Investigating the availability, affordability, and market dynamics of innovative oncology drugs in Morocco: an original report

Abstract

Background

The cost of cancer drugs presents a significant challenge to accessibility of treatment worldwide. Projections indicate that by 2040, two-thirds of cancer cases will occur in low- and middle- income countries. Paradoxically, despite this impending burden, LMICs command less than 5% share of global resources for treating cancer. Morocco, like many LMICs, faces significant obstacles in providing innovative cancer treatments to its population.

Aim

Firstly, we aimed to conduct an original research investigating the availability and affordability of innovative cancer drugs in Morocco. Secondly, we sought to review the broader market dynamics, pricing, and reimbursement policies in the country.

Methods

For the first objective, we identified a preliminary list of medicines approved for oncological indications in the Moroccan market based on resources from ANAM (National Agency for Health Insurance), pharmacy regulators, and online resources that compile information on approved medicines. For the second objective, we exhaustively reviewed the regulatory documents, legal texts and grey literature reports. All the informations were examined by pharma delegates and local experts.

Results

As of January 2024, Morocco has 39 innovative anticancer medicines with market authorization. 30% of these drugs were approved after 2020. The majority of approved drugs were for breast, lung, colorectal, and prostate cancer. The period between FDA approval and entry into the Moroccan market ranges from 2 to 7 years, with a median of 3 years for breast cancer drugs and 7 years for more expensive drugs like Olaparib and Osimertinib. 22 out of the 39 drugs are not reimbursed, with an average reimbursement time of 4 years. Compared to prices in France, the most notable pricing disparities concern immunotherapy agents, priced 600 to 900 euros lower in France, while drugs like Pazopanib and Erlotinib cost 50% less in Morocco.

Conclusion

Our study reveals significant disparities in the availability and affordability of innovative cancer drugs in Morocco. Regulatory hurdles, importation challenges, and pricing strategies contribute to this inequitable landscape. Addressing systemic barriers, fostering collaborations between stakeholders, and adopting a value-based pricing approach are imperative steps toward ensuring equitable access to high-quality interventions for patients, regardless of their geographical location.

Introduction

Cancer is one of the greatest health burdens in African countries. The predictions of the International Agency for Research on Cancer estimate that new annual cancer cases will attain more than one million (1.30 M) in Africa by 2025 and are expected to increase to 2.08 million by 2040 [1]. The scarcity of healthcare resources and the limited access to advanced treatments further increase the burden of cancer in the continent. This is particularly compounded by the overwhelming high cost of oncology drugs which is constantly increasing.

North-African countries, although exhibiting substantive differences with respect to demographics and economic growth, share common social features and similarities in healthcare structure and deficiencies. Poverty and social inequalities have always been a constant characteristic of the region’s social fabric with a disparity between access and demand of care for chronic illnesses, in particular for cancer care [2].

Taking a closer look to Morocco, the country has made significant inroads to improve health outcomes of its population. The improvement has been made in terms of several health indicators: increasing life expectancy, reducing infant and child mortality, improving access to essential health services from primary to tertiary care, etc. [3]. As for cancer care, Morocco was the first northern African country to implement a national plan for cancer control. Over the past two decades, the plan has made great strides in cancer prevention, diagnosis, and treatment to promote access to quality health services for all (National Plan for Prevention and Control of Cancer (2020). Ministry of Health, Morocco).

Quality of care refers to the extent to which the care provided to a person meets his needs and expectations, aligns with evidence-based practice, and achieves the best possible outcomes. A fundamental concept of providing quality care is to ensure that patients have access to healthcare services within a reasonable timeframe and cost. In the context of cancer, affordability has never been an easy task, especially in low- and middle-income countries. As new therapies for cancer are emerging with exponentially rising prices, it has become nearly-impossible to offer the best-care to our patients. In the majority of cases, the cost of a single administration of a targeted therapy or immunotherapy far exceeds the average income by several multiples. For example, the cost of a typical Pembrolizumab course is approximately 8 times the monthly income of an average Moroccan (World bank report 2021). This financial distress of high-cost drugs, to which is added the hidden-expenses of cancer-care (regular lab tests, repeated procedures, transportation and travel, …) falls upon deprived and vulnerable populations. In addition to this, the lack of palliative care facilities adds an extra burden for relatives of terminally ill cancer patients who require in-home care [4].

