Case studies
END-TO-END SUPPORT
-
Exploring the efficacy, safety, impact on quality of life, and economic outcomes of different forms of IV iron
Intravenous (IV) iron supplementation is the preferred treatment option for managing severe iron deficiency (ID) and ID anemia. Three of the available IV iron preparations are ferric derisomaltose (FDI), ferric carboxymaltose (FCM), and iron sucrose (IS). However, FCM has been reported to be associated with a high incidence of symptomatic hypophosphatemia. Our client wanted to understand the efficacy, safety, impact on quality of life, and economic outcomes of treatment of ID with FDI, FCM, and IS, and intended to publish the findings in the form of a rapid health technology assessment (HTA). For this project, we provided end-to-end support, right from the stage of inception of study objectives, restructuring the research questions into PICOS headings, development of search strategy, preparing and registering the systematic review protocol, literature screening, data extraction, risk of bias assessment, reporting, and converting the research findings into a manuscript. We also managed the publication of this manuscript, including responding to peer review and editorial comments. The rapid HTA was finally published in a high-impact PubMed-indexed journal.
-
Establishing cost-effectiveness and inclusion of an immunotherapy into Ayushman Bharat
Our client aimed to include a novel immunotherapy for the treatment of nasopharyngeal carcinoma under the Ayushman Bharat health scheme in India. To support this, we conducted an in-depth evaluation of the burden of illness, focusing on epidemiological, clinical, and economic data for NPC in India. We carried out an SLR to gather evidence on the disease burden, healthcare resource utilization, and treatment costs. We also developed a cost-effectiveness model comparing the immunotherapy to standard care, incorporating local cost data and pivotal clinical trial outcomes. With our assistance, the client was able to successfully demonstrate the value of their product, and position their product for inclusion into the Ayushman Bharat scheme.
-
Dossier submission support to AMCP.
Our client sought to gain formulary inclusion for a novel biologic therapy targeting moderate to severe rheumatoid arthritis in the US managed care market. To support the AMCP dossier submission, we performed a comprehensive review of the therapeutic landscape and conducted an SLR to gather relevant efficacy, safety, and economic data. We developed a cost-effectiveness model, comparing the biologic to both branded and generic alternatives. We also performed a budget impact analyses tailored to specific health plans, highlighting potential cost savings through optimized resource utilization. With our support, the client successfully navigated the AMCP submission process, gaining formulary acceptance in several leading US health plans
-
HTA submission support to NICE
Our client intended to achieve inclusion of one of the newer antiresorptive therapies for the management of osteoporosis in the UK NHS, and for the same purpose was interested in establishing cost-effectiveness of this intervention in comparison with other established therapies for this indication. In this project, we were involved in the development of the project protocol, literature search strategies in multiple databases, preparation of screening sheets, screening of all pooled abstracts and full texts, mining for additional references from relevant systematic reviews, data extraction and risk of bias assessment. We also performed a Bayesian network meta-analysis for fracture outcomes, and developed an individual patient simulation Markov model to evaluate cost-effectiveness of the intervention compared to its main competitors. We also assisted our client in responding to the NICE ERG questions and updating the NMA/ Model accordingly. With our assistance, our client was able to successfully complete the NICE submission and achieve inclusion of their product in the NHS. Therapy area: Endocrinology, Metabolic, Bone health
SYSTEMATIC REVIEWS AND META-ANALYSES
MARKET ACCESS AND VALUE STORY DEVELOPMENT
-
Intravenous Iron Preparations: Polishing the Payer Value Proposition Slide Deck
Intravenous (IV) iron supplementation is the preferred treatment option for managing severe iron deficiency (ID) and ID anemia (IDA). Among the available IV iron preparations, ferric derisomaltose (FDI), ferric carboxymaltose (FCM), and iron sucrose (IS) stand out, each offering unique benefits and drawbacks. Our client had developed a draft value proposition for their IV iron preparation, intending to support global market access initiatives. They sought our expertise to refine and enhance the content and presentation of the slide deck. In this project, we helped our client to ensure the information in the value proposition slide deck was accurate, concise, and relevant. We also standardized the terminology and phrasing for consistency. We organized the slides logically to create a coherent narrative and provided uniform citation and referencing to enhance credibility. Additionally, we included clear definitions and explanations of essential health economic terms to ensure the deck serves as a comprehensive, stand-alone resource for market access activities. By these activities, we transformed the draft slide deck into a polished, professional, and effective tool for supporting the global market access efforts of our client. Therapy area: Hematology.
-
Type 2 Diabetes Market Research: GLP-1 Agonists and SGLT2 Inhibitors in Japanese Market
GLP-1 agonists such as exenatide, semaglutide, and tirzepatide, and SGLT2 inhibitors such as canagliflozin, dapagliflozin, and empagliflozin, represent frontline drugs for the management of type 2 diabetes mellitus (T2DM). With many new drugs being investigated worldwide in these two classes, market competition is quite intense in this space.
Our client was interested in a secondary-only deep dive of the Japanese T2DM market landscape, with a special focus on GLP-1 agonists and DGLT-2 inhibitors. For this project, we prepared an extensive report consisting of T2DM guidelines in Japan, phase 1 to phase 3 assets in the GLP-1 and SGLT2i pipeline, analysis of key clinical trial timelines, estimation of potential launch timelines, market drivers, SWOT analysis of key competitors, and company profiles. The entire project was executed in three phases, consisting of literature review, landscape review, and trial timelines/ insights, and we provided insights into the Japanese T2DM market with comparison and contrasts to the US market. Therapy area: Metabolic, Diabetology.
