Access to Cancer Treatment: A study of medicine pricing issues with recommendations for improving access to cancer medication | Pharmaceutical Drug | Cancer

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According to the World Health Organization, cancer is one of the leading causes of death around the world, with 8.2 million deaths in 2012. More than 60 percent of the world
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  ACCESS TO CANCER TREATMENT   A study of medicine pricing issues with recommendations for improving access to cancer medication    A report prepared for OXFAM By Ellen 't Hoen, LLM. - Medicines Law & Policy. ABSTRACT  According to the World Health Organization (WHO), cancer is one of the leading causes of death in the world, with 8.2 million deaths in 2012. More than 60 percent of the world’s total new annual cases occur in Africa, Asia, and Central and South  America. These regions account for 70 percent of the world’s cancer deaths. In low- and middle-income countries, treatment for cancer is not widely available. Health systems are often not equipped to deal with detection and treatment of cancers. Prevention and early detection programmes are often weak or non-existent. This situation is exacerbated in some cases by the high cost of treatment and in particular the high cost of newer cancer medication. The unsustainability of cancer medication pricing has increasingly become a global issue creating access challenges in low-and middle-income but also high-income countries. This report describes recent developments with pricing of medicines for the treatment of cancer, discusses what lessons can be drawn from HIV/AIDS treatment scale up and makes some recommendations to help increase access to treatment for people with cancer.   This research report was written to share research results, to contribute to public debate and to invite feedback on development and humanitarian policy and practice. It does not reflect Oxfam policy positions. The views expressed are those of the author and not those of Oxfam.     Access to Cancer Treatment:  A study of medicine pricing issues with recommendations for improving access to cancer medication. 2 Acknowledgements I would like to thank Mohga Kamal-Yanni and Philippa Saunders from Oxfam UK for their guidance throughout the project and Stephanie Burgos from Oxfam America for providing useful comments on earlier versions of the report. I thank Joseph Kaiwood for his assistance in the background research on access policies of pharmaceutical companies. I thank Krisantha Weerasurya and Peter Beyer from the World Health Organization for providing information and introductions to useful contacts. David Banta M.D. provided useful research on specific diseases and reviewed medical information used in the report. I am thankful to many others who have responded to my queries throughout this project. I would especially like to mention Leena Menghaney and Aastha Gupta for information about medicine pricing and policy in India. I am immensely grateful to the external reviewers, Niranjan Kondori from Management Sciences for Health, Rohit Malpani from Médecins sans Frontières and Marg Ewen from Health Action International, whose thoughtful comments, suggestions and corrections were essential to produce the final result. Ellen ‘t Hoen Paris, 2 May 2014   Access to Cancer Treatment:  A study of medicine pricing issues with recommendations for improving access to cancer medication. 3 Table of Contents 1   Introduction ......................................................................................................... 4   2   Pricing of medicines ........................................................................................... 5  M EDICINE PRICING ISSUES IN HIGH - INCOME COUNTRIES  .............................................. 5 H OW ARE DRUG PRICES SET ? .................................................................................... 8 3   Cancer and cancer medicine pricing .............................................................. 12  C  ANCER CARE IN I NDIA  ............................................................................................ 13 P RICES OF SELECTED ESSENTIAL CANCER DRUGS IN LOW -  AND MIDDLE - INCOME COUNTRIES . ............................................................................................................ 13 C  ASES OF SPECIFIC CANCER DRUGS  ........................................................................ 15 Trastuzumab - Roche (breast cancer) ............................................................... 16    Letrozole (Femara)– Novartis (breast cancer) .................................................. 18    Imatinib mesylate (Gleevec) – Novartis (CML) .................................................. 19   Dasatinib (Sprycel) – Bristol-Myers Squibb (CML) ............................................ 22    Docetaxel (Taxotere) – Sanofi-Aventis (breast cancer) .................................... 24   4   Lessons from HIV and pricing of ARVs .......................................................... 25  M  ARKET FOR CANCER DRUGS  .................................................................................. 25 G ENERIC COMPETITION  ........................................................................................... 26 S MALL MOLECULES VS .  BIOLOGICS  –  REGULATORY CHALLENGES . ............................. 27 WHO   M ODEL L IST OF E SSENTIAL M EDICINES  .......................................................... 27 P ROCUREMENT ISSUES AND P RICE TRANSPARENCY  ................................................. 