by Robert Galbraith at the International Forum on Cancer Patients Empowerment

MILAN, May 19 (APM) - Value-based assessment of innovative cancer drugs is unlikely to resolve pricing issues or help improve access to new products for patients because of the complexities of new therapies, a conference heard this week.

At the first International Forum on Cancer Patients Empowerment, which was held in Milan on Tuesday and Wednesday, a debate was started about the prices of new drugs.

During the plenary session on innovation and sustainability, the moderator, Massimo di Maio from Italy's medical oncology association AIOM, invited comment about a study published earlier this year in the Annals of Oncology. This looked at 51 new drugs approved by the Food and Drug Administration (FDA) between 2000 and 2015 and found no relation between the price of drugs and benefit to society and patients.

Bengt Jönsson, professor of health economics at the Stockholm School of Economics, responded by saying that innovative drugs cannot necessarily be assessed effectively at the time they are approved. He suggested that the value of a drug is totally dependent on how it is used, and that an appropriate use for the "right patient" is paramount.

"That means discussing value-based pricing for a drug is rather meaningless," he told the conference. "The most important thing is all patients have access to all drugs which could have value for them as quickly as possible. That should be the most appropriate goal."

Jönsson insisted that it is only possible to give a value to a drug once it is being used. "We need to do follow-up studies to really see what the value is for patients, because it will vary," he said.

The economist highlighted Italy's post-marketing monitoring system for innovative drugs, which is used to decide whether managed entry agreement conditions have been met, as a useful method. He also warned that the value of a therapy, especially in immuno-oncology, may not become apparent for a long time.

Only after real-life assessment has been done will the value of a drug become apparent, Jonsson said. "Then we can start to discuss payment, and of course we have to have a payment system which fosters the efficient and ethical use of the drug and rewards innovation in an appropriate way," he explained.

Alberto Sobrero, head of medical oncology at Genoa's San Martino hospital and member of a working group in the European Society of Medical Oncology (ESMO) aimed at creating a 'magnitude of clinical benefit' scale, highlighted the lack of appropriate methods for pricing drugs.

He said the inability to put a monetary value on a therapy led to comparison of prices of a drug in different countries to obtain a global average. Sobrero said this led experts to conclude that "there are no rules about pricing drugs and there is no consistency about pricing around the world".

"This means that when we talk about cost it is something, and when we talk about price and prices we talk about another completely different business that unfortunately to my knowledge is not regulated," he said.

Francesco De Lorenzo, president of the European Cancer Patient Coalition (ECPC), who spoke from the audience, said the real value of a drug for a patient is access. He cited a survey published in 2016 which showed that more than 5,000 patients with metastatic melanoma do not have access to innovative therapies which could prolong survival significantly.

"Sustainability is one major problem, but the other is that something must be done to make lower prices for pharma drugs, so I think the system must change," he said.

De Lorenzo suggested that harmonisation of health technology assessment throughout Europe would lead to faster access to new drugs. He argued that limited access to innovative therapies results in research being conducted on a small number of patients, and warned that the cost of carrying out trials rises as a result.

Massimo Scaccabarozzi, president of the Italian pharma association Farmindustria, emphasised the capacity of innovative therapies to generate savings. He pointed to the 2017 comparator report from the Swedish Institute of Health Economics (IHE). This showed that increased spending on drugs, which results from more patients being treated and the higher cost of innovative therapies, have helped health services save money on other services.

Scaccabarozzi said that personalised medicines will enhance drugs' savings capacity. More than 73% of cancer drugs being developed could become personalised therapies. In colorectal and breast cancer, for example, savings of more than 30% on drug costs can be achieved through genetic tests to find out which patients will benefit from treatment, he explained.

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