Affordability Issues of Biotech Drugs in Low- and Middle-Income Countries (LMICs)
Abdul Kader Mohiuddin*
Department of Pharmacy, World University of Bangladesh, Bangladesh
Submission: July 29, 2019; Published: September 11, 2019
*Corresponding author: Abdul Kader Mohiuddin, Department of Pharmacy, World University of Bangladesh, Bangladesh
How to cite this article:Abdul Kader Mohiuddin. Affordability Issues of Biotech Drugs in Low- and Middle-Income Countries (LMICs). JOJ Pub Health. 2019; 5(1): 555654. DOI: 10.19080/JOJPH.2019.05.555654
Abstract
As indicated by World Bank publication Disease Control Priorities: Improving Health and Reducing Poverty (third edition, 2017), about 20% all out health use universally originated from out-of-pocket payments in 2014. The equivalent was about 40% all out health use for low-income countries, 56% for lower-middle-income countries, and 30% for upper-middle-income countries (WHO, 2016). 33% of the world’s populace needs opportune access to quality-guaranteed medicines while assessments demonstrate that in any event 10% of medicine in low-and middle-income countries (LMICs) are substandard or distorted, costing roughly US$ 31 billion every year (Global Health, 2018). Shockingly, 80% of worldwide cardiovascular passings happen in LMICs which is (halfway) because of the absence of access to healthcare including talented HR, equipped offices and medicines (Global status report on noncommunicable diseases, WHO, 2010). Cost of drugs, antibodies, and diagnostics is a noteworthy weight in LMICs round the globe. Cost of biotech drugs are much higher because of surprising expense caused by the pharmaceutical organizations for clinical preliminary. Biotech drugs have totally changed the administration of a few diseases, including malignant growth and immune system diseases. Albeit essential yet their affordability is as yet a consuming issue, particularly in LMICs.
Keywords:LMICs; Out-of-pocket expenditure; Cancer treatments; Biotech drugs; Pharmaceutical patents; Biosimilars
Abbreviations: PIVI: Partnership for Influenza Vaccine Introduction; NITAGs: National Immunization Technical Advisory Groups; OOP: Out-of-pocket; LMICs: Low-and Middle-Income Countries; RCT: Randomized Control Trial; HPV: Human Papillomavirus; GDP: Gross Domestic Product; EML: Essential Medicine List; R&D: Research and Development; BRICS countries: Brazil, Russia, India, China and South Africa; NCDs: Non-communicable diseases; CVDs: Cardiovascular Diseases
Introduction
(Figure 1) Pharmaceutical organizations put resources into the improvement and testing of their drugs including by financing clinical preliminaries. Moreover, pharmaceutical organizations additionally spend a lot of cash on publicizing. For example, in 2016 US $6.7 billion was spent on direct-to-buyer pharmaceutical publicizing alone in the USA [1]. Worldwide spending on medicines came to $1.2 trillion of every 2018 and will surpass $1.5 trillion by 2023, as per “The Global Use of Medicine in 2019 and Outlook to 2023” [2,3]. In spite of the fact that, entrance to essential medicines is hazardous for 33% of all people worldwide [4]. Restricted access to essential medicines (EMs) for treating chronic diseases is a noteworthy test in lowand middle-income countries (LMICs) [4,5]. Normal public part accessibility of even low-cost conventional medicines ranges from 30% to 55% crosswise over 36 LMICs [6]. Cost of drugs, antibodies, and diagnostics is a noteworthy weight in 105 middle income countries round the globe, containing 70% of the world populace, 75% of the poor [7]. While public hospitals offer free or subsidized treatment including essential medicines, the high patient caseloads, underfunding and wasteful medicine dispersion frameworks are boundaries to predictable administration arrangement [8].
