Rouhollahi MR¹ (MD), Mohammad Nejad S¹ (VMD, PhD Student), Harirchi I¹ (MD), Zarei B³ (PhD), Keshtmand G¹ (MD), Sedighi S¹ (MD), Amanpour S¹ (VMSc), Abdirad A² (MD), Kokhaei P⁴ (PhD), AghiliM¹ (MD), Amozegar Hashemi F¹ (MD), Vand Rajabpour M¹ (Medical Student), Zendehdel K¹ * (MD, PhD)

  * Corresponding Author: Cancer Research Center, Cancer Institute, Imam Khomeini Hospital, Tehran, Iran. Tel: +98- 21- 66581542, Fax: +98- 21- 66581638, kzendeh@tums.ac.ir

  ¹ Cancer Research Center, Cancer Institute of Iran, Tehran University of Medical Sciences, Tehran, Iran

  ² Corporate Entrepreneurship Department, University of Tehran, Tehran, Iran

  ³ Immunology Department of Medical Faculty, Semnan University of Medical Sciences, Semnan, Iran

  Received: 22 May 2012, Accepted: 15 Nov 2012

  Abstract

  Introduction: Allocation of new (expensive) drugs for difficult refractory diseases, and financial protection of patients with eligibility criteria are important challenges in national health systems worldwide, especially in developing countries. Breast cancer is the most common cancer among Iranian women. The new effective but expensive drug, Trastuzumab (Herceptin), put major financial challenges for patients and government in Iran. Therefore, policy makers have decided to implement a national program for appropriate management of breast cancer in Iran. To support decision making with evidence and innovative knowledge, a team of researchers in the Cancer Institute of Iran evaluated the issue, wrote a policy brief, and provided necessary recommendations.

  Methods: Through designing a conceptual model consisting of goals, main processes and support processes for the national program, five macro-processes were selected as main concerns. An expert panel including different scientific disciplines discussed different aspects of the issue and drafted different recommendations. Draft of the policy brief was edited and approved by the panel members.

  Results: At last, we defined 10 policy recommendations related to the five high-priority areas including: 1- Balanced resource allocation in priority of breast cancer control, 2- Modeling for best subsides allocation, 3- Avoiding “poor subsidize the rich” phenomenon, 4- Development and updating the clinical guidelines,
5- Effectiveness study in accepted protocol of the drug, 6- Quality improvement of diagnostic tests,
7- Standardization of the IHC laboratory kits, 8- Band management for price drop, 9- Development of IT infra-structure and Inter-organization Information Systems (IOIS), and 10- Development and implementation of expert systems for empowerment of the laboratories.

  Conclusion: This policy brief consisted of ten policy recommendations in different aspects of the issue. Association of each recommendation with the objectives of the program was determined. Adhering to these recommendations may lead to rational use and prescription of Trastuzumab, and help meeting objectives of the national program in management of breast cancer in Iran. A successful program could be assumed an appropriate model for management of expensive chemotherapy drugs in developing countries.

  Key words: Trastuzumab (Herceptin), New High-Cost Cancer Drugs (NHCCD), Breast Cancer, Policy Recommendation

  Please cite this article as follows:

  Rouhollahi MR, Mohammad Nejad S, HarirchiI, Zarei B, Keshtmand G, Sedighi S, et al. Management of Herceptin (Trastuzumab) in Patients with Breast Cancer in Iran: Procurement, Allocation, Patient Eligibility Criteria, Prescription and Financial Protection. Hakim Research Journal 2013 15(4): 270- 280.

  * Corresponding Author: Cancer Research Center, Cancer Institute, Imam Khomeini Hospital, Tehran, Iran. Tel: +98- 21- 66581542, Fax: +98- 21- 66581638, kzendeh@tums.ac.ir