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Table 2 Criteria for HTA recommendations in England, Italy, France and Spain

From: How innovation can be defined, evaluated and rewarded in health technology assessment

 

NICE (England and Wales)

CIPM & AEMPS (Spain) (‡)

AIFA (Italy)

HAS (France)

NIPH (Japan)

 

All HTA

Medicines

Medicines

Medicines

All HTA

Attributes related to therapeutic added value of technology, compared to relevant comparator

 Therapeutic benefit

(I)

(I)

(I)

Attributes related to step-change

 Step-change in the management of the condition

(I)

(I)

 Disruptiveness

 Breakthrough status

 Demonstratable and distinctive benefit

(I)

(I)

Attributes related to the underlying health condition of the patients & current care

 Severity of underlying disease

(I)

 Impact on the health of the population

(I)

 Availability of existing intervention

 Unmet need

(I)

Attributes related to safety

 Safety

(I)

Attributes related to convenience

 Administration

(I)

 Patient usefulness (i.e. convenience)

(I)

 Carer usefulness (i.e. convenience)

Attributes related to economic impact

 Cost or budget impact

 Impact on non-healthcare resources and productivity benefits

 Incremental cost-effectiveness ratio

C

Attributes related to the evidence base

 

 Strength of clinical evidence

(I)

 Learning curve

Attributes related to R&D and impact on future innovation pipeline (dynamic effects)

 Novelty

(I)

 Spill-over effects

 Real option value

 References

[20, 21]

[21,22,23]

[15, 21]

[21, 24, 25]

[26, 27]

  1. Note: (I) refers to whether the criteria is labeled by the HTA agency as an attribute of ‘innovation’ (C) refers to ‘in certain circumstances’ (‡) Spain has a criteria labeled ‘innovation’ but no definition or further guidance is provided