City of Paris

Last week, China’s State Food and Drug Administration (SFDA) Drug Registration Department Director Zhang Wei was interviewed by the Xinhua news bureau about the upcoming 2009 SFDA annual report. He revealed some interesting statistics about approvals as well as clinical trial activities.

In response to the H1N1 epidemic, the SFDA initiated an expedited review process. This resulted in the approval of 10 different H1N1 vaccines in 2009. Tamiflu (oseltamivir phosphate capsules) received approval for scaled-up manufacturing as well as new indications to include special populations and pediatric use. Expedited approval was also granted for the import of By Le-Wei (zanamivir powder for inhalation).

For HIV therapy, Zhang reported that key pharmaceuticals in currently accepted regimens are now available, and some of these are manufactured in China. The approval of nevirapine, zidovudine and lamivudine will go a long way in managing the disease and disrupting maternal-fetal transmission of the virus.

In oncology, the approval of Tasigna (nilotinib) for CML patients offers an alternative for those who are resistant to Gleevec (imatinib mesylate) treatment. Felodipine, developed in China, entered clinical trials.

For hepatitis B, a major health concern in China, Zhang noted that the approval of generic entecavir will reduce cost and improve access. Similarly, in CV drugs, the generic version of levosimendan was approved, and the generic paliperidone entered clinical trials. In diabetes, a dipeptidyl peptidase-4 (DPP-4) inhibitor for type II diabetes, was approved. In antimicrobials, Cubicin (daptomycin) was approved. Several traditional Chinese medicine (TCM) drugs also received approval. These approvals cover several categories including respiratory and women’s health.

All told, the SFDA approved 2,609 drug applications covering 1,464 different products in 2009. Nine of these are new drug entities that became available for the first time on a worldwide basis. And 69 of the new products are TCM entities. The overall approval rate is at 40 percent, holding steady for the past three years. (By comparison, the approval rate was closer to 90 percent in previous years.)

On the clinical trials front, the SFDA approved the initiation of 773 trials for 627 pharmaceuticals, 81 TCM entities and 64 biologicals, most of them in the anti-infective, oncology, cardiovascular and other chronic disease categories.

Treatment costs of tens of thousands of RMB (equivalent to thousands of U.S. dollars) are out of reach for most citizens in China, and the drugs used are not necessarily on the national formulary and therefore not reimbursed. This leaves patients and hospitals in a quandary, and spurs debates about which government entity (i.e., the Ministry of Health [MOH] or Social Security) should pay. In late January, the MOH announced an increase in the reimbursement limit for both service fees and medication while encouraging citizens with financial hardships to seek help from local government units.

The H1N1 epidemic is still active in China. During the week of January 11-17, the 31 reporting provinces had a total of 1,556 cases, resulting in 27 deaths and 348 hospitalizations. As the Chinese New Year approaches, the MOH is recommending that higher-risk groups (e.g., the elderly, pregnant women, infants) refrain from traveling during the holiday season.

Four months after the implementation of an appointment system for outpatient visits in 49 category III (large, tertiary care) hospitals in Beijing, it is estimated that 1.23 million patients (or 13 percent of the total) took advantage of the system. This level of utilization falls short of the Beijing Health Bureau’s goal of 40 percent utilization for repeat appointments, 100 percent for dental (81.3 percent, actual) and routine prenatal visits (57.8 percent, actual) and 60 percent for post-discharge checkups. The vast majority of patients still opted to show up at the hospital when medical care was needed, and 42 percent of those who did make appointments did so in person at the hospital.

Why are Chinese citizens slow to adopt the new appointment system?

