Subscription model for antibiotic developmentBMJ 2019; 366 doi: https://doi.org/10.1136/bmj.l5364 (Published 06 September 2019) Cite this as: BMJ 2019;366:l5364
- Rebecca E Glover, research fellow,
- John Manton, assistant professor,
- Sam Willcocks, research fellow,
- Richard A Stabler, associate professor
- Correspondence to: R Stabler
In July 2019 the National Institute for Health and Care Excellence (NICE), NHS Improvement, and NHS England announced that they will trial a “subscription model” when paying for new classes of antibiotics.1 This incentive for antibiotic research and development decouples payments to drug companies from the volume of antibiotics sold, to help encourage new products to market.
The model will use a health technology assessment process to identify a base “value” that the NHS would pay to pharmaceutical companies annually, regardless of how many prescriptions are issued. There may also be a small cost for each prescription, but the details of this new incentive have yet to be announced. The scheme’s relation to existing means of valuing antibiotics and to related strategies for infection control requires scrutiny.
Antibiotic resistance is recognised as a major global problem. Only one antibiotic in a new class, teixobactin, has been discovered in the past 30 years, and it was developed by a company spun out of a university research group.23 Policy makers will aim to protect any new antibiotic by prescribing it for only the most severely drug resistant infections, which the industry says discourages antibiotic research.
Unfortunately, even if this subscription model and other pull incentives facilitate the identification of new classes of antibiotic, resistant bacterial isolates will eventually emerge.This is the normal result of evolution given underlying mutations, drug selective pressures, and number of doses given. Teixobactin claims to be evolution proof in the laboratory,2 but these are small experiments compared with the real world experiment that occurs when antibiotics are taken on a global scale.
Although we welcome the news that the UK government will be investing in tackling antimicrobial resistance, and while the pharmaceutical sector may be a key partner in systemic approaches to managing the risk of antibiotic failure, tied investment in a particular pricing or incentive strategy poses considerable risks to public finances and policy goals.
Revitalising the antibiotic pipeline is only one component of the complex response necessary to tackle antibiotic resistance. We must take care that innovations in pricing and incentive strategies do not sideline cheaper and potentially more effective opportunities to tackle systemic antibiotic failure. The subscription model aims to pay a fair price, but it is not clear how value will be assigned to any new antibiotics since their effectiveness in reducing antimicrobial resistance can be measured only retrospectively, after sustained use.
We should also be drawing on innovations in other treatment regimens for infectious diseases. For tuberculosis and HIV, monotherapy would be out of the question, and yet we persist in adhering to a single antibiotic course in many clinical settings.4 Investing in local surveillance may also reap dividends by allowing us to optimise and tailor current treatment options—for example, by allowing local knowledge to modify prescribing guidelines.
If the incentive is successful, patients with a multidrug resistant bacterial infection will benefit from new treatment options. From the perspective of industry, however, this fund may be most useful for already discovered compounds that are known to be effective but were never released because of economic considerations. This might result in new releases but relatively lower investment in new compounds. Creating incentives based on a societal “value” calculation could lead to perverse incentives in the future, with companies holding back innovations in the hope that perceived value will increase as antimicrobial resistance rates get worse.
The dominant discourse around antimicrobial resistance draws heavily on liberal and behavioural economic models: by nudging companies to invest and urging individuals not to demand antibiotics and doctors to restrict prescription.56 But structural and social solutions, such as improving sick pay entitlements for workers, reducing poverty, and providing longer appointment times with better resourced primary care, can also contribute to reducing infections, antibiotic use, and antibiotic resistance in the long term.5678 Unfortunately, these options are not a major part of the policy discourse.
This new payment model might boost drug discovery but it may also siphon away funds from known effective public health, social, and structural interventions; encourage distortions in global pharmaceutical regulatory markets; and create no long term meaningful change in the antimicrobial resistance framework. An international and interdisciplinary approach will be required if this policy is to be successful.
Understanding how this policy option came to dominate discourse is crucial. In a political context that supports market approaches in antimicrobial resistance, incentives can act as a means of capturing public resources for private gain. We must evaluate the subscription model throughout the policy cycle to avoid any risk of moving from an incentive scheme for new antibiotics towards a broader taxpayer funded grant state for big multinational drug companies.
Competing interests: The BMJ has judged that there are no disqualifying financial ties to commercial companies. The authors declare the following other interests: none. Further details of The BMJ policy on financial interests is here https://www.bmj.com/sites/default/files/attachments/resources/2016/03/16-current-bmj-education-coi-form.pdf]
Provenance and peer review: Commissioned; not externally peer reviewed.