We believe that this is the first study to examine the availability, cost, and affordability of innovative cancer medicines in Morocco. Our aim is to provide a reliable and up-to-date list of innovative anticancer drugs registered with marketing authorization in Morocco, along with their cost, and reimbursement status. Additionally, we briefly describe the cancer treatment drugs market in Morocco, focusing on marketing, pricing, and reimbursement policies in the country. The findings of this study will offer valuable information to prescribers, patients, and policymakers, allowing them to identify differences in access to cancer medicines, prioritize rapid access to essential treatments, and make better use of the resources available to deliver quality cancer care to patients.

Material and methods

Original research

A preliminary list of medicines approved for oncological indications in Morocco as of January 2024 was compiled from resources provided by ANAM (National Agency for Health Insurance), the public institution that oversees and regulates health coverage in Morocco. Additionally, we searched informations from pharmacy regulators, pharmaceutical industry websites, and online resources that compile information on approved medicines. After drawing up a preliminary list, we reached out to pharma delegates to provide us with information on the approval status of each drug. The Data was double checked for completeness and accuracy and entered on a standardized Microsoft excel spread sheet for analysis. Descriptive statistics were used to present the results of this analysis.

Inclusion and exclusion criteria

Included

Innovative anticancer drugs with market authorization in Morocco as of January 2024. The listed drugs have been classified based on their mechanism of action (immunotherapy, targeted therapy, endocrine therapy), type of agent (tyrosine kinase inhibitors, monoclonal antibodies or antibody drug conjugates), specific target, and generation. The list specifies the names of molecular entries with dosage, recommended dose, the FDA approval history, the date of market entry in Morocco, the public selling price and reimbursement status.

Excluded

Chemotherapy drugs, conventional endocrine therapies, and targeted therapies used exclusively in hematology. Biosimilars and generics were listed separately.

The price in France was used as a reference for comparing medicines prices in Morocco. While not perfect, the choice of France was justified by several factors. France's proximity and historical ties to Morocco, along with shared regulatory frameworks make it a relevant reference point. Furthermore, the country provides readily accessible and transparent pricing data compared to neighboring countries, simplifying the task. Also, using French prices allows for international benchmarking to conduct comparatives analyses and may be more practical for stakeholders in Morocco. The Comité Economique des Produits de Santé (CEPS), an inter-ministerial body responsible for setting prices for medications reimbursed by health insurance schemes, maintains a comprehensive database of detailed information on drug prices and reimbursement status in France, accessible through the public medication database 'La base de données publique des médicaments.' This database was utilized to extract price information in France.

The displayed information corresponds to the price including VAT per medication package as of January 2023. To provide context for the price comparisons, the average exchange rate in 2024 is: 1 euro = 10.81 MAD.

Literature review

For this second aim of the study, we proceeded to an extensive review of the literature including grey literature reports, legal texts, and official resources of health authorities Web pages to retrieve information relating to drug marketing, pharmaceutical pricing, and reimbursement policies in the country. The gathered informations were examined by local experts including representatives of national regulatory authorities, health insurance organizations, academics and actors within the private pharmaceutical sector.

Results

With the exception of chemotherapy and conventional endocrine therapy, a total of 39 cancer medicines are available in Morocco with market authorization at the time of drafting this manuscript (Table 1). The list includes: 2 immune-checkpoint inhibitors (Pembrolizumab, Nivolumab), 2 CDK4/6 inhibitors for luminal metastatic breast cancer (Palbociclib, Ribociclib), 4 anti-EGFR Tyrosine-kinase inhibitors for EGFR-mutated NSCLC, 3 anti-ALK inhibitors, 5 monoclonal anti-bodies, one antibody–drug conjugate (TDM-1), one PARP inhibitor (Olaparib), 2 anti-HER2 tyrosine-kinase inhibitors (Lapatinib, Neratinib), 9 multitargeted kinase-inhibitors (anti EGFR, PDGFR and VEGFR tyrosine kinase families), one anti-BRAF inhibitor; one anti-PDGFR/KIT inhibitor (Imatinib) and 3 s-generation hormone therapy for prostate cancer (Enzalutamide, Apalutamide, Abiraterone Acetate).

