Table 2 Major themes and corresponding qualitative codes

Uncertainties and disagreements regarding to what extent the marketing authorization process can and should be adapted

Current challenges for regulatory authorities are caused by AMR

Regulatory authorities have addressed most structural challenges in marketing authorization

Current challenges in marketing authorization are due to lack of clinical data

Adaptation to the marketing authorization process causes new challenges

Increased importance of PK/PD

Uncertainties of how to use PK/PD data

HTA agencies asking for more clinical data

Balance between addressing AMR and upholding good quality

Continuous work to address the future antibiotic need, need to find new ways to meet new challenges

Unacceptable to reduce requirements in the marketing authorization process to address AMR

Regulatory authorities have adapted as much as they can

Increased risk of irresponsible use of antibiotics

Lack of clinical data makes it difficult for physicians to make an informed decision and uphold responsible use

Company holds power over how a drug is used, not forced to consider AMR

Limited clinical data lead to limited post-approval data

Limited clinical data lead to greater uncertainty regarding the benefit/risk profile of the drug

Adhering to the regulatory authorities’ recommendations can both reduce and increase the risk for irresponsible use

Antibiotics approved with limited clinical data risks incentivizing off-lable use

Regulatory authorities clear on circumstances for approval and intended use

Limited jurisdiction and clear stakeholder perception

Companies and clinicians have the final say in how an antibiotic is used, not under the control of regulatory authorities and HTA agencies

The increasing population-level spread of resistant strains means that benefit/risk assessment of new antibiotics will vary over time

Marketing authorization based on limited clinical data results in increased safety risks

Lack of clinical data leads to uncertainties regarding benefit/risk profile

Smaller safety databases lead to uncertainties regarding the safety profile

Using an antibiotic in a limited population leads to limited post-approval data

Accepting a higher level of uncertainties regarding the safety profile, if benefits overweigh potential safety risks, does not mean there is an increased acceptance for safety risks

Benefit and risk are relative to the situation

Lack of effective antibiotics targeting unmet needs, including AMR, is a threat to public health

Delay in antibiotic R&D, need to act now before resistant bacteria have spread too much

Continuous work to address the future antibiotic need, need to find new ways to meet new challenges

Adjustments to regulatory requirements for antibiotics misaligned with evidence needs for determining value with HTAs

Regulatory authorities actively work to address AMR

Regulatory authorities have adapted as much as they can

Different objectives

HTA agencies assess cost-effectiveness, regulatory authorities assess benefit/risk

Regulatory authorities consider it problematic that HTA agencies demands additional clinical data in cases, where this is difficult to obtain

HTA agencies ask for different data than regulatory authorities

HTA agencies ask for proof of superiority

If the demand for clinical data is too high companies will exit the field of antibiotic R&D

Disagreement between regulatory authorities and HTA agencies whether HTAs are causing barriers to get new antibiotics to market

Targeting an unmet medical need increases the HTA-score

HTA does not look at public health impact of a resistant bacteria

Antibiotic prices are too low

Limited experience with HTAs of antibiotics

Few countries conducting HTAs

Few new antibiotics have reached the market in recent years resulting in limited experience conducting HTAs for new antibiotics

Different interpretations of ‘novelty’ and ‘need’ translates to differing views on what kinds of antibiotics are urgently needed

Need for a broad armamentarium

Need for antibiotics to treat hospitalized patients suffering from infections caused by multidrug resistant bacteria

Need for new small-spectrum antibiotics to reduce development of AMR in the population at large

Novelty has multiple meanings

Drugs can be novel based on its own characteristics or based on the circumstances of the situation it is being used in

Unmet need is a dynamic term

Different needs in different regions

Size of patient groups

Unclear when additional antibiotics in the same class no longer adds value