Portuguese Hospitals Block Access to New Medicines as Retail Drug Sector Expected to Meet Savings Goal
Access to expensive medicines is becoming increasingly difficult in Portuguese public hospitals, while savings with retail pharmacy expenditure are expected to be better than projections in the Memorandum of Understanding deal signed by the government.
Patient association groups are complaining that the treatment of diseases that involve more expensive medicines is "increasingly becoming more difficult" to access in Portuguese public hospitals. There are hospitals that are refusing or making it harder to access medicines for patients with rheumatoid arthritis, psoriasis or spondylitis, Arisete Saraiva, president of patient association Platforma Mais Saúde told newspaper Sol.
The latest complaints came shortly after the Portuguese Association of Amyloidosis (APP) handed a petition to the national parliament asking for access to Vyndaqel (tafamidis), which has yet to be granted marketing approval by the European Medicine Agency (EMA). In July, the drug was granted a positive opinion by the Committee for Medicinal Products for Human Use in the treatment of transthyretin amyloidosis in adult patients with symptomatic polyneuropathy, a severe and progressive orphan disease.
Portuguese hospitals can order the medicine directly from the manufacturer via a special importation request, but they do not do so because of its expense, according to the head of APP, Carlos Figueira. The drug is manufactured by FoldRx Pharmaceuticals (US), which since September 2010 has become a wholly owned subsidiary of Pfizer (US). The drug costs about EUR 130,000 (USD 177, 157) annually per patient.
Difficulties in accessing expensive biologic medicines are being felt by patients with psoriasis, arthritic psoriasis, rheumatoid arthritis or spondylitis, according to the respective disease's national patient associations. Restrictions are being felt throughout different hospitals, particularly when patients have to start treatment. As treatment with these medicines should be continuous, hospitals have been delaying the start of therapy, according to the head of the National Psoriasis Association, Vitor Baiao.
Better-than-expected savings for retail pharmacy
The retail pharmacy sector is forecast to achieve greater savings than predicted in the Memorandum of Understanding (MoU) deal by 2013, according to the Portuguese doctors' association Ordem dos Medicos. The government signed the deal in May 2011 with the European Commission, European Central Bank and IMF.
The head of Ordem, Jose Silva, revealed during a press conference that public expenditure on retail-sector medicines during the year will reach 0.93% of GDP. This is lower than the 1% of GDP outlined in the MoU for 2013. Considering this forecast, Silva does not believe in the requirement of additional measures that will "jeopardise the quality of life" of patients.
One of the measures being contemplated is the alteration of legislation allowing patients to substitute medicines even when doctors explicitly say that certain prescriptions should not be substituted at the pharmacy level. Silva argues that a "savage substitution of medicines should not be allowed on the basis of economic reasons".
The head also complained that the Ministry of Health is only contemplating the introduction of certain cost-saving measures after this has been delineated in the MoU, while the same policies were put forward by his association back in February. For example, Ordem agrees to halve the price of innovative medicines when patent protection is lost and that the drug regulator Infarmed should establish these prices. This was outlined in the MoU.
Outlook and implications
Difficulties in accessing expensive medicines in Portuguese hospitals—particularly for orphan diseases—is an ongoing problem. New orphan drugs are a particular bone of contention because Infarmed takes a considerable length of time to decide on reimbursement. This was confirmed by a study by branded drug industry association Apifarma, published in April 2010.
While a drug is being evaluated by Infarmed, hospitals can obtain that drug via a "special use authorisation". Earlier in 2011, however, patient associations accused hospital administrators of not using this previously popular route because of cost-containment issues. It is therefore unsurprising that administrators are not using a special importation route for an orphan drug like Vyndaqel, which has yet to receive approval by the EMA.
Cost containment is at the top of the agenda for hospital administrators, particularly as it is one of the cornerstones of the MoU. The government has committed to improve the management and efficiency of public hospitals. With that in mind, in September, it commissioned the formation of a specialist group to propose a set of measures to reform the sector considerably. One of the major issues it will have to tackle is the high level of unpaid debts of the Portuguese hospitals.
A better-than-expect forecast of savings for the retail pharmacy arena is a positive sign that Portugal is on the right track. This should not stop the government from implementing further measures to obtain greater savings though, considering the high growth of public health expenditure in relation to GDP. A greater push in the use of generics should be on the cards, as its penetration is one of the smallest in Europe. The government has a mountain to climb, however, judging by the latest study suggesting that a significant percentage of doctors are still refusing to prescribe generic medicines.
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