Biologics for Psoriasis Battle for Market Access in China as 6.5 Million Patients Pin Hopes on National Reimbursement

The Landscape of Biologics for Psoriasis in China Is Becoming Increasingly Crowded.

HUAPONT LIFE SCIENCES recently disclosed that its controlled subsidiary, Shenzhen Huapu, will engage Pregene to provide drug discovery and pharmaceutical development services for the nanobody innovative drug project HP-1901 (Biological Drug Class 1), in order to continuously strengthen its leading advantage in skin-related treatment fields, particularly in psoriasis.

Since the beginning of this year, two biologics for the treatment of psoriasis from foreign pharmaceutical companies—secukinumab (commonly known as Su Jin Dan Kang) and ustekinumab injection—have been successively launched in China. These two drugs were developed by Novartis and Johnson & Johnson, respectively. The former was first approved for marketing in Japan in 2014, while the latter has been available on international markets for ten years.

The two drugs target IL-12/23 and IL-17, respectively. From the perspective of dermatologists, unlike traditional systemic therapies, biologics can specifically block particular immune pathways in patients, thereby reducing the excessive proliferation of skin cells in psoriasis patients. However, in the eyes of most patients, despite the superior efficacy of biologics, their prohibitive costs remain a significant barrier, leading them to pin their hopes on the inclusion of these medications in the national medical insurance program.

Refractory "Psoriasis"

Psoriasis, commonly known as "tinea psoriasiformis," is a chronic, relapsing, inflammatory, systemic disease mediated by immunity and induced by the combined effects of genetic and environmental factors. Its typical clinical manifestations are scaly erythema or plaques, which may be localized or widespread. The condition is non-contagious, difficult to treat, and often lifelong.

This disease has been listed by the World Health Organization (WHO) as one of the ten most intractable diseases of the 21st century. Its prevalence varies significantly across different regions worldwide, with rates of 1%–3% in Europe and the United States. In China, according to a previous epidemiological survey conducted in six cities, the incidence rate of psoriasis is approximately 0.47%, which translates to an estimated 6.5 million patients in the country.

There are significant differences between domestic and international patients in terms of existing treatment methods. A nationwide epidemiological survey conducted in 2010 revealed that the proportion of Chinese psoriasis patients engaging in self-treatment reached 82.3%, compared to only 40.0% in Europe and America. Furthermore, 24.1% of Chinese patients had relied on false advertisements, choosing irregular medical institutions or purchasing medications on their own.

In fact, even when receiving treatment at accredited medical institutions, Chinese patients are far from accessing the most advanced and satisfactory care. According to the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2018 Abbreviated Edition)" recently published in the Chinese Journal of Dermatology, traditional therapies remain the mainstay of psoriasis management in China, including topical medications, phototherapy, and certain systemic agents.

Systemic therapeutic agents such as cyclosporine and methotrexate are effective in treating psoriasis; however, as immunosuppressive agents with cytotoxic potential, they pose safety concerns. A large-scale statistical study involving psoriasis patients in North America and Europe revealed that safety and tolerability issues were the primary reasons for discontinuation of conventional systemic therapies, accounting for 24.5% of all reported cases.

Furthermore, relevant surveys indicate that nearly 80% of patients with moderate-to-severe disease are dissatisfied with existing treatment regimens. The primary reasons cited are “adverse reactions,” “limited efficacy,” and “lack of durable efficacy.” The most urgent treatment needs expressed by patients are “rapid skin repair” and “the ability to normally participate in social activities and work.”

“The average age of onset for psoriasis in China is in the thirties. Many patients with moderate-to-severe psoriasis are young and middle-aged adults, representing the prime years for contributing to society and serving as the mainstay of their families,” stated Zhang Jianzhong, Director of the Department of Dermatology at Peking University People’s Hospital. “Therefore, there is an urgent need for more effective, safe, and durable therapeutic options to control the disease and help them return to normal life and work.”

Year One of Biologics

In the global market, competition among biologics for psoriasis is currently intense. In addition to secukinumab and ustekinumab, other agents such as adalimumab (Humira), infliximab (Remicade), and etanercept have been approved for psoriasis indications. Companies including Eli Lilly and AstraZeneca also have products approved for the treatment of psoriasis.

In China, Novartis’ secukinumab received approval from the National Medical Products Administration on April 1, with the first prescription issued 50 days later; meanwhile, ustekinumab, launched on June 5 by Janssen Pharmaceutical Companies of Johnson & Johnson’s Chinese subsidiary, Xi’an Janssen, is now available in cities including Beijing, Shanghai, and Guangzhou.

