New reimbursed price for Imfinzi, Venclaxta and Blincyto

Blincyto to lower price by 4% with expanded indication

MOHW: the revised List of Reimbursed Drugs to come in effect from April

From next month, health insurance reimbursement would be granted on AstraZeneca Korea’s locally advanced non-small cell lung cancer (NSCLC) treatment Imfinzi (durvalumab) and AbbVie Korea’s chronic lymphocytic leukemia (CLL) treatment Venclaxta (venetoclax).

 

Two treatments have accepted risk sharing agreement (RSA) terms set down on the negotiation table by Korea’s National Health Insurance Service (NHIS).

 

Amgen’s leukemia treatment Blincyto (blinatumomab) would lower its price by four percent considering the financial impact for increased reimbursed use with expanded indication.

 

According to pharmaceutical industry, Ministry of Health and Welfare (MOHW) is planning to revise the ‘List of Reimbursed Drugs and Maximum Reimbursed Price’ with the said changes.

 

The revision would come in effect from Apr.

 

1.

 

◆Imfinzi: The immunotherapy has been approved to treat unresectable, locally advanced NSCLC patients with no progression after platinum-based concurrent chemoradiation therapy (CCRT).

 

The company has submitted an application to Health Insurance Review and Assessment Service (HIRA) for reimbursement listing on Dec.

 

21, 2018, immediately after receiving an approval from Ministry of Food and Drug Safety (MFDS) in the same month.

 

At a Cancer Deliberation Committee meeting convened in early November last year, HIRA has decided it would be feasible to provide reimbursement on the drug.

 

The committee’s decision was based on clinical study proven clinical efficacy improved than placebo, and also the committee judged its cost-effectiveness would accept ICER value better than the placebo.

 

The refund and expenditure cap type RSA, proposed by the company, was at an acceptable level.

 

The refund type and expenditure cap type of RSA stipulate the applicant company to pay back a set amount of drug reimbursement claim to National Health Insurance Service (NHIS), and to return a certain ratio of the claimed amount exceeding the expected cap.

 

The drug negotiated drug pricing with NHIS from then on to last month As a result, the reimbursed price of the drug would be at 3,350,930 won per 0.5 g and 804,223 won per 0.12 g.

 

◆Venclaxta: Venetoclax is an orally administered anticancer treatment used to treat CLL as third or later-line treatment, and it is approved as a monotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who have been treated with chemo-immunotherapy and B cell receptor inhibitor, previously.

 

From last May last year, the pharmaceutical company has submitted a reimbursement application to HIRA, immediately after MFDS’ green light, and received a nod from Drug Reimbursement Evaluation Committee (DREC) in last December.

 

DREC official said the treatment has demonstrated clinical efficacy and is eligible for pharmacoeconomic evaluation (PE)-exemption track.

 

The three PE-exemption track qualifications include; an anticancer used for treating life-threatening disease with no alternative option at the same level of treatment; a treatment approved by MFDS based on single-group clinical data without placebo and has difficulty producing evidential data with limited number of patients; a treatment listed for reimbursement in at least three countries out of the seven countries the committee has chosen to refer their adjusted average values.

 

A drug can qualify for the PE-exemption track after qualifying all three conditions.

 

Then after, the company has successfully reached an agreement with NHIS last month on pricing negotiation under the expenditure cap type RSA.

 

The reimbursed price would be at 4,469 won per 10 mg, 22,341 won per 50 mg, and 44,682 won per 100 mg.

 

◆Blincyto: The anticancer treatment has been approved to treat adult and pediatric patients with relapsed or refractory Philadelphia chromosome-positive or negative immature B cell acute lymphoblastic leukemia (ALL).

 

From October 2016, the treatment has been provided with reimbursement in Korea for patients at age over 18.

 

The company has applied for expanded reimbursement to HIRA in February last year, after expanding its indication to treat adult and pediatric patients with relapsed or refractory Philadelphia chromosome-positive acute ALL in January last year.

 

At the June meeting convened last year, Cancer Deliberation Committee said selective reimbursement would be granted for remission consolidation therapy to reduce non-reimbursed criteria.

 

The treatment already has essential coverage on its remission induction therapy indication.

 

Its expanded reimbursement was finalized by Drug Reimbursement Evaluation Committee (DREC) in last December.

 

DREC’s decision was based on the treatment’s clinical efficacy and its cost-effectiveness qualification for PE-exemption track for the expanded reimbursement.

 

In this month, the company has finally reached an agreement on negotiated pricing with NHIS.

 

The key was to lower the price by four percent to lessen the financial impact.

 

The negotiated price was decided at 2,346,000 won, reduced from the original price of 2,442,800 won.