Cost analysis study of neuropsychiatric drugs: Role of National List of Essential Medicines, India
Correspondence Address: Source of Support: None, Conflict of Interest: None DOI: 10.4103/0028-3886.241345
Source of Support: None, Conflict of Interest: None
Keywords: Cost per defined daily dose, cost variation, National List of Essential Medicines, neuropsychiatric drugs
The lack of health insurance policy in developing and economically backward countries leads to an unsustainable household income; for instance, 58% of India's health expenditure is being sustained out of pocket of the patients or their relatives. According to the World Health Organization (WHO) report (2016), the economy of 150 million people worldwide gets severely stressed by the health expenditure. A survey conducted in India showed that medicines account for the principal components of the total health expenses –72% in rural and 68% in urban areas. The WHO report has stated that approximately 5% of country's health expenditure can be circumvented by controlling overpricing, promoting the rational use of drugs, and improving the quality of medicines.
The Indian pharmaceutical market is flooded with more than 3,000 pharmaceutical companies, 10,500 manufacturing units (1314 WHO-Good Manufacturing Practice [GMP] certified manufacturers), and more than 60,000 generic brands across 60 therapeutic categories; generic medications account for 70% of the market share.,
Globally, neuropsychiatric disorders are ranked as the leading cause of disability adjusted life years (DALYs) in 2015 (10.2%) and the second-leading cause of death (16.8%). In the current scenario, it is crucial to determine, through a pharmacoeconomic approach, the magnitude and patterns of drug use in neuropsychiatric disorders in India, e.g., the cost analysis of the available drug formulations. This has an immense role in facilitating the planning and prioritizing of health needs, in highlighting the need to revise the cost of drugs, in aiding in the selection of less costly alternatives in the prescribing practice, and in optimizing the cost of therapy, ultimately leading to a rational drug use. The National List of Essential Medicines (NLEM) in India has been revised two times recently, i.e., in 2011 and 2015, with the main objective of inculcating the rational use of drugs, adhering to the basic principles of efficacy, safety, cost-effectiveness, and disease prevalence. However, the implementation of NLEM in the current healthcare scenario is still doubtful, which needs substantial promotion based on evidence. The cost variation profile of drugs provides an insight into the unnecessary cost burdens; however, there is a paucity of studies that compare the cost variations of drugs for neuropsychiatric disorders which are in the NLEM with those medications that are not included in the NLEM. The current study investigated the cost variations among neuropsychiatric medications prevalent in the Indian market with reference to NLEM, 2015.
This cost analysis study was conducted for drugs used for neurological as well as psychiatric conditions such as epilepsy, migraine, psychosis, depression, generalized anxiety disorder (GAD), bipolar disorder, and obsessive-compulsive disorder (OCD). For comparison, the drugs were broadly classified into two groups –the NLEM drugs (enlisted in NLEM, 2015) and the NNLEM drugs (not present in NLEM 2015, but used in clinical practice and available in the Indian market). The drugs that were mentioned in “Harrison's Principles of Internal Medicine, 19th edition"and available in the Indian market according to “Current Index of Medical Specialties (CIMS) 2016 and online CIMS India database” were considered in this study.,,,,
CIMS was used to identify the price (in Indian rupees, INR) of various brands of neuropsychiatric drugs. The price of medications was measured in cost per defined daily dose (DDD) unit. The DDD of a drug is defined by the WHO as “the assumed average maintenance dose per day for a drug used for its main indication in adults.”, DDD is considered for monotherapy based on the route of administration using the 5th level of an Anatomical Therapeutic Chemical (ATC) classification system code. The cost/DDD is calculated by multiplying the unit cost of suitable strength of the formulation with the number of units required to maintain the DDD. The drug strength in the NLEM group was selected as mentioned in NLEM, 2015. The strength of drugs in the NNLEM group was considered as the DDD itself, if that information was available; or the most frequently available strength was considered. The drug strength was considered only if it was available from two or more manufacturers. In this study, only orally available formulations were considered that included tablets, capsules, controlled release medications, sustained release medications, or any other oral formulations available in the CIMS.
The cost/DDD was calculated for drugs, both individually and group wise (NLEM and NNLEM), in terms of minimum–maximum cost, the interquartile range (25th and 75th percentile), the percentage cost variation (Eq. 1) and the cost ratio (Eq. 2). Cost ratio refers to the number of times the costliest brand of NNLEM costed more than the cheapest brand of NLEM in each disease. Microsoft excel 2007 was used for analysis.
