The P&R landscape of Orphan Drugs in Spain
Spanish reimbursement evaluation criteria of Orphan Drugs (ODs) are the same as for any other innovative drug and are defined in the Royal Decree 1/2015 of 24 July of the Law on Guarantees and Rational Use of Medicines and Healthcare Products1:
- Severity, duration, and after-effects of the different pathologies for which they are indicated.
- Unmet needs of specific populations.
- Therapeutic and social value of the drug and its incremental clinical benefit, considering its cost-effectiveness ratio.
- Rationalization of public spending for pharmaceutical services and budget impact on the National Health System.
- Existence of drugs or other therapeutic alternatives for the same conditions at a lower price or lower cost of treatment.
- Degree of innovation of the drug.
In this report, developed by Omakase Consulting in collaboration with the ObserveMHe platform, Omakase analyses the Pricing and Reimbursement situation in Spain of ODs approved by the European Commission until 2021 (included), their administrative timelines & the existence of variables that could influence P&R decisions in Spain.
Key takeaways of the report:
- Out of the 128 ODs approved by the European Commission, 111 (86,7%) ODs had been granted marketing authorisation in Spain. Out of the 111 ODs that had been granted marketing authorisation in Spain, 57 (51,4%) had received P&R approval, 24 (21.6%) were undergoing the P&R process, and 30 (27%) had their P&R request rejected.
- Since the inclusion of the Therapeutic positioning Report (a document issued by the Spanish Agency of Medicines that determines a new drug’s relative positioning to what constitutes standard of care for the same indication to inform P&R decisions in Spain; TPR) the mean time from Spanish marketing authorization to P&R decision was 18,2 months, with a minimum of 3 months and a maximum of 50 months.
Variables that would influence P&R decisions in Spain are:
- Therapeutic area: ODs indicated for oncology diseases, compared to other therapeutic areas, would be more likely to be reimbursed in Spain.
- Rarity of disease: ODs indicated for ultra-rare diseases would be more likely to be reimbursed in Spain.
- TPR conclusion: ODs with a positive TPR conclusion would be more likely to be reimbursed in Spain.
- Conditional approval: ODs without conditional approval would be more likely to be reimbursed in Spain.
Follow the link to download the report:
- Real Decreto Legislativo 1/2015, de 24 de julio, por el que se aprueba el texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios. Boletin Oficial del Estado, no 177 (25 de julio de 2015). Available at: https://www.boe.es/buscar/act.php?id=BOE-A-2015-8343