Polivy granted partial reimbursement after 5 years

A drug that remained non-reimbursed for 5 years… granted reimbursement as part of a combination therapy

The first first-line treatment introduced for DLBLC in 20 years... Keytruda combination therapy for cervical cancer is also newly approved

Reclassification of Tier 1 and 2 anticancer drugs... Review of old treatment regimens announced in the past

Roche’s Polivy (polatuzumab vedotin), a treatment for diffuse large B-cell lymphoma (DLBCL) that is currently non-reimbursed in Korea, has been added to the reimbursement list as a part of combination therapy.

 

With the listing, the other drugs used in the combination, excluding Polivy, will be reimbursed.

 

This measure is in accordance with the partial reimbursement policy for combination cancer therapies that was implemented in May.

 

On the 26th, the Health Insurance Review and Assessment Service announced the reimbursement criteria for anticancer drugs and announced 2 new partial reimbursements for combination anticancer therapies that included Polivy.

 

Partial reimbursement for combination therapy using anticancer drugs grants reimbursement to already covered drugs that are included as part of combination therapy.

 

Previously, combination therapies were not covered by reimbursement unless they were officially added as a whole to the reimbursement criteria.

 

The Ministry of Health and Welfare implemented this policy in May, and earlier this month, HIRA announced 35 therapies to clarify the general principles.

 

HIRA plans to review applications for partial reimbursement for combination therapy submitted by academic societies and make additional revisions as necessary through its Cancer Disease Review Committee.

 

As a result, two combination therapies will be added to the partial reimbursement list in July.

 

Polivy is the first first-line treatment for DLBLC in 20 years, but it has faced difficulties in obtaining reimbursement since its approval in 2020.

 

As a result, it remains non-reimbursed to date.

 

The combination therapy included in the partial reimbursement criteria this time is " polatuzumab Vedotin(non-reimbursed)+rituximab, cyclophosphamide, doxorubicin, and prednisone/prednisolone (R-CHP)" for treatment-naïve adult patients with Diffuse Large B-Cell Lymphoma (DLBCL).

 

HIRA plans to apply reimbursement for all drugs except Polivy.

 

A combination therapy for cervical cancer that uses the immuno-oncology drug Keytruda (pembrolizumab) has also been added.

 

As with the previous case, partial reimbursement will be provided, so all other drugs will be reimbursed excluding Keytruda and Avastin (bevacizumab).

 

The treatments granted partial reimbursement are: pembrolizumab + paclitaxel + carboplatin ± bevacizumab and pembrolizumab + paclitaxel + cisplatin ± bevacizumab.

 

Reimbursement will be applied to patients with recurrent, metastatic (stage IV) cervical cancer or stage IB2 or higher that meet one or more of the following conditions: ▲positive pelvic lymph nodes (pelvic LN) after surgery, ▲positive para-aortic lymph nodes (para-aortic LN) after surgery, or ▲positive parametrium after surgery (stage I or higher, palliative treatment).

 

The reimbursement criteria also include revisions to Tier 1 and 2 anticancer drugs.

 

HIRA explained, “When the criteria were first established in 2006, in the details regarding the application criteria and methods for reimbursement of drugs prescribed and administered to cancer patients, drugs subject to re-evaluation, orphan drugs, or drugs with potential for abuse were classified as Tier 2 drugs and was granted use within the scope of its reimbursement criteria.

 

Tier 1 drugs were to be administered at the discretion of the doctors within the scope of the indication and general principles for anticancer therapy." "However, since the initial enactment, new clinical evidence is being updated every year due to drug price fluctuations, the listing of generic drugs and many new high-priced anticancer drugs, and the development of new drugs with new mechanisms of actions, rendering it necessary to review the old treatment guidelines (mainly the deletion of Tier 1 anticancer drugs that are highly toxic and ineffective and the reclassification of Tier 2 anticancer drugs) and recommend the use of anticancer treatments that are more clinically proven and safer for the public.

 

In this regard, we gathered opinions from academic societies and held TFT meetings on improving the reimbursement criteria for anticancer drugs to establish a reimbursement criteria (draft) for anticancer drugs.

 

After final discussions by the Cancer Disease Deliberation Committee, we established new reimbursement criteria for anticancer therapies that removed the classification of anticancer drugs into Tiers 1 and 2.” However still, for cancers that are difficult to establish clinical evidence due to the small number of drug options and patient population, the current system will be maintained.

 

Detailed information on the revisions can be found on the HIRA website (System/Policy → Drug Criteria Information → Drugs and Therapies Used for Cancer).