Drugs used in the treatment of diseases such as epilepsy (n = 12), migraine (n = 10), psychosis (n = 12), depression (n = 17), bipolar disorder (n = 6), GAD (n = 8), and OCD (n = 4) were analyzed in this study. The number of manufacturers available varied from 2 for oxazepam to 85 for paracetamol. The parameters regarding each drug such as the Anantomical Therapeutic Chemical (ATC) code, the DDD, the strength selected based upon the criteria mentioned in the methodology section, the unit cost, and the calculated cost/DDD are mentioned in [Table 1]. The availability of strengths showed that, out of 61 medicines, 25 (41.0%) medicines had exactly matching strengths as that of DDD. The price range of drugs was found to be the widest for the NNLEM antimigraine drugs, and the narrowest for the NLEM antidepressants; however, the interquartile range of cost/DDD was the widest for the NLEM antiepileptic drugs and the narrowest for the NLEM antidepressants [Table 1] and [Figure 1].
The minimum and maximum cost/DDD among different drugs in each group is represented in [Table 2] and [Figure 2] and 3. The minimum cost/DDD of NLEM antidepressants had a narrow interquartile range (2–3 Indian rupees [INR]), but the NNLEM OCD drugs had a wide variation (2.4–15.8 INR). Similarly, the gap between the median minimum cost/DDD of NLEM and NNLEM was wide for antiepileptic drugs (14.8 INR). The median value of the minimum cost/DDD in the NLEM group was lower than the NNLEM group in several disease categories, except in the category of antimigraine and GAD drugs [Figure 2].
The interquartile range of maximum cost/DDD was narrow in the NNLEM GAD drugs (5.1–12.0 INR) whereas it was wide in the NLEM GAD drugs (9.1–73.8 INR). The gap between the NLEM and NNLEM groups' median maximum cost/DDD was wide for the GAD drugs (32.4 INR). The median value of the maximum cost/DDD in the NLEM group of antiepileptic, antidepressants, and bipolar disorder drugs was less than that of the NNLEM group; however, the reverse trend was present in the antimigraine, antipsychotic, GAD, and OCD drugs [Figure 3].
The cost ratio of neuropsychiatric drugs is compared and depicted in [Figure 4]. There was a wide gap between the minimum price of NLEM and the maximum price of NNLEM bipolar disorder drugs (cost ratio, 168.8 times). Similarly, the narrowest variation was observed in GAD drugs with a cost ratio of 9.7 times.
The comparison of antiepileptic drugs has shown that the maximum cost variation was with carbamazepine (1100%) followed by gabapentin (347.49%), whereas zonisamide accounted for the least cost variation of 82.44% [Table 1]. Previous studies have observed a lot of variation in the cost of antiepileptic drugs, specifically carbamazepine.,, Gupta and Reddy showed that there was a substantial variation in the cost of different brands of the same generic drug. Our study is in agreement with these studies and the cost ratio of NLEM vs. NNLEM antiepileptic drugs was 1:118.8 [Figure 4]. This signifies that more caution should be exercised while prescribing and selecting the brands of highly cost variable drugs such as carbamazepine and gabapentin. The interquartile range for the minimum and maximum cost/DDD [Table 2]; [Figure 2] and [Figure 3] depicts that the NLEM antiepileptic drugs are more economical than the NNLEM antiepileptic drugs.
Among antimigraine drugs, the NLEM group has a higher median value of minimum and maximum cost/DDD compared to the NNLEM group (4.4 vs. 1.7, and 15.0 vs. 7.2 INR, respectively) [Table 2]; [Figure 2] and [Figure 3]. A similar trend was observed for the interquartile range, showing that the NLEM drugs are comparatively higher priced than the NNLEM group. The literature on the cost comparison of antimigraine drugs is sparse, hence, this study gives an overall view regarding its price variation.
