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This document illustrates the results of a discussion of two multi-disciplinary expert panels on pricing and reimbursement of medicines. Experts work in different organizations. The discussion focused on comparator(s), endpoint(s), negotiation of prices of new medicines and/or indications to include in the List 648, as well as the role of cost-effectiveness in the price and reimbursement negotiation. The debate took place during the fourth edition of the Seminari di Mogliano, organized on the 30th of September/1st of October, 2021. The two panels agreed on a general need to enhance interaction among the different stakeholders, in the early assessment and negotiation phases, and to increase the transparency/reproducibility of the decisions taken. The experts have also emphasized the need (i) to improve clarity in the evaluation of additional therapeutic value and the place in therapy with respect to comparators and how comparators are identified; (ii) to create work groups to identify the most appropriate endpoint(s), for each therapeutic area and level of unmet needs; (iii) to provide for a systematic use of cost-effectiveness when an added therapeutic value is delivered by a new medicine. With regard to the 648 List, the experts advocated for an overall reorganization of the current rules governing the special uses of drugs.

GOLD guideline recommendations are currently the "gold standard" for the treatment of COPD patients.The objective of this analysis was to evaluate compliance with GOLD guidelines in managing COPD patients' treatment by general practitioners (GPs) and pulmonologists. Since inhaled corticosteroid (ICS) use is defined as inappropriate in mild and moderate COPD patients, special attention was paid to ICS therapy use in these classes.The study was based on the Italian GP database IMS Health Longitudinal Patient Database (IMS Health LPD) and on the Patient Analyzer specialist IMS Health database. The observed cohort included all patients with a diagnosis of COPD, aged 40 years or more, with at least one ATC R03 class prescription, visited by GPs and pulmonologists during four timeframes: October 2012 - March 2013 (cohort 1), April 2013 - September 2013 (cohort 2), October 2013 - March 2014 (cohort 3); April 2014 - September 2014 (cohort 4). Patients were classified into disease severity groups following 2008 GOLD guidelines, based on FEV1 value.Cohorts were quite similar in size (about two thousand patients per cohort). Pulmonologists visited more severe patients than GPs. About 50% of GPs' mild and moderate patients received treatments containing inhaled corticosteroids. Pulmonologists were more adherent to guidelines, with smaller percentages of mild patients treated with therapies containing ICS (ranging from 19.0% to 30.1%). An improvement in adherence was observed during the four time periods, with a decrease in the use of therapies containing ICS in mild and moderate patients. In absolute terms, it emerged that GPs more often prescribe ICS improperly to patients in the mild and moderate severity classes than pulmonologists.Real world data indicate that adherence to GOLD guidelines is only partially met by GPs in their general practice and shows higher prescription appropriateness by pulmonologists.

Anna Graziella Burroni,1 Mariella Fassino,2 Antonio Torti,3 Elena Visentin4 1IRCCS University Hospital San Martino, IST National Institute for Cancer Research, Genoa, Italy; 2Department of Psychology, Specialization School in Clinical Psychology, University of Turin, Turin, Italy; 3Dermatology practice, Milan, Italy; 4HTA and Scientific Support, CSD Medical Research Srl, Milan, Italy Background: Psoriasis largely affects daily activities and social interactions and has a strong impact on patients’ quality of life. Psoriatic patients have different attitudes toward their condition. Topical medications are essential for the treatment of psoriasis, but the majority of patients do not adhere to these therapies. Objective: The history of treatment success or failure seems to influence patient attitude toward topical therapy. Therefore, it is important to understand the psychological, experiential, and motivational aspects that could be critical for treatment adherence, and to describe the different attitudes toward topical treatment. Furthermore, the physician–patient relationship and the willingness to trust the dermatologist may have a substantial role in encouraging or discouraging patients’ attitudes toward topical therapy. Methods: A survey was designed to collect aspects that could be relevant to understanding different patient attitudes toward psoriasis and its treatments. A total of 495 self-administered questionnaires compiled by psoriatic patients were analyzed from 20 Italian specialized hospital centers in order to provide a nationwide picture. Results: Psoriatic patients have different perceptions and experiences in relation to their condition: half of them consider psoriasis as a disease, while the other half consider psoriasis as a disorder or a nuisance. Topical therapy is the most widely used treatment, even though it is not considered the most effective one and often perceived to be cosmetic. The main findings are: 1) inadequate patient education about this disease, 2) lack of information about topical treatment, and 3) lack of results within the expected time frame. Furthermore, physicians need to build a good relationship with psoriatic patients in order to motivate them, to trust in their care, and to adhere to treatment. Conclusion: This survey adds new and important details about daily life and well-being and the needs of psoriatic patients, providing suggestions for dermatologists to improve patients management. Keywords: psoriasis, topical therapy, survey, dermatologist&nbsp

Palladium-phenanthroline complexes efficiently catalyze the reaction of nitroarenes with arylalkynes and CO to give 3-arylindoles by an ortho-C-H functionalization of the nitroarene ring. Both electron-withdrawing and electron-donating substituents are tolerated on the nitroarene, except for bromide and activated chloride. Nitroarenes bearing electron-withdrawing substituents react faster, but the selectivity of the reaction depends on both polar and radical stabilization effects. Among those tested, only arylalkynes afforded indoles under the investigated conditions. The reaction mechanism was partly investigated. The kinetics is first order in nitroarene concentration and the rate-determining step of the cycle is the initial nitroarene reduction. No primary isotope effect is observed on either rate or selectivity, implying that the cyclization step is fast.

Silvia Franchi,1 Franca Heiman,2 Elena Visentin,2 Paola Sacerdote,1 1Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milan, Italy; 2Cegedim Strategic Data Medical Research Srl, Milan, Italy Background: Appropriateness of use is a key factor in safeguarding patient’s health as well as a product’s therapeutic properties. This paper presents the results of a survey conducted in nine European countries to verify the appropriateness of use of nimesulide in patients with inflammatory pain. Methods: Computer-aided telephone interviews were administered to 1,277 nimesulide-prescribing general practitioners in Bulgaria, Czech Republic, Greece, Hungary, Italy, Poland, Portugal, Romania, and Slovakia, covering an estimated 31,719 patients. The interview questionnaire collected information on nimesulide prescriptions with respect to daily dose, treatment duration, and indication. Results: In the majority of cases, prescriptions of nimesulide did not exceed the recommended daily dose of 200 mg (given as 100 mg twice a day), with a range from 161 mg (Greece) to 190 mg (Slovakia). An adherence to the 15-day treatment limit was observed in over 90% of cases. The average number of treatment days was always less than 15, with a range from 5.4 (Italy) to 13.6 (Czech Republic). Nimesulide was primarily used for the treatment of acute pain and short-term painful episodes in chronic conditions. The presence of gastrointestinal diseases/ulcers was the most frequent reason for not prescribing nimesulide. Conclusion: The results of this survey demonstrate that nimesulide is generally prescribed in compliance with the information reported in the summary of product characteristics (SmPC) with regard to daily dose and treatment duration, and suggest that it is mainly used for the management of episodes of acute pain in patients with a chronic disorder. These findings indicate the appropriateness of use of nimesulide in the European countries considered in this survey. Keywords: non-steroidal anti-inflammatory drug, NSAID, appropriateness of use, European Medicine Agency, computer-aided telephone interviews