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Evidence gap analysis

Strategic analysis of the sufficiency of evidence to obtain reimbursement and HTA approval in Europe and recommendations about evidence generation

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Reimbursement summary for angioplasty of arteries of lower extremities

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.
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Updates in the Spanish Common Package of Benefits

On June 19, 2024, the Order SND/606/2024, of June 13, came into force. This Order, among other things, amends Annexes I, II, III, VI, and VII of Royal Decree 1030/2006, of September 15, which establishes the Common Package of Benefits of the National Health System and the procedure for its update. The changes mostly concern in-vitro diagnostics, ENT, pulmonary and airways, cardiovascular, and some other fields.

Some examples of changes are provided below:

  • Four more diseases are added to the neonatal screening program for endocrine-metabolic diseases: biotinidase deficiency, maple syrup urine disease, homocystinuria, congenital adrenal hyperplasia;
  • The prenatal screening program for infectious diseases is implemented:
    • All pregnant women should be offered screening for syphilis, HIV, hepatitis B and group B Streptococcus;
    • Prenatal screening for hepatitis C infection, Zika virus disease, and Chagas disease will be offered to pregnant women who belong to the risk groups established for each of them;
    • Rubella screening will be offered in pregnant women who lack proven evidence of vaccination;
    • Chickenpox screening will be offered to pregnant women without a history of chickenpox or shingles and who lack proven evidence of vaccination;
  • The prenatal screening program for chromosomal abnormalities is implemented, including:
    • Combined test of the first trimester consisting of a biochemical test with the determination of PAPP-A (glycoprotein synthesized in the trophoblast) and βhCG (free beta fraction of human chorionic gonadotropin) and an ultrasound test for the measurement of nuchal translucency (NT);
    • Circulating free fetal DNA test in maternal blood as a contingent or second-line prenatal screening test in a situation in which the risk of fetal trisomy on chromosomes 21, 18, or 13 is increased. This test will be limited to the detection of fetal trisomies on chromosomes 21, 18, or 13;
  • The population-based neonatal screening program for hearing loss is specified. The target population includes all newborns. Screening tests are automated otoacoustic emissions and/or automated auditory brainstem evoked potentials. These are to be carried out before the end of the first month of life;
  • Percutaneous mitral valve repair system with clip and endobronchial valves are kept in the Common Package of Benefits of the National Health System under the same conditions as the ones set out in the monitoring study protocols;
  • The expansion of the common package of oral health services. It will be carried out progressively, having prioritized the child and adolescent population, pregnant women, people with disabilities, and people diagnosed with oncological processes in the cervicofacial region.

See the full details in Spanish here.

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.