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1. 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)

2. 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)

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)

4. [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.

5. 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

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. 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)

8. <i>The Reading House</i>: A Children's Book for Emergent Literacy Screening During Well-Child Visits. (Abstract)

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

9. 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)

10. 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)

11. 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)

12. Damoctocog alfa (haemophilia A) - Benefit assessment according to §35a Social Code Book V

Damoctocog alfa (haemophilia A) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Damoctocog alfa pegol (Hämophilie A) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 March 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. A18-86 (...) Damoctocog alfa pegol (haemophilia A) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-86 Version 1.0 Damoctocog alfa pegol (haemophilia A) 27 March 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Damoctocog alfa pegol (haemophilia A) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

13. Emicizumab (haemophilia A) - Benefit assessment according to §35a Social Code Book V

Emicizumab (haemophilia A) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Emicizumab (Hämophilie A) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 June 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. A19-26 Emicizumab (haemophilia (...) A) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-26 Version 1.0 Emicizumab (haemophilia A) 13 June 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Emicizumab (haemophilia A) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 18 March 2019 Internal Commission No.: A19-26

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

14. Lumacaftor/ivacaftor (cystic fibrosis) - Benefit assessment according to §35a Social Code Book V

Lumacaftor/ivacaftor (cystic fibrosis) - 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) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 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. A18-08 Lumacaftor/ivacaftor (cystic fibrosis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-08 Version 1.0 Lumacaftor/ivacaftor (cystic fibrosis) 27 April 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Lumacaftor/ivacaftor (cystic fibrosis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

15. Ipilimumab (melanoma) - Benefit assessment according to §35a Social Code Book V

Ipilimumab (melanoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ipilimumab (Melanom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 9 May 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. A18-12 Ipilimumab (melanoma) – Benefit (...) assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-12 Version 1.0 Ipilimumab (melanoma) 9 May 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ipilimumab (melanoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 15 February 2018 Internal Commission No.: A18-12 Address of publisher

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

16. Dupilumab (atopic dermatitis) - Benefit assessment according to §35a Social Code Book (SGB) V

Dupilumab (atopic dermatitis) - Benefit assessment according to §35a Social Code Book (SGB) V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dupilumab (atopische Dermatitis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 February 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. A17-63 (...) Dupilumab (atopic dermatitis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-63 Version 1.0 Dupilumab (atopic dermatitis) 27 February 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dupilumab (atopic dermatitis) - Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 1 December

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

17. Ivacaftor (cystic fibrosis, 2 years and older, with gating mutations) - Benefit assessment according to §35a Social Code Book V

, childpreschool, benefit assessment, NCT01705145, NCT01946412, NCT02742519, NCT00909532, NCT00909727 Extract of dossier assessment A19-67 Version 1.0 Ivacaftor (cystic fibrosis, 2 years and older, with gating mutations) 28 November 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - iii - Table of contents Page List of tables iv List of abbreviations v 2 Benefit assessment 1 2.1 Executive summary of the benefit assessment 1 2.2 Research question 4 2.3 Information retrieval and study (...) Plattform. 2015 [Accessed: 07.06.2019]. URL: http://apps.who.int/trialsearch. 15. Vertex Pharmaceuticals. A phase 3, 2-arm, roll-over study to evaluate the long-term safety and pharmacodynamics of ivacaftor treatment in pediatric subjects with cystic fibrosis and a CFTR gating mutation: study VX11-770-109; clinical study report [unpublished]. 2016. 16. Rosenfeld M, Cunningham S, Harris WT, Lapey A, Regelmann WE, Sawicki GS et al. An open-label extension study of ivacaftor in children with CF and a CFTR

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

18. Dupilumab (asthma) - Benefit assessment according to §35a Social Code Book V

Dupilumab (asthma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dupilumab (Asthma) – 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. 19-74 Dupilumab (asthma) – Benefit (...) assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-74 Version 1.0 Dupilumab (asthma) 28 November 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dupilumab (asthma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 29 August 2019 Internal Commission No.: A19-74 Address of publisher

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

19. Dupilumab (atopic dermatitis in adolescents) - Benefit assessment according to §35a Social Code Book V

Dupilumab (atopic dermatitis 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 Dupilumab (atopische Dermatitis bei Jugendlichen) – 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. A19-75 Dupilumab (atopic dermatitis in adolescents) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-75 Version 1.0 Dupilumab (atopic dermatitis in adolescents) 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: Dupilumab (atopic dermatitis in adolescents) – Benefit assessment according to §35a Social Code Book V Commissioning

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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