-
Viral Hepatitis: Value of Diagnostics
Viral hepatitis, especially due to HBV and HCV, is a cause for major health care burden across the world, and also in India. With multiple genotypes, different modes of transmission, and possibilities for long-term sequalae, management of HBV and HCV hepatitis is a public health issue in India, as evidenced by the launch of National Viral Hepatitis Control Program (NVHCP) in India during 2018. Our client was interested to prepare a dossier discussing the value of different diagnostic tests in the management of viral hepatitis. For this project we performed in-depth research about the epidemiology, natural history, current diagnostic and treatment landscape, patient journey in India, available programs for hepatitis control, and health economics of hepatitis diagnosis. Backed with the above knowledge, we compiled the value of diagnostics in viral hepatitis management in India, and presented our findings in the form of a comprehensive dossier. Therapy area: Infectious diseases.
-
Market projection for the use of uroflowmetry and bladder diary among patients with moderate to severe lower urinary tract symptoms
Lower urinary tract symptoms (LUTS) affects both men and women, and is a sign of urinary tract obstruction due to various causes. Uroflowmetry and bladder diary are two modalities used in the evaluation of moderate to severe LUTS. Our client was interested to develop a model to forecast the number of patients with LUTS in the USA over the next five years, which would be used to predict the number of users of uroflowmetry and bladder diary over the time period. We developed a tool to cater to these requirements, and using the same, we developed a detailed report summarising the disease burden of LUTS in the USA, market size (present and future), pricing and reimbursement market analysis, and competitor landscape for both uroflowmetry and bladder diary, with a prediction in the number of urologists who may adopt these technologies in the next 5 years. This report was used by our client to prepare market access and pricing-reimbursement strategies.
-
Development of key performance indicators for value-based care of orthopaedic surgeries in hospitals
We assisted our client to develop certain key performance indicators (KPIs) which would help the client to objectively assess and quantify the quality of care provided to patients undergoing certain orthopaedic surgeries. Using the KPIs developed by us, the client would ‘score’ the quality of care by the hospital, and objectively assess the lacunae in order to rectify them. For this project, we developed the KPIs, and also provided the client with a framework to capture data for calculating the KPIs. The KPIs developed by us took into consideration both hospital-related parameters (such as duration of hospital stay, infection post-surgery, etc) as well as patient-related outcomes (such as pain, patient satisfaction, activity limitation, etc). Subsequently, we also analysed the KPIs and generated a comprehensive report which was used by the client for benchmarking the services provided by hospitals which practiced value-based healthcare delivery.
-
Expanding access & reimbursement in “Second Tier” markets in India
One of our clients wanted to understand the potential to expand access & reimbursement in “Second Tier” markets in India for a mature oncology biologic drug (not immuno-oncology), which is endorsed by international guidelines for 1L use in select cancers. We helped the client in explaining about the level of utilization and reimbursement of biologics in general in the specific markets (not necessarily in oncology), incl. compliance to international guidelines, recent and future landscape changes (including HC policy) that might have an impact on the oncology treatment landscape and specific market access and reimbursement challenges and opportunities relevant for oncology (tendering, level of formularies, budget caps) in India. The findings were shared in the form of a brief report.
-
Gain and understanding of carcinoma innovation specific market access landscape in China
Primary liver cancer encompasses Hepatocellular carcinoma (most common primary malignancy of the liver), Cholangiocarcinoma (<10%), and some other rare histologic types. Liver cancer is the 5th most common cancer and the 2nd most frequent cause of cancer-related deaths globally. Current treatment options for HCC are majorly dependent upon the tumor size and include surgical resection, liver transplantation, thermal ablation and chemoembolization. Our client wished to enter this therapeutic domain with an innovative product that uses LTSL (lysolipid thermally sensitive liposome) technology to encapsulate Doxorubicin, a proven and commonly used cancer drug. With the product, that was being evaluated in a global phase 3 clinical trial for the treatment of primary liver cancer, the client wanted to seek further clarity and understanding of the HTA scenario in China – considered to be as one of the most important markets for there product. We helped them by liasoning with China HTA experts and creating HTA landscape assessment report along with oncology specific information. We also provided case studies of products, which got successful market access in China in last decade.
-
Multiple Myeloma in Asian Countries
Multiple myeloma is a common hematologic malignancy that has been on rise in Asian countries. Our team aided a pharmaceutical client in generating evidence to demonstrate and support the value of a drug (a selective proteasome inhibitor) for the treatment of multiple myeloma in certain Asian nations. To strengthen the value story, we gathered relevant information through extensive literature search. Approximately 2384 studies were screened for 1st pass, 278 studies were screened for 2nd pass and data was abstracted from 56 studies. Additionally, we developed the value story of the pharmaceutical product of interest based on the data that characterized natural history of disease in the particular Asian locations, burden of illness in those regions, common patterns of care, unmet or under-addressed medical need and benefit-risk profile of the desired pharmaceutical agent
REAL WORLD EVIDENCE/ EHR SERVICES
-
Multiple Myeloma: Utilization Pattern of a Chemotherapy Drug in the USA
Multiple myeloma, also known as plasma cell myeloma, is a cancer involving plasma cells, and can present with varying symptoms. Management involves chemotherapy targeting malignant cells, and is usually followed by stem cell transplant. Our client was interested to understand the utilization of a specific drug used in the chemotherapy of multiple myeloma in the US health care system. For this study, we abstracted around 95 elements per patient from EHRs into e-CRFs provided to us by the client, over a period of 4 months, and completed the project with over 97% accuracy. Therapy area: Hematology, Oncology.
-
Non-Small Cell Lung Cancer: Utilization Pattern of a Chemotherapy Drug in the USA
Non-Small Cell Lung Cancer (NSCLC) accounts for over 85% of all lung cancers, and is a type of epithelial cell cancer that is often associated with a poor treatment outcome and high mortality. Treatment options for NSCLC include surgery, radiofrequency ablation, radiation therapy, chemotherapy, and immunotherapy. Our client was interested to understand the utilization of a specific drug used in the chemotherapy of NSCLC in the US health care system. For this study, we abstracted around 35 elements per patient from EHRs into e-CRFs provided to us by the client, over a period of 6 months, and completed the project with over 98% accuracy. Therapy area: Oncology.