Additionally, 90% of the populace in creating countries buy medicines all through of-pocket (OOP) payments [7]. Poor accessibility of medicines in the public part has pushed up household OOP use, making them the biggest household consumption thing after nourishment [9]. Non-communicable diseases (NCDs) which, as per WHO are currently the world’s greatest executioners. More than 36 million individuals kick the bucket every year (63% of global passings) from NCDs, essentially CVDs, cancer, chronic respiratory diseases and diabetes. Of these, 80% happen in LMICs [10]. Along these lines, The WHO has set at least 80% as objective accessibility of medicines for both communicable and non-communicable diseases in all countries [11]. Yet, Pharmaceutical organizations have a substantial want in creating drugs for chronic diseases and cancer treatments, because of high commonness, yet additionally because these drugs are regularly used in long haul [12].
Pharmaceutical licenses keep up medication costs well over the cost of creation and can limit access to required medicines [13]. Biotech drugs have totally changed the administration of a few diseases, including cancer and immune system diseases, for example, psoriasis, rheumatoid joint pain, multiple sclerosis, and inflammatory bowel disease [14]. The mind-boggling expense of biotech prescriptions (focus on a quality or protein and regularly are infused or infused, related with treating a chronic condition) frequently requires noteworthy OOP uses [15,16]. A few examinations state that pharmaceutical organizations value drugs monopolistically, secured by patent rights, while others accept that the high costs for vagrant drugs basically allow sedate R&D and creation costs. In any case, the global vagrant medication market is evaluated to contact US $209 billion by 2022 representing 21.4% of complete branded physician endorsed sedate deals [17]. As per the Tufts Center for Drug Development, it costs, by and large, $100 million out of 1975, around $900 million preceding 2004 and 1.3 billion after 2005 to build up another medication and put up it for sale to the public [18,19]. While, Scavone et al. [14] detailed that whole time that goes from the R&D stage until the medication’s advertising endorsement can last as long as 15 years, and it is portrayed by amazingly mind-boggling expenses, normally surpassing $1.2 billion [20]. Gouglas et al. [21] assessed at least $2·8–3·7 billion ($1·2 billion–$8·4 billion territory) for one immunization all the way to the finish of stage 2a among 11 pandemic infectious diseases [21]. Aside from the customary plan of RCT, lately further examination structures, including umbrella, container and stage preliminaries, were created and connected to new treatments, particularly in the zone of oncology look into [22].
Tay-Teo et al. [23] expressed the most normally acknowledged assessments of R&D costs, including cancer drugs, are between $200 million and $2.9 billion, after modifications for the likelihood of disappointment and opportunity costs [23]. Genomic studies directed in the previous two decades recognized the sub-atomic drivers of specific cancers and prompted the approach of focused treatments as a significant extra mainstay of the cancer treatment armamentarium [24]. As per the Global Oncology Trend Report, global spending on cancer drugs ascended from $75 billion of every 2010 to $100 billion out of 2014, 10.3% ascent in spending. Asia represents 60% of the world populace and half of the global weight of cancer [25]. There are more than 100 sorts of cancers, situated in various organs and sub-tissues and beginning from various cell types. Some cancer types (e.g., colon, bosom, and non- Hodgkin’s lymphoma) contain significantly increasingly explicit groupings dependent on their sub-atomic subtypes. In spite of this multifaceted nature and inconstancy, most sorts of cancer are treated with similar non-exclusive treatments [26].
