In the specialized field of Italian P&R Dossier management, Justin Stindt Consultants emerges as a key consulting agency. Our team, adept in Pharma, Biotech, and Medtech market access, offers expert guidance in aligning with the Italian Medicines Agency (AIFA) standards. As a global consulting agency, we bring a blend of experts and consultants who are deeply familiar with the nuances of AIFA’s requirements. Our services are critical for accurately classifying medicines and negotiating prices in Italy. We ensure your dossier is comprehensive, precise, and tailored to AIFA’s criteria. The introduction of AIFA’s new e-Dossier Pricing and Reimbursement platform underscores the need for a strategic approach, a forte of our international team of experts. Rely on Justin Stindt Consultants as your partner and expert team in navigating Italy’s healthcare market.
AIFA’s P&R Dossier Requirements: Navigating Medicinal Product Classification and Price Negotiation in Italy
In Italy, the Italian Medicines Agency (AIFA) is the Health Technology Assessment (HTA) body responsible for assessing and classifying medicines at the national level. Medicines can be classified as class H, A or C. While class A and H drugs are fully reimbursed, class C drugs are not reimbursed and manufacturers can set a free price.
For reimbursed medicinal products, AIFA also negotiates the prices with pharmaceutical, biotech and medtech companies. It is fundamental to submit a Pricing & Reimbursement dossier (i.e. e-Dossier Prezzo e Rimborso) that is complete, accurate, and oriented towards AIFA’s requirements. Justin Stindt Consultants is an agency specialized in Italian P&R dossiers. Our experienced team of Consultants and Experts will help you to articulate the innovation and benefit of your product in the AIFA dossier.
Our agency has been selected by many pharma, biotech and medtech companies as service provider of choice to write the Italian P&R dossier. Our company leverages Italian native speakers with extensive experience both in the industry and consulting agencies and a successful track record of P&R dossiers leading to sustainable Pricing & Reimbursement in Italy.
Role of the New Scientific and Economic Commission (CSE)
The new Scientific and Economic Commission (CSE) of AIFA is now responsible for evaluating and providing advisory opinions on the classification of medicinal products for reimbursement purposes and the price negotiations. These responsibilities were previously split between the Scientific technical committee (CTS) and the Price and Reimbursement Committee (CPR).
Innovative Status and Benefits in Italy
The provisions of the Ministerial Decree of August 2nd 2019 determine the criteria and methods used by AIFA to determine, through negotiation with the companies, the prices of medicines reimbursed by the National Health Service (GU no. 185 of 24 July 2020). Given how critical the dossier and its contents are to this decision, it is important to submit a dossier that is complete, accurate, and oriented towards AIFA’s requirements.
The new e-Dossier Pricing and Reimbursement platform is available on the AIFA Services Portal, for drafting dossiers in digital format to support P&R requests.
A medicine can gain extra benefits if it reaches the innovative status when it enters the Italian market. For more information about the Pricing & Reimbursement pathways in Italy, see our Pricing & Reimbursement (pathways) – Italy
Italian Market Access Mastery with Justin Stindt Consultants: Specializing in Pricing & Reimbursement Dossier Expertise
Our commitment lies in delivering HTA submissions that excel in written excellence, technical precision, and the art of weaving clear, captivating narratives. Our goal is to ensure that each submission forms a cohesive, integrated, evidence-based story, moving away from a mere assortment of distinct clinical and health-economic elements typically found in an evidence package.
Justin Stindt Consultants is your consulting agency with the right experts in writing Italian P&R dossiers. Our services include (not limited to):
- Comprehensive project planning with clear timelines and milestones
- Strategic review of drug positioning
- Dossier writing, both Italian original and English translations
- Dossier validation with Key Opinion Leaders and ex-members of AIFA’s commissions and regional payers
- Submission process guidance and support
- Hearing preparation and support
- Strategic advice and participation in price negotiations
- Effective project management and communication throughout the process
At Justin Stindt Consultants, our team of international consultants and experts has extensive experience in providing our clients with tailored support to provide access to Italian patients as soon as possible at sustainable pricing and reimbursement conditions. If you are looking for a vendor to support your Italian Pricing & Reimbursement dossier, select a service provider that will go the extra mile to enable HTA endorsement and sustainable pricing for your product. More than a mere dossier supplier, Justin Stindt Consultants can provide full-service support including engagement with the authorities and price negotiations.
Let Justin Stindt Consultants be your trusted agency partner in unlocking pricing & reimbursement opportunities for your product in Italy.
Contact us today to learn how we can tailor our services to meet your unique needs and make your pricing & reimbursement goals a reality.
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