-
HER2+ Breast Cancer: Utilization Pattern of an Immunotherapy Drug in the USA
HER2 receptor amplification or overexpression is seen in around 20-30% of breast cancer patients. Though untreated HER2 +ve breast cancers have a more aggressive course than HER2 -ve breast cancers, HER2 +ve breast cancers can be treated with immunotherapy agents that target the HER2 receptor, and because of this the prognosis is often better. Our client was interested to understand the utilization of a specific drug used in the immunotherapy of HER2+ breast cancers in the US health care system. For this study, we abstracted around 80 elements per patient from EHRs into e-CRFs provided to us by the client, over a period of 12 months, and completed the project with over 98% accuracy. Therapy area: Oncology.
-
Severe Asthma: Training a Machine Learning Model for EHR Abstraction using NLP
Asthma that is not adequately controlled by approved drugs, or those controlled cases which recur after treatment is reduced, is termed severe asthma. It is estimated that 5-10% of asthma patients suffer from severe asthma. Our client was interested in training a machine learning (ML) model for EHR abstraction using natural language processing (NLP), with an intention to generate insights in support of a particular drug for severe asthma support. For this project, we generated NLP-based automated annotations, analyzed false positives and false negatives with extracted concepts, and trained the ML algorithm until a precision of 90% was met. The end result provided the insights which were in line with the study objective. The evidence synthesized using these inputs gave the clients a quick access to information about different use patterns of the drug of interest in the patient cohort. Therapy area: Respiratory
HEOR AND MODELLING PROJECTS
-
Validating the inputs and calculations in a cost effectiveness model and developing one-way sensitivity analysis calculations
Among various blood glucose monitoring options in diabetes mellitus (DM), a continuous glucose monitor (CGM) stands out by virtue of providing continuous blood glucose trends, which is missed by traditional intermittent blood glucose monitoring. Usage of CGM devices have also been associated with a reduced time spent in hypoglycemia, lower number of severe hypoglycemia events (SHE), fewer episodes of DM-related complications such as diabetic ketoacidosis (DKA), and overall lower values of glycated haemoglobin (HbA1c). However, since the CGM device represents an additional investment, establishing the cost effectiveness of the device is essential.
Our client had developed a basic cost savings model for a CGM device keeping in mind two possible scenarios of clinical outcomes in terms of SHE, DKA, and HaA1c. We validated the inputs and calculations in this model, updated the entire model in terms of the general usability and look-and-feel, and also developed a one-way sensitivity analysis (OWSA) into the model, thereby improving the robustness of the model. Therapy area: Metabolic, Endocrinology.
-
Budget Impact modelling of a drug/ device combination for the treatment of pancreatic cancer
Novel treatment modalities are being developed for treating pancreatic cancer, which has as such a poor prognosis. One such novel modality involved a combination of a chemotherapy drug with a novel drug delivery system through a specially designed catheter. Our client was interested to understand the budget impact and impact on reimbursement of different pricing strategies for the combination, which was granted orphan drug status by the USFDA. We developed a detailed budget impact modelling analysis dissecting the value proposition, reasoning, and risks associated with different price corridor for the combination, for targeting the US market. For doing this, we considered multiple perspectives (insurer, manufacturer, and hospital) and determined the best possible pricing strategy for the manufacturer with best ICER, based on evidence from previous studies, competitor pricing, and current and future reimbursement scenario in the US.
-
Cost of Stigma Associated with HIV: A Cost-consequence Analysis
Stigmas associated with HIV in Saudi Arabia have resulted in an increased clinical, humanistic, and economic burden on the country’s healthcare resources. Interventions such as prevention of mother to child transmission (PMTCT) and HIV self-testing (HIVST) might address some of these stigmas and increase diagnosis and treatment of HIV. Client developed a health economic model (Markov model) to estimate the cost-effectiveness of stigma-addressing interventions to improve diagnosis and treatment of HIV from a societal perspective in a KSA setting, using data from various external sources. The stigmas related to having unprotected sex, testing for HIV infection as a member of a risk group, and seeking treatment if infected, were included in the model. It was found out in the research that both PMTCT and HIVST are costing saving stigma-addressing interventions for PLHIV in KSA. We helped the client in manuscript preparation for the purpose of publication.
-
Clinical, humanistic and economic burden of NAFLD and NASH
The prevalence of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) is high in the Middle East; however, there are no approved therapies currently available for these conditions. The client developed a health economic model (Markov model) to estimate the current and future clinical, economic and humanistic burden of NAFLD/ NASH in KSA, UAE, and Kuwait, from a societal perspective. Model input data was obtained from population projections from previous studies and UN data. Transition probabilities were calculated after extracting data from similar studies in the past using a graph digitization software. Country-specific costs incurred in the treatment of NAFLD (including medication, medical management, and healthcare procedures) and utility inputs were obtained from local experts. The costs, QALYs and LYs associated with each health state were calculated for all three countries. It was found out that NAFLD/ NASH is associated with substantial clinical, economic, and humanistic burden in the KSA, UAE and Kuwait. We helped the client in creating manuscript from the model report provided to us.
-
Clinical, economic and humanistic burden of treatment resistant depression
We helped our client to conduct the targeted literature review/secondary literature search to capture information related to Treatment Resistant Depression (TRD) for GCC region (KSA, UAE & Kuwait) and Emerging Markets (Egypt, Algeria, Lebanon & Turkey). We further helped them to build a universal economic model from scratch to assess the over all economic burden (considering direct and indirect cost) of TRD from payers’ and societal perspective and assisted in developing questionnaire for expert interviews to address the gaps identified in the literature search and to populate/validate the model/(s). The model was adapted by populating it with local data specific for each country. The outcome findings were consolidated in the form of white paper and manuscript.