Table 1 Available innovative drugs in Morocco with dosage, recommended dose, the FDA approval history, the date of market entry in Morocco, the public selling price, the reimbursement status and pricing comparison with France

In terms of the annual growth of listed drugs, a clear upward trend in the market authorization of anticancer drugs in Morocco is observed since 2020, with 30% of listed drugs were approved after 2020, compared to 50% between 2010 and 2020, while the numbers fluctuated yearly before.

Regarding indication populations, Morocco has a greater number of approved drugs for breast cancer, lung cancer, colorectal cancer, and prostate cancer. Multitarget anti-vascular therapy is the most frequently approved target, with the three most common targets being HER2, EGFR, and VEGFR. Roche leads the market with a total of 10 drugs with market authorization, representing 25% of the listed drugs. Following Roche, Pfizer has 5 drugs, while both AstraZeneca and Novartis each have 4 drugs.

The period between the first FDA approval and entry into the Moroccan market ranged from 2 to 7 years. This timeframe was particularly rapid with a median of 3 years for drugs designed for breast cancer treatment (typically anti-HER2 monoclonal antibodies), and 7 years for more expensive drugs like Osimertinib and Olaparib.

In terms of reimbursement, 22 out of the 39 drugs listed are not covered. The reimbursed drugs, notably, do not seem to share specific characteristics related to drug type, specific target, or clinical benefit achieved; rather, their common feature is that they have been approved for clinical use for more than a decade. Time-to-reimbursement, defined as the timeframe from market authorization to reimbursement approval by health authorities in the country, took an average of 4 years for most of the drugs.

At first glance of the results, the most notable pricing disparities when comparing the prices of the drugs in Morocco and France concern immunotherapy agents, which are priced 600 and 900 euros lower in France than in Morocco. It is worth noting that reimbursement for the two immunotherapy agents in the country is still pending, and patients benefit from immune checkpoint inhibitors either through the above described ANAM procedure, private health-insurance, or out-of-pocket payments. In contrast, Pazopanib costs 50% less in Morocco, and the price of Erlotinib (Tarceva®) has undergone a significant reduction, with the cost of a 150 mg box dropping from 17,855 MAD to 9,451 MAD following the entry of the first generic to the market.

Biosimilars and generics

To date, the country boasts a total of 65 registered biosimilars, including 5 anti-cancer monoclonal antibodies, with 3 of them are locally produced. Tables 2 and 3 provide detailed informations on the registered biosimilars and generics in Morocco and compare their costs with those of the brand-name drugs.

Table 2 Registered anticancer biosimilars in Morocco and cost-comparison with the brand-name drugs

Table 3 Registered anticancer generics in Morocco and cost-comparison with the brand-name drugs

Discussion

An overview of the cancer drugs market dynamics in Morocco

Cancer drugs represent a significant chunk of the pharmaceutical market, occupying close to 18% as of 2022. This translates to roughly $196 billion in cancer medicine spending and is anticipated to reach $375 billion in 3 years, according to the IQVIA website [5]. The cancer’ drugs market has an oligopolistic structure with a limited number of major pharma compagnies dominating the landscape. F. Hofmann-La Roche, Pfizer, Merck & Co., Novartis, Bristol-Myers Squibb, and Johnson & Johnson have dedicated oncology portfolios with numerous drugs. To illustrate, Roche alone boasts more than 30 cancer-fighting medications across more than 15 different types of cancer.

The high cost of cancer drugs is related to multiple factors. Every year, billions are spent on cancer research globally. In 2023, the National institute of Health (NIH) invested 7.3 billion dollars on cancer research, compared to 3.9B for cardiovascular disease and 2.8B for neurological disorders [6]. The complexity of cancer biology, the high-level of innovation and the long development timeline needed from preclinical studies to large-scale clinical trials drive the high-cost of cancer’ drugs development.

The rigorous and expensive approval process by health authorities adds to the overall cost of bringing a drug to market. Limited competition for specific cancer drugs and limited treatment options with no comparable alternatives for some cancers further increase the cost. Once the drug is approved, companies receive patent protection with the exclusive right to sell the drug for a limited period (around 20 years in the USA) and preventing generic manufacturers from entering the market and driving down prices. After the FDA approval, companies seek to expand their market presence and engage on registration processes following regulatory standards of each target country [7].

