OBJECTIVES: Discussions on pricing and reimbursement (P&R) conditions have become increasingly common in Spain due to budget constraints. This research aims to analyze national P&R conditions for innovative pharmaceutical products agreed in the last 5 years to estimate the P&R trends in Spain.

METHODS: We analyzed the number and type of P&R conditions applied to new pharmaceutical products (excluding generics and biosimilars) reimbursed in Spain between June 2017 and May 2022. The Spanish database on products funding (BIFIMED) was used to identify new products reimbursed. Separate analyses were conducted for biologic and orphan products.

RESULTS: We identified 2,008 reimbursed products. A number of approvals stipulated specific P&R conditions; 291 (14.5%) reported ≥ 1 and 105 (5.2%) reported 2-6. Over the 5-year period, there was an increase in the percentage of products with ≥ 1 conditions (12.5% in year 1 vs. 23.9% in year 5) and with ≥ 2 conditions (4.8% in year 1 vs. 12.7% in year 5). The most common conditions were sales follow-up (93.8%; 273/291) and clinical protocols (23.0%; 67/291). Outcomes-based agreements (16.5%; 48/291), price-volume agreements (13.1%; 38/291), and expenditure caps per patient (9.6%; 28/291) were also relatively common. Over the 5-year period, 292 reimbursed products were biologics and 121 were orphan. Up to 42.5% (124/292) of the biologics and 76.0% (92/121) of the orphan products had ≥ 1 condition. The number of biologics and orphans with ≥ 1 condition grew consistently between years 1 and 5: for biologics from 21.7% to 74.4% and, for orphans, from 47.3% to 92.3%.

CONCLUSIONS: The frequency of P&R conditions in Spain has grown consistently over the last 5 years. Over the last year, conditions were applied to almost all orphans and to most biologics. Understanding the conditions applied to other products can help drive P&R negotiation with the Ministry of Health.

ISPOR Europe 2022

6 - 9 November

Posters

Clinical Outcomes

No Additional Disease & Conditions/Specialized Treatment Areas

SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory)

SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)

SDC: Gastrointestinal Disorders

SDC: Geriatrics

SDC: Injury & Trauma

SDC: Mental Health (including addition)

SDC: Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)

SDC: Neurological Disorders

SDC: Oncology

SDC: Rare & Orphan Diseases

SDC: Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)

SDC: Urinary/Kidney Disorders

STA: Biologics & Biosimilars

STA: Drugs

STA: Medical Devices

STA: Nutrition

STA: Personalized & Precision Medicine

STA: Surgery

Economic Evaluation

No Additional Disease & Conditions/Specialized Treatment Areas

SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory)

SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)

SDC: Gastrointestinal Disorders

SDC: Geriatrics

SDC: Infectious Disease (non-vaccine)

SDC: Injury & Trauma

SDC: Mental Health (including addition)

SDC: Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)

SDC: Neurological Disorders

SDC: Oncology

SDC: Pediatrics

SDC: Rare & Orphan Diseases

SDC: Reproductive & Sexual Health

SDC: Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)

SDC: Sensory System Disorders (Ear, Eye, Dental, Skin)

SDC: Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)

SDC: Urinary/Kidney Disorders

STA: Biologics & Biosimilars

STA: Drugs

STA: Generics

STA: Genetic, Regenerative & Curative Therapies

STA: Medical Devices

STA: Nutrition

STA: Personalized & Precision Medicine

STA: Surgery

STA: Vaccines

Epidemiology & Public Health

No Additional Disease & Conditions/Specialized Treatment Areas

SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory)

SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)

SDC: Gastrointestinal Disorders

SDC: Geriatrics

SDC: Infectious Disease (non-vaccine)

SDC: Injury & Trauma

SDC: Mental Health (including addition)

SDC: Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)

SDC: Neurological Disorders

SDC: Oncology

SDC: Pediatrics

SDC: Reproductive & Sexual Health

SDC: Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)

SDC: Sensory System Disorders (Ear, Eye, Dental, Skin)

SDC: Urinary/Kidney Disorders

STA: Drugs

STA: Generics

STA: Medical Devices

STA: Surgery

STA: Vaccines

Health Policy & Regulatory

No Additional Disease & Conditions/Specialized Treatment Areas

SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory)

SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)

SDC: Oncology

SDC: Rare & Orphan Diseases

SDC: Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)