Why Immunotherapy Drugs Prescribed to Cancer Patients Should Be Covered by the SSI?

Summary

It is known that the costs of immunotherapy drugs used in some types of cancer are not paid by the SSI since they are not regulated in the Health Implementation Communiqué (SUT). In such cases, an application is made to the courts to demand the collection of the paid drug costs from the SSI.

In cases where it is determined by an expert report that the drug, the cost of which is not covered by the SSI, is of vital importance in the treatment of the disease and its use is mandatory, even if the drug is not covered by the SUT or even if its use is not regulated for the type of cancer/disease in question, the courts rule that the SSI should pay for it.

The State's obligation to protect the right to life and the material and spiritual existence of the individual, and to ensure that everyone maintains his/her life in physical and mental health, makes it obligatory for the SSI to pay for the prescribed medication when the conditions are met. The expert report, court decisions and Constitutional Principles are analysed below, including the concrete cancer disease. 

Immunotherapy Drugs in General and Health Implementation Communiqué (SUT) Regulation 

Although there are many methods for the treatment of cancer patients today, the most commonly used methods are chemotherapy, radiotherapy and immunotherapy. Chemotherapy is the treatment of cancer with medication. The drugs used in chemotherapy prevent the growth and proliferation of cancer cells.  Radiotherapy is the use of high doses of radiation energy for treatment.  Immunotherapy, also known as biological therapy, is a method of treating diseases by activating or suppressing the body's immune system. Chemotherapy acts by targeting the structures in the nucleus of the cancer cell. It destroys this structure and eliminates the cancer cell. The aim of immunotherapy treatment is to strengthen the immune system and trigger it to fight cancer, that is, to enable the body to defeat cancer on its own.

In our country, citizens who fight with cancer and resort to immunotherapy may have to use high-cost drugs in order to get positive results from the relevant treatment method. The main ones are "Opdivo" containing the active substance nivolumab and "Keytruda" containing the active substance pembrolizumab. Unfortunately, there are currently no equivalents for these drugs.  These drugs are immunotherapy drugs designed to improve the immune system's ability to target and kill cancer cells. Physicians decide on the application of the drugs according to the course of the patient and the disease. 

The costs of the drugs included in the Health Implementation Communiqué by the Social Security Institution are covered by the state. However, the drugs included in the aforementioned communiqué are often required to be used in the treatment of certain types of cancer diseases. In other words, the presence of a medicine in the Health Implementation Communiqué does not mean that the cost of the medicine will be covered by the Social Security Institution.

With the amendments in the Social Security Institution Health Implementation Communiqué published in the Official Gazette dated 08.02.2022, Nivolumab was included in the scope of reimbursement by the SSI only for non-small cell lung cancer treatment, malignant melanoma treatment, classical Hodgkin lymphoma treatment and kidney cancer treatment. This situation causes great financial losses for patients who apply Opdivo for the treatment of other types of cancer diseases. In the pharmacological opinions regarding the active substance nivolumab, it is stated that the drug is indicated in non-small cell lung cancer types and squamous cell head and neck cancer types and the drugs are prescribed. 

In a file followed by us, it was decided to apply immunotherapy to our client using the above-mentioned drug Opdivo for the treatment of our client who was diagnosed with "oropharynx malignant neoplasm", more commonly known as "oropharyngeal cancer". Since the Health Implementation Communiqué of the Social Security Institution does not include the regulation that the drug price will be reimbursed by the Social Security Institution if the Opdivo drug is used for oropharyngeal cancer, the client had to pay for the drug himself. This situation put the client in a difficult financial situation.  Subsequently, we filed a lawsuit on behalf of the client for the payment of the drug price not paid by the Social Security Institution and for the determination that the future drug prices should be paid by the SSI. 

Summary of the Case

The client has been diagnosed with "ICD-10 C10.9 - Malignant neoplasm of the oropharynx" and his treatment continues in the relevant health institutions. Since the tumour in the client's body was in an area that could not be removed by surgery, the client received 33 cycles of radiotherapy and 6 cycles of chemotherapy. Although 7 cycles were planned for the client, the last cycle could not be applied due to his weakened constitution.

As a result of the treatments applied, the disease regressed, but in the PET Report dated 9 April 2021, it was determined that metastasis (spread of the disease to another location) occurred and the newly formed tumour occurred in the area where radiotherapy cannot be applied. For this reason, it was decided to apply immunotherapy to the client. Throughout this process, the client continued to receive immunotherapy with a total of 11 doses. 

