Changes to Price-Volume Agreement (PVA) negotiation guidelines

Expansion of one-time rebate scope

Inclusion of one-time rebates for usage increases driven by low birth rate policies

The scope of drugs eligible for one-time rebate contracts as an alternative to permanent price cuts during Price-Volume Agreement (PVA) negotiations will be expanded.

Under the government's policy to address low birth rates, drugs reported increased use due to expanded coverage for infertility procedures will now be eligible for one-time rebate agreements.

When medicines from national stockpiles are deployed to respond to legal infectious diseases, they will be included in the list of drugs excluded from PVA negotiations.  

On the 11th, according to industry sources, the National Health Insurance Service (NHIS) is collecting opinions on the draft amendment to the "Detailed Operating Guidelines for Price-Volume Agreement Negotiations" until this afternoon.

The NHIS aims to clarify the targets for one-time rebates, which serve as an alternative to price cuts, and expand their scope by establishing new criteria.

As these regulations were originally introduced in response to COVID-19, the targets have been clarified as follows ​▲Cases where a production/import request or administrative action from related agencies is confirmed for responding to an infectious disease at the 'Caution' level or higher of the crisis alert ▲Cases where it is confirmed through related agencies that an unavoidable supply disruption or shortage occurred for the sole alternative to the negotiated drug during the year preceding the analysis period due to issues with production facilities or raw material supply.

Furthermore, a new clause has been established for cases where the use of drugs under 'infertility procedure reimbursement standards' has increased due to expanded policy support, such as changes to reimbursement criteria.

Inclusion in these categories does not automatically mandate a one-time rebate contract. The new regulation also allows for the adjustment of the negotiation reference price for one-time rebate targets.

Regarding drugs excluded from negotiations, drugs under a Risk Sharing Agreement (RSA) will be removed from the exclusion list. Drugs used as state-stockpiled materials to respond to legal infectious diseases will be added.

For ingredients classified as national stockpiled materials under the Act on the Prevention and Control of Infectious Diseases, any usage of these stockpiled drugs for legal infectious disease response will result in an exclusion from PVA negotiations.

In contrast, considering the purpose of the RSA, which is to share the uncertainty of the impact on insurance finances, relevant drugs will no longer be eligible for exclusion from negotiations.

The definition of 'voluntary price reduction,' which qualifies a drug for exclusion from negotiations, will also be clarified. Currently, items where the 'reduction rate through voluntary application is greater than the reduction rate according to the negotiation reference price' are excluded from negotiations.

However, this will be restricted so that voluntary price reductions resulting from evaluation outcomes, such as reimbursement adequacy re-evaluations or prior price cuts for reimbursement expansion, or those following specific contract terms with the NHIS do not qualify for exclusion.

The updated PVA negotiation guidelines containing these details will be implemented following the opinion-gathering period and will apply starting with drugs currently undergoing monitoring or negotiation.