-
Cost effectiveness analysis of accelerated transition from oncological treatment to specialised palliative care at home
While hospitals remain the most common place of death in many western countries, specialised palliative care (SPC) at home is an alternative option to improve the quality of life in their final days of life. This manuscript is a full economic evaluation (Cost-utility analysis) of an accelerated transition to home for incurable cancer patients in need of palliative care. The analysis is performed from a societal perspective within a randomised controlled trial – the Danish Palliative Care Trial (DOMUS). The researchers looked outcome in the form of incremental cost-effectiveness ratio (ICER) and found out that accelerated specialised palliative care and psychological treatment yields better QALYs than usual care with a large increase in costs. Based on usual willingness-to-pay thresholds, the intervention is not found to be cost-effective relative to usual care. We helped the client in manuscript editing and making it publication ready.
-
Comparing the cost effectiveness of two anticoagulants for the treatment of VTE
Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). Treatment primarily aims at preventing pulmonary embolism (PE), reduce morbidity, and minimize the risk of post-thrombotic syndrome. So far the mainstay of medical therapy has been anticoagulation. A pharmaceutical company wanted to compare the cost-effectiveness of two anticoagulant drugs used for the treatment and prevention of VTE. The source document and the manuscript outline were provided to us and we assisted our client with drafting the manuscript. The abstract of the manuscript was presented at a conference.
-
Report on the cost of cancer treatment and available options in India
In India, the average cost of cancer treatment ranges from Rs. 2.5 L to Rs. 20 L for six months leading the families into huge economic burden. On the demand of one of our clients,, the information was gathered on the sources of funding for cancer; the services availability in hospitals and clinics; government and non-government schemes for cancer; the process of incentivizing the healthcare providers; the role of drug manufacturer, wholesalers, distributors and providers in drug costing; and reimbursement strategy for cancer treatment in India. It also reports on the complications Indians are facing during cancer treatment.
ORIGINAL RESEARCH
-
Dyspepsia: Real-world evidence on demographics and treatment patterns in India
Dyspepsia includes a spectrum of symptoms ranging from epigastric pain, early satiety to post-prandial fullness. Precise prevalence of Dyspepsia in India is not available, and available evidence indicates that it affects 7.6-49% of Indian population. Through the analysis of a cross-sectional study involving nearly 3750 dyspepsia patients across India in the real-world setting, we found out that dyspepsia is more prevalent in males and in the 31-50 age group; functional Dyspepsia is more common than organic dyspepsia; and patients receiving rabeprazole had higher levels of medication adherence, higher satisfaction levels in symptom relief, better convenience of therapy, and higher perception of safety compared to patients on other PPIs. Therapy area: Gastrointestinal.
-
Blood Safety: Importance of nucleic acid testing (NAT) to detect infections in serononreactive blood donations
Serology is used routinely in all blood banks to identify several transfusion-transmitted infections (TTIs) including HIV, HBV, and HCV. But at times serology can be negative in blood donations that harbor these infections, for a variety of reasons. Nucleic acid testing (NAT) for viral genetic material is capable of identifying these infections undetectable by serology, thereby improving blood safety. The two forms of NAT, the minipool (MP)-NAT and the individual donor (ID)-NAT have their own merits and demerits. Our client wanted to assess the sensitivity and benefits of MP-NAT in a blood bank, through a retrospective data analysis. For this project, we performed data analysis, wrote a publishable manuscript out of the analysis, and also managed the publication by answering questions raised by the peer reviewers. Therapy area: Transfusion medicine.
-
Generating country-specific and instrument-specific reference intervals for thyroid function tests
Accurate identification of the changes in serum levels of thyroid-stimulating hormone (TSH) and free thyroxine (fT4) are crucial for the diagnosis of thyroid disorders. Given the sensitive nature of TSH and fT4 levels, it is essential that the appropriate reference intervals (RIs) are established adequately, and are accurate for the population and the assay technique. Our client wanted to establish RIs for TSH and fT4 specific for the Indian population, using TSH and fT4 values among clinically euthyroid non-smoking adult population, following CLSI criteria. For this project we performed complete statistical analysis including outlier identification through Tukey’s test and establishing the RIs based on the 2.5th and 97.5th percentile values. We also derived RIs for different subgroups, including males, females, age ≥30 years, and age >30 years and performed a comparison of values between these subgroups as well. Finally we drafted the results into a publishable manuscript.
-
Impact of nucleic acid testing (NAT) on Transfusion Transmitted Infections (TTIs)
Transfusion-transmitted infections (TTIs) are one of the biggest fears to blood transfusion safety. Nucleic acid testing (NAT) in blood donor screening has been implemented in many countries to reduce the risk of TTIs. Our client’s objective of this observational study was to assess the ability of NAT to detect hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) from donor blood samples declared seronegative. Every donor blood sample was screened for HBsAg, anti-HCVnti-HIV-1, anti-HIV-2 and p24 antigen by electrochemiluminescence assay. All initial serology non-reactive samples were subjected to NAT discriminatory assay for HBV, HCV and HIV. It was found out that the routine utilization of MP-NAT testing for HBV, HCV and HIV-1 has the potential to improve the efficacy of screening for protecting blood recipient from TTIs. It enables detection of these viruses, which were undetected by serological test and thus helping in providing safe blood to the patients. We assisted the client in preparing the manuscript for the purpose of publication.
-
A cytogenetic study of down’s syndrome in Iraqi population
Down’s syndrome is the most common type of chromosomal abnormality found in neonates. It is associated with characteristic abnormal facial features and mental retardation. However, clinical diagnosis is not sufficient to confirm the disease. Classical karyotyping has long been used as diagnostic tool for confirming Down’s syndrome. Our client conducted a study to confirm the cytogenetic composition of individuals suspected with Down’s syndrome after the preliminary clinical diagnosis in Basra, Iraq. We helped the client in manuscript preparation, which is due for publication. Study provided the basic information required to forecast the various complications associated with Down’s syndrome.
