MILAN, 16 Aug (APM) - The reimbursement method agreed for Novartis' CAR-T therapy Kymriah (tisagenlecleucel) is an effective way to pay for the treatment but it is not as new as it has been made out to be, a health economist suggested in an opinion piece published by Quotidiano Sanità on Friday.
Medicines agency AIFA described the 'payment at results' agreement as being a change with past (APMHE 63970
). It will mean a payment is made after six and 12 months only if it is demonstrated to be effective.
The economist, Fabrizio Gianfrate, claimed that he had proposed such a scheme last year. He also noted that Italy has been using various conditional payment models, including risk sharing and success fee for about 10 years.
He asserted that a form of 'payment at result' has already been used for the gene therapy, Strimvelis, which was developed by GlaxoSmithKline for treating inherited immunodeficiency disorder ADA-SCID
He suggested that these types of conditional reimbursement schemes have been ignored by AIFA recently so Kymriah's reimbursement agreement is a welcome return to an effective model. Gianfrate stressed economists will be the first to recognise its effectiveness.
However, he warned that there are possible negative effects. The economist gave a lengthy explanation about the potential impact on pricing.
With a CAR-T therapy, the health service buys only a certain outcome where, in the traditional reimbursement model, it buys a probability of success. According to Gianfrate, the lower volumes of advanced therapies and other factors could create inflationary pressure on drug prices.
Nonetheless, he insisted that the scheme is a good one, speculating on whether it could be used to be paid for other drugs, complete segments of drugs and in other therapeutic areas.
ICG, Mercier take majority stake in Doc Generici
Investment funds Intermediate Capital Group (ICG) and Mercier have taken a majority stake in the Italian generics firm Doc Generici, according to Tuesday's Corriere della Sera.
The paper gave no details of the acquisition listing the deal only among many recent private equity operations targeting Italian businesses and brands. Other reports suggest it happened in April.
Doc Generici was previously owned by CVC Partners. Corriere della Sera said the stake held by ICG and Mercier in the generics firm is worth €1.1 billion.
Africa has 158,000 deaths a year caused by counterfeit medicines
Africa has 158,000 deaths a year which are caused by counterfeit medicines, La Repubblica reported on Monday.
The paper cited World Health Organization (WHO) data as showing that one in 10 drugs in countries with low or medium incomes have been altered or is fake.
In some areas, the problem is even more serious: one in three malaria medicines are fake. The number of counterfeit drugs to treat cancer and some chronic diseases such as hypertension is rising fast.
The WHO has identified three different aspects of the problem: drugs deliberately counterfeited, those that do not meet international standards and therapies which have not been registered, not even in national systems.
The WHO estimates there are two billion people in the world who do not have safe access to medical treatments. Most of the products used in the "parallel market" come from China and India, the paper said.
However, there are virtuous examples of countries making progress in tackling the problem. The Ivory Coast and Kenya have started crackdowns on illicit trading, Nigeria has reached trafficking by 80% and Tanzania has introduced an effective quality control system.
New rules about medicines advertising on social media causing confusion
New rules about advertising medicines on social media have caused confusion in the year since they were introduced, according to Wednesday's Il Sole 24 Ore.
The guidelines were drawn up by the health ministry after consultation with Facebook and the self-medication industry association Assosalute. They were introduced in July last year.
Operators have reported that there are still areas that are not clearly defined and concern about the severe restrictions on how products can be advertised. For example, comments, reactions and emoticons cannot be used on Facebook.
The guidelines have created significant legal issues which will take time to be resolved, the paper said.
Rome hospital discovers new treatment option for brain tumours in adults
Rome's Regina Elena hospital has discovered a new treatment option for brain tumours, Il Messaggero reported on Saturday.
Results of a Phase II study were published in the Journal of Neuro-Oncology. They showed benefits of a chemotherapeutic, carboplatin, which is mostly used for paediatric cancers, in adult patients with malignant glioma which had relapsed after standard chemotherapy treatment, the paper said.
The study showed there was control of the disease in more than 30% of patients and the response lasted for more than 7 months.