In addition, adalimumab injection, the first treatment for psoriasis to enter the Chinese market, also saw significant price reductions in some provinces and cities starting in May. Furthermore, in May of this year, the National Medical Products Administration accepted the marketing application for a biosimilar of etanercept from Qilu Pharmaceutical.

With the entry of multiple monoclonal antibodies into the Chinese market and the approval of biosimilars for clinical trials or commercial launch, many experts have dubbed this year the “Year One” of biologic agents for psoriasis in China.

Professor Li Chengxin, Director of the Department of Dermatology at the Chinese PLA General Hospital, stated, “The application of biologics has brought about a significant transformation in the treatment of psoriasis. Unlike traditional systemic therapies, it specifically blocks the particular immune pathways responsible for the excessive proliferation of skin cells in patients with psoriasis.”

A Phase III clinical study of secukinumab involving 441 Chinese patients demonstrated that among all patients with moderate-to-severe psoriasis treated with secukinumab 300 mg, nearly 98% and nearly 81% achieved PASI 75 (i.e., a 75% improvement in the Psoriasis Area and Severity Index) and PASI 90, respectively, at Week 12. By Week 16, the proportion of patients achieving PASI 90 increased to 87%, indicating that nearly nine out of ten patients attained clear or almost clear skin.

The Phase III LOTUS trial of ustekinumab in the Chinese population also demonstrated that 82.5% of patients treated with ustekinumab achieved the primary endpoint of PASI 75 at Week 12, compared to 11.1% in the placebo group. All key secondary endpoints showed significant improvement, including PASI 90 achievement in over 80% of ustekinumab-treated patients by Week 28.

A psoriasis patient has received three injections of secukinumab at a hospital in Shijiazhuang. According to the patient’s statement to Times Finance, their condition was relatively mild, and the therapeutic effect became highly evident after just two doses. “About three days after the second injection, my condition improved noticeably day by day. Currently, there are no more plaques on my arms and legs, with only a few dark marks remaining on my back.”

Can it be included in the national medical insurance?

Multiple patients have expressed recognition of the efficacy of the aforementioned biologics; however, at present, the prices of these biologics are significantly higher than those of conventional therapies.

Although the price of ustekinumab has not yet been officially announced, many patients on online discussion platforms have mentioned that it is priced at 39,950 yuan per injection with a “buy one, get one free” offer. Even during the maintenance phase, where patients receive an injection every three months, the monthly cost still exceeds 6,000 yuan.

According to the prescribing information for secukinumab (i.e., 300 mg administered weekly for the first five weeks during initial therapy, followed by 300 mg every four weeks for maintenance therapy), Times Finance roughly calculated that, based on a 52-week year, the cost of secukinumab in the first year would be approximately RMB 90,000+, with subsequent annual maintenance therapy costs amounting to approximately RMB 70,000+.

The aforementioned psoriasis patient also told Times Finance that, due to having previously received a RMB 600 coupon, the current price per injection (150 mg) of secukinumab is RMB 2,398. “With approximately 32 injections per year, the first 16 injections are eligible for coupons totaling a RMB 9,600 discount, bringing the estimated annual cost to around RMB 86,000. This largely depends on one’s financial capacity.”

“Beyond regulatory approval, inclusion in the national medical insurance scheme is another key factor determining patient access to new drugs,” pointed out Asgar Rangoonwala, President of Janssen China, at the launch of ustekinumab. He noted that the update cycle of China’s National Reimbursement Drug List has been accelerating, thereby increasing the likelihood of patients accessing innovative medicines and facilitating smoother pathways for reducing their financial burden through insurance coverage.

According to Times Finance, secukinumab and ustekinumab are currently not included in the National Reimbursement Drug List. However, infliximab and adalimumab, biologics also used for the treatment of psoriasis, have been included in the Zhejiang Provincial Medical Insurance, with a reimbursement rate of 60%.

Zhang Ying, President of Novartis Pharmaceuticals (China), stated in an exclusive interview with E-Drug Manager a week ago that although secukinumab missed the negotiations for the 2019 National Reimbursement Drug List adjustment, the company is actively seeking all opportunities to collaborate with national healthcare security authorities. For instance, it is striving to include Cosentyx in provincial and municipal medical insurance schemes to address issues of drug accessibility.

(Editor:Wang Xing）

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