Faultfinders guarantee that costs of creative drugs are over the top and contend that lowering costs won’t hurt the flourishing advancement. On the furthest edge, the pharmaceutical business demands that prohibitive valuing arrangements will detrimentally affect their capacity to produce advancement [27]. During 2017, PIVI worked with its nation accomplices and the WHO territorial and nearby workplaces to survey NITAGs fortifying needs and to give specialized help with 7 LMICs (Laos Peoples Democratic Republic, Mongolia, Vietnam, Armenia, Côte d’Ivoire; Moldova and the Republic of Georgia) [28]. In Europe, complete cancer tranquilizes deals dramatically increased somewhere in the range of 2005 and 2014, expanding from €8.0 billion to €19.8 billion [29]. Biologics were assessed to represent US$289 billion pharmaceutical deals in 2014 and are anticipated to reach US $445 billion of every 2019. It is additionally foreseen that a lot of global solution and OTC pharmaceutical deals will ascend to 26% by 2019 [30]. It is anticipated that new instances of cancer will increment from about 14 million of every 2012 to 22 million out of 2030, with most cases in LMICs situated in Africa, Asia and Latin America [31]. The anticipated increment in cancer frequency is anticipated to be most noteworthy in LMICs in Asia. In these countries, over 60% of the complete healthcare consumption originates from private assets, of which over 80%
Their staff are not required to indicate aptitudes in pharmaceutical warehousing and the executives, regularly with tragic results [50]. The month to month medication costs were the most astounding in the U.S and lowest in India. Be that as it may, regardless of having the lowest medication costs, drugs were the least reasonable (affordability evaluated as medication costs separated by GDP per capita or normal compensation) in India [39,40]. Those drugs that guarantee fix ought to be given the main need. The administrations and strategy producers in LMICs ought to organize access to profoundly successful biotech drugs used in therapeutic setting and cutoff spending on costly yet insufficient or insignificantly viable drugs used in palliative setting. Bury joint efforts between the BRICS countries like Brazil, China and India need to establish the tone and make more motivating forces to build nearby generation of drugs with LMICs [51]. There are different mediations or changes in approaches exhorted that can help in lowering the cost of biotech drugs like breaking the syndication in medication makers, changing the administrative rules by government offices for those organizations which production less expensive drugs and making the new medication endorsements quicker, expanding the cost adequacy proportion of drugs, accomplishing a harmony between doctor self-governance in recommending biotech drugs and costs caused by patients, empowering nonbenefit nonexclusive organizations which assembling biotech drugs by giving them charge motivating forces and different measures, esteem based repayment by restorative insurance agencies.
Acknowledgement
I’m thankful to Gautam Kumar Saha, Apollo Hospitals Educational and Research Foundation, New Delhi, India for his precious time to review my letter to the editor and for his thoughtful suggestions. I’m also grateful to seminar library of Faculty of Pharmacy, University of Dhaka and BANSDOC Library, Bangladesh for providing me books, journal and newsletters.
References
- Beck EJ, Mandalia S, Dongmo Nguimfack B, Pinheiro E, 't Hoen E, et al. (2019) Does the political will exist to bring quality-assured and affordable drugs to low- and middle-income countries? Glob Health Action 12(1): 1586317.
- Philippidis A (2019) Top 15 Best-Selling Drugs Of 2018 Sales for most treatments grow year-over-year despite concerns over rising prices GEN Magazine.
- IQVA (2019) The Global Use of Medicine in 2019 and Outlook to 2023: Forecasts and Areas to Watch Institute Report.
- Stevens H, Huys I (2017) Innovative Approaches to Increase Access to Medicines in Developing Countries. Front Med (Lausanne).
- Faruqui N, Martiniuk A, Sharma A, Sharma C, Rathore B, et al. (2019) Evaluating access to essential medicines for treating childhood cancers: a medicines availability, price and affordability study in New Delhi, India. BMJ Glob Health 4(2): e001379.
- Lexchin J (2013) Canada and access to medicines in developing countries: intellectual property rights first. Global Health 9: 42.
- Moon S (2017) Powerful Ideas for Global Access to Medicines. N Engl J Med 376(6): 505-507.
- Prinja S, Bahuguna P, Tripathy JP, Kumar R (2015) Availability of medicines in public sector health facilities of two North Indian States. BMC Pharmacol Toxicol 16: 43.
- Oberoi SS, Oberoi A (2014) Pharmacoeconomics guidelines: The need of hour for India. Int J Pharm Investig 4(3): 109-111.
- Ewen M, Zweekhorst M, Regeer B, Laing R (2017) Baseline assessment of WHO's target for both availability and affordability of essential medicines to treat non-communicable diseases. PLoS One 12(2): e0171284.
- Khuluza F, Haefele-Abah C (2019) The availability, prices and affordability of essential medicines in Malawi: A cross-sectional study. PLoS One 14(2): e0212125.
- Ahmadiani S, Nikfar S (2016) Challenges of access to medicine and the responsibility of pharmaceutical companies: a legal perspective. Daru 24(1): 13.
