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Core value dossiers for medical technologies

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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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Med Tech-related technology assessments and clinical guidelines from NICE in December 2022

Medical Technologies Guidance (MTG) evaluates new, innovative medical devices and diagnostics. It looks at medical technologies that deliver treatment, like those implanted during surgical procedures, give greater independence to patients, or detect or monitor medical conditions.

In December 2022, NICE issued one new MTG on Memokath 051 Ureter stent for ureteric obstruction. NICE recommended Memokath 051 as an option to manage ureteric obstruction in adults with:

  • Malignant ureteric obstruction and anticipated medium- or long-term survival after adjunctive therapy;
  • Benign ureteric obstruction who cannot have or does not want reconstructive surgery;
  • Any type of ureteric obstruction and they cannot have or do not want a double‑J stent, or when repeat procedures are particularly high risk.

NICE concluded that there is enough clinical evidence to continue recommending Memokath 051 for selected adults with ureteric obstruction. But prospective data is still needed to be collected about the cost savings of using it, compared with other stents.

The MedTech Innovation Briefings (MIBs) is the advice program of NICE for innovative technologies. It provides an overview of clinical effectiveness, safety, and cost. It does not offer formal guidance, and it, therefore, does not provide any recommendations.

One new MIB was published in December 2022 on PromarkerD for predicting the risk of diabetic kidney disease in people with type 2 diabetes. The test combines three biomarkers measured by immunoassay (ApoA4, CD5L, and IGFBP3) with three routine clinical factors (age, high-density lipoprotein-cholesterol, and estimated glomerular filtration rate). Using an algorithm, the test generates a prognostic risk score for a person developing diabetic kidney disease up to four years in advance.

Two new clinical guidelines were published in December 2022:

  • Fetal monitoring in labor;
  • Thyroid cancer: assessment and management, which provides recommendations for the assessment using ultrasound imaging, radioisotope scans, blood tests, fine-needle aspiration cytology (FNAC) and/or core-needle biopsy, molecular testing, CT, MRI, different treatment options, including surgery, radioactive iodine, and external beam radiotherapy.

One clinical guideline on intrapartum care for healthy women and babies was updated in December 2022. NICE withdrew the recommendations on monitoring during labor because they have been replaced by the NICE guideline on fetal monitoring in labor.

See the full details for guidance here and for MedTech Innovation Briefings here.

This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Contact us to get a free, three-month, no-obligation trial.