12/24/2022 0 Comments Atc4 youtube![]() Clawback system: Pharmacy discounts negotiated between the pharmacy and the manufacturer will need to be refunded by the pharmacies to the National Health System. Together with the prescription by active substance, this aims to foster competition among manufacturers and lower prices 3.ħ. Pharmacy substitution: It will become mandatory for pharmacists to dispense the less costly drug, allowing automatic substitution of the originator by generic/biosimilar if needed. Prescription by active substance 2: It will become mandatory for physicians to prescribe by active substance.Īctions related to dispensation of generic and biosimilar drugs:Ħ. Additionally, this price will be based on the originator’s real acquisition price (instead of list price).Īctions related to the prescription of generic and biosimilar drugs:ĥ. originator: Generics and biosimilars’ prices would be fixed to a lower price vs. Lower price for generics and biosimilars vs. The new system would have a reference price group based on the broader ATC-4 classification L04AB, and include drugs for the same indication, such as infliximab drugs (Remicade and its biosimilars), etanercept drugs (Enbrel and its biosimilars), adalimumab drugs (Humira and its bio¬similars), certolizumab drug (Cimzia) and golimumab drug (Simponi).Ĥ. For example, currently infliximab drugs, including the originator (Remicade) and its biosimilars (Inflectra, Zessly, Remsima, Flixabi, etc.) are grouped following ATC-5 classification L04AB02. Reference groups by ATC-4: The Plan would create reference price groups based on ATC-4 drug classification (i.e., chemical subgroup) instead of ATC-5 (i.e., chemical substance). the total sales of the active substance 1.ģ. Dynamic prices: Price of the drugs within an FRP group will be re-negotiated based on volume of original and biosimilar sales vs. These voluntary discounts will not be considered for the reference price recalculation the next year.Ģ. Upon creation of the group, all products (originator and generics/biosimilars) will need to have the same price (reference price), but afterwards, manufacturers can offer discounts. Voluntary discounts within the Fixed Reference Price (FRP) System: Products within the same reference group will no longer be required to have the same price. The key measures proposed in the Plan are the following:Īctions related to P&R setting of generic and biosimilar drugs:ġ. This is expected to lead to an increase in competition among manufacturers and eventually reduce pharmaceutical expenditure. In this context, the Ministry has proposed an Action Plan to promote the use of generic and biosimilar drugs. However, having a sustainable Healthcare System remains a key priority for the Ministry of Health. ![]() ![]() With four general elections and four different Ministries of Health in the last years, the Spanish Healthcare System has needed to adapt to the changing political environment. The key priorities and work streams of the Spanish Ministry of Health are uncertain, due to current political instability in Spain. What are the proposed key measures? And what do manufacturers, physicians, pharmacies, and patients think about the plan? On their mission toward more sustainability, the Spanish Ministry Of Health has recently published an action plan to promote the use of generic and biosimilar drugs. Political instability in Spain rubs off on the healthcare system. Article written by Ana Mozetic, Patricia Lavina, Iñigo Cubillo, and Manuela Martin
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