The need for new anti-infective drugs – a global imperative
Infections caused by Anti-Microbial Resistant (AMR) strains of bacteria continue to rise at an alarming rate. They pose a threat to humanity.
Antibiotics represent the foundation for all modern medicine. However, this has been taken for granted and now we find that bacteria have become resistant to almost every antibiotic developed by man and the vast majority of bacterial infections are now caused by AMR strains. These AMR bacteria, dubbed by the media as ‘Superbugs’, are harder to treat, cause greater mortality, and additional cost to the healthcare system.
Unless action is taken to address this huge global issue, the Independent Review on antimicrobial resistance (Lord O’Neill) estimates that it will cost the world an additional 10 million lives a year by 2050, more than the number of people currently dying from cancer annually. It will also have a cumulative cost of $100 trillion, more than one and a half times annual world GDP today.
New antibiotics will ‘buy time’, however perhaps more importantly we need to adopt strategies that may reduce the emergence of AMR strains. At Destiny Pharma, one such strategy is being developed in the form of a new group of antibacterial drugs ‘the XF Drug platform’, who’s novel, ultra-rapid mechanism endows them with the extraordinary ability to reduce the chance of bacteria becoming resistant to their action.
Government/health agency support
Many initiatives to spur the development and approval of new antibiotics/antibacterial drugs are under consideration. The US government is particularly active in this area. Key initiatives in recent years are set out below:
The Pioneering Anti-microbial Subscriptions To End Up Surging Resistance (PASTEUR) Act, introduced October 2020
The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act will support the development of new antibiotics and promote appropriate use of existing ones, helping to limit the increase and spread of resistant infections. PASTEUR would establish an innovative way to pay for critically needed new antibiotics, delinked from the sales or use of those antibiotics with a subscription model providing federal payment to companies that develop antibiotics.
Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act, currently going through US legislative process
The DISARM act is currently making its way through the US legislative process and the act is intended to improve critical Medicare reimbursement for antibiotics and promoting their appropriate use. The legislation has the potential to stabilize the antibiotics market, spur the development of new infection-fighting drugs, and preserve the effectiveness of existing medicines. The act is proposing separate Medicare reimbursement of antibiotic drugs in the hospital setting and provide for cost +2% reimbursement. DISARM will apply to drugs with QIDP designation.
NTAP Reform, August 2019
The US government reformed the existing new technology add-on payments (NTAPs) to include an alternative pathway for novel antibacterial drug payments. The changes increase the value of these payments to 75% for products that obtain qualified infectious disease product (QIDP) status.
NHS England launch antibiotic subscription model, July 2019
NHS England is collaborating with the National Institute for Health and Care Excellence (NICE) on a pilot project under which NHS England will buy two antibiotics on a delinked (volume- and usage-independent) subscription model basis. The new payment model is intended to incentivise pharmaceutical companies to develop new drugs for resistant infections.
5 Year AMR Plan, January 2019
The UK Government announced its 20-year vision and second five‑year action plan on AMR which outlines how the government will contribute to the global effort against AMR through optimising use of antimicrobials and investing in innovation, supply and access.
Davos announcement, February 2018
$1 billion rewards proposed at Davos 2018 for new antibiotics: the study, titled “Revitalizing the Antibiotic Pipeline: Stimulating Innovation while Driving Sustainable Use and Global Access”, was produced by an international group made up of 23 partners from big pharma, academic institutions and public health organisations. The complementary measures laid out in the study cover 30 incentives on how to drive antibiotic innovation.
G20 Declaration, May 2017
Recognised the importance of reactivating the R&D pipeline through incentive mechanisms that avoid the reliance on high price/volume combinations and the need to promote prudent and responsible use of antimicrobials.
21st Century Cures Act, December 2016 (US)
Instructs the FDA to enable approval of QIDPs in Limited Patient Populations which will allow more efficient clinical trial design and greater ease of drug approval for a limited label population.
Independent Review on Antimicrobial Resistance, May 2016
Predicts ten million deaths and $100 trillion cost of AMR globally by 2050 if not addressed. Recommends global fund to drive R&D and $1 billion market entry rewards for new drugs.
In support of DISARM Act
“These combined measures are urgently needed. Antimicrobial resistance also threatens medical advances, including cancer chemotherapy, and organ transplants that depend on effective infection fighting medicines.”Infectious Diseases Society of America
NHS England antibiotic subscription model
“I am proud the UK is taking the first steps towards a solution and I am urging the rest of the world to join us in the fight against superbugs” Matt Hancock, UK Government Health and Social Care Secretary
“Today we are sending a strong signal to the rest of the world that there are workable models to stimulate investment in these vital medicines and that together we can tackle AMR” Nicola Blackwood, UK Government Health Minister