FLORENCE, 5 June (APM) - Celgene and Novartis are supporting a project launched by Veneto to draft guidelines for the use of high-cost haematology cancer drugs and implement a system to monitor treatments, a group of HTA and medical professionals said in an article published by Il Sole 24 Ore on Monday.
The entry of haematological oncology drugs on to the market in recent years has raised concerns about the regional health system's sustainability. Specific government policies aimed at ensuring fair and sustainable access to therapies have been introduced, the group said.
Veneto has a specific programme for research, innovation and health technology assessment (Prihta). It will now include a new project: 'Elaboration of recommendations on the use of high-cost haematological oncology drugs and activation of an adhesion monitoring system'. Celgene and Novartis have agreed to support the initiative.
Its objectives include the establishment of a pathology data linkage system using, among other things, current administrative flows of information, clinical laboratory analysis data and microbiology and computerised medical records.
It will focus on three cancers, multiple myeloma (MM), chronic myeloid leukaemia (CML) and myelodysplastic syndromes (MDS). These are the haematological oncology pathologies with the greatest impact on expenditure, the group said.
The aim is to assess the possibility of integrating information flows for the identification of patients who are eligible for new therapies as well as for the monitoring of aspects such as efficacy, safety, appropriateness of use and costs. It is hoped that manual insertion of information by clinicians can be completely replaced, or at least reduced to a minimum.
Assessing all aspects of these diseases, including prevalence, mortality, the population eligible for the new therapies, diagnostic-therapeutic pathways and the costs, will lead to improved access to new high-cost drugs according to shared criteria of appropriateness, efficacy and efficiency, the group wrote.
In addition, the creation of a data-linkage system between existing databases will permit a reduction in the time health workers spend inserting data and collecting information.
Multiple myeloma next target for CAR-T therapies
After leukaemia and large B-cell lymphoma, the next target of cutting-edge CAR-T therapies appears to be multiple myeloma, according to Saturday's La Repubblica.
Several research groups have been testing the effectiveness of an approach based on the modification of the T lymphocytes of the patients for this blood cancer which relapses in more than 90% of cases.
New data on a new CAR-T therapy (BMS/bluebird's Ide-cel) confirm that this is an effective option with an overall response rate of 73%, the paper said. Updated results of the KarMMa Phase II trial were presented during the first day of the ASCO conference, it added.
Puglia suspends use of Bayer's Resochin for Covid-19 patients
Puglia has suspended the use of Bayer's antimalarial, chloroquine-based drug Resochin, La Gazzetta del Mezzogiorno reported on Wednesday.
It had been donated by the Pakistani Armed Forces to Italy at the height of the coronavirus emergency. But an investigation by La Gazzetta del Mezzogiorno showed that Resochin, which is produced by Bayer at a Karachi plant, had been imported without the necessary authorisation from regulatory authorities and without an inspection of the production facilities by the Italian medicines agency AIFA.
The paper cited reports by other media outlets, such as Thomson Reuters and Al Arabya, which expressed doubts about the safety of the drug and its possible toxicity. It noted that AIFA has ruled that hydroxychloroquine and chloroquine should not be used for Covid-19 in Italy outside clinical trials.
New Covid-19 infections down to lowest level since February
New Covid-19 infections fell to 177 this week, the lowest level since February, Il Sole 24 Ore reports on Friday.
The paper cited the latest bulletin by the civil defence department, which was published on Thursday evening, as showing that half of the new cases were in Lombardy, the worst affected region.
The number of deaths rose by 88, 17 more than the previous day, but numbers in hospital and intensive care units continue to fall significantly. More than 161,000 people have now recovered and the number of people currently infected has fallen to 38,429.