The Department of Health has defended the Government's €90 million deal for antiviral drugs to treat Covid-19, saying any new medicines have to meet safety and effectiveness standards before they can be used in Ireland.
“Ireland works within the EU system that regulates medicines and vaccines and makes sure they are safe and effective,” the department said, responding to criticism of the deal from the State’s adviser on the cost-effectiveness of new drugs.
Prof Michael Barry said there was "a real question" about the value and safety of the deal, agreed by Cabinet last week.
Minister for Health Stephen Donnelly has said the new drugs could be a "game-changer" in the fight against the virus, but Prof Barry described this description as "a bit premature".
He warned some of the drugs being acquired under the deal had side-effects that were so serious they could be fatal. While not suggesting they do not work, he criticised the lack of peer-reviewed clinical trial data for one of the main drugs being purchased.
The cost of the deal is three times the €30 million budget usually in place for new drugs in the Republic annually. The drugs can be used in Ireland in advance of any Europe-wide authorisation, under the approval given by Cabinet.
The department said the European Commission was currently progressing a joint procurement agreement for antivirals, which includes MSD’s Lagevrio (molnupiravir) and Pfizer’s Paxlovid. Ireland has formally indicated its intention to participate in this arrangement and is already participating in a separate agreement to purchase the GSK’s Xevudy (sotrovimab).
“These are ongoing procurement processes, therefore the department cannot comment on cost at this time,” a spokeswoman said.
"These discussions are also subject to European Medicines Agency marketing authorisation. Licensed medicines undergo thorough testing in multiple phases of trials before they are approved for use."
Prof Barry, head of the National Centre for Pharmacoeconomics, said his organisation had not been asked to assess the new deal. The contract would be legally binding and even if better products came available later, the State would be obliged to pay for the €90 million deal announced last week, he claimed.
"Our issue is, are we getting value for that? Because we didn't assess it, it's very difficult to say," he told RTÉ's Claire Byrne Live on Monday.
He explained it would cost about €650 to €700 for every patient who undergoes a planned five-day treatment. This was “a lot of money” considering the number of patients who would likely require the drugs.
“I do have an issue with the safety profiles of some of [the drugs], and particularly the one we are spending the most money on and that’s Paxlovid,” Prof Barry said.
His organisation planned to write to GPs to highlight what he said were the potential hazards associated with the new drugs for some patients, due to interactions with other medications.
Many people who would be treated with Covid-19 antiviral drugs would be older and on a range of “common medications” used to treat conditions that older people regularly suffered from, Prof Barry explained.
Dublin GP Dr Mark Murphy said it looked like Paxlovid would have have an important role in a small cohort of high-risk patients. "However, it is not the blockbuster that Pfizer is trying to imply."
Dr Murphy estimated that for high-risk patients, Paxlovid might reduce the absolute risk of hospitalisation and death by about 3-4 per cent. “That means roughly 30 people who are high risk and vaccinated with a new diagnosis of Covid would have to take the medication for one person to benefit. In medicine, that is actually quite a strong benefit – so that is good news.”
However, Dr Murphy said, information about possible side-effects are lacking and the full data has yet to be published and interrogated.
“For standard-risk patients, there is no data at all that an antiviral medication will be effective.”