• Not enough telephone lines and operators. A survey showed that busy signals and limited choices of dates and times were some of the reasons that about a third of those who attempted to make appointments by telephone were dissatisfied. Yet, hospitals are reluctant to invest in a call center because they have little trouble filling physicians’ schedules.
• Lack of available appointments with top specialists. With the lack of a primary care (gatekeeper) function in China, access to top specialists is based more on the patients’ prowess in securing appointments rather than clinical need. Since specialists are a scarce resource, many hospitals are reluctant to fill these specialists’ schedules by telephone.
• Lack of triage to direct patients to appropriate department. The appointment system does not accommodate patients who rely on coming to hospitals to find out which doctor they need to see. Some hospitals have started telephone services staffed by healthcare professionals to guide patients through the process.
• Lack of standardized rules. Some patients complain about the different rules imposed by individual departments and/or specialists. To encourage participation by all departments and physicians in the appointment system, some hospitals are implementing rules to penalize departments and individual physicians that schedule fewer than 50 percent of appointments in advance. Penalties are in the form of demerits and pay cuts.
• The resale market for appointments and Internet bookings. About 3 percent of appointments are made online, and often by people who are reselling the appointment to a true patient. A prepaid appointment that costs 15 RMB can be sold for 400 RMB or more.

Clearly, managing patient expectations is a top challenge for hospitals. Should patients expect to see the doctor they want to see within a week or a month? Is it reasonable to reserve some appointment slots for walk-in patients? How much waiting time is acceptable? The reality is that the appointment system cannot solve the fundamental issue: There are 1.78 million specialist appointments available, and 12 million patients competing for them. In other words, only one out of 67 patients seeking to see a specialist will actually secure an appointment. This goes back to the problem of the lack of a gatekeeper system, as well as the general public’s lack of information about how to seek appropriate care and their tendency to default to big-name doctors and specialists.

Hepatitis B carriers in China hailed the announcement by the Ministry of Health on December 31 that positive hepatitis B status would no longer be a barrier to schools and employment as a significant breakthrough. This announcement came four years after the publication of hepatitis B prevention and management guidelines, which stated that hepatitis B is not transmitted through general day-to-day contact such as handshakes, sharing of meals or use of public restrooms. On the Internet, 175,453 exuberant comments were immediately posted.

In January, the “Notice Regarding the Protection of Rights of Hepatitis B Surface Antigen Carriers to Education and Employment” was published for public comment. The policy statement eliminates routine pre-entry or pre-employment screening of the hepatitis B panel, which in China includes surface antigen, surface antibody, e antigen, e antibody and core antibody, except when explicitly permitted by the Ministry of Health based on justifications provided by the educational institution or employer. Alanine aminotransferase (ALT) testing for evaluating liver function is, however, permitted under this new policy. Abnormal results will trigger additional testing and medical intervention as needed. (Does this sound a little like a loophole?) Additionally, the policy includes a provision for protecting the privacy of those tested, as well as public education on the modes of transmission of hepatitis B. The policy paper was issued jointly by the Ministry of Human Resources and Social Security, Ministry of Education and Ministry of Health. The public was given a week (January 21-27) to comment by email. As of last week, a newspaper in southern China had published an editorial that pointed out some of the fallacies of this new policy. Referring to the privacy provision, the editorial suggested that protecting the rights of the infected might result in an environment that breeds suspicion and discomfort. It also suggested that the new policy diminishes the independence of institutions and their right to make their own policy decisions.

On December 31, China’s Ministry of Health published “Electronic patient record basic framework and standards (Preliminary).” Importantly, detailed records of all related expenses are required. This is another step to ensure visibility of charges and to quell continuing complaints about high medical expenses.

This preoccupation with expenses is reflected in the year-end survey conducted jointly by China’s consumer health publication and portals, which asked visitors about their overall impression of the impact of reform. (China began implementing healthcare reform earlier in 2009.) Two-thirds of the 2,073 who completed the survey were between ages 30 and 50; 55 percent were male and 45 percent were female. Only 11.6 percent felt that healthcare reform improved their access to care. When asked what the most significant practical impact was, 36 percent believed that drug prices have come down and, just as important, more are included in the national formulary for reimbursement. None of the other impacts, such as better facilities, ability to make appointments to see doctors, or a simplified payment process, was noted by 20 percent or more of the respondents. In fact, 6 percent of those surveyed said they continued going to tertiary care hospitals to seek routine care.