28 P OLITICAL ENVIRONMENT  ........................................................................................ 29 F INANCING OF HIV  VERSUS FINANCING OF CANCER CARE  ......................................... 30 C ONCLUSION  .......................................................................................................... 30 5   Pharmaceutical companies’ access policies for cancer drugs in low- and middle-income countries. ....................................................................................... 30  R OCHE  ................................................................................................................... 31 N OVARTIS  ............................................................................................................... 32 S  ANOFI -A VENTIS  ..................................................................................................... 33 B RISTOL -M YERS S QUIBB  ......................................................................................... 34 B  AYER  .................................................................................................................... 35 C ONCLUSION  .......................................................................................................... 35 6   Country strategies aimed at decreasing the prices of cancer drugs. .......... 36  I NDIA  ...................................................................................................................... 37 Compulsory licensing of cancer drugs. ............................................................. 37    Cases of patent grant opposition for cancer drugs ............................................ 38    Responses from industry – fierce response from US ........................................ 38   T HAILAND  ............................................................................................................... 38 Compulsory licensing for cancer drugs ............................................................. 38    Effects on export trade and foreign direct investment ....................................... 40    7   Conclusions and recommendations ............................................................... 41  S PECIFIC RECOMMENDATION TO IMPROVE ACCESS TO CANCER MEDICINES  ............... 45   Access to Cancer Treatment:  A study of medicine pricing issues with recommendations for improving access to cancer medication. 4 1 INTRODUCTION  According to the World Health Organization (WHO), cancer is one of the leading causes of death in the world, with 8.2 million deaths in 2012. 1  Lung, female breast, colorectal, and stomach cancers were the most commonly diagnosed cancers: more than 40 percent of all cancers. Lung, stomach, liver, colon and breast cancer cause the most deaths. While cancer is often categorized as a non-communicable disease (NCD), 20 percent of cancer deaths in low- and middle-income countries are linked to viral infections such as hepatitis and human papilloma virus (HPV). 2  Infection-related cancers in Sub-Saharan Africa account for 33 percent and in China for 27 percent. 3  While death rates from cancer in wealthy countries are slightly declining because of early diagnosis and the availability of treatment, this is not the case in low- and middle-income countries. The rates are rising in low- and middle-income countries, partly because of the aging of the population. Currently 14 million people a year are diagnosed with cancer. That will increase to 19 million by 2025, 22 million by 2030 and 24 million by 2035. More than 60 percent of the world’s cancer cases occur in Africa, Asia, and Central and South America. 4  Some of the common cancer types such as breast cancer, cervical cancer, oral cancer, and colorectal cancer respond well to treatment when detected early. Some cancer types, such as leukaemia and lymphoma in children and testicular seminoma, can be cured provided the appropriate treatment is given, even when disseminated. In low- and middle-income countries, however, treatment for cancer is not widely available. According to the Global Task Force on Expanded Access to Cancer Care and Control, only 5 percent of global resources for cancer are spent in the developing world, yet these countries account for almost 80 percent of disability-adjusted years of life 5  lost to cancer globally. 6  Health systems are often unable to deal with cancer treatment. Prevention and early detection programmes are weak or non-existent. This situation is exacerbated by the lack of financing for healthcare and low health insurance and social security coverage. In low-income countries, the lack of resources requires prioritization of life-saving treatments with high public health impact over cancer care. In certain cases, the high cost of treatment and in particular the high cost of cancer medication throws up additional barriers. This report will describe recent trends in the pricing of medicines for the treatment of cancer, it will discuss what lessons can be drawn from dramatic price reductions of antiretrovirals (ARVs) and subsequent HIV/AIDS treatment scale up, and make some recommendations to help increase access to treatment for cancer medications, with a particular emphasis on India. India is a particular focus of the report because it is an important lower middle-income country with large unmet needs in cancer care and it has considerable production capacity and potential to produce low-cost medications. Some states in India have announced programmes to provide free medicines to its
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