G-BA wants to introduce newborn screening for Type I tyrosinemia by tandem mass spectrometry in the SHI in Germany

31

Oct 2017

Tyrosinemia type I is a genetic disorder due to a defect in the metabolism of the amino acid tyrosine. It is characterized by elevated levels of the amino acid tyrosine in the blood. Symptoms include diarrhea, vomiting, jaundice, failure to thrive and nosebleeds and usually appear during the first few months of life. Tyrosinemia type I can lead to serious damage of the liver, kidney and nervous system as well as an increased risk of liver cancer. The treatment entails a combination of special diet and medication with nitisinone (NTBC). The incidence of the condition in Germany is about 1 per 135,000 newborns. It is inherited in an autosomal recessive manner.

On October 19th 2017, the Joint Federal Committee (G-BA) advocated for the introduction of newborn screening for Type I tyrosinemia using tandem mass spectrometry as a benefit into the German statutory health insurance (SHI). It made a normative decision to add the condition to the list of screenings in the guideline for the early detection of diseases in children.

The guideline for the early detection of diseases in children includes a list of diseases or medical conditions for screening in newborns (§17). The G-BA suggests adding tyrosinemia type I as point 13 on this list and to specify tandem mass spectrometry as the adequate screening method. Treatments and preventive methods included in the guideline are part of the German statutory health insurance and must be reimbursed by the Sickness Funds. The decision was made by the committee of the G-BA that is in charge of method evaluations in the statutory health insurance (SHI) in Germany.

The change will come into effect with the announcement in the Federal Law Gazette. Before this, the Genetic Diagnostics Commission (GEKO) must give written approval of the change of the guideline. This is a regulation by the German Genetic Diagnostics Act (Gendiagnostikgesetz). A patient organization initiated the review process by the G-BA.

The decision by the G-BA and the guideline for the early detection of diseases in children are available in German here.

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24

Oct 2017

In June of 2017, the Ordering Forum RHF commissioned rapid method assessment for the Prosigna test. Only when the Norwegian Institute of Public Health receives documentation from the suppliers they carry out a quick method assessment. On 16th of the October, suppliers were requested to submit data to the Norwegian Institute of Public Health (NIPH) regarding clinical efficacy, safety and economics of Prosigna test.

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11

Oct 2017

German Federal Joint Committee (G-BA) passed directives for co-funded trials to create evidence on two high-intensity focused ultrasound methods that showed potential benefit in the early benefit assessment process in relation to the innovation funding (NUB). Manufacturer refused to cover required contribution to trial costs and thereby risk exclusion of the methods from benefit catalogues in the German social health insurance.

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06

Oct 2017

The Joint Federal Committee (G-BA) resumes assessments of methods that have been intermitted due to missing evidence: LDR brachytherapy in localized prostate carcinoma and PET or PET/CT for malignant lymphomas as well as for interim staging in Hodgkin's lymphoma. Studies conducted in the meantime are expected to provide sufficient evidence base for the assessment about the inclusion of the methods into the social health insurance benefit catalogue in Germany.

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02

Oct 2017

On 25th of September, the Norwegian Decision Forum of “New Methods” had a meeting to review several medical technologies and IVD tests. Decisions were made in relation to the introduction of 2 new newborn screening tests, prehospital emergency thoracotomy, aortic valve replacement using sutureless stent Perceval, and digital breast tomosynthesis.

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29

Sep 2017

After successful trial application by the manufacturer (Okuvision) of a stimulation technology (Okustim), the Federal Joint Committee (G-BA) decided on a trial guideline for a co-funded study defining the key points of the planned study, including type and time period of the study, target population and control intervention. Results from the trial will be evaluated and may lead to reimbursement of the method in both, the inpatient and outpatient sectors.

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27

Sep 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New diagnostic codes cover different indications and analytical methods.

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26

Sep 2017

Too little evidence was available to evaluate the efficacy and safety of liposuction for the treatment of lipedema in the inpatient sector in Germany. However, the Federal Joint Committee (G-BA) regards the method as a potential treatment alternative. It, therefore, plans a co-funded trial in cooperation with the manufacturer to create missing evidence with a start in 2018.

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25

Sep 2017

Ministry of Health will close applications for proposals for inclusion of novel innovative tests into the List of Acts Outside Nomenclature in 2018 (Référentiel des actes Innovants Hors Nomenclatures, RIHN) 3rd of October 2017. RIHN provides early reimbursement for innovative tests, for which value is not yet validated to allow enlisting in the NABM Nomenclature.