Process of market authorization in Morocco

The process of obtaining market authorization for cancer drugs in Morocco is relatively well defined but rather complex, involving multiple steps and regulatory instances. The formal application consists of submitting a comprehensive file containing detailed information about the drug, including its efficacy, safety, labelling information, and manufacturing process to the National Health Insurance Agency (ANAM) for evaluation. A committee of experts appointed by the agency thoroughly reviews the application to assess the clinical effectiveness, cost-effectiveness and overall value of the new drug. Based on the recommendation of the committee, the agency issues either a marketing authorization (AMM = Autorisation de mise sur le marché) or a rejection notice. Time-to-market estimates suggest a timeline of 14 months for new drugs and 13 months for generics [8].

Before gaining market access, the public selling price and reimbursement agreements are established following negotiations between the producer or importer and the public authorities. These negotiations are facilitated by the Transparency Commission, an independent scientific body whose operations are regulated and endorsed by the Ministry of Health [9]. The Transparency Commission conducts an assessment of the improvement in the Medical Service Rendered (Service medical rendu) in terms of the effectiveness of the drug (quantity of effect), adverse effects, existing of alternative options, and its relevance to public health. Reimbursement decisions and terms involve estimating the cost of the drug, considering the size of the target patient population, and evaluating the overall impact on the healthcare budget. Adjustments to reimbursement terms may be made as new evidence emerges or market conditions change. Notably, the period for revising the public selling price is currently five years in Morocco.

Pharmaceutical pricing in Morocco

In general, producers determine the price at which the medicine is purchased by wholesalers and retailers based on the cost of production, the development cost of the drug, and the desired profit margin. The public selling price is set based on the manufacturer's price (PFHT = manufacture price excluding taxes), to which is added the distribution margins of wholesalers, the profit margins of pharmacists, and the VAT (Value added Tax). For imported drugs, the PFHT is increased by 10% to cover the importer's margin, approach costs and customs fees. Since December 19, 2013, the Ministry of Health in Morocco implemented a reform to contain out-of-pocket spending and improve access to affordable medicines. The main improvement consisted in reducing the wholesale and pharmacy margins (previously set at 30% for all drugs) from linear to regressive scheme: the higher the cost of a drug, the lower the margin profit is [10]. Under this national drug policy, the prices of more than 3600 medications have been reduced. However, the representation of oncology medicines in this list was quite limited. The second main change consisted of introducing external price reference to determine the public selling price of imported medicines, based on seven benchmark countries (Spain, Portugal, France, Belgium, Turkey, Saudi Arabia, and the country of origin of the medicine). The price considered is determined by taking the average price observed in reference countries for existing products and the minimum price for newly introduced pharmaceuticals. These prices are then converted into local currency in accordance with national regulations. Importantly, the public selling price is the same nationwide and cannot vary from one Officine to another. In a comprehensive review comparing pharmaceutical pricing and reimbursement policies for patent medicines in North African countries, including Algeria, Morocco, and Tunisia, the study notes that External Reference Pricing is the predominant method that influences pricing decisions in these three neighboring nations [11].

To secure lower drug costs, public hospitals often negotiate directly with pharmaceutical companies, obtaining prices below the public selling price paid directly by insurers. This negotiated price, which also applies to private facilities, ensures pharmaceutical companies a guaranteed volume due to the substantial procurement volume of hospitals. Overall, the difference between the hospital price and public selling price generally does not exceed 2–5%.

Health coverage in Morocco

Morocco's health policy is mainly state-run with the majority of health services provided by public institutions. However, the ever-growing private sector contributes to a greater share of the overall healthcare spending (58% of total health expenditure in 2021) and household out-of-pocket payments account for majority of total payments (45% of total health expenditure in 2020) [12]. Prior to 2005, medical coverage was voluntary. Following the implementation of the mandatory health insurance system in 2005, 40% of the population gained coverage through two entities: CNOPS (National Fund for Social Welfare for public sector employees, retirees, and their dependents) and CNSS (National Social Security Fund for private and self-employees). Although there are some private health insurance companies, their financial contribution to healthcare funding is marginal. In addition, the Royal Armed Forces Health services provide healthcare services to active military personnel, their relatives and retired veterans within a dedicated medical coverage. To promote access to health services, a health insurance program (RAMED) was launched in 2012 to support the low-income population. Patients concerned were able to receive free medical care in public health facilities. In 2019, 18.44 million people had been registered as beneficiaries. The subset of patients not eligible for RAMED and not covered by health insurance continued to pay out-of-pocket for healthcare expenses. Despite these efforts, the unprecedented pressure on government health resources resulted in low availability of innovative medicines through the public sector.

