Module 6

03/10/2024

What is required by theseagencies? What is required by these agencies?

Proof of efficacy and safety Usually from clinical trials

Assessment of cost effectiveness Usually by comparing with current standard of care • Where this is not available other means must be used eg • What clinicians are doing in practice eg treatment patterns questionnaires • What patients and consumers would choose eg utility studies

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How do HTAs fit into the decision-making process?

HTAs as part of the market access continuum

report

submission

Manufacturer

HTA agency

Payer

• Conducts literature review, economic analysis, etc. • Submits HTA-like document based on agency template

• Assesses

• Makes final decision on

manufacturer submission • May conduct independent review or rely on HTAs from 3rd parties • Submits recommendation to payer

reimbursement and availability of drug or device

✓

✓

Payer often agrees with HTA agency, although may be influenced by additional factors



 

✓



✓

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