Roche concerned over slow pace of approval of new medicines

The directors of the Irish sales and marketing arm of pharma giant, Roche continue to be concerned about the slow pace of the approval of new medicines here and the consequent impact on patients.

In a report attached to new accounts filed by Roche Products (Ireland) Limited, the directors said that for a number of years, they have drawn attention to worsening reimbursement timelines – the time it takes for the HSE to cover the cost of a drug for paients – for new medicines here.

They said that once medicines are approved as being cost effective by the HSE, there is often a delay in making available the necessary funds for those medicines to be used.

The directors said that with Covid-19, the situation on reimbursement of medicines worsened in the second half of 2020, before a number of medicines were finally reimbursed, with a further group of medicines reimbursed in October.

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The directors said they hope that any new pricing agreement will address the slow approval of drugs, with a firm commitment by the State to make innovative new medicines readily available for patients here in line with access in other western European countries.

They said they remain positive for the future given the company’s pipeline of new medicines and new indications for existing medicines.

Profits declined

The latest accounts for Roche Products (Ireland) show pretax profits declined by 19 per cent to €6.95 million in 2020. This came as revenues dipped slightly from €102.49 million to €102.11 million.

The directors said the outturn for 2020 “was actually quite positive” in the context of the Covid-19 impact on business.

The marginal reduction in sales followed a return to growth in 2019 after two years of decline.

Numbers employed by the company in 2020 increased from 83 to 89 and staff costs reduced from €13.5 million to €11.54 million.

At the end of 2020, the company’s accumulated profits totalled €20.2 million.

The directors said that in 2020 the extension of reimbursement of cancer drug, Perjeta translated into increased sales. They also highlighted strong growth in Hemlibra, for the treatment of haemophilia, and Ocrevus for the treatment of multiple sclerosis.

They noted biosimilar erosion on two of the company’s top medicines, Herceptin and Mabthera which reduced margins as well as top line sales. A third medicine, Avastin, gained biosimilar competition at the end of 2020.