[Reporter's view] Improving guidelines excluding PVA

The NHIS announced the revision of Article 6 (1) and (2) of the Price-Volume Agreement (PVA) detailed operation guidelines for "Article 6 (Drugs Excluding Negotiations)." According to the policy, The NHIS guidelines will be implemented immediately after the revision is made, but this time, they will be applied from January 1 next year after inquiring opinions as opposition from the pharmaceutical industry is expected.

 

The revision calls for expanding the "same product group with an annual claim of less than 1.5 billion won" to "less than 2 billion won" in Paragraph 1, Paragraph 2, "items with an upper limit of less than the arithmetic average of the main component code." The NHIS unveiled a plan to improve the PVA (excluding) system at the 10th public-private consultative body held on the 2nd.

 

The reason is that PVA has been reserved for drugs with small insurance financial savings in consideration of the burden of the pharmaceutical industry and administrative costs required to conduct drug price negotiations, but guidelines have been improved due to various problems.

 

When the health authorities made the guidelines in 2014, the standard for making the exclusion clause for PVA was a drug with a small effect on insurance financial savings.

 

While operating PVA for 7 years and 4 months, drugs with a large effect of reducing insurance finances were often excluded from negotiations for reasons below the arithmetic average, or they voluntarily cut drug prices to avoid PVA.

 

These drugs included blockbuster drugs with an annual claim of more than 80 billion won, which went against the PVA system.

 

As a result of the NHIS' analysis of drugs that have avoided PVA negotiations with voluntary cuts within the past two years, a total of 39 drugs have been cut by 1 won, and some of them have exceeded the arithmetic average price.

 

If the NHIS suddenly lowers its arithmetic average exclusion standard from 100% to 90%, the pharmaceutical industry will face a backlash.

 

The NHIS said it has set the PVA negotiations to be omitted if it accepts a 10% drop in drug prices according to the "weighted average of alternative drugs 90%" of the new drug negotiations criteria.

 

Like new drugs, it means to voluntarily cut 10% of the usage, or otherwise proceed with the NHIS and PVA.

 

PVA will be able to proceed smoothly if it is a pharmaceutical company that makes a trick at the arithmetic average price, but it is also understandable that the pharmaceutical industry will protest if the arithmetic average price is reduced by 1%.

 

There is no reason for the pharmaceutical industry to oppose the expansion of claims for the same product group under paragraph (1) 1.

 

If the NHIS' simulation results raise the billing amount from 1.5 billion won to 2 billion won, 23 out of 59 items under the same regulation that completed PVA negotiations this year will be excluded from the list.

 

The NHIS will receive opinions from the pharmaceutical industry on the PVA guidelines containing such information.

 

KPBMA, KRPIA, and KOBIA, which have already participated in public-private consultations, have opposed the revision of the guidelines.

 

There are two main contents of this amendment.

 

The pharmaceutical industry may want only the criteria for expanding the amount of claims to be reflected and the criteria for reducing the arithmetic average to be not reflected.

 

However, the NHIS may not be meaningful in improving the PVA guidelines with just one thing.

 

The association's opinion is important during the opinion inquiry period, but it is also important to reflect the opinions of individual pharmaceutical companies according to their size.

 

This is why it is important for pharmaceutical companies to express their opinions on improving PVA guidelines during this period.