During immunotherapy, "Opdivo 40 mg/4 ml IV vial containing solution concentrate for infusion" and "Opdivo 100 mg/10 ml IV vial containing solution concentrate for in-fusion" with the active substance "Nivolumab" were prescribed for the treatment of the client with the diagnosis of "c50.9 breast malignant neoplasm" and "c11.9 nasopharynx malignant neoplasm".

Since the payment of the aforementioned medicines was not covered by the SSI, all medication costs have been paid by the client so far. Due to the very high prices of the medicines, the client and his family were financially devastated. A lawsuit had to be filed. 

Expert Report

In the expert report, in summary, it was stated that the said drug was included in the scope of payment with the Provision in the Communiqué on Amendment to the Health Implementation Communiqué, but it was possible to pay for malignant melanoma Skin Cancer, renal cancer Kidney Cancer, hodgkin lymphoma Lymph Cancer, and that the Defendant SSI excluded the payment since the plaintiff patient was diagnosed with lung cancer and this diagnosis was not included in the three indications defined in the SUT. 

In the expert report, the American Cancer Society Medical and Editorial Content Team stated that: whether a person's cancer can be treated depends on the type and stage of cancer, the type of treatment they can receive and other factors, some cancers are more likely to be cured than others, but each cancer should be treated differently and there is no single treatment for cancer.

In order to ensure that the general health insured and his/her dependents remain healthy and regain their health in case of illness, it is stated by the expert that the medical care and treatment to be performed by the physician, clinical examinations, laboratory tests and analyses and other diagnostic methods required for diagnosis upon the necessity to be seen by the physician, and medical care and treatment will be covered by the SSI in case of illness. 

The cost of the medication called nivolumab, which the patient is medically obliged to use, does not qualify as health services that will not be financed, and although the drug is authorised by the Ministry of Health, the drug use request made due to the fact that it is not included in the reimbursement list of the SSI, The fact that it was not covered by the Defendant Institution and the Scientific / Objective / Auditable justification of this decision was not in accordance with the legislation, and in the SUT Annex "List of Chronic Diseases for which Attendance Fee for Outpatient Physician and Dentist Examination will not be charged" (Annex-1 / A); Due to the disease (C00-C14 Malignant Neoplasms of the Lip, Oral Cavity and Pharynx), it was evaluated that the Plaintiff was exempt from the Drug Contribution Fee.

In summary, it has been concluded by the expert that although the Ministry of Health of the Republic of Turkey has authorised the purchase, sale and use of the drug called NİVOLUMAB, which is permitted by the Ministry of Health, the Defendant Institution's request for the use of the drug, which was made due to the fact that it was not included in the reimbursement list of the SSI, was not met by the Defendant Institution and the Scientific / Objective / Auditable justification of this decision was not in accordance with the legislation.

Examination of the Constitutional Court's Application of Nail Artuç with Application Number 2013/2839 on the Subject

"According to the basic approach adopted by the Constitutional Court in terms of the positive obligations of the state under the right to life, Article 17 of the Constitution imposes a duty on the state to take effective administrative and judicial measures, using all available means, to ensure that the legal and administrative framework established in this regard is properly implemented to protect persons whose lives are in danger and that violations of this right are stopped and punished. This obligation applies to any activity, whether public or non-public, in which the right to life may be jeopardised. Article 34 of the Constitution extends this positive obligation to activities carried out in the field of health.

As a matter of fact, Article 56 of the Constitution stipulates that everyone has the right to live in a healthy and balanced environment, that the State shall regulate "the planning and service provision of health institutions from a single source in order to ensure (...) the maintenance of everyone's life (...) in physical and mental health (...)" and that it shall fulfil this duty by making use of and supervising health and social institutions in the public and private sectors.

The State is obliged to regulate health services, whether they are provided by public or private health institutions, in such a way that the necessary measures can be taken to protect the lives of patients (for similar ECtHR judgments, see Calvelli and Ciglio v. Italy, B. No. 32967/96, 17/1/2002, § 49, Sevim Güngör v. Turkey, B. No. 75173/01, 14/4/2009)."  The judgement concludes. 

The Constitutional Court underlined that the State has a positive obligation to protect the right to life of all individuals within its jurisdiction against the risks that may arise from the actions of public authorities, other individuals or the person himself/herself.

