Greece's health minister Andreas Xanthos has stated that the planned new pricing and reimbursement measures – which will make the addition of new drugs to Greece's positive list condition on reimbursement in 14 EU countries, of which 7 must have HTA evaluation systems – will act as a "filter" in the context of the current "uncontrolled" admission of new innovative drugs to the list.
Implications | The innovative pharmaceutical industry association, the SFEE, is strongly opposed to the measures, and estimates that a planned new additional discount of 25% would bring the amount that producers would have to pay back to the Greek authorities on the sales of new drugs to around 60%. |
Outlook | The measures are likely to be opposed strongly by the beleaguered Greek pharmaceutical industry, while the government, seeking a quick solution to its pharmaceutical budget problems, will hope to implement the measures to buy time to continue work on longer-term solutions. |
"Uncontrolled" number of new innovative medicines entering positive list
The number of innovative drugs being added to the positive reimbursement list in Greece today is "uncontrolled", according to Greece's health minister, Andreas Xanthos, quoted by Greek medical news source Iatronet. According to Xanthos, new innovative and expensive medicines are added to the positive list without proper evaluation – specifically, health technology assessment (HTA) – and price negotiations, which then compromises the "closed" budget of medicines of the Greek National Organisation for Healthcare Provision (EOPYY). Xanthos is reported by the source as saying that the Ministry of Health (MoH) intends to establish a valid HTA evaluation system, and that a special committee is working on this.
New pricing measures will act as interim HTA "filter"
Iatronet reports that these statements were made by Xanthos in response to the complaints made by the Hellenic Association of Pharmaceutical Companies (SFEE) concerning the MoH's planned new measures on drug pricing and reimbursement. The most important elements of these measures are the implementation of conditions for access of new innovative medicines into the market, so that they will only be added to the positive list if they are already reimbursed in 14 EU member states, of which seven must have HTA evaluation systems in place. Furthermore, as Iatronet reports, an additional upfront rebate/discount of 25% will be required – in previous reports, it has been implied that this 25% discount would only apply for the first two years of marketing (see Greece: 14 December 2016: Pharma firms oppose planned Greek P&R changes to restrict market access for new originator medicines).
According to Xanthos, quoted by the source, these measures are to be put in place on an interim basis, pending the completion of the work on a full HTA evaluation system and system of price negotiations; the conditions for entry on to the Greek market would act, effectively, as a "filter", while the new additional discounts are a response to a "difficult budgetary position".
SFEE: Additional discount to bring amount due to Greek authorities on new drugs to 60%
The SFEE has estimated that were the measures to be introduced in their current form, the amount of the revenue from new products that pharmaceutical companies would have to hand over to the Greek authorities would be about 60% of the total – considering that currently, the rebate level is 20%, clawback is on average 17%, and the new discount would amount to 25%. These additional payments combine with the very low prices of medicines in Greece, in the European context, to make the situation of pharmaceutical companies in the country almost unbearable.
SFEE president: Prescribing needs to be controlled
Greek online news source News Bomb reports the statements of the president of the SFEE, Paschalis Apostolidis, that although the pharmaceutical industry accepts that new innovative drugs should be assessed, it does not agree on the manner being proposed. Apostolidis is reported as saying that binding therapeutic protocols should be employed, in order to control prescribing and access to expensive treatments. Additionally, he is reported as saying that the EOPYY's price negotiation committee has not worked, and will become inactive again "for legal reasons". According to Apostolidis, the committee was supposed to start its work with new treatments for hepatitis C, but this was not completed.
Outlook and implications
Xanthos has stated his commitment to continuing to work together with the pharmaceutical industry before the finalisation of the measures. However, it is difficult to envisage that much will change in terms of the industry's position on the measures. The Greek government is obliged under its bailout commitments to reduce the amount of clawback paid by pharmaceutical companies substantially in 2017; clawback has been rising as the pharmaceutical budget has been declining, and greater pressure has been put on the budget by the addition of more expensive medicines, and the need to provide free medicines to uninsured people. It would appear that the government's "interim" solution is a particularly blunt instrument, which it hopes will remove the problem while work carries on towards a longer-term solution. Under the bailout commitments, the Greek authorities are due to establish an HTA agency by the end of 2017. Judging by the poor progress in other areas – such as price negotiation and therapeutic protocols – there will be justified scepticism as to whether this can be achieved.