Manual Kleine Mitsu (German Edition)

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A total of 94 guidelines were reviewed. Thirty four guidelines covered oncological conditions i. For the remaining guidelines, the G-BA documentation was analyzed as the documents were no longer available. However, ratings were not consistent across guidelines. For gaxilose metabolic diseases and microbial collagenase musculoskeletal disorders no guidelines could be identified both by the G-BA and at the time of this analysis.

For the benefit assessment of bromfenac ophthalmic diseases , no systematic literature search was conducted by the G-BA. Instead, guidelines used for a German HTA rapid report in the relevant indication were used for this analysis [ 23 ]. Aliskiren is recommended within clinical guidelines both as monotherapy and in combination with other antihypertensives. However, the fixed combination of aliskiren and amlodipine that was appraised by the G-BA is not covered within the guidelines. Guidelines suggest the therapeutic class NSAID in the perioperative period in cataract surgery, but do not specify any medicine.

Guidelines strongly support the use of preservative-free medicines if there is evidence that patients are allergic to the preservative, but do not specify any medicine. Guidelines evolved over time. Basal insulin analogues are recommended within guidelines. Within that class, insulin degludec is one option. Lomitapide and other new therapeutic options are part of the suggested treatment algorithm in patients with homozygous familiar hypercholesterolemia.

Only one updated guideline is available [ 28 ]. Guidelines generally recommend second generation antipsychotic drugs, but the evidence base for appropriate comparisons is considered limited. Guidelines evolved over time and included mirabegron as second-line treatment [ 31 ]. Guidelines are heterogeneous [ 44 ] and partially not updated, e.

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Retigabine is recommended as adjunctive second line treatment [ 32 ]. Sipuleucel-T is recommended by various guidelines in patients with metastatic prostate cancer and asymptomatic or minimally symptomatic disease. Guidelines generally recommend phosphate binding agents but do not specify any medicine. Only one guideline from is available [ 35 ].

Living larvae considered superior versus hydrogel therapy in terms of wound cleansing. Its aim was to manage prices and total public expenditure of pharmaceutical products [ 24 ].


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In order to achieve this, a link between the reimbursed price of newly approved drugs and the additional benefit that they offer is stipulated. Clinical guidelines, on the other hand, are focused on treatment options for patients. Considering the different goals of G-BA appraisals and clinical guidelines, it is not necessarily contradictory that a medicine is recommended within a guideline while being assessed as having no additional benefit by the G-BA. An obvious heterogeneity between guideline recommendations and G-BA appraisals occurred in diabetes.

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The critical approach to widely accepted primary clinical trial outcomes by the G-BA is an example of a fundamental difference of German HTA appraisals and more clinically centered guidelines. Several of the 22 medicines such as linaclotide [ 28 ], lomitapide [ 29 ], lurasidone [ 30 ], mirabegron [ 31 ], retigabine [ 32 ], and regorafenib [ 33 , 34 ] are recommended as later -line treatments in their respective disease area. While each of these medicines has to be considered individually, the unavailability of later-line treatment options generally carries a risk of suboptimal care, particularly in patients with advanced conditions.

In some therapeutic areas, guidelines primarily support a class of products rather than specific medicines: nonsteroidal anti-inflammatory drugs are recommended for the postoperative management in cataract surgery, preservative-free medicines are supported for the subset of glaucoma patients allergic to preservatives, and phosphate binding medicines are recommended for the treatment of hyperphosphatemia.

Furthermore, unavailable medicines that are specifically recommended in clinical guidelines might potentially be substituted by other medicines as long as comparators from the same class with similar product characteristics are available. In addition to the inconsistencies between G-BA appraisals and guideline recommendations, our review also revealed major heterogeneities across guidelines.

In contrast, 20 guidelines covered prostate cancer, 9 of which had included specific recommendations for sipuleucel-T in patients with asymptomatic metastatic prostate cancer prior to the withdrawal of the medicine due to bankruptcy of the manufacturer [ 36 ]. Heterogeneity between guidelines can partially been explained by different standards of care across various countries.

