Table 1

Positive reimbursement decisions in reports with suboptimal evidence of effectiveness; arguments that advocated for the acceptance of the available suboptimal evidence

InterventionArguments that advocated for the acceptance of the available suboptimal evidence‡
I. Metal on metal (MoM) resurfacing arthroplasty of the hip for patients with primary or secondary osteoarthritis*10
  • Technique has already been used for approximately 10 years

  • Patients will probably not participate in a randomised study given the available data

  • Availability of lower level evidence of effectiveness (comparative studies, short to medium term)

II. Preimplantation genetic diagnosis (PGD) to predict β-thalassaemia in second child with human leucocyte antigen (HLA) typing during PGD for stem cell transplantation11
  • PGD as a technique has been proven effective in predicting other diseases

  • It is unfeasible to perform comparative studies on the use of PGD to predict β-thalassaemia

  • It is unfeasible to perform comparative studies of HLA typing

III. Potassium-titanyl-phosphate (KTP) laser treatment for patients with lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia†12
  • (Double)-blinding is unfeasible in comparing KTP laser treatment with transurethral resection of the prostate (TURP) for patients with a mildly enlarged prostate (surgical intervention)

  • Technique is already frequently used

  • Patients will probably not participate in a randomised study

  • No alternative treatment if drugs provide no adequate relief (for high-risk patients or patients being treated with anticoagulants)

  • Availability of lower level evidence of effectiveness and safety (only non-comparative studies for high-risk patients)

IV. Transcatheter pulmonary valve implantation (TPVI) for patients with an abnormal pulmonary valve due to a congenital heart defect13
  • (Double)-blinding is unfeasible in comparing TPVI with surgical pulmonary valve replacement

  • Rare condition; only 30 patients are eligible for percutaneous pulmonary valve implantation in the Netherlands per year

  • Safety concerns seem limited regarding percutaneous pulmonary valve implantation, particularly in comparison to open cardiac surgery

  • Availability of lower level evidence of effectiveness and safety, case series showed good short-term success rates

V. Proton therapy for patients with intraocular tumours, chordomas and chondrosarcomas, and paediatric tumours14
  • Side effects are rare and mostly happen (many) years later, and the purpose of the therapy, in particular, is to reduce or prevent late side effects (instead of to prove effectiveness)

  • Rare conditions

  • Technique is already frequently used and there is international consensus between radiation therapists and oncologists

  • Availability of lower level evidence of effectiveness (mainly case series)

  • *This intervention complied with medical science and medical practice, according to the Dutch National Health Care Institute (ZIN), for patients with primary or secondary osteoarthritis who failed on conservative treatment, or patients younger than 65 years of age with a sufficient level of activity. However, in January 2012, this advice was changed in line with the advice of the Netherlands Orthopaedic Association, based on new national and international published experiences, to not place large-head MoM hip implants and MoM resurfacing implants.

  • †This intervention complied with medical science and medical practice, according to ZIN, for patients with a mildly enlarged prostate, high-risk patients or patients being treated with anticoagulants.

  • ‡Essential arguments are shown in bold.