To enhance healthcare access, local initiatives have been launched fostering partnerships between the government and prominent pharmaceutical companies. In October 2009, an agreement was signed with the Ministry of Health and Roche to implement the ACCESS program to improve access to innovative cancer medicines for low-income patients who do not benefit from medical insurance [13]. This program helped over 1,500 patients yearly to benefit from Roche’s innovative therapies (Trastuzumab, Bevacizumab, and Rituximab). Similarly, the Amal access program was launched by Pfizer company to provide financial assistance to eligible patients to cover the cost of Pfizer's oncology medicines. The program covers up to 50% of the annual cost of the following drugs (Palbociclib, Sunitinib, Crizotinib Lorlatinib, and Axitinib).

Since 2022, Morocco engaged in an ambitious reform of universal health-insurance promising up to 90% population coverage. The transition to the new health system reform has made it possible to cover the care dispensed in both public and private health facilities, provided they are on the list of expenses approved for reimbursement. In terms of cancer care, this enables access to treatments such as surgery, radiation therapy, and most chemotherapy drugs, with a fixed reimbursement rate of 95%. Newer and innovative cancer treatments, however, are not all available in the country, and those that are, either are not reimbursed, or do not have reimbursement for all the indications for which they were approved in high-income countries. To this end, the National Health Insurance Agency (ANAM) has set up a derogation process to provide coverage of medicines that are not reimbursed or grant off-label use for prescriptions outside approved indications. This process relies on assertions submitted by insured patients supported by a thorough medical file. A panel of experts assesses these assertions and provides their evaluations. Reimbursement for the patient is approved following a rigorous examination of the submitted medical file and an assessment of the anticipated clinical benefits of the prescribed medication. However, the impact of this approach remains highly constrained due to the minimal number of patients who can benefit from it, coupled with the time-consuming process of scrutinizing each file before reaching a decision.

Discussion of the main results of the study

This study systematically summarized and compared the list of anticancer drugs approved in Morocco over the past 20 years. The findings revealed significant progress in the availability of anticancer drugs in Morocco over the past decade, with a total of 39 drugs entering the market. However, despite proactive measures implemented by stakeholders and governments, accessing new and innovative therapies remains a major challenge in the country. For instance, while 134 unique new cancer drugs have been registered in the US and Europe in the past decade, with many receiving approval for multiple indications [14], the local market has only seen an expansion of 10 medicines.

Another concern pertains to the time lag between the initial approval of oncology drugs by the FDA and their subsequent entry into local markets. For example, Olaparib, first approved by the FDA in 2014 to treat high-grade advanced ovarian cancer and subsequently in 2018 in patients with BRCA-mutated metastatic breast cancers, was only granted marketing authorization in Morocco in December 2023, and reimbursement approval is still pending. The number of patients who would have benefited from Olaparib in this timeframe can only be very significant. New antibody drug conjugates (Trastuzumab Deruxtecan, Sacituzumab Govitecan), the major innovation in metastatic breast cancer in the last few years, are currently unavailable in Morocco and are unlikely to be accessible in the near future due to their associated costs. Overall, it can be concluded that except of breast cancer, colorectal, lung and prostate cancers, many patients do not receive guideline concordant care for their disease.

One way to improve accessibility to innovative medicines in resource-limited countries is to prioritize investments in generics and biosimilars. Unlike generics which are synthetic copies of a brand-name drug; biosimilars, also referred as biologic based medicines, comprise large molecules that are manufactured by cells or living organisms via complex biological processes, and are not considered to be chemically identical to the reference products. In the last decade, when the patent protection for some of the most extensively used biologics had begun to expire, local companies have embarked on the local manufacture of biosimilars to improve access with lower-cost options for biological anti-cancer agents. The first biosimilar was approved in Morocco in 2016 (2006 in Europe). The marketing authorization of biosimilars does not differ from that of other drugs but with special and rigorous requirements, notably in terms of raw material comparability tests and manufacturing, which must be carried out in accordance with the WHO standards and guidelines for biosimilar medicines.

