About NOA

Background

The Novartis Oncology Access program is a medical access program designed to enhance access to continuous medical treatment by donating some of the treatment costs using Imatinib mesylate to patients requiring financial support to receive the treatment.

Imatinim mesylate is a breakthrough therapy for patients who have been properly diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase, accelerated phase and blast crisis. The therapy is also indicated for Adult patients with Kit (CD117)-positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST), patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL), myelodysplastic syndrome/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements, systemic mastocytosis (SM) with c-Kit no D816V mutation or unknown c-Kit mutations, hypereosinophilic syndrome (HES), chronic eosinophilic leukemia (CEL), and unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

The Novartis Oncology Access (NOA) program only provides the medication and does not cover the type of treatment or other laboratory tests. This program provides Imatinib mesylate (Glivec) for qualified patients. It is an access to medication program and not a clinical trial.

The Novartis Oncology Access (NOA) is an addition to the GIPAP program for new patients which can fully or partially cover the cost of the treatment. Patients already registered on the GIPAP program are to remain on that program and are not forced to transfer to the NOA program.

Patient Request and Information for Patients

After the patient has been checked, properly diagnosed and has been decided by the doctor to receive treatment with Imatinib mesylate (Glivec), the patient and doctor must sign the Registration and Agreement Form. The doctor shall ask the patient to self-register at the Yayasan Kanker Indonesia cabang Jakarta (Indonesia Cancer Foundation – Jakarta branch), the NOA Officer, to enroll in this program.

YKI Jakarta Branch (NOA Officer) will then ask the patient to complete the necessary documents to enroll. The documents completed by the patient will then be forwarded to PT. Survindo for the necessary financial evaluation.

PT Survindo will review the required documents and conduct a financial assessment of the patient. Once the documents and assessment are complete, PT. Survindo will then provide the patient with the assessment form and a date to contact YKI Jakarta (NOA officer) to find out whether or not the patient qualifies for the program. The financial assessment performed by PT. Survindo will be valid for 12 months, after which the is to undergo a repeat assessment to determine whether or not the donation for the treatment should continue under the same scheme.

On the date set by PT. Survindo, the patient shall contact YKI Jakarta (NOA Call Center) or the local NOA Assistant or PT. Survindo or use the www.novartis.id.com website to find out the patient’s eligibility for the program. YKI Jakarta and PT. Survindo will determine the access to treatment plan and YKI Jakarta will determine the delivery of the supply of Imatinib mesylate for each quarter.

If based on the recommendation, the patient is to purchase part of the medication then the patient may purchase it at a designated pharmacy. Patients living in Jakarta can purchase the medication from the Yayasan Kanker Indonesia cabang Jakarta.

When the patient receives the donation, the patient should contact Yayasan Kanker Indonesia cabang Jakarta to obtain the donated medication.

Information flow

Novartis can access the enrolled patient list where a patient can be identified by using the patient code number. Novartis can also access patient private information at random intervals to check if the patient complies with the terms and conditions to continue receiving Imatinib mesylate through this program.

Authorized parties from the medical industry/profession may be used to ask for doctors to report unwanted side effects arising from the treatment on behalf of Novartis. Should a patient suffer from unwanted effects arising from the Imatinib mesylate treatment, the doctor can forward the information to Novartis.

The rights and privacy of the patient shall be protected. The patient’s private information shall only be identified through the private code number.

Terms and Condition for Patients undergoing the Novartis Oncology Access (NOA) Program

The patient may ask medical questions regarding the Novartis Oncology Access program to his/her doctor, or to YKI cabang Jakarta for questions regarding the program or medication supply.

The patient shall give complete and accurate information regarding his/her financial status to YKI cabang Jakarta and PT Survindo.

Wrong or inaccurate information can result in termination of enrolment for both new and ongoing patients.

Should, for any reason, the patient treatment be terminated, the patient or his/her family shall return all unused medication to YKI cabang Jakarta.

Patients shall be given the free Imatinib mesylate (Glivec) in accordance to the medication access plan deemed suitable for the patient.