Reasonable compromise between industry-govt is key

Lacks a level of evidence but is used to promote drugs drug

Administrative costs are also burdensome... a government-led registry should be established

The pharmacoeconomic evaluation exemption system has received unflattering attention since its implementation.

 

It is no wonder that the government has been gathering voices in support of its 'reduction' under the pretense of 'improvement'.

 

The PE exemption system is the only system in Korea's insurance policy landscape that helps patients with rare diseases and rare cancers get the treatments they need.

 

Applying double pricing through risk-sharing agreements (RSAs) and other measures has also contributed to reducing barriers and improving access to new drugs, but the PE exemption system has made otherwise impossible acceptance possible.

 

But always, the government has to work with a limited amount of finances.

 

This is why the government’s proposed plan to use RWD for reevaluations is also seen as a ‘reduction’ measure.

 

-The growing interest in RWD and the industry's original sin How did RWD come to be in the spotlight?

 

Of course, it's not a new concept, but the pharmaceutical industry is the one that has mentioned RWD and RWE.

 

As mentioned in the first part of the feature article (Is RWD needed for post-listing control of PE-exempt drugs?), the level of evidence for RWD is lower than that of randomized controlled trials (RCTs).  As the KRPIA points out, the results can vary depending on the intentions of the entity collecting the data, and there is a high risk of bias.  However, multinational pharmaceutical companies have been actively promoting RWD data of their new drugs whenever it is released.

 

Especially when the research results on Asians and Koreans were released, they were often covered in articles and discussed in interviews.

 

It is not uncommon to see comments from experts who highly regard the evidence level of RWD.

 

The RWD includes patients with higher disease severity than RCTs but the results are good, it is highlighted even more.

 

In other words, data with a low level of evidence is being used to promote the efficacy of a drug.

 

Re-evaluation of PE exemption drugs is a different story.

 

But it's worth asking whether the industry is really finding it difficult to collect the data and whether it could have been more proactive in discussing with the government to find a compromise.

 

As one MA (Market Access) representative at a multinational pharmaceutical company said, “I know that the industry has used RWD to its advantage.

 

However, we do not have RWD available for all of our drugs, and it is very costly to extract the data.

 

It is clearly unreasonable to unilaterally request RWD for the evaluation of PE exemption drugs.” “And even if the RWD results are better than RCTs, it is unlikely that they will increase the price of the drug.

 

It is more likely that they will raise the barrier and act as a mechanism for price reduction.”

Post-listing control will nevertheless be added to the system...then what? So what can be done?

 

In single-arm trials, uncertainty exists in the control group even for RWD, which makes it difficult to conduct PE evaluations that require a comparator-control analysis.  The industry argued that the indirect comparison guideline should be revised to allow more drugs to be evaluated using meta-analysis of all available data, which would then increase pharmacoeconomic evaluations.

 

Various post-listing mechanisms have led to a 50% reduction from the initial listing price of drugs that have comparator drugs that were listed a long time ago or become off-patent.

 

For example, clinical reevaluation and the price ceiling amount reevaluations were conducted the previous year, and a reduction in the actual transaction price, a revision of the price-volume agreement system, and external reference pricing reevaluations were set to be conducted this year.

 

However, it is also clear that the number of high-priced anti-cancer drugs and orphan drugs is increasing rapidly, and there will be more drugs that would want to seek listing through the PE exemption system.

 

KRPIA emphasized, “To improve the system in practice, the government, along with researchers who have experience in building pharmacoeconomic evaluation data, and the pharmaceutical industry that is required to submit the data, should work together to come up with an improvement plan to ensure that innovative treatments are supplied promptly to patients.” “We are not saying that we will look at RWE unconditionally.

 

We prioritize RCTs or equivalent data and consider alternatives when this is not possible.

 

We are well aware that the level of data evidence is very important, as is the opinion of the industry.

 

We will continue to listen to the stakeholders' views on the burden of administrative costs on industry and the establishment of a national registry.”