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22

Sep 2017

On August 15th, the German Institute of Medical Documentation and Information (DIMDI) published the preliminary version of the new procedure catalogue for the inpatient sector in Germany. The final version of the catalogue will come into effect with the start of the year 2018. MTRC will report about new procedures and other changes included in the catalogue after the release of the official version in the beginning of 2018.

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19

Sep 2017

NHS Improvement together with providers of pathology (laboratory) services in England determined ways to integrate laboratory services to increase efficiency and reduce cost. The final proposal includes integration of pathology services of 105 English hospitals into 29 pathology networks, which would save NHS up to £200m annually.

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12

Sep 2017

On 6th of September, the Joint Federal Committee (G-BA) released announcement for manufacturers of OCT equipment to notify about their devices till 4th of October before G-BA makes the final decision about coverage of the procedure in out-patient settings within statutory health insurance. 

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07

Sep 2017

In 2016, Joint Federal Committee (G-BA) commissioned Institute for Quality and Efficiency in Health Care (IQWIG) for benefit assessment of telemonitoring systems in patients with implantable cardioverter defibrillators (ICD). In July 2017, IQWIG published a preliminary report. Due to lack of evidence, no benefit statement was made.

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24

Aug 2017

G-BA started review process for number of procedures for treatment of benign prostate enlargement in 2009. After publication of the results of rapid health technology assessment by the Institute for Quality and Efficiency in Health Care (IQWiG), G-BA was able to come to the conclusion in June 2017 about efficacy and safety of the thulium laser resection of prostate are well documented and procedure can be covered within statutory health insurance in Germany.

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16

Aug 2017

In the second two weeks of July, the National Institute for Health and Care Excellence published one new (FebriDx for C-reactive protein and Myxovirus resistance protein A testing in primary care) and 3 updated Medtech Innovation Briefings, new Diagnostics Guidance for quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care and three new Interventional Procedures Guidance for laparoscopic insertion of a magnetic titanium ring for gastro-oesophageal reflux disease, transcatheter aortic valve implantation for aortic stenosis and hysteroscopic sterilisation by insertion of intrafallopian implants.

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15

Aug 2017

European Network for health technology assessment (EUnetHTA) is initiating a project on assessment of screening of fetal aneuploidies (trisomy 13, 18 and 21) using non-invasive prenatal test (NIPT) in collaboration with Galician Agency for Health Technology Assessment (AVALIA-T) and Italian HTA agency Regione Emilia-Romagna. Completion of the project is planned to be on 30th of January, 2018 and aimed to evaluate effectiveness and safety of prenatal screening with NIPT, and also to assess organizational, ethical, legal issues and patient outcomes associated with this procedure.

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10

Aug 2017

Article “Cost-utility analysis of bariatric surgery compared with conventional medical management in Germany: a decision analytic modeling” was published in the BMC Surgery. Surgery was found cost-effective at 10-year time horizon and cost saving over life time of operated cohort. Delay in provision of surgery led to reduction of gained health benefits.

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09

Aug 2017

Changes will be made in eleven chapters of Nomenclature. In relation to medical technologies and in-vitro diagnostics, the most important changes include changes in conditions for Stomatology, Radiotherapy and Nuclear Medicine codes, introduction of new codes for IVD tests, including diagnostics of tuberculosis and screening for EGFR mutation.

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03

Aug 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. Several codes were added to both procedural and diagnostic Schedules, including procedures for treatment of knee and hip osteoarthritis, robotic procedure, insertion of wireless pacemaker.

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25

Jul 2017

Reinhard Busse et al. published article “Statutory health insurance in Germany: a health system shaped by 135 years of solidarity, self-governance, and competition” in the Lancet. Article provides valuable insights into history and current state of statutory health insurance system in Germany.

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24

Jul 2017

Hofmann and Gilbert published article exploring potential value of four novel diagnostic tests for clinicians: immunosignature for cancer and infections, breath test for lung cancer, patch vital sign monitoring and biomarkers for Alzheimer’s disease.

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20

Jul 2017

New version 5.0 of the guidance “Allgemeine Methoden” provides basis for the scientific work of the Institute and its external experts. Multiple changes were made to existing sections, several new sections were added as well. Guidance provides brief overview of assessments performed in connection to benefit assessment for high class risk medical technologies, submitted for the innovation funding (NUB) for the first time.

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19

Jul 2017

Researchers evaluated care process, access, administrative efficiency, equity and health care outcomes in 11 countries on the basis of published health care statistics for 72 indicators. The best overall performers among European countries were the UK (ranked 1st), the Netherlands (3rd), Norway (4th), Sweden and Switzerland (6th). Germany (8th) and France (10th) were low in the ranking.