-
A human EGFR2 over-expression by immuno-histochemistry in patients with gastric adenocarcinoma
Gastric cancer is one of the leading causes of cancer-related deaths across the world and in the Middle East. Human Epidermal Growth Factor Receptor 2 (HER2) overexpression has been observed in gastric cancers. Trastuzumab, a recombinant monoclonal antibody targeting HER2 protein, is now being used for treatment of metastatic gastric cancer. Our client wanted to study the frequency and association of HER2 overexpression with age, gender, histopathological subtype and grade of differentiation in patients with gastric adenocarcinoma. It was a cross-sectional single-centre study. Demographic (age, gender), histopathological (histological subtype, grade of differentiation) and immunohistochemical (HER2 overexpression status) data from 100 consenting adult patients (male: 56) with histopathologically confirmed gastric adenocarcinoma from samples obtained through endoscopy or surgery was collected. We helped the client in preparing the manuscript. It was found that HER2 over-expression was 6% in the population; statistically significant correlation was found with histological grade. Manuscript is still under peer-review.
-
Combined effect of two anti-hyperglycemic agents in diabetes management
Diabetes affects a major proportion of the Indian population. Single anti-diabetic agents are not always effective in controlling this condition. Our client wanted to determine the combined effectiveness of two anti-hyperglycemic agents with complementary mechanisms of action in managing diabetes. An open, prospective, multicenter, single-arm, non-interventional study was conducted across several sites in India. The study was registered under the ClinicalTrials.gov and the Clinical Trial Registry of India. Postprandial glucose, fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c) levels were measured to determine the clinical effectiveness of the drugs. This study found that the combination of the two anti-hyperglycemic agents was well tolerated, safe and efficacious in Indian patients and could be considered a treatment option for diabetes management.
-
Prevalence and consequences of vitamin D deficiency in patients with chronic low back pain
Vitamin D deficiency has often been linked to chronic low back pain (CLBP). In many patients, vitamin D deficiency remains undiagnosed therefore untreated leading to persistent, musculoskeletal pain as observed in CLBP. So far no prospective studies have focused on the prevalence of vitamin D deficiency in Indian patients with CLBP. The client wanted to determine the prevalence of vitamin D deficiency in Indian patients and its role in CLBP. Data were obtained from a controlled, open label, single arm clinical trial that assessed the effectiveness of vitamin D supplementation in patients with CLBP. The study was conducted in an outpatient pain clinic of a tertiary care hospital. The findings were reported in accordance with the STROBE (Strengthening the Reporting of Observational studies in Epidemiology) guidelines. Pain and functional disability was determined. Chi-square test and independent t-test was used for the categorical and continuous variables, respectively. Multivariate logistic regression model, univariate analysis of variance (ANOVA) and post hoc Bonferroni test was also used for statistical analysis. The study revealed increased prevalence of vitamin D deficiency among Indian patients with CLBP and indicated the importance of determining the vitamin D status for effective management of CLBP.
-
Efficacy, safety and tolerability of a preservative-free NSAID ophthalmic solution
Topical non-steroidal anti-inflammatory drugs (NSAIDs) are a preferred over topical steroids to control inflammation post cataract surgery and a preservative-free variation is considered the most effective. While the clinical effectiveness of the preservative-free NSAID in reducing cystoid macular edema (CME) and macular thickening in patients with cataract surgery is well established across many countries, its safety and efficacy was not studied in Indian patients. The client wanted to evaluate the safety, tolerability and efficacy of the preservative-free NSAID in controlling inflammation in Indian patients who were subjected to cataract surgery. A retrospective, open-labeled, single-arm study was conducted and data was obtained from the records of 96 cataract patients. The results confirmed that the preservative-free NSAID successfully reduced ocular inflammation and was well-tolerated in patients after cataract surgery.
-
Early initiation and goal directed enteral nutrition for effective ICU management
Early Nutritional Support is considered important for ICU management. Previous observational studies have indicated adverse clinical outcomes as a consequence of cumulative calorie debt. Our client hypothesized that early and goal directed enteral nutrition (EN) support to meet the calorie debt could lead to better outcomes. A retrospective observational study was conducted at a multidisciplinary ICU in a tertiary health care facility in India. The data obtained indicated that early initiation and goal directed EN could improve clinical outcome and thus aid in effective ICU management.
-
Efficacy and safety of supplemented low protein diet in patients with diabetic nephropathy
Diabetic nephropathy can lead to end stage renal disease (ESRD). Patients with chronic kidney diseases are put on low protein and very low protein diets to improve associated metabolic disorders and uremic symptoms. However, it is important to ensure that the diet fulfills the essential amino acid and energy requirements of the patients. Our client wanted to determine the efficacy and safety of low protein diet supplemented with keto-analogues of essential amino acids and its superiority over low protein diet without such supplementation. A randomized control trial was conducted at a reputed hospital in Mumbai and a total of 48 patients with diabetic nephropathy were included in this study. The demographic features, post-treatment survival probability etc. were studied. The results suggested the clinical effectiveness of supplemented low protein diet in delaying kidney complications that leads to ESRD. Additionally, the supplemented diet was found to be safe, improve metabolic conditions, and met the nutritional requirement of the patients.
-
Human Anti-Chimeric Antibodies (HACA) seen with a biologic drug is associated with higher BASDAI in axial spondyloarthritis patients
Treatment with chimeric mAb often results in the formation of human anti-chimeric antibodies (HACA) that may worsen the condition in axial spondyloarthritis (AS) and rheumatoid arthritis (RA) patients. In this case, our client’s KOL wanted to investigate the effect of infliximab therapy on both AS and RA patients. We did the data analysis and manuscript writing for the client. It was found that HACA was formed in AS patients treated with infliximab, but not in RA patients following same treatment. HACA-positive AS patients treated with chimeric mAb showed a higher post-treatment disease activity as measured by BASDAI and were associated with lesser post-treatment reduction in BASDAI than HACA-negative patients.
