Evan Loh speaking at World Antimicrobial Resistance Congress

Evan Loh, M.D., CEO, Paratek Pharmaceuticals 

 

What do you see as the biggest challenges facing the AMR space into 2022?

Antimicrobial resistance (AMR) is a global healthcare pandemic that continues to threaten our ability to treat common infections and will result in prolonged illness, disability and death if drastic action is not taken to create a sustainable commercial marketplace for novel antibiotics. Most alarming, the pipeline of antimicrobials capable of addressing killer superbugs is growing leaner and more fragile all the time. The bugs are winning and the innovation curve for novel antimicrobials is flattening and falling well behind what is needed to stem this global crisis.

Developing novel antimicrobials is a risky bet for most drug makers, large and small. Despite the headwinds of a dysfunctional reimbursement system in the United States, Paratek, the company I lead, has been able to bring a novel, life-saving antibiotic to the marketplace. However, the current U.S. reimbursement system denies access to patients who need novel life-saving antibiotics and other novel antimicrobials capable of curing drug-resistant infections.

Modernizing the reimbursement system so that it recognizes the life-saving value and innovation of newly FDA-approved antimicrobials is the most pressing challenge I see. Fixing it will require urgent and deliberate action by the Centers for Medicare and Medicaid Services (CMS) and the U.S. Congress through the passage of the DISARM Act (Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms).

In the United States, CMS has the responsibility for providing healthcare to nearly one in three people. CMS provides senior citizens and people with very low incomes with medical and prescription drug benefits. CMS’s current prescription drug policy and decades-old DRG (diagnosis-related group) system are out of date. We need to modernize them so that they no longer create unintended consequences for patients in delaying or restricting access to novel, life-saving antibiotics. Medicare Part D plan sponsors and Medicaid programs must ensure patients with appropriate access to the novel antibiotics that have been shown to save lives.

In the hospital care setting, we need to provide separate payments outside of the diagnosis-related groups (DRGs) for novel antibiotics to treat serious or life-threatening infections. Otherwise, we can expect to hear even more stories of patients dying in the aftermath of minor infections or routine surgical procedures because they couldn’t get the right antimicrobial medicine at the right time.

To improve outcomes, CMS must require Medicare part D sponsors to allow patients and providers access to much needed novel antimicrobials in hospitals and also require third-party payers to reimburse these medicines for patients in the outpatient or community setting without “fail first” policies.

Changes resulting from successful passage and implementation of the DISARM Act and the PASTEUR Act are critically important to revitalizing the antimicrobial ecosystem. Each policy addresses different challenges.

DISARM is intended to address the antiquated and dysfunctional reimbursement system. It would establish a separate antimicrobial payment schedule that would de-link the cost from hospitals’ calculus when choosing which antimicrobial to allow onto the hospital formulary, allowing them to modernize their formularies for the current and future resistance landscape. Equally important, it strengthens hospital stewardship practices to ensure appropriate use of novel antimicrobial products. This will help mitigate the risk of future resistance. I encourage action to advance the DISARM Act in the House and reintroduce it in the Senate before it’s too late. The PASTEUR Act complements

DISARM by creating a new subscription-style model through which the government would pay upfront for access to new antimicrobials for certain federal health systems rather than linking payment and sales volume. It would also increase resources for critical antimicrobial stewardship programs around the country. However, PASTEUR does not address the commercial marketplace nor does it address the need for reimbursement reform needed for local patient and clinician access in each hospital setting.

In addition to the dearth of novel antimicrobials in development and widely accessible on prescription drug formularies, in the United States we need to ensure abundant supplies of novel antimicrobials are available in our strategic national stockpile (SNS). Currently, the stockpile relies completely on older drugs that have resistance and safety challenges that newly approved antimicrobials are designed to address. Further, these older products are not manufactured in the United States and are sourced from other countries, namely China and India. Congress must consider policies today that will ensure the stockpiling of novel antimicrobial therapeutics in the event of a widespread, multi-drug resistant (MDR) bacterial pandemic – COVID has been a lesson in pandemic preparedness that must not be repeated.

