Navigating the intricate landscape of Pricing & Reimbursement in Italy requires a blend of expertise, local insights, and strategic vision. Justin Stindt Consultants, is your trusted consulting partner on the Italian Peninsula, offering unparalleled guidance to firms aiming for a successful market entry. With a global team of experts and specialists, our firm is dedicated to demystifying the complexities of the Italian healthcare system, ensuring your products achieve optimal market access. Whether you’re a pharma, biotech or medtech company, our consulting agency stands ready to provide strategic advice on pricing & reimbursement in Italy, ensuring you’re well-positioned for success in this dynamic market. Trust in Justin Stindt Consultants to be your strategic consulting partner in this endeavor.
Italian Healthcare Market Access: Navigating Pricing & Reimbursement Pathways for Innovative Medicines
Early Access Programs in Italy for Innovative Medicines: the Three Key Pathways
In order to enable early access to innovative medicines addressing an unmet need, 3 Italian early access programs are available:
- Law 648/1996: Reimbursed program for a cohort of patients
- Law 326/2003: Reimbursed named patient program
- Compassionate use: Both expanded programs and on a named basis
With the expertise of our consulting agency, Justin Stindt Consultants, we can guide you seamlessly through this process. If you are interested, discover how our agency with its team of experts can provide tailored support for these specific early access pathways in Italy.
AIFA’s Drug Classification System and Pricing Negotiations in Italy’s Healthcare Sector
In Italy, AIFA is the Health Technology Assessment (HTA) body responsible for assessing and classifying medicines. Medicines can be classified as class H, A or C:
- Class H drugs are fully reimbursed, dispensed only in the hospital setting, and they are not available to community pharmacies
- Class A drugs are fully reimbursed and are available through community pharmacies
- Class C drugs are not reimbursed and manufacturers can set a free price.
- Class C(nn): medicines that have a European Marketing Authorization and are in progress or awaiting Italian P&R negotiations (nn stands for non-negotiated)
For reimbursed medicinal products, AIFA also negotiates the prices with pharmaceutical companies. If you are looking for a vendor to understand the Pricing & Reimbursement pathways in Italy, Justin Stindt Consultants is ready to help. We have been selected as supplier by many pharma, biotech and medtech clients looking for a service provider with relevant expertise in Italy.
Finding your way in Italy's regional healthcare system
The Italian Healthcare System can be very complex to navigate given that it is organized in 21 regional health agencies. These regions are responsible for including the drugs in the regional formularies and, therefore, have the power of exclusion.
A medicine can gain extra benefits if it reaches the innovative status in Italy. This enables access to certain benefits such as access to the innovative drugs special funds, exemption from payback mechanisms, and immediate inclusion in the Regional Formularies.
Justin Stindt Consultants can advise you on key decisions that need to be taken to get your medicine on one of these lists and fully reimbursed.
Medical Devices in Italy’s healthcare market
Medical devices are typically directly purchased by the NHS in the context of tender offers governed by the Italian procurement law. There is a positive list of commercialized medical devices introduced by the law 266/2002, however, neither this nor the CE approval guarantees reimbursement by the SSN. Reimbursement decisions are often made on a regional and local level.
Justin Stindt Consultant, as an expert consulting agency, provides strategic advice on pricing & reimbursement pathways for Italian market access.
Our agency offers a strategic assessment of the Pricing & Reimbursement pathways for your asset in Italy. This will include an overview of the available pathways and specific recommendations on which pathway would be optimal for your asset.
If you want to determine the price potential of your product, our team of experts develops Pricing & Reimbursement strategies.
If you have any questions on Pricing & Reimbursement pathways – Italy and you are looking for a service provider in identifying the optimal pathways for your asset, please contact one of our specialists.
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