A study of value transitions in the basal insulin regimen for treatment of type 2 diabetes

• Main Author: Gludsted, Emil Brohl
• Other Authors: Prado Júnior, Sérvio Túlio
• Language: English
• Published: 2016
• Subjects: Value; Insulin; Glargine; Pharmaceutical; Differentiation; Biosimilar; Prices; Risk-sharing; Insulina; Valor; Diabetes; Farmacêuticos; Compartilhamento de riscos; Glargina; Diferenciação; Preços; Ciência política; Diabetes - Tratamento; Insulina - Preços; Medicamentos - Aspectos econômicos; Indústria farmacêutica
• Online Access: http://hdl.handle.net/10438/17639

Submitted by Emil Gludsted ([e-mail]) on 2016-12-19T21:20:10Z No. of bitstreams: 1 MPGI Thesis - Emil Brohl Gludsted - Dec'19 2016 vf.pdf: 3020698 bytes, checksum: 358ae13dcfdff17ec0c5c1b1a639c91d (MD5) === Rejected by Josineide da Silva Santos Locatelli ([e-mail]), reason: Dear Emil, The pages before introduction must to be considered, however, but they can’t appear (example, if there were 8 pages before introduction, then the first page to be numbered is 9 – Introduction), The epigraph must to be before the abstract. on 2016-12-20T10:49:17Z (GMT) === Submitted by Emil Gludsted ([e-mail]) on 2016-12-20T19:52:24Z No. of bitstreams: 2 MPGI Thesis - Emil Brohl Gludsted - Dec'19 2016 vf.pdf: 3020698 bytes, checksum: 358ae13dcfdff17ec0c5c1b1a639c91d (MD5) MPGI Thesis - Emil Brohl Gludsted - Dec'20 2016 vf.pdf: 2957721 bytes, checksum: 148202567b3f2d2bd77107e5c9ea53ac (MD5) === Rejected by Josineide da Silva Santos Locatelli ([e-mail]), reason: Emil, There was just two change to do, but the thesis is the same way. All the pages must to be considerated, but the numbers must to start (appear) in the introduction. So, if your work has 11 pages before the introduction, the number on the introduction must to be 12. The epigraph must to be before the abstract, the sequence is: epigraph, abstract and resumo. on 2016-12-21T11:15:58Z (GMT) === Submitted by Emil Gludsted ([e-mail]) on 2016-12-21T12:26:05Z No. of bitstreams: 1 MPGI Thesis - Emil Brohl Gludsted - Dec'21 2016 vf.pdf: 2957630 bytes, checksum: 1ff24b2e9893e6d5bdcb3d6f7e5f5f9e (MD5) === Approved for entry into archive by Josineide da Silva Santos Locatelli ([e-mail]) on 2016-12-21T13:52:43Z (GMT) No. of bitstreams: 1 MPGI Thesis - Emil Brohl Gludsted - Dec'21 2016 vf.pdf: 2957630 bytes, checksum: 1ff24b2e9893e6d5bdcb3d6f7e5f5f9e (MD5) === Made available in DSpace on 2016-12-22T13:14:35Z (GMT). No. of bitstreams: 1 MPGI Thesis - Emil Brohl Gludsted - Dec'21 2016 vf.pdf: 2957630 bytes, checksum: 1ff24b2e9893e6d5bdcb3d6f7e5f5f9e (MD5) Previous issue date: 2016-12-07 === Type 2 diabetes is a progressive disease projected to grow tremendously in prevalence. Basal insulin analogues used to be the most efficacious treatment and last step in therapeutic intensification. Today, demographic, economic and epidemiologic transitions have placed pressure on healthcare systems and payers’ budgets. Three imminent threats require the basal insulin regimen to rethink how value can be addressed in the market: mounting institutional pricing pressure, biosimilar competition and, new innovative anti-diabetic drug classes with the potential to delay insulinization. Products aspiring to compete in the basal insulin regimen must avoid commoditization and steer clear of new threats. This paper identifies seven strategies and tactics to successfully address value in the diabetes market and particularly in the basal insulin regimen: 1) cost-based advantage and price competition; 2) value-based pricing; 3) risk-sharing agreements; 4) redifferentiation and post-approval evidence generation; 5) combination products carrying complementary mechanisms of action; 6) treating comorbidities and adjacent diseases; and, 7) indicating for patient sub-populations. === A diabetes tipo 2 é uma doença progressiva cuja projeção é crescer tremendamente em prevalência. Análogos de insulina basal eram considerados o tratamento mais eficaz, e utilizados em último instância durante a intensificação terapêutica. Hoje, transições demográficas, econômicas e epidemiológicas tem colocado pressão nos sistemas de saúde e no orçamento dos usuários. Três iminentes ameaças levam o regime de insulina basal à necessidade de repensar a maneira como seu valor é apresentado ao mercado: crescente pressão institucional sobre os preços, competição de biosimilares e novas classes medicamentos inovadores anti-diabetes com o potencial de atrasar a insulinização. Produtos que buscam competir no regime de insulina basal devem evitar a comoditização e esquivar-se de novas ameaças. Este trabalho identifica sete estratégias e táticas para apresentar de maneira bem sucedida valor no mercado de diabetes e particularmente no regime de insulina basal: 1) vantagem baseada em custo e competição por preço; 2) precificação baseada em valor; 3) acordos de compartilhamento de riscos; 4) rediferenciação e geração de evidencias pós-aprovação; 5) produtos combinados que apresentam mecanismos complementares de ação; 6) tratamento de co-morbidades e doenças adjacentes; e, 7) indicação para pacientes de determinados sub-grupos da população.