CLINICAL REVIEWS
-
Dry eye disease: role of flourescein staining for differential diagnosis
Dry eye disease (DED) is a multifactorial disease of the ocular surface that occurs due to loss of tear film homeostasis, and has multiple etiologies and subtypes. Fluorescein staining is a widely used diagnostic modality in the evaluation of various ophthalmological conditions affecting the corneal surface, including various etiologies leading to DED. With a historical use dating back to over 150 years, fluorescein staining has stood the test of time and continues to be a popular vital dye that does not require any specialized equipment other than slit lamp biomicroscope. Our client wanted a comprehensive review of the role of fluorescein staining in DED differential diagnosis. For this narrative review, we started with an overview of DED, reviewed the practical aspects of fluorescein staining, evaluated the place of fluorescein staining in modern ophthalmological practice, and included a visual atlas of fluorescein staining picture of ocular surface of common ophthalmological conditions. Therapy area: Ophthalmology.
-
Milk intolerance and milk allergy in infants and the role of modified infant formulas
Milk intolerance and milk allergy are two different conditions that are often used interchangeably, albeit erroneously. Milk intolerance arises due to deficiency of lactase enzyme, whereas milk allergy is an immunologically mediated condition. Our client wanted a comprehensive narrative review surrounding these two topics, which also touched upon alternatives to cow’s milk, recommendations from reputed bodies regarding use of these alternatives, and the role of modified infant formulas for infants who need milk supplementation but are having milk intolerance and/ or milk allergy. At the end of the review, we found out that though most guidelines recommend milk alternatives such as extensively hydrolyzed milk formula and amino-acid based formula, they suffer from palatability and cost. On the other hand, modified goat’s milk-based formula likely has nutritional profile and growth outcomes among infants that is comparable with cow’s milk. Therapy area: Nutrition and Dietetics.
-
The role of dydrogesterone in the management of threatened miscarriage and recurrent miscarriage
Threatened miscarriage and recurrent miscarriage are two frequent complications of pregnancy, which have been associated with lower levels of progesterone in circulation. Our client wanted a thorough review about the role of different types of progesterones in the management of these two conditions, with a special emphasis on dydrogesterone. Our literature review found out that dydrogesterone, a retroprogesterone that is produced from a natural source, has favourable pharmacokinetic profile, is well tolerated and has a favourable safety profile in all approved indications. It is safe in pregnancy, and is not associated with any adverse maternal or foetal outcomes attributable to teratogenicity. The efficacy, safety, and tolerability profiles of dydrogesterone have been extensively investigated, with favourable results in numerous large-scale RCTs and meta-analyses. Therapy area: Obstetrics and Gynaecology.
-
Bone turnover markers as a reference tool in therapeutic monitoring of bone pathologies
Bone turnover markers (BTMs) are key tools in monitoring the effect of anti-resorptive and anabolic therapies against bone pathologies. These tools assist in the management of osteoporosis therapy and predict the associated risks such as, the elevated bone turnover rate could indicate the bone pathologies. International Federation of Clinical Chemistry and International Osteoporosis Foundation have proposed serum C-telopeptide cross-links of type I collagen (CTX-1) and procollagen type 1 amino-terminal propeptide (P1NP) to be used as reference markers for bone resorption and bone formation, respectively. The BTM outcomes could be affected by the uncontrollable factors such as age, gender, pregnancy, menstruation, excess or under mobility, recent fracture, co-morbidities, and medications. We did a thorough literature search to bring the review on the above mentioned topic. We found out that the assessment of BTMs is crucial in elderly patients when adherence with and persistence to the therapy is essential to increase the efficacy of drugs. The advancement of BTMs in clinical and research settings of bone metabolic diseases treated with anti-resorptive and anabolic therapies were described in this review. Therapy area: Rheumatology.
-
Current scenario and the future trend of diabetes management in India
India ranks as one of the highest contributors to the global diabetes mellitus (DM) pandemic, with 65 million people i.e. 17% of global 382 million diabetics, residing in India. Diabetes imposes serious threat on overall health status of an individual and can be a risk in itself for multiple chronic and life-threatening diseases such as myocardial infarction, stroke, metabolic syndrome etc. Despite the growing concern regarding DM and its socioeconomic burden, diabetes control in India is far behind what is ideally expected. The mean hemoglobin A1c of diagnosed population is 9.0% – at least 2.0% higher than what is suggested by international bodies. The main objective of this article was to understand the scenario of diabetes in India with respect to its prevalence rate and future disease burden. Our client further aimed to determine the status of diabetes care and management in terms of available facilities, point of care, cost of treatment, various points of intervention and involvement of the non-governmental organizations. They further assessed the awareness level, screening and treatment initiatives for DM within the country with a focus on programs conducted by government bodies and finally reviewed the financial aspect in terms of source of funding and proportion of patients who can afford the treatment. We helped in creating this very interesting white paper for the purpose of publication, out of the information provided to us in the form of power point presentation. Therapy area: Metabolic, Diabetology.
-
A review on vitamin D deficiency associated complications
Vitamin D deficiency is a common occurrence and has been linked to several medical conditions including rickets in children to osteoporosis in adults. It also contributes to diabetes, metabolic disorders and cardiovascular disease. Our client wanted to review the pathophysiology of vitamin D deficiency and the associated clinical complications. A detailed review indicated the requirement for novel guidelines on Vitamin D supplementation to achieve better treatment outcomes, improve morbidity and patient health. Therapy area: Metabolic.
-
Role of superoxide dismutase in ameliorating reactive oxygen species related toxicity
Toxic reactive oxygen species (ROS), such as hydrogen peroxide, organic hydro peroxides, nitric oxide, superoxide and hydroxyl radicals etc. are constantly produced under physiological conditions and results in oxidative stress. The resultant imbalance in pro-oxidant/antioxidant homeostasis is responsible for the pathogenesis of different diseases. Our client wanted to obtain clinical evidence from global studies on the critical role of ROS in deteriorating human health and the importance of superoxide dismutase (SOD) in ameliorating the ROS toxicity. Electronic databases (Medline, Pubmed) were searched to identify relevant studies (peer reviewed case studies, observational studies, case control and cohort studies). Extensive data suggested the major role of ROS in the causation of several diseases. It also indicated that in order to maintain defense against ROS, SOD as an exogenous source would be necessary for anti-oxidative defenses.