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17

Jul 2017

The NIP test is a non-invasive prenatal test aimed at detecting Down's syndrome in fetus. This test is a screening performed using mother's blood sample from the 12th week of pregnancy. From 1 July 2017, non-invasive prenatal test will be reimbursed for all pregnant women.

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27

Jun 2017

Assessments were directed by national HTA body AGENAS. They cover renal denervation for hypertension, next generation sequencing in oncology, robotic surgery, sling operation for urinary incontinence and vertebral disc replacement.

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16

Jun 2017

In March 2017, G-BA approved two additional indications for application of PET/CT for management of neck and head tumors in hospital settings after reevaluation of evidence by IQWiG in 2016. New indications concern decision making about need for neck dissection and laryngoscopic biopsy.

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14

Jun 2017

Recently the Institute for Quality and Efficiency in Health Care (IQWIG) published final report of evaluation extracorporeal shock wave therapy in patients with heel pain. On 31st of May, the Federal Joint Committee (G-BA) requested manufacturers for notification of their devices for extracorporeal shock wave therapy before final decision will be given.

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09

Jun 2017

Eleven national population screening programmes are implemented in the NHS on the advice of the UK National Screening Committee (UK NSC), which makes independent, evidence-based recommendations to ministers in the 4 UK countries. The Screening Quality Assurance Service ensures programmes are safe and effective by checking that national standards are met. Changes in 2017 are related to KPIs for bowel, breast, and cervical cancer screening.

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08

Jun 2017

Administrators of the “New Method” program, which is focused on managed introduction of innovations into Norwegian system, have initiated technology assessments of 10 technologies and now have requested manufacturers to make submission of clinical and economic evidence.

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30

May 2017

The Institute for Quality and Efficiency in Health Care (IQWIG) published final report of evaluation of extracorporeal shock wave therapy in patients with heel. Results demonstrated benefit of the extracorporeal treatment in comparison with placebo, ultrasound and iontophoresis.

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24

May 2017

In 2016, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to perform evaluation of controlled active motion (CAM) in patients with rupture of the anterior cruciate ligament. The final report of assessment was published on May of 2017. No definite conclusion can be made in relation to comparative efficacy and safety of studied technologies due to lack of evidence.

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19

May 2017

In 2014, Federal Joint Committee (G-BA) commissioned Institute for Quality and Efficiency in Health Care (IQWiG) to conduct health technology assessment of different approaches for lung volume reduction in patients with severe pulmonary emphysema. And now IQWiG has published the final report. The main conclusion is that it was not possible to draw any conclusion about relative effectiveness of bronchoscopic and surgical methods due to lack of the data.

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16

May 2017

Changes will be made in nine chapters of Nomenclature. In relation to medical technologies and in-vitro diagnostics, the most important changes include changes in conditions for two ophthalmology and endoscopy codes, new conditions for reimbursement of photodynamic therapy in dermatology, introduction of two new codes for IVDs, and creating of requirements for reimbursement of number of IVD tests in pregnancy.

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10

May 2017

This post presents an extract from our reimbursement analysis for angioplasty of arteries of lower extremities with stenting using bare metal and drug-eluting stents for peripheral arterial disease in England, France and Germany. Procedure is reimbursed via combination of diagnosis-related group (DRG) and add-on reimbursement in England and France and solely via DRG in Germany.

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09

May 2017

Ludwig Boltzmann Institute - HTA conducted a budget impact analysis on request from the Federal Ministry of Health and Women (BMGF) for testing of TSH as screening for hypothyroidism, urine culture as screening for asymptomatic bacteriuria and ultrasound screening for foetal anomalies.

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04

May 2017

Check out reimbursement summary for the most established transcatheter mitral valve repair procedure in England, France and Germany. Reimbursement is established in Germany and France (for one indication). It is in process to be established in England and in France (for other indications).

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02

May 2017

The Forum of Norwegian payers made decision about introduction of three medical technologies: mechanical thrombectomy for stroke, baroreflex activation therapy for resistant hypertension and non-invasive prenatal testing for detection of trisomy 13, 18 and 21.

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01

May 2017

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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28

Apr 2017

Three mini-HTAs were published since beginning of 2017: procalcitonin for diagnostic of bacterial infections, Per Oral Endoscopic Myotomy (POEM) for achalasia, and use of the Prosigna test (PAM50 ROR) for decisions on adjuvant treatment in breast cancer. These assessments can support introduction of methods at local hospital level in Norway.

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26

Apr 2017

German Federal Joint Committee (G-BA) has released information about results of benefit assessment (in connection to the §137h SGB V) for two methods: catheter-based lung denervation system for COPD and high-intensity focused ultrasound.

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