China has the greatest burden of hepatitis B and liver cancer in the world. In 2014 chronic hepatitis B virus (HBV) infection affected nearly 89.8 million people in China; we expect the total number of HBV prevalent cases will decline to approximately 86.7 million in 2019. The nationwide vaccination against HBV in infants and the stringent administration and monitoring of blood products have been successful in the control of chronic HBV infection; however, only a small percentage of carriers are diagnosed and treated. As patients with HBV infection are treated with long-term, disease-modifying therapies, the increasing rate of diagnosis and/or treatment for HBV will lead to a significant expansion of the drug-treated population.

In China, nucleoside/nucleotide analogues (NAs) are most commonly prescribed for HBV infection due to the convenience of oral formulations and good safety profiles. Lamivudine (GlaxoSmithKline’s Heptodin) and entecavir (Bristol-Myers Squibb’s Baraclude) are the leading brands in the HBV therapeutic market. Inclusion of conventional and pegylated interferons (PEG-IFN) and NAs into the national reimbursement list have increased the availability of anti-HBV therapies, thereby further decreasing the morbidity and mortality associated with chronic HBV infection. However, affordability still remains a market access barrier to premium-priced HBV treatments. Emerging therapies, such as Valeant Pharmaceuticals International pradefovir and Zymogenetics/Bristol-Myers Squibb’s PEG-IFN-lambda, must properly address the government and patients’ ability to pay for HBV treatments, in addition to the ongoing cost-containment policies in China in their launch strategy in order to optimize brand uptake in this market.

Questions Answered in This Report:

  • Explore current and evolving prescribing trends: What are the current prescribing patterns for immunomodulators and NAs? How do physicians expect these therapies to evolve over the next few years? What are the current brand shares of HBV antivirals? What are the forces that will shape the market in terms of novel drugs and diagnostics? What factors are driving/constraining physicians prescribing of anti-HBV drugs? How do physicians and payers perceive new anti-HBV drugs under Phase III clinical development in China?

  • Assess payer attitudes toward approved antiviral agents for HBV: What is the reimbursement landscape for HBV therapies? What reimbursement restrictions apply to the anti-HBV drugs? How do reimbursement restrictions affect the prescribing of current therapies? What therapies do payers expect to be included in the new versions of the National Reimbursement Drug List (NRDL) and/or Provincial Reimbursement Drug Lists (PRDLs)? What are payers’ views on the pricing and reimbursement landscape for emerging anti-HBV drugs? How might the new “free pricing” policy and “public hospital reform” in China affect the pricing and reimbursement of HBV therapies? How are the upcoming biosimilars perceived by payers? Will the presence of biosimilars drive a price cut on the branded products and have an impact on the reimbursement status of HBV agents?

  • Explore the outlook for emerging agents: What are the greatest unmet needs in HBV treatment? How are the emerging drugs PEG-IFN-lambda-1a and pradefovir mesylate perceived? How do physicians expect to prescribe them? What are payers’ expectations for access to emerging therapies? How will payer policy impact their uptake? How will market access barriers evolve and what challenges are companies likely to face in the future? How do physicians expect to prescribe biosimilars?

Scope:

This Emerging Markets Physician & Payer Forum report entitled Hepatitis B Virus in China: Reimbursement and Market Access Dynamics Against a Backdrop of High Prevalence summarizes the collective insights of 50 Chinese physicians and three interviewed payers on the prescribing patterns of current antiviral drugs, the potential impact of the new drugs under clinical development in China (Phase III trials), and key national and regional market access factors which will affect the use of antiviral drugs in China over the next 3 years..

Markets covered: China.

Primary research:

50 50 physicians (including 16 Infectious disease specialists, 8 gastroenterologists and 26 hepatologists) completed an online quantitative survey designed by therapeutic and country experts.

Three payers/payer-advising thought leaders who have influence on reimbursement of HBV drugs at a national or regional level were interviewed:

- Expert for new drug/NRDL evaluation at CFDA, Beijing.

- Hepatologist key opinion leader (KOL) at CFDA, Shanghai.

- Panel member for PRDL update, Hubei.

Author(s): Guo Youling, Ph.D.

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