-
Diabetic foot: A major complication of long-term diabetes
Diabetic individuals are at increased risk of peripheral arterial disease and neuropathy. Long-term diabetes can cause nerve damage and poor blood flow leading to diabetic foot (DF). It is a major complication that increases the risk of infection, gangrene and amputation in affected individuals. Our client wanted to review the recent advances and evidences that could improve DF management. Medline and PubMed were searched for relevant information (peer reviewed case studies, observational studies, case control and cohort studies) on DF as a major complication of diabetes. Data obtained indicated major gaps in novel approaches for DF prevention. It was concluded that appropriate awareness regarding diabetes related foot complications, importance of footwear and regular checkups can help to reduce diabetes related DF. Therapy area: Metabolic, Diabetology.
-
An overview of polycystic ovarian syndrome
Polycystic ovary syndrome (PCOS) is a common endocrine disorder among women of reproductive age. Our client wanted to summarize the underlying causes and common symptoms of PCOS and suggest suitable guidelines for effective management. It was evident that successful treatment of PCOS required proper diagnosis. Therapy mostly depended on the symptoms, age and future pregnancy plans. It was concluded that with accurate diagnosis, appropriate lifestyle interventions, and suitable PCOS treatment (birth control pills to regulate menstruation and insulin-sensitizing or androgen-blocking medications), this medical condition and the associated overwhelming health problems can be controlled. Therapy area: Endocrinology.
-
Literature review for better understanding of an uncommon variant of osteosarcoma
Telangiectatic osteosarcoma (TO) is an uncommon variant of an intramedullary high grade osteosarcoma that accounts for 2.5-12% of all osteosarcomas. There is limited understanding regarding the incidence, clinical presentation, treatment, and prognosis of this medical condition. The client wanted to systematically study the available literature to obtain detailed information on this high grade osteosarcoma. Literature review revealed poor prognosis of TO patients in earlier studies, however, recent use of neoadjuvant chemotherapy with surgery was reported to improve survival rates of the patients. The finding of this study corroborates the importance of early diagnosis and optimal treatment for improved outcomes. Therapy area: Oncology.
-
Hospitalization due to heart failure with dipeptidyl peptidase-4 inhibitor
The hypoglycemic efficacy of dipeptidyl peptidase-4 inhibitor has been demonstrated as monotherapy or in combination of other anti-hyperglycemic drugs. The SAVOR-TIMI 53 trial have raised the concerns about the increased risk of hospitalization due to heart failure following this particular dipeptidyl peptidase-4 inhibitor administration. As per the demand of our clients, all the relevant research articles along with reviews and other data was systematically reviewed. This systematic study showed that increase in hospitalizations due to heart failure have not been demonstrated by other trials as well as by real-world data analyses from insurance claims data involving a huge number of patients. The vast available evidences favour the clinical usage and safety of this dipeptidyl peptidase-4 inhibitor in various clinical conditions. Therapy area: Metabolic, Diabetology.
-
Indirect treatment comparison for biosimilars
Biosimilar is a biologic drug that is structurally and functionally similar to an original drug molecule of biological origin that has already been authorized for use. Generation of evidences for comparing a biosimilar with original biomolecule using direct head-to-head randomized controlled trials can be expensive, time-consuming and laborious. The client wanted a review about the indirect treatment comparison (ITC) for biosimilar that would provide useful evidence for judiciously selecting the best choice of treatment. A well-designed and appropriately conducted ITCs, being increasingly used for biosimilar approval in the EU, can be a valid alternative and means for efficacy and safety evidence generation.
COMPETITIVE INTELLIGENCE
-
Companion Diagnostics: Competitive Intelligence to Support Access and Evidence Generation
Companion diagnostics (CDx) are tools in the precision medicine landscape that are used in identifying patients most likely to benefit from specific therapies enabling targeted treatment. Our clients sought to target competitive intelligence exercise to understand adoption challenges, access pathways, evidence requirements and competitive positioning of these tools. We conducted data extraction from commercial and global databases for Asian countries. We generated our findings in a structure report to support internal evidence planning and access strategy development across multiple geographies.
Therapy area: Companion Diagnostics
-
Biologics: Competitive Intelligence for Biologic Manufacturers in Asia
Biologics are large and complex molecules derived from living cells and are increasingly becoming a component of modern medicine with expanding pipelines and posing global competition. To support strategic planning, our client sought to gain competitive intelligence insights on biologic manufacturers across Asian countries. We conducted the data extraction using commercial websites and global databases not limited to FDA, EMA and WIPO, focusing on patents, clinical developments, regulatory approvals and manufacturing licenses to generate evidence on global market understanding and pipeline assessment.
Therapy area: Biologics
CASE SERIES
-
Clinical efficacy of a tumor necrosis factor-α inhibitor in managing inflammatory polyarthritis in a patient with autoimmune inner-ear disease
Autoimmune inner-ear disease (AIED) is a rare autoimmune disorder characterized by progressive hearing loss. Of the several medical therapies proposed for the treatment of AIED, corticosteroid therapy is considered the most effective. Commonly tumor necrosis factor-α inhibitors are administered in combination with corticosteroids for favorable outcomes. The client examined the use of a popular anti-TNF drug in an AIED patient who developed inflammatory polyarthritis (IPA) and was non-responsive to therapy with steroids. The findings confirmed that the anti-TNF agent was successful in managing IPA in the patient with AIED.
