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1. Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (HIV-infected children) - Benefit assessment according to §35a Social Code Book V

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (HIV-infected children) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Elvitegravir/Cobicistat/Emtricitabin/Tenofovir- alafenamid (HIV-Infektion bei Kindern) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 April 2018). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German (...) original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A18-01 Elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide (HIV-infected children) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-01 Version 1.0 EVG/COBI/FTC/TAF (HIV-infected children) 12 April 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

2. Lumacaftor/ivacaftor (cystic fibrosis in children aged 2 to 5 years) - Benefit assessment according to §35a Social Code Book V

Lumacaftor/ivacaftor (cystic fibrosis in children aged 2 to 5 years) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Lumacaftor/Ivacaftor (zystische Fibrose bei Kindern zwischen 2 und 5 Jahren) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 May 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely (...) authoritative and legally binding. IQWiG Reports – Commission No. A19-13 Lumacaftor/ivacaftor (cystic fibrosis in children aged 2 to 5 years) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-13 Version 1.0 Lumacaftor/ivacaftor (cystic fibrosis in children aged 2 to 5 years) 13 May 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Lumacaftor/ivacaftor

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

3. Vandetanib (medullary thyroid carcinoma in children and adolescents from the age of 5) ? Benefit assessment according to § 35a Social Code Book V

Vandetanib (medullary thyroid carcinoma in children and adolescents from the age of 5) ? Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Vandetanib (Schilddrüsenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 1 June 2017). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally (...) . There are justified doubts about a comparable prognosis between adults versus children and adolescents. These are due to the partly advanced age in the adult population, but also based on the data on overall survival and progression of the disease under vandetanib presented by the company and available from the earlier dossier assessment in adults. In addition, the origin of the disease differed between the populations (mainly sporadic in adults, only hereditary in the paediatric population). Even under

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

5. [Vandetanib (medullary thyroid carcinoma in children and adolescents from the age of 5) - Benefit assessment according to õ 35a Social Code Book V]

[Vandetanib (medullary thyroid carcinoma in children and adolescents from the age of 5) - Benefit assessment according to õ 35a Social Code Book V] Vandetanib (Schilddrüsenkarzinom): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17-01 [Vandetanib (medullary thyroid carcinoma in children and adolescents from the age of 5) – benefit assessment according to § 35a Social Code Book V] Vandetanib (Schilddrüsenkarzinom): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17 (...) -01 [Vandetanib (medullary thyroid carcinoma in children and adolescents from the age of 5) – benefit assessment according to § 35a Social Code Book V] Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Vandetanib

2017 Health Technology Assessment (HTA) Database.

6. The association between baby care books that promote strict care routines and infant feeding, night time care, and maternal-infant interactions. Full Text available with Trip Pro

The association between baby care books that promote strict care routines and infant feeding, night time care, and maternal-infant interactions. Baby care books that promote strict infant care routines are popular but little research has considered their impact upon maternal infant care behaviours. We explored whether mothers who have read these books guide their infant care behaviours based on their concepts, and how this is associated with infant feeding, night time care, and response (...) to infant's needs. Three hundred and fifty-four UK mothers with a baby aged 0-12 months completed an online questionnaire exploring use of baby care books, motivations for use, whether guidance was followed, and infant care behaviours. Mothers who read the books were drawn to them for information about how to settle their infant, infant sleep and infant feeding behaviour. Those who read the books were less likely to breastfeed, feed responsively, have their infant sleep in the same room, cuddle

2019 Maternal & child nutrition

7. The Role of Book Features in Young Children's Transfer of Information from Picture Books to Real-World Contexts Full Text available with Trip Pro

The Role of Book Features in Young Children's Transfer of Information from Picture Books to Real-World Contexts Picture books are an important source of new language, concepts, and lessons for young children. A large body of research has documented the nature of parent-child interactions during shared book reading. A new body of research has begun to investigate the features of picture books that support children's learning and transfer of that information to the real world. In this paper, we (...) discuss how children's symbolic development, analogical reasoning, and reasoning about fantasy may constrain their ability to take away content information from picture books. We then review the nascent body of findings that has focused on the impact of picture book features on children's learning and transfer of words and letters, science concepts, problem solutions, and morals from picture books. In each domain of learning we discuss how children's development may interact with book features