Experts offered perspective on why the impact of healthcare reform seems relatively minor, or, as the Chinese saying goes, like “loud thunder for just a little rain.” One expert noted that healthcare reform is a process and it will be years before significant impact can be felt by the average citizen. Another suggested that some policy changes, such as increased investment in human resources, will not have an immediate, noticeable effect on the average citizen. Another suggested that much of healthcare reform targets the older population and those suffering from chronic diseases, and both groups were not well represented among those surveyed.

There are subtle but noticeable behavioral changes. Of those surveyed, 23 percent reported that they no longer procrastinated in seeking medical care when they felt ill. An impressive 36 percent changed their habit of only visiting a clinic (at a hospital) early in the morning and are now likely to schedule their visits to the doctor during other times of the day and weekends. (Previously, patients went to hospital clinics early in the day to make sure they saw the doctor, usually a specialist, of their choice.) And 29 percent are willing to try smaller or community hospitals and resort to tertiary care hospitals only if their symptoms persist. The bias toward seeing specialists is abating as well. Even though a full 40 percent still choose the leading doctors at major hospitals, the majority now believe that it is not always necessary to head to a tertiary care hospital on the first sign of illness.

When asked about the type of improvements they are looking for, almost 50 percent wanted cost comparisons from doctors, once again suggesting that lowering healthcare costs is still a primary concern. The next most important is reducing drug costs (26 percent). The ability to make appointments with doctors ranks third (13 percent).

More sobering is the overall image of community hospitals. More than 51 percent still believe that community hospital doctors cannot meet the standard of doctors practicing at larger hospitals. Substandard facilities were cited by 35 percent of those surveyed, while 10percent felt that charges are unreasonable and another 3 percent complained about the attitude of doctors.

Five-Year Progress Report from Traditional Chinese Medicine AIDS Treatment Program

Encouraging results from a pilot program initiated in 2004 showed that 5,972 HIV/AIDS patients in 17 provinces are currently receiving free traditional Chinese medicine (TCM) treatment. The nationwide program is managed by the State Administration of Traditional Chinese Medicine (SATCM) with 160 million RMB in funding, to date, from the central government. About 25 percent of close to 6,000 patients have received uninterrupted treatment for 48 months. The results showed that TCM is efficacious for treating fever, coughing, weakness, diarrhea, shortness of breath, skin diseases, digestive diseases and other clinical symptoms, in improving and stabilizing immune function, elevating the patient’s quality of life and reducing adverse reactions to medications. The SATCM has established the AIDS Prevention and Treatment Center at the Academy of Traditional Chinese Medicine and is building regional and local infrastructure to evaluate treatment and management models. The report states that clinical trials in Tanzania initiated in 1987 have demonstrated the efficacy of dozens of TCM treatments for AIDS and identified an additional 20 TCM entities for additional research.

Heated Debates About Healthcare Cost Shifting Continue

When the opinion paper “Reform of drug and healthcare service pricing model and system” from the Ministry of Health and related government bureaus was released on November 23, one of the key premises—reducing drug costs while elevating service costs—garnered immediate, heated comments. Some typical questions raised were: Is it possible to fix the old system of subsidizing services with high drug costs? Can the doctor’s value be fully recognized? Will this reduce overall healthcare costs? Will this improve the quality of service? Here is a snapshot of the opinions voiced.

• Service fee increases do not compensate for lowered drug costs. One hospital that reduced the cost of 1,054 drugs (Western) and 562 TCM items and reduced the cost burden on patients experienced a huge increase in outpatient volume (at the expense of nearby hospitals that have not reduced prices). But the corresponding 4 percent increase in service fees is inadequate for covering the lost drug revenue, and the hospital administrator does not believe current price levels are sustainable.
• Higher service fees elevate expectations of better quality care. The hospital administrator of a major tertiary care center believes that the shift could break the vicious cycle of physicians seeking compensation by prescribing more expensive drugs. Another hospital administrator commented that improving physician compensation may encourage more young people to become doctors. But the bottom line is that higher service fees must be reflected in improved care.
• Government subsidy may be the way. The recurring theme seems to be that the rise in service fees cannot happen fast enough or substantially enough to cover the lost drug revenue. And the government needs to step in to fill the gap.