FEATURE
Global Patient-Assistance Programs
Pharmaceutical companies engage in patientassistance programs to bring life-saving medications to patients in limited-resource countries . Two initiatives are taking innovative steps to improve patient access .
The Glivec International Patient Assistance Program
The Glivec International Patient Assistance Program ( GIPAP ) was established in 2002 by Novartis and the Max Foundation , a non-profit , non-governmental organization , to make imatinib accessible to medically and financially eligible patients in more than 75 countries . To date , GIPAP has benefited more than 78,000 patients with chronic myeloid leukemia ( CML ). 1
In late September 2017 , Novartis and the Max Foundation announced their intention to replace GIPAP with a new collaboration , called CMLPath to Care , which will continue to provide access to imatinib in the developing world , along with secondline nilotinib for approved indications . 2
The Pfizer-Cipla Program
In June 2017 , the American Cancer Society and the Clinton Health Access Initiative ( CHAI ) announced two separate groundbreaking market-access agreements with pharma giant Pfizer and Mumbai-based Cipla Inc . 3 The agreements steeply discount the prices of 19 cancer medicines in Ethiopia , Nigeria , Kenya , Uganda , Rwanda , and Tanzania .
Negotiated by CHAI , the agreements are part of a broad effort to improve access to cancer care throughout Africa . “ While cancer treatments and the tools for early diagnosis are readily available in developed countries , market forces and other barriers [ lead to ] limited access in Africa ,” CHAI Chief Executive Officer Ira Magaziner said . “ As was done for the HIV / AIDS crisis before it , this public-private collaboration will help revolutionize cancer treatment in sub- Saharan Africa and has the potential to save thousands of lives each year .” 4
As an added benefit , a group of top U . S . oncologists are set to simplify cancer-treatment guidelines for underequipped African hospitals . Their protocols will then be built into an online tool available to any oncologist with internet access .
The agreement with Pfizer will give discounted access to the following medicines : carboplatin , cisplatin , docetaxel , doxorubicin , epirubicin , fluorouracil , gemcitabine , leucovorin , methotrexate , oxaliplatin , and paclitaxel .
The Cipla agreement covers anastrazole , bleomycin , capecitabine , carboplatin , cisplatin , cytarabine , oxaliplatin , and vinblastine .
Pfizer has agreed to charge prices that are just above its manufacturing costs , and Cipla has said it will provide some oral medications for just 50 cents per pill and some infusions for $ 10 per dose . Cipla hopes to start manufacturing the drugs at its factories in Uganda and South Africa .
REFERENCES
1 . The Max Foundation . Glivec ® International Patient Assistance Program ( GIPAP ). Accessed November 4 , 2017 , from www . themaxfoundation . org / what / treatment / glivec-internationalpatient-assistance-program-gipap .
2 . Novartis . Novartis and the Max Foundation transform pioneering cancer access program for people in lower-income countries . Accessed November 4 , 2017 , from www . novartis . com / news / mediareleases / novartis-and-max-foundation-transform-pioneeringcancer-access-program-people .
3 . American Cancer Society . American Cancer Society and Clinton Health Access Initiative announce collaborations with Pfizer and Cipla to increase access to lifesaving cancer treatment in Africa . Accessed November 4 , 2017 , from http :// pressroom . cancer . org / 2017-06-20-American-Cancer-Society-and-Clinton-Health- Access-Initiative-Announce-Collaborations-with-Pfizer-and-Ciplato-Increase-Access-to-Lifesaving-Cancer-Treatment-in-Africa .
4 . McNeil DG Jr . As cancer tears through Africa , drug makers draw up a battle plan . New York Times . Accessed November 4 , 2017 , from www . nytimes . com / 2017 / 10 / 07 / health / africa-cancer-drugs . html .
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inexpensive new treatment protocol is associated with a 90 percent reduction in death . The hematology world glimpsed the outsized benefits of “ simple solutions ” at the 2016 ASH Annual Meeting , when Eugenia Vicky Asare , MBChB , a hematologist at the Korle Bu Teaching Hospital in Accra , Ghana , presented a study conducted in pregnant women with SCD in Ghana . 7
For Ghanaian women with SCD , morbidity and mortality associated with pregnancy are about 11-fold higher than that of Ghanaian women without SCD . To reduce the burden , Dr . Asare and researchers developed a multidisciplinary team approach that included admitting patients only to select wards in the hospital and facilitating timely transfer to the intensive care unit , when needed . The team included obstetricians , hematologists , pulmonologists , nurses , and midwives .
The results speak for themselves : With their relatively low-tech , multidisciplinary approach to improve care for pregnant women with SCD , mortality fell by 89.1 percent ( p = 0.007 ). Perinatal mortality decreased from 60.8 per 1,000 total births at pre-intervention to 23.0 per 1,000 total births at post-intervention , representing a 62.2 percent risk reduction ( p = 0.2 ).