Constitutional Court Kaan Antoni Gerede, (B. No: 2020/22945, 22/2/2022) Decision 

The applicant requested an injunction ordering the Social Security Institution (SSI) to pay the cost of the medication to the institution authorised to import the medication during his treatment. The applicant was diagnosed with adrenal gland malignant neoplasm by Hacettepe University Hospital (Hospital). With a letter dated 18/6/2020, the Ministry of Health, Turkish Medicines and Medical Devices Agency (Medicines Agency) informed Dr. B.Y. at the Hospital about the 6-month use of the drug Qarziba in the treatment of the applicant's disease and that it was deemed appropriate to import this drug from abroad only through the Turkish Pharmacists Association (TEB). 

Upon the rejection of the application of Ibni Sina Health Social Security Centre (SSGM) with the letter dated 23/04/2020, he filed a lawsuit against SSI before Ankara 5th Labour Court with a request for an injunction. In the expert opinion dated 14/8/2020; it was understood that the disease could not be fully controlled although intensive chemotherapy was applied to the applicant, it was evaluated that immunotherapy with dinutuximab beta should be started without delay, there is no other drug treatment approach equivalent to immunotherapy for fourth stage high-risk neuroblastoma patients, there is no alternative product with dinutuximab beta active ingredient other than the previously prescribed product (Qarziba), and delay in treatment would pose a vital risk. The applicant made an individual application to the Constitutional Court on 10/8/2020 and requested an injunction ordering the SSI to pay the cost of the medicine to the institution authorised to import the medicine during his treatment. 

The Constitutional Court accepted the request with an interim decision dated 14/8/2020 and decided "to ensure the immediate payment of the cost of the medicine named Qarziba for the treatment of the applicant during the treatment period". The decision on the acceptance of the request for interim measures was notified to the relevant institutions for compliance. On 19/8/2020, the applicant made a new individual application to the Constitutional Court on the same issue and stated that the SSGM rejected their request for the immediate payment of the drug price in accordance with the injunction decision with its letter dated 18/8/2020 on the grounds that "the invoice price can be reimbursed in accordance with the court decision if the empty medicine boxes of the medicine used are submitted together with the original invoice for the medicine supplied" and requested a new injunction decision to be issued for the payment of the drug price to the institution authorised by the SSI to import the medicine without any conditions. Thereupon, with the letter sent to SSGM and SSI on 19/8/2020, it was requested to fulfil the injunction dated 14/8/2020 and to pay the drug price immediately and to inform the Constitutional Court that the requirements of the decision have been fulfilled.

Examination of the Decision of the 10th Civil Chamber of the Court of Cassation No. 2022/11960 E. 2022/13341 K. on the Subject

In the principled decisions of the Supreme Court, it has been concluded that whether the drug is of vital importance or not is the determining factor;

"The plaintiff receives a pension within the scope of 4/1-a and is eligible for health assistance, lung cancer is diagnosed, due to lung cancer, the patient's use of pembrolizumab active ingredient (...) report was issued as appropriate, Ministry of Health Turkey ... ...) drug / drugs with pembrolizumab active ingredient (...) in the treatment, the application made to the Institution in order to cover the cost of the drug was not included in the list of drugs to be paid by the Institution by stating that it is not included in the list of drugs to be paid for in Annex-4 / A of the health practice communiqué by the Institution, and the court decided to dismiss the case in line with the expert report containing abstract statements.

Article 63 of the ... and General Health Insurance Law No. 5510 lists the health services to be financed by the Institution in order to ensure that the general health insured and their dependents remain healthy; to regain their health in case of illness; to provide medically necessary health services as a result of occupational accidents and occupational diseases, illness and maternity, and to eliminate or reduce incapacity for work; in subparagraph (f) of the aforementioned article, the Institution is required to "... "... blood and blood products, bone marrow, vaccines, medicines, orthoses, prostheses, medical tools and equipment, medical devices for personal use, medical consumables, medical consumables of curative nature that may be necessary for the diagnosis and treatment related to the health services to be provided, the provision, installation, maintenance after the warranty period, repair and renewal services. ...", and in the amended paragraph 2, the Institution is authorised to determine the diagnosis and treatment methods of the health services to be financed and the types, quantities and usage periods of the health services specified in subparagraph (f), and the payment procedures and principles by taking the opinion of ... and the Ministry of Health. However, obtaining the opinion of the Ministry of ... covers the amount, standards, provision, application, usage periods, maintenance, repair and renewal of orthosis, prosthesis and other curative tools and equipment specified in subparagraph (f). The Agency may establish commissions for this purpose and may co-operate with national and international legal entities. 

