Pharmaceutical News
Comments on the Managed Entry Agreement
2018/07/22

Written by Chen Gau-Tzu/ President of the Taiwan Drug Relief Foundation

The Taiwan Alliance of Patients’ Organizations (TAPO) has successfully submitted the petition for speeding up the NHI reimbursement for immunotherapies for cancers.  The NHIA’s reply to the petition gives hope for the NHI listing of anti-cancer drugs.

In order to expedite the NHI listing of new drugs, the NHIA proposed the “Managed Entry Agreement (MEA)”, which is now waiting to be approved by the MOHW.  Under the MEA, the reimbursement prices of new drugs are available for public access on the internet.  However, drug companies are obliged to return part of the payments according to the terms in the Agreement.  By doing so, the NHI actually pays less than the listed prices which can be used as a pricing reference for international marketing.

The clawback provision can be based on drug efficacy or a financial plan.  The financial plan implies that drug companies have to return a certain percentage of the drug fees if the total payment exceeds a pre-determined threshold.  The efficacy-based clawback provision requires drug companies to return the payment based on the treatment results. 

The concept of risk sharing has been adopted by many countries; but, the details of the risk sharing plans are mostly kept confidential.   Risk sharing is a reasonable concept.  However, according to the NHIA’s proposal, the payment criteria are a bit ambiguous.  Some cases will be reimbursed as long as they are alive; but some cases will not be reimbursed even though their quality of life is greatly improved.  The criteria are based on the results of clinical trials.

New drug clinical trials are conducted by doctors. The results are published in medical journals. Doctors have to carefully prescribe suitable drugs for patients and closely monitor the efficacy and side effects. For doctors, drugs are one of their weapons for defeating diseases.

If drug companies are to shoulder a large proportion of treatment responsibilities due to the MEA, the role played by doctors seems less important because patients’ health is actually at the hand of drug companies.  Under such circumstances, would it affect drug company’s decisions to introduce new drugs into Taiwan?  Would the new drug launch in Taiwan be later than in other countries, e.g. China and South Korea?

Hospitals are under the pressure of increasing medical demand and treatment fees while performing their duties of caring the patients and taking risks.  That’s part of the reasons why some hospitals are against the inclusion of new drugs into the NHI Benefit Scheme as it may lower the reimbursement point value.

Therefore, I personally suggest that all stakeholders should jointly share the cost and responsibility of introducing new medical technology.   The NHIA should provide better payment prices and monitor the misuse and abuse of the system.   Hospitals should be self-sufficient rather than profit-driven.   The patients should understand the NHI financial pressure, cherish the resources and consider sharing some costs if necessary.

【2018-07-09/ United Daily News】