Adapting Health Technology Assessment for Cancer Care in India
Introduction
India faces a significant “double burden of disease,” with high rates of communicable and non-communicable illnesses. Cancer incidence is rising, placing a strain on resources given the expensive treatments and the fact that most patients rely on the private sector for care.
To address this, a collaboration between the National Cancer Grid (NCG) and the National Health Authority (NHA) is working to expand public access to cancer care. The NCG, a network of cancer hospitals, develops clinical practice guidelines, which the NHA links to oncology health benefit packages under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) national health insurance scheme. This expands treatment access for poorer patients.
However, India has limited public funding for cancer treatment, and the AB-PMJAY needs to cover all disease areas efficiently. This necessitates value-based care, especially given rising costs of new cancer therapies. The NCG aimed to prioritize the most cost-effective treatments for AB-PMJAY, requiring an objective assessment of their economic impact.
Health Technology Assessment (HTA)
Health technology assessment (HTA) is used to determine the value of a health intervention using a multidisciplinary process. India’s national HTA body has conducted many studies, but national-level topic prioritization did not cover all of the interventions which needed to be evaluated by the NCG because of resource, capacity, and time constraints.
A potential answer was to adapt the HTA process, known as rapid or adaptive HTA (aHTA), which adjusts for analytical time, data, capacity, and source of conduct, by leveraging information from other settings where possible. Several countries use aHTA methods, but there isn’t a single established method.
In the absence of standardized methods, the NCG employed a pilot method to evaluate 10 prevalent cancer treatments to inform the development of clinical guidelines.
Methods
A bespoke aHTA method was created by combining two existing strategies: a rapid review of the literature and a ‘de facto’ HTA that included a price benchmarking analysis. In addition, the study team estimated annual treatment costs. The approach was based on the standard HTA process, but with necessary adaptations, and also drew from adaptive or rapid review processes used in other settings.
A technical aHTA working group, comprised of health economists and oncologists, conducted 10 oncology aHTAs, with iterative adjustments. The aHTA process included topic selection, scope development, evidence review (including data extraction, price benchmarking analysis, and annual drug cost calculations), and an appraisal of the evidence to decide on cost-effectiveness.
Topic Selection and Prioritisation
A rapid process was employed to identify, select, and prioritize interventions for aHTA based on clinician requests for inclusions in the health benefits package. The priority was to identify interventions for common cancers that were the least likely to be cost-effective and which had sufficient international evidence to conduct an assessment.
To inform topic selection and prioritization, a table of all interventions was compiled that summarized background information, including treatment landscape, disease prevalence, drug prices and expert opinions on disease severity, and equity concerns. A rapid search confirmed the availability of relevant international HTAs and cost-effectiveness analysis. The working group selected each aHTA topic through group consensus based on the evidence gathered and the NCG’s priorities.
Development of a Scope
The PICO (Population, Intervention, Comparator, Outcome) framework was used to develop a scope for each analysis. The scoping process fully defined the doses of the intervention and the comparators, the indication, the line of therapy, any disease-specific attributes and outcomes of interest. NCG clinicians designed the final research question to reflect the local context and represent the current standard of care in India.
To ensure relevant international evidence was available, a rapid, targeted search of established HTA agency websites, the Tufts Cost-Effectiveness Analysis registry and the peer-reviewed literature was conducted to create a list of the available HTA reports and economic evaluations that addressed the same decision problem.
HTA agencies that were reviewed, included the National Institute for Health and Care Excellence (NICE), the Canadian Agency for Drugs and Technologies in Health, the National Centre for Pharmacoeconomics (Ireland), the Pharmaceutical Benefits Scheme (Australia) and the Pharmaceutical Management Agency (New Zealand). HTA reports were only used if they had the same intervention, comparator(s), dose, indication and population.
If sufficient evidence was lacking, the topic was referred for assessment via a full HTA process. Finalizing the scope was an iterative process. Clinicians from the working group provided broad information on the intervention, which together with the sourced reports helped determine the final decision problem.
Data Extraction
After developing the scope, data extraction was conducted on the available international evidence regarding the background, safety, clinical benefits, and cost-effectiveness. The objective was to check consistency across settings and identify differences and uncertainties in the evidence across contexts.
The data extraction fields were taken from the Consolidated Health Economic Evaluation Reporting Standards 2022 checklist to evaluate reporting completeness, supplemented with additional fields for the broader context. The first four aHTAs extracted top-line clinical and cost-effectiveness data, while later aHTAs included additional details to broaden the evidence base for decision-making. This process identified potential sources of uncertainty, particularly those that could affect the generalisability or transferability of the evidence to India.