With the high-demand on essential cancer medicines, generic manufacturers have also gained increasing traction over the last years. A generic drug is defined as a medicine that is identical to a marketed brand-name drug in terms of composition of active-ingredient formula, pharmaceutical form, stability and bioavailability, produced by competitor companies after the patent expiry. Inactive ingredients such as coloring agents, stabilizers and bindings usually vary from the reference drug and from a manufacturer to the other. In the last decade, Indian generic manufactures have been increasingly supplying the anticancer pharmaceutical market in Morocco, making it one of their main export destinations. Sun Pharma, Dr Reddy’s laboratories and Aurobindo pharma, the India’s largest pharmaceutical companies, have a strong presence in Morocco, with a portfolio of numerous genetic anti-cancer drugs, primarily focusing on chemotherapy. Generics provide lower costs and enhance access to essential anti-cancer drugs. The first generic to enter the market is typically priced 20 to 30% lower than the brand-name drug. Subsequently, reimbursement policies often prioritize the price of the generic over the brand-name molecule. This is notably the case in Morocco for drugs like Imatinib, Erlotinib, and Fulvestrant, where reimbursement is based on the generic price (Table 3). Importantly, generics can exert a competitive pressure on pharmaceutical companies, promoting them to adjust their prices to maintain their market share and competitiveness. This was the example of Erlotinib (Tarceva®) that was initially set at 17,855 MAD. However, with the introduction of the first generic competitor to the market, priced at 7,073 MAD, Roche responded by reducing the price of their brand-name drug to 9,451 MAD. It also highlights the importance of a robust generic drug market in driving down healthcare costs and improving access to essential medications for patients in limited-resources countries.

In an era increasingly emphasizing personalized medicine, the accessibility of innovative treatments hinges upon the availability of pertinent molecular diagnostic tests, including but not limited to genetic sequencing and biomarker analysis. While these tests offer improved diagnosis, personalized treatment options, and potentially better outcomes, their high cost and complex infrastructure requirements limit their widespread use in limited-resources context. In Morocco, Immunohistochemistry (IHC), in situ hybridization (ISH), and polymerase chain reaction (PCR) are widely available in pathology laboratories across the country and covered by insurance. Emerging tests however, such as Next Generation Sequencing (NGS), are only accessible at select centers and, for the most part, are not reimbursed.

What has changed since the health reform and what can be improved?

The 2022 health reform in Morocco aimed to improve access to healthcare for all citizens, including access to essential medicines. Preliminary reports indicate that during the first semester of 2023, more than 9 million individuals were recorded in the national population registry, out of a target of 10 million, achieving 90% of the set objective. Its impact on accessibility of innovative anticancer drugs specifically isn't explicitly documented. Comprehensive data on access to anticancer drugs after the reform is scarce, making it difficult to measure the exact impact. Additionally, the reimbursement terms for most of the available drugs are not well known by the practitioners.

The complexity of reimbursement procedures -increased since the implementation of the new reform- presents a significant burden for patients and their relatives. Paper forms, multiple visits to different offices, and unclear instructions can make reimbursements a daunting task for patients, especially those with limited education, digital illiteracy, language barriers, or physical limitations related to their disease. The lack of real-time information about the application status, eligibility criteria, or reasons for rejection is likely to fuel anxieties and frustrations and lead patients to abandon their reimbursement claims, adding to the burden of illness.

At a local level, there is a room of improvement across multiple fronts. Ensuring access to the most effective medicines to treat cancer must be at the core of priorities for policy makers and third-party payers. In the context of LMICs, adopting a value-based pricing approach is crucial to best estimate the true generated value of novel drugs and their clinical impact [15]. Cost-effectiveness decisions are essential to limit excess spending on drugs that yield little benefit. This is particularly important in an era marked by rapid drug development. However, the current cost-effectiveness strategies may not fully apply to Morocco's reimbursement system, where only proven, long-standing drugs that have shown consistent benefit are reimbursed. Conversely, some drugs with marginal benefit, such as Neratinib or Aflibercept, have entered the market. This indicates a misalignment between market entry and the actual clinical benefit, suggesting that the market could be better enhanced with more valuable evidence of efficacy.

Proposed by ESMO, the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) was introduced in 2015 in response to the immense number of new cancer drugs. The ESMO-MCBS offers a measure of the relative clinical benefit expected from a new treatment indication for solid tumors, drawing from data obtained from pivotal clinical trials or meta-analyses [16]. This scale can serve as a tool to assess value, aiding national health authorities prioritize access to cancer medications, particularly when resources are limited. Local cancer researchers can also contribute to value-based research by investing in drug deescalation trials, defining the optimal dose, schedule, duration of treatment, and selecting patients that most likely to benefit from it. Several countries have adopted value-based pricing strategies by using real-world performance data of novel agents to establish market prices or reevaluate the prices of existing drugs based on population outcomes [17].

