The lackluster global antibiotics pipeline and surge of antibiotic resistance in clinical isolates in China have triggered a new quest for novel antibiotics against complicated HTI. Many local and Asia-based biopharmaceutical companies are seizing this opportunity, such as TaiGen Biotechnology, which in May 2013 submitted an NDA for its innovative non-fluorinated quinonlone, Taigexyn, in China and Taiwan for treating community acquired pneumonia. In addition, AstraZeneca has started a Phase III trial for ceftazidime-avibactam (CAZ-AVI) combination therapy for complicated intra-abdominal infections and nosocomial pneumonia, and Bayer has acquired the exclusive rights to commercialize tedizolid in China, a second-generation oxazolidinone developed for treatment of Gram-positive infections. However, the Chinese government has been actively tackling abusive use of antibiotics through promulgation of administrative regulations for the clinical use of antimicrobials and the establishment of the National Antimicrobial Resistance Investigation Net to advocate rational use of antibiotics in hospital settings. This report analyzes how the different reimbursement and public health policies are shaping the antibiotics market in China.

Questions Answered in This Report:

  • Explore Current and Evolving Prescribing Trends:

     

    - What formulary/reimbursement constraints are influencing the prescribing patterns of Chinese physicians?  What are the differences between empiric treatments and treatments for confirmed MRSA and gram-negative infections? 

    - What are the prescribing restrictions for different antibiotics? How do physicians anticipate the prescribing of antibiotics will evolve over the next 12 months? 

    - How have cost-containment measures affected physicians’ practice?  How will the reimbursement environment for antibiotics evolve over the next 12 months? 

    - What are the key drivers for the prescribing of a specific antibiotic over others? How is the ad-hoc purchase policy for antibiotics implemented in practice?  What are the differences between the hospital formularies among different tier-level hospitals?

     


  • Assess Payer Attitudes Toward Approved Antibiotics:

     

     

    - What pathogens are payers’ biggest concerns?

    - Which approved novel antibiotics are/will be included in the National Essential Drug List (NEDL), the National Reimbursement Drug List (NRDL), or Provincial Reimbursement Drug Lists (PRDLs)?

    - How do the NEDL expansion and other healthcare reform initiatives affect the reimbursement of formulary-listed antibiotics? How does the administrative regulation on clinical use of antimicrobials in 2012 affect the inclusion of novel antibiotics in hospital formulary? 

    - What underlying factors hinder/drive the inclusion/exclusion of an antimicrobial agent from the different reimbursement lists and hospital formulary? 

    - How do payers perceive the differences in hospital formularies among different tier-level hospitals?

    - What is the role of ad-hoc purchase for including antibiotics not included in a hospital’s formulary? 

    - What impacts do payers anticipate rapid diagnostics may have on empiric treatment?

     


  • Explore the Outlook for Emerging Antibiotics:

     

     

    - What hurdles will emerging therapies encounter in the market? 

    - Which indication will have the most pressing need for new therapies in the future? 

    - How is nemonoxacin perceived? How is the CAZ-AVI combination therapy perceived? How is tedizolid perceived? How do physicians hope to prescribe nemonoxacin, CAZ-AVI, and tedizolid?  What antibiotic would physicians replace with nemonoxacin, CAZ-AVI, and/or tedizolid? 

    - What clinical and economic factors would be most likely to convince payers to grant emerging antibiotics formulary coverage?

    - What is the price sensitivity of physicians in prescribing these emerging antibiotics?

    - What are payers’ expectations for the reimbursement of these three antibiotics over the next three years/upon approval?   

Scope:

This Emerging Markets Physician & Payer Forum report explores how national and local market access factors will influence the treatment of HTI across China in the next three years. The report is based on a survey of 57 infectious disease specialists and primary care physicians, as well as interviews with 3 payers who have an influence at a national or regional level as follows:

- Panel member, drug assessment group for Provincial Reimbursement Drug List update, Fujian province;

- Panel member, drug assessment group for National Reimbursement Drug List update;

- Member, antimicrobial agent management working group, Tier-3 hospital.

Author(s): Kwok-Fai Ng, M.B.A.