2018 Frontiers in psychology

8. Larotrectinib (solid tumours) - Benefit assessment according to §35a Social Code Book V

next generation sequencing NSCLC non-small cell lung cancer NTRK neurotrophic tyrosine receptor kinase PedsQL Pediatric Quality of Life Inventory RCT randomized controlled trial RECIST Response Evaluation Criteria in Solid Tumours RT-PCR reverse transcriptase polymerase chain reaction SAE serious adverse event SAP statistical analysis plan SGB Sozialgesetzbuch (Social Code Book) SPC Summary of Product Characteristics VAS visual analogue scale Extract of dossier assessment A19-90 Version 1.0 (...) Larotrectinib (solid tumours) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Larotrectinib (solide Tumore mit einer neurotrophen Tyrosin-Rezeptor-Kinase [NTRK]-Genfusion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 January 2020). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

9. Ramucirumab (hepatocellular carcinoma) - Benefit assessment according to §35a Social Code Book V

Ramucirumab (hepatocellular carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ramucirumab (hepatozelluläres Karzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission (...) No. A19-73 Ramucirumab (hepatocellular carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-73 Version 1.0 Ramucirumab (hepatocellular carcinoma) 28 November 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ramucirumab (hepatocellular carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

10. Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V

Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ivacaftor (Kombination mit Tezacaftor/Ivacaftor; zystische Fibrose, ab 12 Jahre, F508del-Mutation, heterozygot) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2019). Please note: This translation is provided as a service (...) by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A19-71 Ivacaftor (combination with tezacaftor/ivacaftor, cystic fibrosis, 12 years and older, F508del mutation, heterozygous) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-71 Version 1.0 Ivacaftor (with TEZA/IVA; CF, from 12 years, F508del mutation, heterozygous) 28 Nov 2019 Institute for Quality

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

11. Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V

Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ivacaftor (Kombination mit Tezacaftor/Ivacaftor; zystische Fibrose, ab 12 Jahre, F508del-Mutation, homozygot) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2019). Please note: This translation is provided as a service (...) by IQWiG to English- language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A19-70 Ivacaftor (combination with tezacaftor/ ivacaftor; cystic fibrosis, 12 years and older, with F508del mutation, homozygous) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-70 Version 1.0 Ivacaftor (with tezacaftor/ivacaftor; CF, 12 years and older, F508del mutation, homozygous) 28 November 2019

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

12. Asfotase alfa (hypophosphatasia) - Benefit assessment according to §35a Social Code Book V

to the patients considered, the studies on asfotase alfa and the data based on medical records had different objects of investigation. None of the 3 studies investigated the outcome category of health-related quality of life. No comparative analyses versus the comparator therapy were available for the outcome category of side effects. Data not relevant for the benefit assessment The company presented different studies on children (aged 5 years and older), adolescents and adults with paediatric-onset HPP (...) added benefit of asfotase alfa versus the ACT BSC for infants (up to 5 years of age) with perinatal or infantile HPP. Further patient groups in the approved therapeutic indication Since the company either submitted no data (infants with juvenile HPP) or submitted no data suitable for a benefit assessment (children [aged 5 years and older], adolescents and adults with perinatal, infantile or juvenile onset of disease) for the other patient groups in the approved therapeutic indication, an added

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

13. Belimumab (SLE) - Benefit assessment according to §35a Social Code Book V

– Commission No. A19-94 Belimumab (systemic lupus erythematosus in children and adolescents) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-94 Version 1.0 Belimumab (systemic lupus erythematosus in children and adolescents) 13 February 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Belimumab (systemic lupus erythematosus in children and adolescents (...) ) – Benefit assessment according to §35a Social Code Book V Commissioning agency Federal Joint Committee Commission awarded on 15 November 2019 Internal Commission No. A19-94 Address of publisher Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Im Mediapark 8 50670 Köln Germany Phone: +49 221 35685-0 Fax: +49 221 35685-1 E-mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A19-94 Version 1.0 Belimumab (systemic lupus erythematosus in children and adolescents) 13

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

14. <i>The Reading House</i>: A Children's Book for Emergent Literacy Screening During Well-Child Visits. Full Text available with Trip Pro

The Reading House: A Children's Book for Emergent Literacy Screening During Well-Child Visits. The American Academy of Pediatrics recommends literacy promotion and developmental assessment during well-child visits. Emergent literacy skills are well defined, and the use of early screening has the potential to identify children at risk for reading difficulties and guide intervention before kindergarten.The Reading House (TRH) is a children's book designed to screen emergent literacy skills (...) . These are assessed by sharing the book with the child and using a 9-item, scripted scoring form. Get Ready to Read! (GRTR) is a validated measure shown to predict reading outcomes. TRH and GRTR were administered in random order to 278 children (mean: 43.1 ± 5.6 months; 125 boys, 153 girls) during well-child visits at 7 primary care sites. Parent, child, and provider impressions of TRH were also assessed. Analyses included Rasch methods, Spearman-ρ correlations, and logistic regression, including covariates age

