Key considerations in reimbursement decision-making for multiple sclerosis drugs in Australia

Phan, YHL; De Abreu Lourenco, R; Haas, M; van der Linden, N

Key considerations in reimbursement decision-making for multiple sclerosis drugs in Australia

Phan, YHL De Abreu Lourenco, R

Haas, M

van der Linden, N

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Publication Type:: Journal Article
Citation:: Multiple Sclerosis and Related Disorders, 2018, 25 pp. 144 - 149
Issue Date:: 2018-10-01

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Field	Value	Language
dc.contributor.author	Phan, YHL	en_US
dc.contributor.author	De Abreu Lourenco, R https://orcid.org/0000-0002-5978-8774	en_US
dc.contributor.author	Haas, M https://orcid.org/0000-0002-9726-3063	en_US
dc.contributor.author	van der Linden, N https://orcid.org/0000-0003-1646-9834	en_US
dc.date.available	2020-05-25T19:03:20Z
dc.date.issued	2018-10-01	en_US
dc.identifier.citation	Multiple Sclerosis and Related Disorders, 2018, 25 pp. 144 - 149	en_US
dc.identifier.issn	2211-0348	en_US
dc.identifier.uri	http://hdl.handle.net/10453/126162
dc.description.abstract	© 2018 Elsevier B.V. Background: : In Australia, the Pharmaceutical Benefits Advisory Committee (PBAC) advises on the reimbursement of drugs to be subsidised through the Pharmaceutical Benefits Scheme (PBS). This study aims to provide insights into the PBAC process and key considerations regarding the reimbursement of MS drugs in Australia. Methods: : The factors considered by the PBAC and its advice on whether to reimburse a drug are documented in public summary documents (PSDs). Qualitative content analysis of PSDs was conducted for all MS drugs considered by the PBAC between January 2006 and January 2018. Key issues identified by the PBAC were extracted and categorised. Common issues were identified and compared between drugs indicated for MS. Results: : A total of 23 submissions were evaluated relating to 13 MS drugs. Eight were recommended for reimbursement; an approval rate of 35% per submission and 62% per drug. Approval rates were higher for disease modifying treatments (73% per drug) than for symptomatic drugs (0% for nabiximols and fampridine submissions). The most frequently discussed issues in PSDs, irrespective of PBAC decision, were: (1) the validity of the indirect comparisons formed (n = 11); (2) the validity of the approach to obtain utilities (n = 6); (3) the lack of appropriate/long-term safety data (n = 8); and (4) the time horizon used in the economic models (n = 3). Conclusion: : A small but important number of issues have been consistently identified by the PBAC in relation to submissions for reimbursement of MS drugs. Drug developers and clinical trial investigators who are aware of these issues will be able to anticipate data requirements for reimbursement decision-making and thus potentially improve the evidence submitted for listing of MS drugs in Australia.	en_US
dc.relation.ispartof	Multiple Sclerosis and Related Disorders	en_US
dc.relation.isbasedon	10.1016/j.msard.2018.07.020	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Multiple Sclerosis	en_US
dc.subject.mesh	Immunologic Factors	en_US
dc.subject.mesh	Retrospective Studies	en_US
dc.subject.mesh	Drug Approval	en_US
dc.subject.mesh	Decision Making	en_US
dc.subject.mesh	Cost-Benefit Analysis	en_US
dc.subject.mesh	Advisory Committees	en_US
dc.subject.mesh	Australia	en_US
dc.subject.mesh	Female	en_US
dc.subject.mesh	Male	en_US
dc.title	Key considerations in reimbursement decision-making for multiple sclerosis drugs in Australia	en_US
dc.type	Journal Article
utslib.citation.volume	25	en_US
utslib.for	140208 Health Economics	en_US
utslib.for	1109 Neurosciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Business
pubs.organisational-group	/University of Technology Sydney/Strength - CHERE - Centre for Health Economics Research and Evaluation
utslib.copyright.status	open_access
pubs.publication-status	Published	en_US
pubs.volume	25	en_US

Abstract:

© 2018 Elsevier B.V. Background: : In Australia, the Pharmaceutical Benefits Advisory Committee (PBAC) advises on the reimbursement of drugs to be subsidised through the Pharmaceutical Benefits Scheme (PBS). This study aims to provide insights into the PBAC process and key considerations regarding the reimbursement of MS drugs in Australia. Methods: : The factors considered by the PBAC and its advice on whether to reimburse a drug are documented in public summary documents (PSDs). Qualitative content analysis of PSDs was conducted for all MS drugs considered by the PBAC between January 2006 and January 2018. Key issues identified by the PBAC were extracted and categorised. Common issues were identified and compared between drugs indicated for MS. Results: : A total of 23 submissions were evaluated relating to 13 MS drugs. Eight were recommended for reimbursement; an approval rate of 35% per submission and 62% per drug. Approval rates were higher for disease modifying treatments (73% per drug) than for symptomatic drugs (0% for nabiximols and fampridine submissions). The most frequently discussed issues in PSDs, irrespective of PBAC decision, were: (1) the validity of the indirect comparisons formed (n = 11); (2) the validity of the approach to obtain utilities (n = 6); (3) the lack of appropriate/long-term safety data (n = 8); and (4) the time horizon used in the economic models (n = 3). Conclusion: : A small but important number of issues have been consistently identified by the PBAC in relation to submissions for reimbursement of MS drugs. Drug developers and clinical trial investigators who are aware of these issues will be able to anticipate data requirements for reimbursement decision-making and thus potentially improve the evidence submitted for listing of MS drugs in Australia.

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http://hdl.handle.net/10453/126162