Failed reimb negotiations for Lorviqua, was it for the best?

Reimbursement negotiations break down over RSA Expenditure Cap Type amount issue

Flexible administration is needed, including converting the application to general listing

After a long wait, the result was still a ‘no go.’ A solution does exist, but hesitation seems to be holding them back.

 

The insurance reimbursement expansion for the 3rd-generation ALK anticancer drug Lorviqua to first-line therapy has become unclear again.

 

Negotiations between Pfizer Korea and the National Health Insurance Service on the drug price of the ALK-positive NSCLC treatment Lorviqua (lorlatinib), which passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review in January and began in March, recently broke down.

 

This is the first time negotiations have broken down for a drug seeking reimbursement expansion risk-sharing agreement (RSA) scheme.

 

The reason for the breakdown is believed to be related to the ‘expenditure cap amount’ rather than 'drug price'.

 

Lorviqua was granted pharmacoeconomic evaluation exemptions when it was first listed.

 

Such PE exemption drugs are required to be reimbursed through the RSA Expenditure Cap Type scheme.

 

As such, a new cap amount would have been derived to account for the increased usage due to the expanded reimbursement during negotiations, and it is likely that Pfizer was unable to accept it.

 

Pfizer's unacceptance may be seen as greed on the pharmaceutical company’s part.

 

However, negotiations are always conducted within a set framework.

 

Pfizer did conduct a pharmacoeconomic evaluation as part of the reimbursement expansion process.

 

So the solution would be to eliminate the disputed expenditure cap requirement and convert Lorviqua to a drug listed through the general process.

 

The other ALK anticancer drugs available in the market - the 1st generation drug ‘Xalkori (crizotinib),’ 2nd generation drug ‘Alecensa (alectinib),’ ‘Zykadia (ceritinib)’ – were all listed through the general track.

 

In fact, Pfizer offered to switch Lorviqua’s reimbursement path to general listing during negotiations, but the government turned it down as it was "unprecedented," and that hesitation led to the breakdown of negotiations.

 

However, patients are left to suffer the damage.

 

It's important to make things work.

 

If necessary, there's no reason not to take the road less traveled.

 

Moving RSA drugs to the general track will also ensure additional price transparency.

 

Pfizer quickly announced plans to reapply for reimbursement expansions.

 

A company spokesperson said: "We are disappointed that final negotiations were unsuccessful.

 

We plan to reapply for first-line reimbursement as soon as possible to ensure patient access to the treatment and we will do our best to engage in effective discussions with the government and facilitate a forward-looking review.” As such, its progress upon reapplication will also be interesting to watch.

 

This was the e first time RSA negotiations have failed.

 

After the unprecedented event, starting the process all over again would be a lengthy process.

 

Regardless of whether reimbursement is expanded or not, the government would need to be flexible in its administration to achieve a quick result.

 

Lorviqua was specifically designed and developed by Pfizer to penetrate the blood-brain barrier (BBB).

 

The drug’s high clinical value as a first-line treatment was recognized in the 5-year long-term follow-up results of the CROWN study that was presented at ASCO.

 

Results showed that Lorviqua reduced the risk of disease progression or death by 81% compared to crizotinib, with 60% of patients surviving without disease progression at 5 years.

 

The risk of brain metastasis progression was reduced in 94% of patients, with only 4 of 114 Lorviqua-treated patients without brain metastases developing brain metastases.