However, in contrast to HTA appraisals that are automatically initiated upon availability of an innovative medicine, clinical guidelines are often characterized by a lack of timely renewal and therefore may not always be up to date with the most recent developments.

In contrast to e. Withdrawal from the market is particularly painful if a high utilization of the medicine had already occurred. The epilepsy treatment perampanel is considered a useful treatment option for patients with drug-resistant disease due to its unique mechanism of action [ 39 ]; moreover, the product is one of the few anticonvulsants with an explicit approval for use in adolescents above the age of 12 [ 15 ].

At the time of market withdrawal, more than 5. Also, when Novo Nordisk withdrew its basal insulin analogue insulin degludec from the German market in January , health care professionals were asked to switch the approximately Diabetes experts considered this mandated therapy change to the disadvantage of patients, as insulin degludec offers a unique safety profile and a longer half-life [ 41 ].

Interestingly, it has to be noted that there are several medicines that were re-introduced into the market after the initial withdrawal decision by the pharmaceutical manufacturer. For three medicines bosuitinib, pitavastin, and dapagliflozin the re-entry occurred within the time frame of our analysis cut-off June 1st Also, ataluren, the only orphan medicine to be withdrawn from the market, as well as mirabegron, linaclotide, and perampanel, were reintroduced later on. An analysis of the reasons why the involved companies decided to withdraw the medicines e. Our analysis compares HTA appraisals and clinical guidelines only.

The determination of the appropriate comparative therapy within the G-BA procedures also includes systematic reviews and Cochrane reviews. Including those additional sources of evidence in this comparative analysis is therefore part of the future research agenda. An in-depth comparison of clinical guidelines, the recommendations for the various treatment lines and the rating systems of the guidelines is part of the upcoming research agenda.

Our analysis revealed considerable differences across clinical guidelines, as well as between clinical guidelines and HTA appraisals, for the medicines that were withdrawn from the German market. Better alignment of the clinical perspective in the determination of future treatment algorithms and close collaboration between all involved parties G-BA, IQWiG, physician associations, and patient representatives is required to achieve and maintain optimization of patient care in an increasingly HTA-shaped clinical environment.

Epidermal growth factor receptor. European Medicines Agency.

Health Technology assessment. National Institute for Health and Care Excellence. As explained in the manuscript all data are available in the public domain. Sources are referenced in the methods section. All authors participated in the writing of the manuscript. All authors read and approved the final manuscript. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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Health Economics Review 8 Methods Medications withdrawn from the German market between January and June following benefit assessment were categorized as opt-outs max. Results Among medications, 10 opt-outs and 12 supply terminations were identified. Conclusion Our analysis revealed considerable differences across clinical guidelines as well as between clinical guidelines and HTA appraisals of the medicines that were withdrawn from the German market.

Therapeutic areas All therapeutic areas were included. Benefit assessments Details on the benefit assessments including date of decision, extent of granted additional benefit, and reason for no additional benefit, if applicable, were obtained from the G-BA database [ 15 ]. Arbitration procedures Medications that underwent the arbitration procedure were extracted from a recent publication [ 5 ]. Approval and withdrawal dates The date of approval by the European Medicines Agency EMA was extracted from the database of European public assessment reports [ 16 ]. Guideline recommendations The G-BA chooses the appropriate comparative therapy for the benefit assessment based on, among other factors, relevant literature and guidelines identified in a systematic literature search prior to the assessment according to the G-BA Rules of Procedure, par.

Recommendation status was assessed as follows: Medications, or their class, were defined as recommended if at least one of the identified guidelines issued a positive recommendation, i. You must provide copyright attribution in the edit summary accompanying your translation by providing an interlanguage link to the source of your translation. A model attribution edit summary using German : Content in this edit is translated from the existing German Wikipedia article at [[:de:Exact name of German article]]; see its history for attribution.

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