“Lowest A7 price for latecommer PE-exempted RSA drug”

HIRA presents Review Criteria on New Drug and Negotiating Drugs

Expanding RSA eligibility to improve coverage, accepting public opinion until June 11

When a first-in-class drug is listed with risk sharing agreement (RSA), a follow-on pharmacoeconomic evaluation (PE)-exempted drug would be reviewed for reimbursement feasibility with price higher than the lowest A7-adjusted price.

 

And the revised review criteria added a phrase, ‘only referring to drugs with public health insurance reimbursement in foreign countries or equivalent level of coverage,’ for reviewing international adjusted average price based on overseas reimbursement listing status.

 

Korea’s Health Insurance Review and Assessment Service (HIRA) is accepting public opinion for 80 days until June 11 on the revised ‘Review Criteria on New Drug and Negotiating Drugs’ with the said changes.

 

The review criteria has been set to provide basis for the Article 11-2 of Rules on National Health Insurance Reimbursement Standard, the Article 7 of Pharmaceutical Decision and Adjustment Standards and the Article 4 of Regulation on Pharmaceutical Reimbursement Listing Evaluation Standard and Procedure.

 

The revised notice preannounced by Ministry of Health and Welfare (MOHW) includes details of applying RSA on follow-on drugs, which HIRA has specified by setting down ‘Evaluation Criteria on Drugs Applied with Manufacturer’s Compliance Terms (RSA).’

For RSA eligible drug groups, MOHW has included drugs exempted from PE data submission among drugs reviewed as cost-effective for reimbursement.

 

HIRA defined drugs that fall under ‘the Article 6-2 of Regulation on Pharmaceutical Reimbursement Listing Evaluation Standard and Procedure’ are the RSA applicable subjects.

 

These drugs could be subject to RSA when qualifying conditions with their main indications.

 

But, even drugs qualifying with additional indication could be applicable as well, if the main indication has been verified as cost-effective.

 

The standard of a ‘main’ indication depends on the patient size.

 

One of the PE exemption conditions, ‘the committee evaluates the subject patient size is too limited for evidence development,’ is decided based on the reimbursement beneficiary patient size (within Korea) and projected patient size status.

 

Regardless of the Article 6-2, a reimbursement-seeking follow-on drug with treatment level equivalent to first-in-class PE-exempted RSA drug would follow the evaluation criteria and post-management standards of the first-in-class drug.

 

These drugs’ pricing would be decided based on the lowest of adjusted price from A7 countries (the U.S., the U.K., Germany, France, Italy, Switzerland and Japan).

 

The labeled price for the refund type RSA would be decided considering the price offered by the pharmaceutical company, and the offered price should be higher than the lowest A7 adjusted price.

 

But in case the estimated selling price (actual price) offered by the company is higher than the evaluation standard price, the company may offer unit cost of the applicant drug taking the lowest A7-adjusted price into account.

 

A Korean-developed drug approved first time in the world in Korea, with reimbursement listing in three A7 countries, would be priced considering lowest A7-adjusted price of a same-class drug, and the ones with listing in less than three A7 countries would receive price decided by Drug Reimbursement Evaluation Committee (DREC) based on 10 percent premium on the highest price of alternative drug and external adjusted price of same-class drug.

 

A phrase stating ‘only referring to drugs with public health insurance reimbursement in foreign countries or equivalent level of coverage’ has been added to the definition of foreign adjusted average price, as a part of overseas listing status evaluation criteria.