MILAN, Oct 14 (APM) - Italian medicines agency AIFA has set out its strategy for providing early drug approval and access though managed entry agreements and adaptive licensing in an 'editorial' published on its website on Tuesday.

The Italian regulator’s head, Luca Pani, said there was a need for policy makers to focus on effective pharma regulation to keep pace with increasing complexity in the health field which includes the spread of ebola and difficulties in having sustainable prices for new hepatitis C drugs.

The AIFA chief suggested effective collaboration between industry and regulators to bring new therapies to the market quickly and safely can help meet the new challenges.

He urged pharma companies to take opportunities for early dialogue with regulators for more effective clinical study design, quicker development processes and reduced risks of failure. He said: “The scientific advice supplied by regulatory agencies to companies, as demonstrated by recent data, are fundamentally important for having positive decisions on marketing applications.”

The AIFA chief pointed to his own agency’s development of a series of clinical and administrative initiatives designed to obtain better information on which to base its regulatory decisions. He claimed AIFA’s system of managed entry agreements and monitoring register, introduced several years ago, have become a model for other agencies round the world.

According to Pani, the registers provide a wealth of post-marketing clinical data used to assess performance and safety. “They allow for patients to have access to new treatments while ensuring at the same time careful monitoring of the therapeutic benefits and the efficacy/safety relationship in real time.”

Pani suggested an interactive relationship between regulators and treatment providers would allow the authorisation process to evolve, passing from a static idea of approval to one of progressive authorisations.

He pointed to the European Medicines Agency (EMA) and its strategy for adaptive licensing as the way forward for regulators. At Milan conference organised by AIFA in September, EMA’s executive director, Guido Rasi, said a system of adaptive licensing for innovative therapies is an effective way to accelerate medicines development and provide early access to patients. The idea is not without critics however and has been discussed at the ongoing Topra regulators conference. (APMMA 40070)

Pani said EMA has numerous pilot projects underway in, what he called, “progressive patient access schemes”. Early authorisation of medicines in a restricted number of patients allows for continuous assessment of data as it is collected and modification of the authorisation so that access is progressively granted to a wider patient population, he said.

He stressed the importance of intervention through health technology assessment (HTA) procedures and scientific advice at an early stage in the development of a new drug. This will allow for the benefit-risk relationship and the benefit-reimbursement price relationship to be reviewed as new data is collected, he added.

Pani described his own agency’s intention. “AIFA is moving exactly in this direction in a strategy which puts new monitoring registers and dynamic databases with certified and validated epidemiological information, provided directly from clinical practice, at the heart of the process.”

The registers supply a wealth of valuable information about real effectiveness and appropriateness of the use of medicines. They are therefore the only generators of real time regulatory evidence available, he claimed

According to Pani, AIFA has a third avenue for the collection of data, besides HTA and the monitoring registers. It is provided by the pharmacovigilance network, whose role has been highlighted by new European regulations which extend the number of organisations involved in collecting information about adverse reactions.

Pani suggested the most important “adverse reaction” is when a drug does not work and reporting this fact should be seen as “an enormously significant” event for the whole system.

rg/ns