- 't Hoen EFM, Kujinga T, Boulet P (2018) Patent challenges in the procurement and supply of generic new essential medicines and lessons from HIV in the southern African development community (SADC) region. J Pharm Policy Pract 11: 31.
- Scavone C, Sportiello L, Sullo MG, Ferrajolo C, Ruggiero R, et al. (2017) BIO-Cam Group. Safety Profile of Anticancer and Immune-Modulating Biotech Drugs Used in a RealWorld Setting in Campania Region (Italy): BIO-Cam Observational Study. Front Pharmacol 8: 607.
- Goldman DP, Joyce GF, Lawless G, Crown WH, Willey V (2006) Benefit design and specialty drug use. Health Aff (Millwood). 25(5): 1319-1331.
- Vogenberg FR, Young C (2004) Biotech injectable drugs: clinical applications and financial effects. Biotechnol Healthc 1(3): 31-40.
- Jayasundara K, Hollis A, Krahn M, Mamdani M, Hoch JS, et al. (2019) Estimating the clinical cost of drug development for orphan versus non-orphan drugs. Orphanet J Rare Dis 14(1): 12.
- Edelman B (2004) Explaining the cost of biotech therapies. Biotechnol Healthc 1(2): 37-41.
- Kunnumakkara AB, Bordoloi D, Sailo BL, Roy NK, Thakur KK, et al. (2019) Cancer drug development: The missing links. Exp Biol Med (Maywood) 244(8): 663-689.
- Scavone C, di Mauro G, Mascolo A, Berrino L, Rossi F, et al. (2019) The New Paradigms in Clinical Research: From Early Access Programs to the Novel Therapeutic Approaches for Unmet Medical Needs. Front Pharmacol 10: 111.
- Gouglas D, Thanh Le T, Henderson K, Kaloudis A, Danielsen T, et al. (2018) Estimating the cost of vaccine development against epidemic infectious diseases: a cost minimisation study. Lancet Glob Health 6(12): e1386-e1396.
- Simon R (2017) Critical Review of Umbrella, Basket, and Platform Designs for Oncology Clinical Trials. Clin Pharmacol Ther 102(6): 934-941.
- Tay-Teo K, Ilbawi A, Hill SR (2019) Comparison of Sales Income and Research and Development Costs for FDA-Approved Cancer Drugs Sold by Originator Drug Companies. JAMA Netw Open 2(1): e186875.
- Kaufman HL, Atkins MB, Subedi P, Wu J, Chambers J, et al. (2019) The promise of Immuno-oncology: implications for defining the value of cancer treatment. J Immunother Cancer 7(1): 129.
- Salmasi S, Lee KS, Ming LC, Neoh CF, Elrggal ME, et al. (2017) Pricing appraisal of anti-cancer drugs in the South East Asian, Western Pacific and East Mediterranean Region. BMC Cancer 17(1): 903.
- Chivukula MV, Tisocki K (2018) Essential cancer medicines in the national lists of countries of the WHO South-East Asia Region: a descriptive assessment. WHO South East Asia J Public Health 7(2): 90-98.
- Krzyszczyk P, Acevedo A, Davidoff EJ, Timmins LM, Marrero-Berrios I, et al. (2018) The growing role of precision and personalized medicine for cancer treatment. Technology (Singap World Sci) 6(3-4): 79-100.
- Moreno SG, Epstein D (2019) The price of innovation - the role of drug pricing in financing pharmaceutical innovation. A conceptual framework. J Mark Access Health Policy 7(1): 1583536.
- Ba-Nguz A, Shah A, Bresee JS, Lafond KE, Cavallaro K, et al. (2019) Supporting national immunization technical advisory groups (NITAGs) in resource-constrained settings. New strategies and lessons learned from the Task Force for Global Health's Partnership for influenza vaccine introduction. Vaccine 37(28): 3646-3653.
- Owoeye O, Owoeye O (2018) Biologics and Public Health: Prospects and Challenges. JLaw Med 26(1): 170-187.