The working procedures and principles of the commissions shall be determined by the Institution in consultation with the Ministry of ... and the Ministry of Health. According to the regulation of Article 64 of the aforementioned Law in the period in dispute; health services that will not be financed by the Institution are all kinds of health services for aesthetic purposes and orthodontic dental treatments for aesthetic purposes, except for health services to ensure the integrity of the body and health services to be performed in cases arising due to occupational accidents and occupational diseases, accidents, diseases or congenital causes; Traditional, complementary, alternative medicine practices and health services that are not permitted or licensed by the Ministry of Health and health services that are not medically accepted as health services by the Ministry of Health, chronic diseases of foreign citizens that existed before the date when they were considered as general health insured or dependent of the general health insured. 

Likewise, in Article 72, the Health Services Pricing Commission is authorised to determine the daily, travel, bed and meal expenses to be paid by the Institution in accordance with Article 65. The Commission may classify health service providers separately for pricing purposes by taking into consideration medical education, service level, infrastructure, resource utilisation and cost factors. The Commission is authorised to determine the prices to be paid by the Institution for the health services financed in accordance with the provisions of Article 63 individually or in groups for each class by taking into account the province and step where the health service is provided, the subsidies provided directly or indirectly by the State, whether the health service is of vital importance due to its nature, evidence-based medical practices, cost-effectiveness criteria and the general health insurance budget.

In the same way, in the 68th article titled as participation share, those who will be charged participation share from the health services listed in the 63rd article are as follows: Physician and dentist examinations in outpatient treatment, out-of-body prostheses and orthoses, medicines provided in outpatient treatment, health services financed in inpatient treatment according to the disease groups to be determined by the institution, and the health service amounts determined according to Article 72 will be taken as basis in the calculation of co-payments, The procedures for the payment of co-payments and other procedures and principles regarding the implementation of this article will be regulated by a regulation to be issued by the Institution, and in Article 69, the cases where co-payments will not be charged from the health services listed in Article 68, health services and persons, provided that they are documented by a medical report; Chronic diseases determined by the Institution and vital health services within the scope of subparagraph (b) of the first paragraph of Article 68 and organ, tissue and coke cell transplantation.

In the concrete case, first of all, all treatment documents of the plaintiff were summoned and examined within the scope of the legislation described above; whether the medication subject to the lawsuit is of vital importance in the treatment of the cancer disease in question and whether its use is mandatory, therefore whether its use will contribute to the recovery of the insured medically and physically, at which stage and in which dose the medication will be used in which round cancer patients and how these issues will be determined, It should be determined by a medical board report to be obtained from the medical oncology department of the universities whether the treatment to be performed with the drug subject to the lawsuit is more effective and more beneficial than the current known treatment methods, and while making this determination, the opinions, decisions and reports available in the file should be examined and the contradictions, if any, should be eliminated, and it should also be taken into consideration that what should be understood from the concept of improvement is that the insured patient regains his health and the disease is cured. 

As a result of the researches to be carried out within this scope; if it is concluded that the use of the drug subject to the lawsuit in the treatment of the said disease for the cure of the disease is of vital importance and compulsory, an auditable calculation report should be obtained in terms of the appropriateness of the drug price and the contribution share and a decision should be made according to the result.

Without taking these material and legal facts into consideration, the establishment of a written decision with incomplete examination and research is contrary to the procedure and the law and is a reason for reversal." 

Conclusion

As explained above, in cases where it is determined by the expert report that the drugs containing the active substance nivolumab or pembrolizumab, which are used in immunotherapy in the treatment of cancer and which are allowed to be imported and sold to the country by the Ministry of Health and used for treatment purposes, are of vital importance in the treatment of the disease according to the characteristics of the patients or the disease and that their use is mandatory, it is concluded that the cost of the drug should be covered by the SSI. In the event that the prescription price is not paid by the Social Security Institution just because the name of the drug is not included in the reimbursement list, it may result in a violation of the right to life and the right to protection of the material and spiritual existence of the person in Article 17 of our Constitution. 

In addition, Article 56 of our Constitution imposes a positive duty on the state by stating that the state shall ensure that everyone maintains his/her life in physical and mental health, and shall regulate the planning and service provision of health institutions from a single source in order to increase savings and efficiency in human and material power and to realise cooperation. Considering all these issues together, it would be more appropriate to cover the cost of medicines by the Social Security Institution according to the principle of social state and constitutional principles.