The third-generation targeted drug Lorlatinib has been launched in China. What is the price status and how can patients save the most money by using the drug?

Recently, as targeted therapies for lung cancer continue to be updated, a much-anticipated new drug - Lorlatinib (Lorlatinib) has once again become a hot topic of public opinion due to its powerful ability to "extend life" and has become the focus of manyALK-positive non-small cell lung cancer (NSCLC) patients and their families.

Today, with the rapid replacement of targeted drugs, after the first-generation crizotinib, second-generation alectinib, brigatinib and other drugs have been released one after another, the third-generation ALK inhibitor lorlatinib is gradually becoming a new hope for late-stage ALK-positive patients with its remarkable ability to respond to drug-resistant mutations. So, how is the launch of this "new generation of blockbuster drug" in China? Is it expensive? Can it be included in medical insurance? Are there alternative purchasing channels abroad? This article will give you a comprehensive answer.

1. ALK New hope for patients with positive lung cancer: Lorlatinib is officially approved for marketing

In 2022, China’s National Food and Drug Administration (NMPA) officially approved Lorlatinib (Lorlatinib) for marketing in China, which is suitable for Patients with pan>ALKpositive metastatic non-small cell lung cancer (NSCLC), including those who have developed drug resistance after previously receiving ALK inhibitor treatment. This approval marks the entry into the era of "third-generation ALK inhibitors" in the field of precision treatment of lung cancer in China.

Lorlatinib was developed by Pfizer and was first approved by the USFDA in 2018. It is used to treat patients who have previously received at least AALKinhibitor for ALKpositiveNSCLC patients. Compared with previous generation drugs, lorlatinib has stronger central nervous system penetration and is particularly effective for patients with brain metastases. In addition, it also shows significant efficacy against refractory drug-resistant mutations such as G1202R mutation, and is known as "the ultimate weapon against ALK resistance."

2. Detailed explanation of the mechanism of action and clinical advantages of lorlatinib

Lorlatinib is an oral small molecule tyrosine kinase inhibitor (TKI). Its main target is the ALK and ROS1 fusion genes. Its clinical advantages include:

1.Breakthrough brain metastasis control: Lorlatinib can effectively penetrate the blood-brain barrier, and the response rate to brain metastases is as high as 81%, which is better than the previous generation TKI;

2.Solving the problem of drug resistance: It has strong inhibition on multiple second-generation ALK-TKI drug-resistant mutations, especially G1202R;

3.Clinical research data support: inCROWN In phase III clinical studies, the progression-free survival (PFS) of patients treated with lorlatinib in the first line has not yet been reached, while the median PFS of aletinib is 11.1 months.

These data show that lorlatinib is not only suitable for treatment after drug resistance, but is also expected to become a new standard for first-line treatment in the future.

3. Lorlatinib price situation: The comparison between domestic and foreign countries is obvious. How to choose a more economical one?

At present, lorlatinib has been launched in mainland China and has been officially included in the medical insurance catalog, but the price is still high. The following is a price comparison at home and abroad:

It can be seen that for patients who are not covered by medical insurance or have a heavy financial burden, it is more economical to choose foreign generic drugs or original versions, especially those from regular pharmaceutical manufacturers such as Incepta in Bangladesh and LUCIUS in Laos. The price is only about 1/10 of the domestic price.

4. Medical insurance reimbursement strategy: How to get the maximum subsidy?

According to2023 version of the National Medical Insurance Directory, lorlatinib has been included in the scope of medical insurance, but the implementation details of medical insurance vary slightly in different regions. Patients who want reimbursement usually need to meet the following conditions:

1.ALK positive confirmation: A genetic test report issued by a regular medical institution is required, which is clearly positive for ALK fusion.

2. Compliant indications for medication: either first-line or second-line treatment is acceptable, and a doctor must evaluate the condition before issuing a prescription.

3.Prescribe medication in designated hospitals: Only when a prescription for lorlatinib is issued at a designated medical insurance pharmacy or hospital can you use medical insurance settlement.

4.Outpatient chronic disease registration/Special disease reimbursement: In some areas, higher reimbursement ratios can be obtained through the registration of "chronic diseases/special diseases".

It is recommended that patients contact the medical insurance center or cancer hospital in their city before seeking medical treatment to learn about the latest policies.

5. Are generic drugs reliable? How to judge quality and safety?

Many patients choose foreign generic drugs due to cost considerations. So are generic drugs reliable? The answer is: choose generic drugs produced by regular pharmaceutical factories, whose quality is guaranteed.

Criteria for judging high-quality generic drugs:

1.The manufacturer has WHO certification or PIC/SQualification;

2.The drug ingredients are consistent with the original drug (generic nameLorlatinib);

3.Pharmaceutical equivalence: most generic drugs have been verified through bioequivalence experiments;

4.English packaging, batch number, and production date can be provided to avoid purchasing fake medicines;

5.Recommended brands: LaosLucius, BangladeshIncepta, Beximco, etc.

However, generic drugs have not yet been certified by ChinaNMPA and are legally "imported for personal use". Patients are advised to use them through formal channels and under the guidance of professional doctors.

6. Answers to frequently asked questions by patients

1. What are the common side effects of lorlatinib?

Common adverse reactions include: high cholesterol/Triglycerides, cognitive impairment, peripheral neuropathy, edema, weight gain, etc. Some patients may also experience irregular heartbeat, elevated liver enzymes, etc.

2. Can I take lorlatinib for a long time?

Yes, lorlatinib is designed as a long-term targeted drug. It is generally recommended to continue taking it until disease progression or intolerable adverse reactions occur. Discontinuation or reduction of dosage should be done under the guidance of a doctor.

3. Which one is better, lorlatinib, alectinib or brigatinib?

Lorlatinib is a third-generation ALK inhibitor, which is more advantageous in treating brain metastasis and drug-resistant mutations. While alectinib is suitable for first-line patients, brigatinib is effective against some drug-resistant mutations. The decision should be based on the patient's specific mutation status and medication history.

4. Can lorlatinib be used in combination with other drugs?

In some cases, doctors may recommend combination chemotherapy or immunotherapy. However, lorlatinib has certain effects on liver enzyme metabolism, so care should be taken to avoid co-administration with CYP3A inducers or inhibitors.

7. Expert opinion: Lorlatinib is changing the treatment landscape ofALK positive lung cancer

"The launch of lorlatinib provides a more precise treatment option for patients with ALK positive non-small cell lung cancer. Especially for patients with multi-line drug resistance or brain metastasis, it provides a breakthrough effect." - Professor Lu Guoliang from Sun Yat-sen University Cancer Hospital commented.

In the future, with the accumulation of real-world data, lorlatinib may be more widely used in first-line treatment and become the "core weapon" for targeted treatment of lung cancer.

8. Conclusion: Choose lorlatinib rationally and use the right drug.“Worth the money spent”

The launch of lorlatinib and medical insurance coverage have greatly improved the survival hope of patients with ALK positive lung cancer. Although the price of original drugs is relatively high, with the negotiation of medical insurance, the popularity of generic drugs, and the transparency of overseas drug channels, patients can more flexibly choose the medication path that suits them.

Using medicine is not only "treating diseases", but also "investing in life". Mastering the latest drug information and choosing channels rationally may save families unnecessary financial burdens and buy patients more time to survive.

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References:

1.FDAOfficial website aboutLorlatinibapproval information

2.National Medical Insurance Administration2023Announcement on Drug Catalog Adjustment

3.CROWN III phase clinical study results

4.Chinese Society of Clinical OncologyCSCOLung Cancer Diagnosis and Treatment Guidelines (2023 Edition)