2019 Pediatrics

15. Influenza: the green book, chapter 19

information on influenza vaccination relating to the benefit of quadrivalent vaccines. 28 August 2015 Clarification regarding asthma and egg allergy; updated background on the decision to extend vaccination to children, the choice of the LAIV vaccine and the benefit of quadrivalent vaccines. 26 August 2015 Extension of the influenza programme to children section has been deleted. 21 May 2015 The flu chapter of the Green Book has been updated to reflect the latest guidance from the Joint Committee (...) Influenza: the green book, chapter 19 Influenza: the green book, chapter 19 - GOV.UK Tell us whether you accept cookies We use about how you use GOV.UK. We use this information to make the website work as well as possible and improve government services. Accept all cookies You’ve accepted all cookies. You can at any time. Hide Show or hide search Search on GOV.UK Search Menu National restrictions in England from 5 November Take action now for new rules in 2021 Guidance Influenza: the green book

2020 Public Health England

16. Governance responsibilities for patients who do not attend booked appointments in Emergency Departments

to attend emergency departments but did not follow this advice. This did not need any attempts to follow up patients or perform welfare checks. Patients had been given advice, and simply exercised their right not to follow this advice. The patient group who are giving booked appointments are the same. There are some special cases where non-attendance at a booked appointment may indicate additional concerns. This might include a patient with a mental health crisis or a child where there is a sustained (...) Governance responsibilities for patients who do not attend booked appointments in Emergency Departments Governance responsibilities for patients who do not attend booked appointments in Emergency Departments October 2020 Patron: HRH Princess Royal 7-9 Bream’s Buildings Tel +44 (0)20 7404 1999 London Fax +44 (0)20 7067 1267 EC4A 1DT www.rcem.ac.uk RCEM Position Statement Governance responsibilities for patients who do not attend booked appointments in Emergency Departments October 2020

2020 Royal College of Emergency Medicine

17. Melatonin (sleep disorders) - Benefit assessment according to §35a Social Code Book V

Psychotherapie. Nichtorganische Schlafstörungen (F51) [online]. 07.2018 [Accessed: 17.01.2019]. URL: https://www.awmf.org/uploads/tx_szleitlinien/028- 012l_S1_Nichtorganische_Schlafstoerungen_2018-07.pdf. 4. Nunes ML, Bruni O. Insomnia in childhood and adolescence: clinical aspects, diagnosis, and therapeutic approach. J Pediatr 2015; 91(1): 26-35. 5. Vriend JL, Corkum PV, Moon EC, Smith IM. Behavioral interventions for sleep problems in children with autism spectrum disorders: current findings and future (...) authoritative and legally binding. IQWiG Reports – Commission No. A19-04 Melatonin (Insomnia in children and adolescents with autism spectrum disorder and/or Smith-Magenis syndrome) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-04 Version 1.0 Melatonin (Insomnia in children and adolescents with ASD and/or SMS) 11 April 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

18. Glecaprevir/pibrentasvir (chronic hepatitis C in adolescents) - Benefit assessment according to §35a Social Code Book V

AE adverse event G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) GLE glecaprevir HCV chronic hepatitis C virus IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) LDV ledipasvir PedsQL Pediatric Quality of Life Inventory PIB pibrentasvir RBV ribavirin RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SOF sofosbuvir SVR sustained virologic response SVR12 sustained (...) Glecaprevir/pibrentasvir (chronic hepatitis C in adolescents) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Glecaprevir/Pibrentasvir (chronische Hepatitis C bei Jugendlichen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 July 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

19. Lisdexamfetamine (ADHD) - Benefit assessment according to §35a Social Code Book V

Lisdexamfetamine (ADHD) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Lisdexamfetamindimesilat (Aufmerksamkeitsdefizit- Hyperaktivitätsstörung bei Erwachsenen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 July 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding (...) . IQWiG Reports – Commission No. A19-40 Lisdexamfetamine dimesylate (attention deficit/hyperactivity disorder in adults) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-40 Version 1.0 Lisdexamfetamine dimesylate (ADHD in adults) 30 July 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Lisdexamfetamine dimesylate (attention deficit/hyperactivity

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

20. Ivacaftor (cystic fibrosis, 6 years and older, with G551D mutation) - Benefit assessment according to §35a Social Code Book V

Ivacaftor (cystic fibrosis, 6 years and older, with G551D mutation) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ivacaftor (zystische Fibrose, ab 6 Jahre, mit G551D-Mutation) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative (...) and legally binding. IQWiG Reports – Commission No. A19-65 Ivacaftor (cystic fibrosis, 6 years and older, with G551D mutation) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-65 Version 1.0 Ivacaftor (cystic fibrosis, 6 years and older, with G551D mutation) 28 November 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ivacaftor (cystic fibrosis, 6

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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