Why Tagrisso and Opdivo failed reimbursement expansions

Background on why the two drugs did not pass the last CDRC meeting

Failed to convince authorities of the drugs’ cost effectiveness despite proposing progressive cost-sharing proposals

Opdivo proposed standards based on Europeans, “More expensive than the existing standard”

The 3rd generation targeted therapy for lung cancer, ‘Tagrisso (osimertinib)’ once again failed to expand reimbursement to first-line treatment.

 

The reason was that the drug was more appropriate as a second-line treatment in terms of cost-effectiveness.

 

By failing to expand reimbursement at the last Cancer Drug Review Committee meeting held this year, the two drugs will not have to wait until the next year to reattempt reimbursements.

 

#According to the industry on the 26th, the National Health insurance Service held the 8th Cancer Drug Review Committee meeting on the 24th to deliberate on the reimbursement standards for drugs used by major cancer patients.

 

As the last meeting planned for the year, the blockbuster drugs that were delayed deliberation due to data submissions from pharmaceutical companies and collecting academic opinions, the agenda of expanding reimbursement of the drugs was finally put on the table for deliberation.

 

One representative drug that was put on the agenda for discussion was ‘Tagrisso (Osimertinib).’ With Tagrisso, which failed to extend reimbursement 3 times after adding an indication as a first-line treatment in lung cancer in December 2018, its company, AstraZeneca had attempted to receive approval once more with a more progressive cost-sharing plan.

 

However, the company once again ‘failed.’ AstraZeneca had presented results from Phase III clinical studies conducted in China among others to support the need for extended reimbursement, however, the evidence provided by the company was not sufficient enough to convince the CDRC members.

 

At the same time, the reimbursement approved for Tagrisso’s competitor, Yuhan Pharm’s ‘Leclaza (lasertinib),’ from the second half of this year as second-line treatment had also influenced the CDRC results.

 

A CDRC official who requested animosity said, “We concluded that the use of Tagrisso or Leclaza as second-line treatment in line with the current reimbursement standards was more cost-efficient than using Tagrisso first-line as proposed.

 

The cost-sharing proposal submitted by AstraZeneca was also adjusted and improved than before, it was not satisfactory.

 

“ He added, “The discussions had been put on hold in the first half of this year because the level proposed by the company was not satisfactory in terms of cost-effectiveness.

 

The other data submitted, such as the Chinese trial, were just referenced.” The CDRC also postponed the reimbursement extension for the cancer immunotherapy ‘Opdivo(nivolumab).’ Its company had applied to extend its reimbursement standards for melanoma, non-small-cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, head, and neck cancer (240mg 2 weeks/480mg 4 weeks), but was unable to pass CDRC review.

 

The CDRC official said, “Opdivo’s dosage was increased based on Europeans.

 

Opdivo’s 240mg dose may be applied to Europeans in consideration of the 1kg/3mg dose recommendations as they weigh over 80kg.” He continued, “However, the average weight of Koreans is different from that of Europeans.

 

They do not exceed 80 kg.

 

Therefore calculating the dose by kg/3 mg is more cost-effective, but the company is attempting to expand reimbursement at a higher price.”