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Table 4 Role of HTA and requirements for launch of new indications across Germany, France, England, Scotland, Canada, and Australia

From: Launch sequencing of pharmaceuticals with multiple therapeutic indications: evidence from seven countries

Country

HTA agency

Type of assessment

Role of HTA

Requirements for public reimbursement

Germany

Federal Joint Committee (G-BA)

Relative clinical benefit assessment

Informs pricing negotiations with the National Association of Statutory Health Insurance Funds

EMA authorisation

France

Transparency Committee—Haute Autorité de Santé (HAS)

Relative clinical benefit assessment

Informs pricing (ASMR) and reimbursement rate (SMR)

EMA authorisation and SMR rating above insufficient

England

National Institute of Health and Care Excellence (NICE)

Clinical and cost-effectiveness

Issues binding reimbursement recommendations. Indirectly influences pricing through cost-effectiveness thresholds

EMA authorisation and NICE approvala

Scotland

Scottish Medicines Consortium (SMC)

Clinical and cost-effectiveness

Informs pricing and reimbursement decisions by NHS boards. NHS boards not required to follow recommendation, but must wait for an SMC assessment to be issued

EMA authorisation and SMC assessment

Canada

Canadian Agency for Drugs and Technologies in Health (CADTH) and pan-Canadian Oncology Drug Review (pCODR)

Clinical and cost-effectiveness

Informs provincial pricing and reimbursement. Provinces are not required to follow recommendation and negotiate either jointly or individually with manufacturers

Health Canada authorisation and CADTH/PCODR assessmentb

Australia

Pharmaceutical Benefits Advisory Committee (PBAC)

Clinical and cost-effectiveness

Informs pricing and reimbursement in Pharmaceutical Benefit Scheme (PBS). Minister of Health makes final decision following positive PBAC recommendation

TGA authorisation and PBAC approval

  1. Source: The authors from [28,29,30,31,32,33,34,35,36]
  2. Abbreviations: ASMR Amélioration du Service Médical Rendu (France), EMA European Medicines Agency, HTA Health Technology Assessment, NHS National Health Service, SMR Service Médical Rendu (France), TGA Therapeutic Goods Administration (Australia)
  3. aNHS organisations are able to start using a new drug prior to NICE guidance but uptake is low and commissioning groups typically wait for NICE guidance to be issued. Since 2019, NICE evaluates all new drugs launched in the UK
  4. bProvinces are able to fund drugs without CADTH/PCODR assessments but uptake is low and CADTH/PCODR recommendations typically inform negotiations. The province of Quebec does not rely on CADTH recommendations and has its own health technology assessment agency for informing pricing and reimbursement decisions
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BMC Health Services Research

ISSN: 1472-6963

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