Reimb discussions restart for BMS’s Camzyos in KOR

Will the NA audit results help the oHCM drug be listed for reimbursement?

Pfizer’s Lorviqua, whose reimb discussions fell through, may be rediscussed…will likely skip the DREC review stage

The National Health Insurance Service was found to have restarted reimbursement discussions for the obstructive hypertrophic cardiomyopathy treatment Camzyos (mavacamten, BMS).

 

BMS and the NHIS entered into drug price negotiations for Camzyos in August but failed to reach an agreement within the 60-day deadline.

 

However, the deadline has been extended, and it is expected that the company may be able to list the drug for reimbursement as early as next month.

 

In particular, there are opinions that the criticisms made during the NA audit may have accelerated the drug’s reimbursement discussions.

 

Lorviqua, whose reimbursement progress was also criticized during the NA Audit, may likely skip the Drug Reimbursement Evaluation Committee review and re-enter into negotiations with the NHIS.

 

According to industry sources on the 24th, during the NA Health and Welfare Committee’s Audit that ended on the 23rd, Democratic Party of Korea Rep.

 

Hee-Seung Park inquired about the Camzyos’s reimbursement progress and requested its prompt reimbursement.

 

Camzyos’s reimbursement has been in the drug price negotiation stage since early August.

 

The deadline for negotiations was 60 days, so an agreement was supposed to be reached in early October.

 

In response to Park's inquiry, the NHISon explained, “Based on DREC’s review results, we are in the process of negotiating with the company to set an appropriate drug price and expected claims amounts, and signing the risk-sharing agreement.

 

However, during the current negotiation process, the pharmaceutical company requested a pause in the negotiation as it needed time to submit additional data, upon which the NHIS accepted the request and extended the negotiation deadline.” In other words, the period needed to submit the additional data was excluded from the negotiation period, which was why the deadline was extended.

 

“In order to ensure access to new drugs for the active treatment of cardiomyopathy patients while minimizing the financial burden, we plan to closely review the financial impact data such as patient size and market share submitted by pharmaceutical companies and clinical literature to reflect the financial impact and clinical value of the drug under negotiation,” said the NHIS.

 

Camzyos had been the focus of recent media coverage, as well as the NA audit, to ensure expedited access for the patients.

 

As a result, payers are also reportedly considering expediting its reimbursement.

 

As such, negotiations have resumed, raising the possibility of the drug being listed as early as next month.

 

However, time is running out to finalize and report the negotiation results to the Health Insurance Policy Review Committee meeting that will be held next week.

 

If not next month, there is still a good chance of reimbursement by December.

 

Also, industry eyes are on whether Lorviqua (lorlatinib, Pfizer), which had failed negotiations with them in June, will enter into negotiations again.

 

Lorviqua is a treatment for ALK (anaplastic lymphoma kinase)-positive NSCLC that was in the process of extending its reimbursement to first-line treatment.

 

Initially, the company submitted an application to extend the drug’s reimbursement standards as an Expenditure Cap type RSA, but after negotiations broke down, the company reapplied for the drug’s reimbursement through the general listing pathway.

 

According to the regular procedure, the drug must be first reviewed by HIRA’s Drug Reimbursement Evaluation Committee to start negotiations with the NHIS, but as it is a special case where the drug is switching its status from RSA to general listing, there is a high possibility that the government will simplify the procedure.

 

during the NA Audit on the 16th of this month, Dong-Kyu Lee, Director General of MOHW’s Bureau of Health Insurance Policy, said, “We are currently in negotiations with the pharmaceutical company,’ and showed a proactive stance, saying, “We will complete negotiation as soon as possible for the benefit of the patients.’ As a result, the industry expects Lorviqua’s reimbursement agenda may skip the DREC stage and restart negotiations with the NHIS.