Paratek has a partnership with the U.S. government through project BioShield to develop our novel antibiotic NUZYRA® (omadacycline) against pulmonary anthrax1. As part of this, we are working to become the first and only antibiotics company to establish full manufacturing capacity – from API to final drug product – in the United States. By the end of 2022 we expect to have U.S. manufactured tablets available commercially in the United States.

 

If you could wave a magic wand, what would you like to see occur in the coming year to further combat AMR?

If we could wave a magic wand, we would pass and implement the DISARM Act and PASTEUR Act and require CMS to mandate Medicare part D plans cover novel antibiotics without onerous prescribing requirements and “fail first” policies. By removing cost disincentives, formulary access will be less of an impediment, thus allowing physicians to choose, in a timely fashion, the antimicrobial that is right for the patient. It also would recognize and value the innovation contained in newly approved antimicrobial products.

 

What would you like to highlight about your work/your organization for this coming year?

Paratek continues to advocate for policy and legislative changes that will encourage innovation through new funding mechanisms and improve access of novel antimicrobials in the hospital and community settings. We are advancing our program with BARDA to study our novel antibiotic NUZYRA® (omadacycline) against specific biothreats – multidrug-resistant drug pathogens for which there are no effective treatments – and moving forward with next steps on the U.S. onshoring program we have with NUZYRA as part of this effort. 

 

Do you have any predictions for the AMR space in 2022 and beyond? Any calls-to-action you’d like to highlight?

The fact that AMR infections killed nearly 1.3 million people in 2019 and are escalating beyond all earlier predictions is the clearest call to action yet. Understandably, the response to AMR has been subsumed with the needs of the COVID-19 pandemic, which is still a global priority. However, AMR is a leading cause of death; its rise and impact on acceptable patient outcomes continues to be relentless and inexorable without the introduction of new antimicrobials to stay ahead of the innovation curve. It has been nearly impossible to convince payers and to get government officials to act as they do not see that AMR is today’s unspoken pandemic – and over time, will be even more deadly than COVID. It is not clear to me who in the U.S. government will demonstrate the courage to own the solutions that I have mentioned above.

 

Any additional comments?

Innovation is needed to address the AMR pandemic today and for future generations. Sadly, the current environment is an existential crisis for the biotech sector today and big pharma is not a current R&D participant in providing innovative solutions. I’d like to provide some context for why I feel so passionate about modernizing the system now.

For many newly approved drug classes, such as in oncology, there are physicians eager to adopt them for patients with pre-existing, unmet needs; there is reimbursement at levels that recognize the value of innovation providing access with immediate adoption of these agents that are perceived as “life-saving” – in point of fact, the majority are only life-prolonging. With this type of reimbursement and adoption culture, companies can reasonably expect to see an appropriate return on their significant R&D investments that were expended in order to develop these medicines.

In contrast, a company with a newly approved antimicrobial is in an entirely different situation because there is a long path to achieving a return on our investment.

Because of appropriate and well-considered antimicrobial stewardship principles, antimicrobials are the only drug products where the newest versions – those which have demonstrated and enhanced efficacy, safety and tolerability attributes – are kept in “reserve” by physicians, restricted by payers and used only when there are no other options; this is the exact, life-threatening clinical situation when antimicrobials have the lowest clinical cure rates. This approach has translated into hospitals and other healthcare providers such as Medicare and Medicaid, to limit, or in some cases, deny access to these new agents by either restricting or completely blocking their listing on formularies.

These environmental realities result in a significant lag between approval of a novel antimicrobial and its awareness by clinicians, trial and adoption by physicians, creating the “commercialization abyss” – roughly a multi-year, capital-intensive period at the start of commercialization before seeing any real adoption and use in terms of sales or achievement of sustainability for the company. The abyss and its associated capital requirements are major hurdles for any antibiotics company, especially because today 95 percent of antibiotics R&D worldwide is conducted at small biotechs like Paratek, many of which have just one product, with no other sources of revenue. Additional investment in this sector is desperately needed in the near-term. U.S. government interventions from a regulatory and legislative perspective will send an important message to biotech investors that there is a commercial model that recognizes innovation and that AMR, writ large, is an important clinical unmet need for all Americans. The reality of today is that for select patients with AMR, the pre-penicillin era is upon us now and without urgent and timely action we are woefully unprepared to be able address this inexorable and ongoing pandemic.

 


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