- Wilking N, Lopes G, Meier KSS, et al. (2017) Can we continue to afford cancer treatment? Eur Oncol Hematol 13(2): 114-119.
- Barrios CH, Reinert T, Werutsky G (2019) Access to high-cost drugs for advanced breast cancer in Latin America, particularly trastuzumab. Ecancermedical Science 13: 898.
- Paudel S, Owen AJ, Owusu-Addo E, Smith BJ (2019) Physical activity participation and the risk of chronic diseases among South Asian adults: a systematic review and meta-analysis. Sci Rep 9(1): 9771.
- Rijal A, Adhikari TB, Khan JAM, Berg-Beckhoff G (2019) The economic impact of non-communicable diseases among households in South Asia and their coping strategy: A systematic review. PLoS One 13(11): e0205745.
- Giri M, Giri M, Thapa RJ, Upreti B, Pariyar B (2018) Breast Cancer in Nepal: Current status and future directions. Biomed Rep. 8(4): 325-329.
- Siegel RL, Miller KD, Jemal A (2019) Cancer statistics CA Cancer J Clin 69(1): 7-34.
- Sankaranarayanan R, Bhatla N, Gravitt PE, Basu P, Esmy PO, et al. (2008) Human papillomavirus infection and cervical cancer prevention in India, Bangladesh, Sri Lanka and Nepal. Vaccine 26 Suppl 12: M43-M52.
- India State-Level Disease Burden Initiative Cancer Collaborators (2018) The burden of cancers and their variations across the states of India: the Global Burden of Disease Study 1990-2016. Lancet Oncol 19(10): 1289-1306.
- Gyawali B (2017) Cancer drugs in LMICs: cheap but unaffordable. Oncotarget 8(52): 89425-89426.
- Goldstein DA, Clark J, Tu Y, Zhang J, Fang F, et al. (2017) A global comparison of the cost of patented cancer drugs in relation to global differences in wealth. Oncotarget 8(42): 71548-71555.
- Ramsey S, Blough D, Kirchhoff A, Kreizenbeck K, Fedorenko C, et al. (2013) Washington State cancer patients found to be at greater risk for bankruptcy than people without a cancer diagnosis. Health Aff (Millwood) 32(6): 1143-1152.
- Saqib A, Iftikhar S, Sarwar MR (2018) Availability and affordability of biologic versus non-biologic anticancer medicines: a cross-sectional study in Punjab, Pakistan. BMJ Open 8(6): e019015.
- Kolasani BP, Malathi DC, Ponnaluri RR (2016) Variation of Cost among Anti-cancer Drugs Available in Indian Market. J Clin Diagn Res 10(11): FC17-FC20.
- Gronde TV, Uyl-de Groot CA, Pieters T (2017) Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks. PLoS One 12(8): e0182613.
- Eniu A, Torode J, Magrini N, Bricalli G (2015) Back to the ‘essence’ of medical treatment in oncology: the 2015 WHO Model List of Essential Medicines. ESMO Open 1(2): e000030.
- Thomas Z, Saha GK, Gopakumar KM, Ganguly NK (2019) Can India lead the way in neglected diseases innovation? BMJ 364: k5396.
- Kalra S, Azad Khan AK, Raza SA, Somasundaram N, Shrestha D, et al. (2016) Biosimilar insulins: Informed choice for South Asia. Indian J Endocrinol Metab 20(1): 5-8.
- Abdul Kader Mohiuddin (2019) Safety Issues of Biosimilar Products. J Cancer Res Therap Oncol 7: 1-4.
- Kaduskar PU (2016) Biosimilar insulins: An unavoidable option in South-East Asia. Indian J Endocrinol Metab 20(4): 574-575.
- (2013) Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products; Board on Global Health; Institute of Medicine; In: Buckley GJ, Gostin LO (Eds.), Countering the Problem of Falsified and Substandard Drugs. Washington (DC): National Academies Press (US); Weaknesses in the Drug Distribution Chain.
- Ezziane Z (2014) Essential drugs production in Brazil, Russia, India, China and South Africa (BRICS): opportunities and challenges. Int J Health Policy Manag 3(7): 365-370.