Shah et al., (2017) showed that the cost of many antipsychotic formulations has a percentage price variation above 100%; the maximum percentage price variation was 2282.85% for tab. risperidone 3mg and its cost ratio (costliest vs. cheapest) was 23.82. In this study, among the antipsychotic drugs, risperidone had a cost variation of 1724.32% (maximum with olanzapine [1780%] and least with paliperidone [4%]) [Table 1]. The minimum and maximum cost/DDD signifies that the NLEM group has a wide variation in price and also contains higher-priced drugs compared to the NNLEM group [Table 2]; [Figure 2] and [Figure 3].
Regarding antidepressant drugs, Paunikar and Bhave (2015) have shown that the maximum price variation in the selective serotonin reuptake inhibitor (SSRI) group was 1166.66% for paroxetine (37.5 mg), which is in line with the current study (maximum cost variation 1000% for paroxetine and minimum 21.53% for selegiline) [Table 1]. Shukla and Sharma (2016) found that the highest cost ratio and percent cost variation was for amitriptyline 50 mg, followed by bupropion 25 mg, amitriptyline 75 mg, and dosulepin 50 mg. They also opined that the inclusion of amitriptyline 50 mg and 75 mg in the NLEM, 2015 will lead to a decrease in the existing wide cost variation as a result of price regulation. The current study observed that the price of amitriptyline became regulated after its inclusion into the NLEM, 2015. This study also revealed that the NLEM antidepressants are more economical than NNLEM antidepressants based on the minimum and maximum cost/DDD [Table 2]; [Figure 2] and [Figure 3].
Similarly, the analysis of minimum and maximum cost/DDD [Table 2]; [Figure 2] and [Figure 3] also depicted that NLEM drugs for bipolar disorder are more economical than the NNLEM drugs; however, the reverse trend existed in the case of antianxiety drugs. There was no clarity appreciated on the economic aspects of the NLEM OCD drugs over the NNLEM group.
An increased cost sharing among the patients is related with decreased medication adherence, which ultimately results in poorer health outcomes. The government can use the NLEM list as a guiding tool to frame the strategy for health programs. The recent initiatives include the National Health Policy 2015, which aims to promote public expenditure in the health care sector and provides free generic medicines to half the population at an estimated cost of USD 5.4 billion. The aim of the Drug Price Control Order is to ensure that essential drugs are available to all those who require them at affordable prices, and the National Pharmaceutical Pricing Authority has recently revised and fixed the prices of 814 scheduled formulations.
The NLEM in India has been formulated and revised with the core objective of promoting the rational use of medicines and the optimum use of resources available for health care delivery. In the NLEM, 2011, there were 348 medicines listed; after addition and deletion, the NLEM, 2015 comprises a total of 376 medicines. Though the main motive of the NLEM is to ensure a wide availability and accessibility of cheaper drugs to the Indian population, physicians rarely consider the NLEM while prescribing medications, which results in a significant financial burden to the patients. One of the major impacts of the NLEM is that currently it has become the reference point for price regulation.
This study provides the cost comparison of the NLEM and the NNLEM drugs, and brings into the limelight, the immense differences in cost prevailing in them. A close study of these differences in cost and ensuring that the most economical medications are prescribed will ensure that the financial load on patients is relieved. There are many previous studies comparing the price variation in the drugs, but none of them have compared the NLEM with the NNLEM drugs. Among the drugs for neuropsychiatric diseases discussed in this paper, the NLEM drugs were found to be more economical than the NNLEM drugs in the case of antiepileptic medications, antidepressant medications, and drugs for bipolar disorder. In categories such as antimigraine and antianxiety drugs, the NLEM drugs are comparatively higher-priced than the NNLEM drugs. In categories such as the antipsychotic medications and drugs for OCD, though the minimum cost is lower for the NLEM drugs, the maximum cost is higher than that seen in the NNLEM drugs. This summarizes that, though the NLEM group has economically-priced drugs in some disease categories, there is more room for consideration of cost-effectiveness of all categories of drugs while revising the NLEM next time. This study has limitations. The focus was on the cost of the drug without comparison of efficacy and safety parameters among the drugs; hence, more studies are needed in this direction. This type of study is also needed for each section of drugs listed in the NLEM. However, this study has revealed significant findings with respect to the cost of the drugs. These findings need to be considered by the physicians while prescribing medications to their patients. The government, during policy-making, should carefully study these price variations among medications used for neuropsychiatric disorders and take steps to ensure price regulation. This will go a long way in attaining the goal of the rational use of drugs among Indian patients.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2]