-
Role of novel TNF-α inhibitor in the treatment of Hidradenitis Suppurativa: A study of two cases
Hidradenitis suppurativa (HS), also known as acne inversa, is a rare and long-term skin inflammatory condition diagnosed by small and painful swollen lumps, typically affecting the armpits, the groin, area between the buttocks, and under the breast. The unresponsive routine multiple treatment modalities necessitated a more efficacious treatment for HS. On demand of our clients, the effect of a novel TNF-α inhibitor was studied on two adult patients who were severely affected by HS (Hurley stage III). These two cases were the first of its kind demonstrating the success of this particular TNF-α inhibitor treatment on patients of Indian origin suffering from HS.
-
DRESS Syndrome Induced by Sulfasalazine, triggered by Ceftriaxone and Improved with N-acetyl cysteine
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome is a delayed type of systemic hypersensitivity reaction caused by the intake of anti-convulsants, allopurinol, sulfasalazine, NSAIDs and other drugs. It is characterized by maculopapular rashes, fever and eosinophilia affecting the systemic features. This syndrome is severe and fatal than acute drug reaction as it affects internal organs as well. Intake of certain antibiotics, especially the β-lactams such as amoxicillin, may trigger the reaction in the patients of DRESS syndrome. Our client needed a case study for their KOL on a patient who was suffering from DRESS syndrome induced by sulfasalazine and aggravated by ceftriaxone. A prompt withdrawal of sulfasalazine along with intake of systemic corticosteroids and N-acetyl cysteine was found to be useful for a such life-threatening condition.
PHYSICIAN’S PERCEPTION MAPPING AND CLINICAL PRACTICE GUIDELINES
-
Alzheimer’s Disease: Community Research Findings
Alzheimer’s disease (AD) remains one of the most pressing challenges in neurology, with growing research efforts aimed at advancing understanding and improving outcomes. For this project, our client sought support in communicating findings from a survey conducted among neurologists, focusing on their perspectives, experiences, and insights related to AD management.
We collaborated closely with the research team to translate the insights into a clear, scientifically accurate, and audience-friendly communication piece. Our deliverables included a concise press release, highlighting key physician perspectives, emerging practice patterns, and perceived unmet needs. In addition, we developed a technical note outlining the survey design, methodology, and respondent profile, supporting credibility and scientific rigor.
Therapy area: Neurology, Alzheimer’s Disease
-
A multifaceted approach for diabetes management in India
Diabetes is a serious health burden and is on the rise across the world. India is no exception with a large population being affected with this condition and newer therapeutic regimes are required for better control. Our client wanted to conduct a survey to understand the view of Indian physicians and endocrinologists regarding the available therapeutic considerations for type 2 diabetes treatment. A questionnaire focusing on issues pertaining to lifestyle intervention prior to initiation of medication was distributed among the physicians working at several primary secondary and tertiary care centers across India. Based on the data from the questionnaires, it was concluded that for newly diagnosed type 2 diabetes, lifestyle intervention was most preferred before pharmacological therapy. Additionally, most physicians preferred metformin as the OHA of initial choice. Drugs of second choice included one of the α-glucosidase inhibitors and DPP4 inhibitor, which were preferred over sulfonylureas.
-
Good Clinical Practice Recommendations (GCPR) for the use of Combined Hormonal Contraceptives
Combined Hormonal Contraceptives (CHCs) belongs to a group of hormonal contraceptives. CHCs have been successfully used to reduce undesired pregnancies. With this clinical guideline the client wanted to promote awareness among Indian doctors regarding contraception methods and provide an update on the effectiveness and safety of CHC. We obtained clinical evidence from global studies, which was subsequently reviewed by the FOGSI expert committee before finalization of the guidelines. The final guideline addressed issues such as: 1) the unmet need for CHCs, 2) their usage (as contraceptive as well as non-contraceptive), 3) associated side effects, and 4) the importance of structured patient counseling. The guidelines also stressed on the CHC-associated safety concerns including contraception in special situations and provided information on patient counseling tips as well as ways to tailor CHC usage as per the patients’ need.
This guideline was considered the FOGSI Position Statement on the use of Progestogens. Combined Hormonal Contraceptives: Counselling and Use in Clinical Practice.
-
Deriving expert consensus to enhance optimal implementation of thromboprophylaxis after major orthopaedic surgery
Venous thromboembolism (VTE) is a global health concern with substantial morbidity and mortality. It is often asymptomatic and under-diagnosed, leading to long-term complications and reduced survival. VTE has also been identified as an immediate threat to patients undergoing major orthopedic procedures such as total hip arthroplasty (THA) and total knee arthroplasty (TKA). National Orthopedic Advisory Committee meeting was conducted to gain understanding of the clinical relevance of the International VTE prevention guidelines for orthopedic patients in India and to derive expert consensus to enhance optimal implementation of thromboprophylaxis after major orthopedic surgery for Indian population. We helped the client to have guided discussion for better VTE prevention after TKR and THR in Indian patients such as: 1) Thromboprophylactic agents, 2) Minimal duration of thromboprophylaxis, 3) Anticoagulation protocol with neuraxial anesthesia and indwelling epidural catheters, and 4) Bleeding management guidance. The guideline also focused on expert opinion on VTE prevention in patients with renal impairment, bilateral TKR / Revision surgery, mobilization and patient convenience, tolerability and adherence to therapy.
-
Role of TNF-α inhibitors in meeting the unmet needs of treating psoriasis in India
This particular anti-TNF-α factor, is considered effective not only in improving clinical symptoms of psoriasis but also in terms of quality of life. Our client wanted the current evidence from the systematic reviews, post-hoc analyses, registries and real-world data that would represent the associated benefit-risk of this anti-TNF-α factor and other biologics such as anti-T cell agents for psoriasis patients. It was found to be cost-effective and efficacious with no increased incidence of adverse events with escalated dosing. The proven post-marketing safety and efficacy phase, and ease of administration over infliximab are the additional benefits of the molecule.

