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Same-Day Analysis

Greece's positive list excludes new innovative drugs as first therapeutic protocols set to take effect

Published: 03 October 2013

The new Greek positive drug list will come into effect on 10 October, but the recently priced new innovative products do not feature in it.



IHS Global Insight perspective

 

Significance

Greece's Ministry of Health (MoH) has revealed the new positive drug list, which is set for implementation on 10 October. However, the list does not feature the new innovative medicines that were recently priced in August – these are now due to be assessed ahead of their possible addition to the list at a later date.

Implications

Alongside the implementation of the new positive list, a new system of treatment protocols is set to be enforced, under which doctors will be expected to prescribe specific medicines for particular chronic diseases – this is the latest measure in Greece's cost-containment efforts.

Outlook

The MoH will continue to face the suspicion and mistrust that Greek patients harbour towards generics as it attempts to fulfil its objectives for generic uptake. Meanwhile, the forthcoming assessment of the recently priced innovative medicines is likely to leave a good number out of the reimbursement list, for cost-containment reasons.

New innovative drugs miss out but are due to be assessed

The new Greek positive drug reimbursement list has been revealed and is set to become effective from 10 October, stated the Greek Ministry of Health (MoH) in a press release. The list contains over 7,600 products, with 1,223 new generics that were assigned prices in June and August this year. However, the innovative medicines priced in August – the first time such to be assigned prices in Greece for 31 months – have not been included in the list. According to the MoH, these drugs will be evaluated in the near future by the competent committee for the supplemental positive list. The list can be accessed here, in Greek, at the website of the Hellenic Association of Pharmaceutical Companies.

Deep price cuts and high co-payments

The new list features price cuts for medicines of between 0.1 and 43%, reports Greek medical news outlet Iatropedia. According to the source, patients who wish to have an off-patent originator medicine rather than a generic will have to pay out of pocket the entire difference between the reference price and the price of the off-patent originator. In the case of generics, patients only have to pay half the co-payment under the MoH's latest regulations (see Greece: 24 September 2013: Troika happy with healthcare cost-containment progress in Greece, as new legislation to result in major price cuts for generics).

Pharmaceutical reimbursement in Greece, under the agreement with the troika (Greece's bailout creditors, the International Monetary Fund, the European Union, and the European Central Bank), is set to fall to EUR2.37 billion (USD3.21 billion) in 2013, from EUR2.88 billion in 2012, and should not exceed EUR2 billion in 2014, reports Iatropedia. According to the outlet, the amount paid by pharmaceutical producers in the form of clawback amounted to EUR78.9 million in 2012.

Therapeutic protocols primed for enforcement

It has also been announced that the first 19 therapeutic protocols – under which doctors will be expected to prescribe specific medicines in the treatment of particular chronic diseases – are set to be enacted alongside the new positive drug list and integrated with the electronic prescription system. The 19 protocols apply to five disease groups: dislipidaemia, diabetes, osteoporosis, hypertension, and neurological disorders. These disease groups are reported to account for 50% of the monthly pharmaceutical reimbursement costs of Greece's National Organisation of Healthcare Provision (EOPYY).

Protocols expected to help rationalise pharma spending

Greek medical news provider On Med reports that in the next phase of the roll-out of the therapeutic protocols, rheumatologic agents and biotech medicines will be added to the new system. According to Christína Papanikoláou, the general secretary at the Greek MoH, the introduction of the therapeutic protocols for the first five disease groups is an important test to gauge how much more savings can be made from pharmaceutical expenditure, keeping in mind that the Greek MoH has committed itself to realising the goal of the troika to increase the proportion of the volume of the Greek drug market made up by generics to 60% by the end of this year. Papanikoláou reportedly also said there is an excessive use of biotech medicines in Greece at present and has argued that the therapeutic protocols will make it possible for similarly rational methods of treatment in effect in other European countries to become the norm in Greece, according to which patients only receive new, expensive innovative medications – including biotech drugs – when other treatments have not worked.

Outlook and implications

Greece's health minister Adonis Georgiadis likes to remind Greeks that they pay among the lowest proportions of the cost of prescription medicines out of their own pockets in Europe. However true this may be, it remains a major feat for the Greek authorities to manage the transition from the over-generous and economically unsustainable system of public pharmaceutical provision in the country to a rational and more restrictive one. The challenge is great, because managing a transition within an economic and social crisis is always more difficult than otherwise.

The lack of an established culture of generics and the suspicion Greek doctors and patients have towards generics are the most significant elements of this obstacle. The Greek MoH is hoping that the lower co-payments offered to patients if they opt for cheaper generics will persuade more to do so, but it may take some time to reach the 60% target, which is unlikely to be realised this year.

For producers of innovative drugs, the fact that their products that were priced in August – around 100 medicines– are now being assessed ahead of their potential addition to the reimbursement list at least represents some progress. Considering the need to restrict pharmaceutical expenditure to under EUR2 billion, which is around 50% less spending than in 2011, there is a strong likelihood that only a limited number of these drugs will be approved for reimbursement.

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