Handok Pharmaceuticals, which entered the anticancer market for the first time this year, has begun laying the groundwork for a soft landing of its new cancer drugs in Korea.

Handok is reportedly running a patient support program to support drug costs for acute myeloid leukemia drug Vyxeos (cytarabine/daunorubicin), oral FGFR inhibitor Pemazyre (pemigatinib), and CD19-targeted immunotherapy Minjuvi (tafasitamab), which it introduced through the Korea Blood Disease and Cancer Association (KBDCA).

Pharmaceutical companies are selectively operating programs to support drug costs for expensive new drugs to reduce the burden of treatment costs on patients and minimize treatment gaps between drug approval and insurance coverage.

These patient support programs are usually launched at the same time as the product's reimbursement application, which shows the commitment of pharmaceutical companies to getting insurance coverage.

Moreover, Handok Chairman and CEO Kim Young-jin expressed his strong commitment to entering the anticancer market in an interview with the media earlier this year. He admitted that "Handok's weakness in the specialty pharmaceutical sector is that it has not been able to participate in the anticancer market," vowing to enter the market in earnest this year.

As Kim said, Handok has introduced three new anticancer drugs in less than a year.

The first was Vyxeo, approved by the Ministry of Food and Drug Safety (MFDS) in November last year. The company immediately applied for reimbursement but failed to set reimbursement standards at the Cancer Disease Review Committee held in June.

Ireland-based global pharmaceutical company Jazz Pharmaceuticals introduced Vyxeos. Through the development of liposomal formulations, the Irish company has improved the effectiveness of the combination of cytarabine and daunorubicin, used as intensive chemotherapy in treating acute myeloid leukemia.

Simultaneously with applying for Vyxeos benefits, Handok is supporting drug costs (2.16 million won, or $1,600 per vial) for patients who used the product within the scope of the approval. The support period has been set from Jan. 30, 2023 to April 30, 2024.

Handok's second product is the targeted therapy Pemazyre, approved by the MFDS in April. Pemazyre is a fibroblast growth factor receptor (FGFR) inhibitor developed by Incyte. It is used in Korea to treat "locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements in adults who have received one or more systemic therapies".

Notably, Pemazyre is the first FGFR inhibitor to be approved in the U.S. for use in hematologic cancers as well as solid tumors, suggesting potential for expansion in a variety of cancers.

Handok applied for insurance benefits at the same time as the approval of Pemazyre. It was on the cancer review panel’s agenda in October but was decided to be “redeliberated.” Pemazyre also has a patient support program.

Handok will provide 5.5 million won per pack (14 tablets) to patients who use Pemazyre within the scope of the approval from Aug. 1 until the “end of the program.”

Handok also brought in Minjuvi, which won approval in June. Minjuvi is a CD19-targeted immunotherapy designed to treat B-cell malignancies. It is indicated as "monotherapy following combination therapy with lenalidomide in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplantation (ASCT) and have failed one or more prior therapies.” Handok has also acquired exclusive domestic distribution rights from Incyte.

Minjuvi is undergoing a global phase 3 clinical trial, Front-MIND study, comparing R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) with lenalidomide in the first-line treatment of DLBCL. Recent data from an earlier (1b) study (First-MIND) demonstrated acceptable safety in the first-line setting and raised expectations.

In addition, global pharmaceutical giant Pfizer is conducting a collaborative study with Minjuvi as a potential partner drug for its hematologic cancer immuno-oncology candidate TTI-622 in relapsed or refractory DLBCL patients. That will likely expand the use of Minjuvi in the first-line treatment of DLBCL in combination with other immunotherapies in relapsed or refractory patients, according to Handok.

While it is unknown whether Minjuvi will be reimbursed, Handok has indicated that it will apply for insurance benefits by launching a drug cost support program for Minjuvi in October.

Handok will provide 255,000 won per vial to patients who use Minjuvi within the scope of the approval, setting the support period from Oct. 1 to "before getting insurance coverage.”