outcomes for patients.” Ireland is now 18th of 26 European countries in 2017 in the availability (reimbursement) of new medicines first authorised by the European Medicines Agency over 2014-16, as shown by new EFPIA research.

EFPIA, the European Federation of Pharmaceutical Industries and Associations, conducts an annual survey on the relative availability of medicines across Europe (including Switzerland and Norway).

The most recent analysis was completed in March and reviews the availability in 2017 of medicines approved by the European Medicines Agency in the previous three years (2014 to 2016).

Medicines authorised by the EMA in 2014, 2015 and 2016 were reimbursed and available in the public health services by the end of 2017. Whereas in Denmark, 115 such medicines were available in 2017, more than twice as many as in Ireland. It shows that Ireland is ranked 18 the out of 26 countries on this measure.  

IPHA is the representative organisation of the research based pharmaceutical industry in Ireland. It represents 47 international companies who discover and develop new medicines which can treat or cure many medical conditions and so improve both the quality of life and the life expectancy of patients.

The industry argues it is delivering €785 million in savings on the HSE drugs bill over the course of the pricing accord, which runs to 2020. The HSE points to the medicines it has approved and the costs these have added to the annual drugs bill in an environment where there is continuous pressure on the health budget.

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