Assessment of a New Antibiotic

Antimicrobial Resistance (AMR) develops when microorganisms (bacteria, viruses, fungi, and parasites) evolve in such a way that the drugs used to treat illnesses become ineffective. Patients will die from previously curable illnesses if new antibiotics are not introduced. A fundamental challenge, however, is appropriate antibiotic evaluation, particularly by payers and/or Health Technology Assessment (HTA) Bodies, to account for AMR and represent the whole value delivered to patients and society.

Two key challenges

• Clinical studies are intended to show non-inferiority, whereas HTA bodies seek clinical superiority.
• HTA bodies lack a method for assessing the health benefits of antibiotics and controlling the growth of AMR.

Elements of value relevant to antibiotics -

Relevant benefits that are included in traditional HTA are -

Health gain

• Usually, all the evidences that are necessary and needed for the HTA bodies are often inaccessible for antibiotics. (Superiority trails)
• This includes the quality life gains as well as the life extensions.
• For a positive HTA recommendations, it is accepted as a criteria.

Unmet need

• The use of priority pathogen lists is involved in this.
• This includes the current availability of all the alternative treatments and the severity of the disease.

Cost offsets

• This involves the use of evidence from all the clinical trials as well as the modelling studies (modelling studies can be optional).
• As a result of the new medicine, it includes the reduction in costs in all the other areas.

Productivity benefits

• It involves earnings or losses connected to the value of the patient's time spent seeking medical treatment or being absent from work.
• It involves the application of modelling research as well as information from clinical trials/observational investigations.

Other types of benefits that may be relevant to antibiotics include:

Insurance value

• It is the cost of therapy available in the event of a catastrophic health catastrophe, such as an epidemic of MDR illnesses that cannot be treated with current last-line medicines.
• The use of modelling studies is included.
• Availability of a fire engine is analogous
• There is a huge need for to add it in the “precautionary principle”.

Diversity value

• The use of modelling studies is involved
• It is the selection pressure, i.e., the antibiotic may remove susceptible bacteria but not other resistant pathogens, allowing these pathogens to persist and reproduce, rendering the antibiotic useless.
• It includes evidence that lowering selection pressure by withholding antibiotics for a period of time may result in susceptibility restoration.

Diagnostic value

• The test accuracy evidence is needed.
• If an infection is detected early, proper antibiotic therapy can begin sooner.

Uniqueness or innovation value

• The new mechanism of action evidence is needed.
• Antibiotics with unique mechanisms of action may avoid the cross-resistance issues that plague several present classes.
• The discovery of a new mechanism of action for an antibiotic makes it simpler for "follow-on" drugs to enter the market.
• It is the potential value associated with a novel or one-of-a-kind mechanism of action.

Enablement value

• The use of modelling studies is involved
• It is the availability of efficient antibiotics that supports many surgical operations and therapies for persons with weakened immune systems.

Spectrum value

• This depends on antibiotic
• Narrow spectrum antibiotics may be more helpful than broad spectrum antibiotics because they can minimize AMR transmission by reducing 'collateral harm' to the microbiome.

Reasons why more antibiotic value factors are required:

The following are the reasons why additional value factors for antibiotics are required:
AMR is the public health priority - The emergence of AMR is a severe danger that must be addressed by national and international health organizations. Current HTA approaches do not take into consideration the benefit of minimizing this public health concern, such as the insurance value of having a treatment accessible in the event of a future significant or fast developing resistance problem.

Diverse set of non-inferior antibiotic is valuable to society - Because AMR is becoming more prevalent, it has become worthwhile to create a new antibiotic for MDR bacteria, even if it is less effective than existing antibiotics in treating susceptible (non-resistant) pathogens. This is a notion peculiar to antibiotics and is not taken into account by HTA bodies.

Non-clinical and microbiological data are critical for demonstrating the value of antibiotics - Antibiotic non-clinical and microbiological data can predict their outcomes. Because clinical trials for antibiotics against MDR bacteria are difficult to undertake, authorities consider these alternate sources of evidence as part of the licensing procedure in regions with significant unmet need.

Antibiotics offer advantages that extend beyond the patient being treated - When one patient receives antibiotic treatment, the spread of the infectious disease is slowed, benefiting the entire population. Other Treatments and Procedures are Made Possible by Antibiotics - Antibiotics, in addition to curing infections, lower the risks associated with other forms of treatment, such as surgery and chemotherapy.

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