The countdown has begun to provide insurance benefits for the controversial breast cancer therapy Ibrance (compound: palbociclib) made by Pfizer Korea한국화이자.
Ibrance has passed the “adequacy of benefit” assessment by the Pharmaceutical Benefits Committee of Health Insurance Review and Assessment Service(HIRA)건강보험심사평가원 early this month. And what’s left now are the drug price negotiation between National Health Insurance Service(NHIS)국민건강보험공단 and Pfizer Korea within 60 days and the final decision by Health Insurance Policy Deliberation Committee.
Ibrance that won the sales approval in August last year is very expensive. Patients with mutated breast cancer who need the drug have protested against Pfizer Korea and the government, calling for a swift conversion into insurance-covered medication. The problem is high-priced new medicines, such as Ibrance, are likely to continue to be at the center of controversy for insurance coverage.
The government has also set about to work out countermeasures. A case in point was the activation of the Pharmaceutical Benefits Management Policy Improvement Team약제관리제도개선팀 announced by HIRA last Thursday. The team set up within the Pharmaceutical Benefit Department will prepare concrete steps for the swift insurance coverage of expensive new drugs, follow-up management of the existing expensive drugs registered, and the control of drug costs concerning chronic diseases.
Korea Biomedical Review met with Lee Byeong-il이병일, general director of HIRA’s Pharmaceutical Benefit Department, to hear about the operational plans of the new team and his views about the Ibrance controversy
Q: It’s not exactly news but many people are pointing out the period to give insurance benefits to new drugs is too long.
Answer: There have been comments about the extended period from giving an approval (to new drugs) till the application of insurance benefits to them. Some anticancer medications took more than 1,000 days to get benefits. And the long non-benefit period has increased patients’ financial burdens.
The prolongation of registration for insurance coverage is due to the wide gap between the positions of drugmakers and HIRA – pharmaceutical firms call for high prices citing the high efficacy of new drugs, but the pharmaceutical benefits committee can’t often accept their requests based on their economic evaluation data alone. To narrow down the difference, the companies sometimes submit additional economic data, but it also takes much time to make, assess and these data. Moreover, if pharmaceuticals make a policy decision and multinational drugmakers have to persuade their headquarter offices, the registration can’t help but become much longer.
Accordingly, we have activated the new team to help reduce patients’ burden during the process. It will try to improve the registration methods for expensive new drugs and readjust reasonable prices and their scope of use for swiftly registered new drugs through post-registration management.
Q: Please explain in greater detail about the backgrounds to create the team and its role.
A: The management of medications for chronic diseases has become necessary as drug costs for the elderly increased. Also needed is the adjustment of administrative domains between HIRA and the Ministry of Food and Drug Safety (MFDS)식품의약품안전처 over drugs that exceed permitted extent. And under the current “positive list” system (a method to screen and register medications), there are many uncovered drugs because drugmakers have not applied for their insurance coverage. It will examine them comprehensively.
Q: Do you mean to make new systems to register insurance-covered drugs or set their prices?
A: We are examining various ways, and if we find some methods worthy of promotion, we can give shape to them and make them rules. To turn into reality the new government’s policy to turn uninsured drugs into insured ones and reduce disastrously big medical bills, we have no other choices but to readjust the administrative turf mentioned earlier, do we?
Q: You mentioned the need for readjusting administrative domains of HIRA and MFDS concerning the drugs that exceed permitted extent or the management of off-label prescription in other words.
A: Some years ago, the MFDS said it would manage off-label prescription. To use over-the-counter drugs as off-label, they have to undergo the review of medical institutions’ Institutional Review Board (IRB) and pass the screening of HIRA. In 2014, as the ministry began to manage the off-label, it asked HIRA for the application papers submitted by medical institutions. Afterward, the ministry decided the usage of off-label drugs. Citing the lack of preparations concerning the off-label use of anticancer drugs, however, it let HIRA decide it. Accordingly, we couldn’t make a long-term road map regarding the organization and workforce on the management of off-label drugs. We need to streamline it.
Also, over-the-counter drugs can be used without insurance coverage through IRB in the case of using them beyond stipulated indications. In the case of prescription drugs, however, they can use them as insured drugs if only doctors write down reasons upon prescription, although they have age limits, banned for pregnant women and prevent combined usage. Is it fair? We have to check whether some prohibitions are well kept.
Q: It will not be easy to set criteria about off-label prescription, given doctors’ autonomy about prescription.
A: That’s right. Because overuse standards for each drug have different limitations by indication, age, and pregnancy, we can’t help but wonder whether to regard these as same. Some say even though a drug has the limit by age and pregnancy, if they exceed approved standard, IRB has to discuss it.
Q: Recently, patients have actively requested the insurance coverage of Ibrance. And this has inevitably led to the criticism of Pfizer Korea and the government. As the committee decided to uncover the drug several times, their rage reached a boiling point. These patients might as well be curious about undisclosed assessment procedures.
A: Some people tend to think applying insurance coverage will be faster for drugs handed out free of charge or for which there are high demands for coverage. But these acts don’t affect the coverage or its period at all. The registration proceeds only according to rules and standards. High demand and noisy complaints never guarantee preferential tabling and screening. The passage is made only when they meet certain conditions and offer reasonable prices.
Q: Given the period and procedures taken for some expensive anticancer drugs in the market, Ibrance’s passage of the committee took a relatively short period of one year. Some people think this is owing to patients’ complaints. Are they wrong?
A: Yes, they are. Ibrance could pass the committee because Pfizer Korea reduced the price. We don’t know whether Pfizer Korea cut the price because of patients’ demands and complaints. Some drugs took more than 1,000 days to receive insurance coverage for similar reasons. Ibrance didn’t take such a long time
Q: But the government can’t ignore patients’ opinions
A: HIRA officials got many phone calls and emails in the course of handling the Ibrance case. Some patients used harsh expressions. We felt falsely charged but thought it understandable because patients are more desperate.
We have operated the system based on rules and standards but know many patients have financial burdens. This is why we created the team. We want to relieve their burdens and make the patient-centered system. From this perspective, we will make efforts to push for many projects and produce results.