Some of their fixes were incredibly simple : “ We realized that about 60 percent of these patients died from
FIGURE . The GO Map cardiopulmonary complications , and acute chest syndrome was the major event ,” Dr . Asare said in an interview with ASH Clinical News at the 2016 annual meeting . “ Recognizing this , we [ instituted a policy of ] using latex balloons as incentive spirometry , because incentive spirometry in itself is expensive .”
The new protocols involved “ no added costs and no expensive technologies ,” she added , “ so I think it will be easy to replicate [ as long as ] you really have it in mind to help these patients .”
In an update to be presented at this year ’ s annual meeting , Dr . Asare and colleagues will share new data demonstrating that the multidisciplinary approach has allowed clinicians to reduce maternal and perinatal mortality rates in Ghanaian women with SCD to levels similar to women without SCD . 8
A Multifaceted Approach
Dr . Bhatt feels strongly that , although the world needs expanded access to medications , drugs are far from the only issue needing attention in LMICs .
In addition to her work at Stanford , Dr . Bhatt is the co-founder and co-president of Global Oncology ( GO ), a non-profit that addresses the disproportionate share of the global cancer burden shouldered by LMICs . She co-founded GO with Franklin Huang , MD , PhD , during her hematology and oncology fellowship at the Dana-Farber Cancer Institute in Boston .
Diagnostics are lagging far behind in many countries , she noted . Immunohistochemistry and flow cytometry , which are particularly important for hematology care , can be difficult to access and costly , and few lower-resource countries have working radiation-therapy systems .
“ While drug access is a major issue , it is by no means the only issue ,” Dr . Bhatt said . “ Once drug access is solved , we will quickly realize that we still can ’ t deliver high-quality care because we are missing a lot of other pieces .”
It is also unrealistic to think that cancer care has to fall by the wayside in limited-resource countries just because so much is needed just to raise the level of basic care . It ’ s not “ one or the other ,” she said . “ Of course , I think it ’ s critically important to address malnutrition , infant mortality , and other such issues , but I think we should be careful not to create a false dichotomy .” GO aims to facilitate a collaborative environment and break down silos so that people with the will to get involved can work together to find solutions .
“ Addressing cancer and hematology care properly should be a priority , in part because of the economic burden these diseases place on patients and their families ,” Dr . Bhatt said . “ Sick patients do not say , ‘ I have cancer , but I ’ m not going to seek care .’ What they do is bankrupt themselves , their extended families , and their supportive communities to pay for care , and it is often too little and too late .”
One of GO ’ s flagship projects is the GO Map , a web-based platform that catalogs international cancer research , care , and outreach programs ( see FIGURE ). 9 At the time of publication , it listed and described 3,981 projects worldwide . “ My heart breaks for [ patients with ] CML who have to be switched from imatinib to hydroxyurea . With the stroke of a pen on a prescription pad , we shorten their lifespan by 25 years ,” she said . “ We are lucky – we have an opportunity to collaboratively do something to change this .”— By Debra L . Beck ●
REFERENCES
1 . Bhatt AS . Technological solutions for global hematology and oncology . Blood Advances . 2017 ; 1:396 .
2 . World Health Organization . Cancer fact sheet , February 2017 . Accessed November 5 , 2017 , from www . who . int / mediacentre / factsheets / fs297 / en .
3 . Stefan DC . Cancer care in Africa : an overview of resources . J Glob Oncol . 2015 ; 1:30-6 .
4 . Afungchwi GM , Hesseling PB , Ladas EJ . The role of traditional healers in the diagnosis and management of Burkitt lymphoma in Cameroon : understanding the challenges and moving forward . BMC Complement Altern Med . 2017 ; 17:209 .
5 . Jim JJ , Campos NG , O ’ Shea M , et al . Model-based impact and cost-effectiveness of cervical cancer prevention in sub-Saharan Africa . Vaccine . 2013 ; 31 : F60-72 .
6 . PEPFAR . Using data to deliver on an AIDS-free generation . Accessed November 5 , 2017 , from www . pepfar . gov / documents / organization / 266089 . pdf .
7 . Asare EVNK , Adomakoh Y , Olayemi E , et al . Prospective implementation of multi-disciplinary obstetric team decreases the mortality rate of pregnant women with sickle cell disease in Ghana . Abstract # 1017 . Presented at the ASH Annual Meeting and Exhibition , December 5 , 2016 ; San Diego , CA .
8 . Oppong SA , Olayemi E , Adomakoh Y , et al . Multi-disciplinary obstetrics and sickle cell disease clinic in low resource setting lowers maternal and perinatal death rates to the same levels as those without sickle cell disease . Abstract # 616 . Presented at the ASH Annual Meeting and Exhibition , December 11 , 2017 ; Atlanta , GA .
9 . Global Oncology . The GO Map . Accessed November 5 , 2017 , from http :// globalonc . org / Projects / global-cancer-project-map .
ASHClinicalNews . org ASH Clinical News
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