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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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Current status of disease management program for type 2 diabetes in Germany

Disease management programs (DMPs) should be updated on a regular basis in order to adapt them to the current medical knowledge level. The Institute for Quality and Efficiency in Health Care (IQWiG) has thus researched current evidence-based guidelines on diabetes mellitus type 2, summarized their recommendations and checked the need for DMP update.

The core statements (a total of 1802 recommendations) for the report were extracted from 35 evidence-based guidelines, published during the last 5 years by various European and international entities.

The following aspects of care were analyzed:

  • Diagnostics (initial diagnosis)
  • Treatment of diabetes mellitus type 2
  • Basic therapy
  • Blood glucose lowering medication therapy
  • Treatment of hyper- and hypoglycemic metabolic disorders
  • Concomitant and secondary diseases of type 2 diabetes mellitus
  • Pregnancy in pre-existing diabetes mellitus type 2
  • Cooperation of care sectors
  • Training of insured persons.

The main results of the analysis included:

  • The guidelines of the American Association of Clinical Endocrinologists (AACE) 2015, American Diabetes Association (ADA) 2018, American Optometric Association (AOA) 2014, Canadian Diabetes Association (CDA) 2018 and European Renal Best Practice (ERBP) 2015 recommend avoiding increasingly severe hypoglycemia and making appropriate drug choices, e.g., to prescribe fewer sulfonylureas
  • The guidelines AACE 2015, CDA 2018, and Scottish Intercollegiate Guidelines Network (SIGN) 2017 Management recommend performing a medical examination before patients with diabetes mellitus and a sedentary lifestyle begin sports activities. The guideline ADA 2018 advises all adults to exercise regularly; the guideline CDA 2018 also recommends that elderly patients with diabetes mellitus integrate regular exercise into their everyday lives, claiming that even smaller activities may be beneficial for glycemic control
  • Depression is mentioned in the Disease Management Program Requirement Directive (DMP-Anforderungen-Richtlinie, DMP-A-RL), in section 1.7.5 "Mental comorbidities" (sentence 4). An international study (Lloyd CE, 2018) indicates that depressive moods and depression itself are common in patients with type 2 diabetes mellitus: about 10% of patients in this study were diagnosed with major depression and another 17% reported depressive moods. There is also evidence that chronic diseases, such as diabetes mellitus, which are accompanied by depression, are associated with increased mortality. The guidelines AACE 2018, ADA 2018 and SIGN 2017 Management recommend regular screening for depression for the patients mentioned
  • The guidelines ADA 2018, CDA 2018, the International Working Group on the Diabetic Foot (IWGDF) 2015 Peripheral artery disease (PAD), National Institute for Health and Care Excellence (NICE) 2015 Foot, SIGN 2017 Management and the American Department of Veterans Affairs and the Department of Defense (VADoD) 2017 recommend the transfer of patients with severe “foot findings” (non-healing ulcers or massive peripheral circulatory disorders, and thus imminent amputations) to special facilities for further clarification and treatment. This substantially corresponds to the requirements of the DMP-A-RL. In the German Health Report Diabetes 2018, Lawall states a total of approximately 39,000 amputations annually for Germany. The number of high amputations has been decreasing since 2005, but with timely adequate care, many amputations could be avoidable
  • The guidelines included in the report usually recommend groups of various antidiabetic drugs or their combinations. Only occasionally for specific indications of individual drugs, e.g., metformin, empagliflozin, or liraglutide, are explicitly recommended; these active substances mentioned as examples are already contained in the DMP-A-RL. In contrast, newer agents, e.g., ertugliflozin or its combination with other antidiabetics or more recent study results on clinical endpoints (e.g., the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) study) have not yet been included in the guidelines
  • No recommendations were available regarding polypharmacy (concurrent use of multiple medications by a patient). However, avoiding drug interactions with a daily intake of 5 or more active ingredients with corresponding associated adverse effects would be desirable
  • Training of insured persons is provided by the DMP-A-RL, section 4.2. The guidelines AOA 2014, CDA 2018, and NICE 2015 recommend training oriented towards the needs of patients with diabetes mellitus. This includes repeated self-management training that can improve outcomes such as the HbA1c value and reduce hospitalization rates.

Therefore, IQWiG identified a need for revision for most of the DMP cornerstones. This applies to the "blood glucose lowering drug therapy" as well as to "concomitant and secondary diseases" of type 2 diabetes. The only exception is the "Diagnostics (initial diagnosis)."

IQWiG could not comment on "Special Measures in Polypharmacy.” On average, the patients enrolled in the DMP are 68 years old and usually have a whole range of other diseases also treated. Often, they receive a combination of drugs that may have problematic interactions, especially in older people. However, the guidelines do not adequately cover this problem.

As in diabetes mellitus type 1, the consequences of hypoglycemia have now come to the fore in the guidelines for diabetes type 2 as well. In DMP they are already subject though, albeit less prominent. There is another analogy to type 1 diabetes: according to the guidelines, technical aids for the control and regulation of blood sugar levels, such as continuous glucose monitoring (CGM), can also be recommended for type 2 diabetes. This is not included in the DMP guidelines to date.

Patient education has long been an integral part of DMP type 2 diabetes. However, there are hardly any content and time requirements presented. Recent guidelines emphasize now that such training would focus on the needs of patients. This includes repeated training for self-management, possibly to achieve HbA1c values improvement and to reduce unplanned hospital admissions.

The preliminary results are now available. Accordingly summarizing the IQWiG preliminary conclusions, almost all aspects of the DMP should or could be revised. However, the guidelines do not adequately reflect all issues that are important for patient care. Until June 5, interested parties can comment on the preliminary report, presented by IQWiG.

The full details in German can be found here.

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