Another aspect requiring improvement is the reliance on benchmark pricing as a reference for setting medicine prices in Morocco, which may present several limitations. Prices that are benchmarked against countries with different economic and demographic profiles, distinct healthcare structures and needs, often lack accuracy and fail to adequately reflect the specific demands of the Moroccan population, potentially straying from their affordability thresholds. In addition, relying solely on benchmarking limits the ability of public institutions to negotiate affordable price arrangements [18].

Encouraging local manufacturing of essential drugs and generic alternatives can increase affordability and reduce reliance on external markets. Improvement efforts can also focus on simplifying procedures, standardizing forms, and improving communication channels to expedite approvals and reduce reimbursement delays. Ensuring robust data collection and transparent reporting on drug accessibility and affordability are essential to effectively monitor progress and identify gaps to fill.

With all this considered, the impact of such actions will remain marginal. What is required to enhance access to cancer drugs extends beyond local efforts. Cancer medicines came with a very high price tag, and this is primarily because profit-making drives the oncology business model. Pharmaceutical industry often attributes the high drug prices to the expenses incurred in research and development, particularly in clinical trials, which represent the most expensive part of it. While their crucial role in advancing cancer research is undeniable, pharmaceutical companies allocate more of their revenues from cancer drugs sales to areas such as marketing and expansion into new markets, rather than to research and development (R&D). A study examining 99 cancer drugs approved by the FDA between 1989 and 2017 aimed at comparing sales revenue with R&D costs found that the median income return generated at the end of 2017 was $14.50 (range, $3.30-$55.10) for every $1 spent on research and development [19].

Accordingly, the evolving trends in oncology drug development hold promise for reducing the costs associated with clinical trials timelines. Strategies such accelerated approval based on early surrogate endpoints, fast track pathways to expedite drug review, combining phase II and III trials into a unified phase II/III design, as well as umbrella and basket trials design enabling the testing of multiple drugs within a single framework or a single drug across multiple cancer types, and the implementation of adaptive trial designs allowing for adjustments based on interim data, are all emerging approaches expected to potentially lower drug development costs. A study was carried out in 2017 to provide an estimate of median R&D spending on cancer drug development of 10 cancer-approved drugs, half of them obtained accelerated approval from the FDA. The median expense incurred for developing a single drug amounted to $648.0 million USD. Notably, the median cost of drug development was lower for drugs that received accelerated approval, totaling $328.1 million USD, compared to $817.6 million USD for those without accelerated approval (p = 0.08) [20]. Paradoxically, the expectation that drugs granted accelerated approval will cost less than regular approved drugs is contradicted by reality. The same holds true for second-in-class drugs, commonly referred to as "me too drugs," which are often priced similarly to or even higher than first-in-class drugs.

Ultimately, we must remember that preventing cancer is better than treating it, and cure is better that palliate. Thus, investing in prevention policies as a cost-effective strategy to mitigate the burden of cancer is of its utmost need, especially in developing countries. Preventive measures must be vigorously pursued, including raising awareness about cancer risk factors, enforcing tobacco control policies, prioritizing vaccination programs against cancer-causing infections, promoting healthy lifestyle, and implementing affordable screening and early detection programs for prevalent cancers.

Conclusion

The exorbitant cost of cancer drugs presents a significant burden in low- and middle- income countries, where limited resources strain healthcare budgets. While innovative cancer treatments seem largely available in Morocco, a critical issue persists regarding the time lag to market entry and reimbursement approval. Furthermore, the absence of reliable data within the country make it difficult to track the accessibility of these medications to patients in need, and to accurately assess the number of patients receiving the necessary treatment. This underscores the urgent need for streamlined regulatory processes and improved data infrastructure. As highlighted in this review, our capacity as middle-income nation to influence drug pricing is severely constrained, resulting in comparable costs across high and middle-income countries. This uniform pricing fails to consider the diverse needs and resources of individual countries. It is imperative to recognize that achieving universal access to essential cancer therapies requires not only local efforts but also global collaboration. By addressing these barriers collectively, we can move closer to ensuring that every individual, regardless of their socioeconomic status or geographical location, has equitable access to life-saving treatments.