by Robert Galbraith

ROME, Nov 18 (APM) - Italy's health minister has expressed hopes that health and drugs spending can be seen more as an investment than a cost, and as a way to improve access.

Speaking at a conference organised by the economics consultancy The European House - Ambrosetti this week, Beatrice Lorenzin pointed to treatments for HCV infection as an example of long-term benefits coming from high immediate costs.

She predicted that paying for treatment for 58,000 hepatitis C patients will allow Italy to make significant savings because of a reduced need for transplants and other treatments. But she acknowledged that the health service still finds it difficult to take the longer-term view.

"This means that we have to change our ways of managing health resources. We have to find new strategies and ways to distinguish between costs and investment," she explained.

Lorenzin described the health system as an organism with many different parts which interact. She said this is why it is so difficult to manage. "My own priority is to have a health service which is accessible to all patients throughout the country," she said.

The health minister pointed to drugs innovation as one of the biggest challenges because of the cost of new therapies. She said that this will be the case when drugs to treat Alzheimer's disease are approved in 2017.

Italy's strategy will be based on early diagnosis and screening of patients to decide who can benefit from the new therapies. "This is part of an efficient system which uses innovation effectively," she told the meeting.

Mario Melazzini, president of medicines agency AIFA who is expected to become the regulator's new director general shortly, highlighted Alzheimer's as a disease that threatens the sustainability of health systems.

He said the number of cases worldwide will rise from 36 million now to 115 million by 2050. Unless there is the necessary investment in prevention and effective treatments, health costs will be driven up at an alarming rate, Melazzini warned.

But he said health systems also need to brace themselves for a flood of new drugs which will come onto the market in a few years. These will include new hepatitis C therapies, monoclonal antibodies to treat Alzheimer's and dementia, novel cancer drugs and new antiretrovirals, the AIFA chief predicted. There will be also be new gene therapies, gene editing, 3D-printed drugs and immunotherapies, he added.

Melazzini warned that this will present serious challenges to drugs regulators, which will have a tricky balancing act to reconcile uncertainty about costs and outcomes of treatments with the need to provide rapid patient access.

The AIFA president said the key to successful regulation will be accurate assessment of innovation and efficient drugs pricing. He said AIFA's strategy has been based on four steps: early dialogues with companies, including scientific advice, followed by conditional reimbursement agreements linked to outcomes, registries to monitor post-marketing performance and reassessment of the therapies thereafter.

Amgen's CEO in Italy, Francesco Di Marco, also highlighted the importance of assessing innovation. He stressed the need to weigh up the value a drug provides in relation to its cost before deciding on its usefulness. He used the example of osteoporosis to show that costs, such as those for fractures, can be significantly reduced through drug treatments.

Di Marco told the meeting that drug budgets must be adequately financed and spending caps realistic if therapies are to realise their full potential. The whole of pharmaceutical services, not just R&D, needs to benefit from innovation to ensure the right treatments are used for each patient, he explained. He also expressed hopes that savings from biosimilars can be used to pay for new innovative therapies that come onto the market.

/rg/clg