Price Benchmarking Analysis
To supplement the evidence review, a comparative price benchmarking analysis was conducted using a published methodology. The objective was to compare the list price in India with prices in other countries, accounting for currency conversion and GDP per capita adjusted for purchasing power parity (GDP PC PPP).
The GDP PC PPP adjustment was conducted because the list price for drugs in India may appear similar to prices paid abroad once adjusted for currency, but they could still be considered less affordable if India’s purchasing power is lower than the benchmark country.
Annualized Treatment Cost
The availability of drug prices enabled the estimation of potential annual drug costs per patient, excluding factors such as wastage, administration costs, other resources, or the wider costs of illness. The objective was to understand the potential cost impact of introducing new technologies under the AB-PMJAY scheme by determining the difference in drug costs between the intervention and comparator. Annual drug costs were determined based on the list price, pack size, dose, and number of cycles. If a generic version was available, the analysis was repeated with the generic prices. Drug prices were sourced from the NCG centres by coauthors, using the price paid by the hospital at the time of the analysis. A full budget impact analysis was not feasible due to data, time, and resource limitations.
Treatment costs were also quantified as the potential fraction of the family AB-PMJAY allowance.
Appraisal, Generalisability, and Recommendations
The evidence from the data extraction, price benchmarking analysis, and annualised drug cost calculations was appraised through group deliberation. A recommendation was made by group consensus by placing the intervention into one of four categories: ‘potentially cost-effective’, ‘potentially not cost-effective’, ‘potentially cost-effective for specific subgroups’ or ‘full HTA required.’ Recommendations would inform the guideline development group in deciding treatment inclusion for clinical guidelines but would not solely determine entitlements.
Finally, a policy brief was produced for each case study, summarising the evidence from the rapid review process, the price benchmarking analysis results, the annual drug cost calculations, additional considerations, and the intervention’s likely cost-effectiveness designation.
Methodological Adaptations
As the aHTAs were completed, methods were iteratively refined. Additional criteria were added to the data extraction table, to make it more comprehensive. Peer-reviewed literature from similar contexts was included to strengthen the evidence base. The treatment cost calculator was adapted to compare treatment costs with the yearly family allowance under the national public health insurance scheme. Reporting in the policy briefs was expanded to improve transparency and replicability.
Results
Ten cancer interventions were assessed by aHTA, including breast cancer (n=4), lung cancer (n=3), head and neck cancer (n=2) and prostate cancer (n=1). Three aHTAs were potentially cost-effective. Five were not, and one was only cost-effective in a subgroup. A full HTA was recommended for one intervention due to uncertainty. Eight aHTAs reviewed pharmaceutical technologies, while two assessed the aHTA method to non-pharmaceutical interventions.
For non-pharmaceutical interventions, a lack of available HTA evidence led to the introduction of peer-reviewed published literature to supplement the evidence base. However, without an economic evidence base, the method proved unsuitable for assessing non-pharmaceutical interventions. Economic evaluations continued to be included for pharmaceutical interventions as they provided valuable insight into the potential cost-effectiveness in lower-income settings relevant to India.
Price benchmarking revealed that India commonly pays 2–4 times more than other countries for the same drug and dosage when adjusted for currency and GDP PC PPP. The results suggest further discounts are required for cost-effectiveness in India.
Annual drug costs for the eight pharmaceutical aHTAs ranged from 37% to 1,322% of the yearly AB-PMJAY family allowance. The treatment costs often exceeded the full annual AB-PMJAY family allowance. All interventions had higher associated treatment costs than their comparators.
Discussion
Performing 10 aHTA analyses saved time and resources compared with the traditional HTA process. This approach enabled more interventions to be pragmatically assessed in the time it takes to conduct one HTA, increased the economic evidence base for decision-making and conserved resources for conducting full HTAs only for high-priority technologies with significant uncertainty or marginal cost-effectiveness.
The NCG found that aHTA was most suitable for reviewing interventions where there was ample cost-effectiveness evidence or a rapid answer was needed. The aHTA process revealed that many interventions had very high costs, often exceeding the annual family AB-PMJAY allowance and were unlikely to be considered affordable in the Indian context. An additional benefit was that the aHTA process allowed for rapid generation of evidence on value for money that could help explain to clinicians and patients why certain interventions were unaffordable.
While the aHTA methods proved to be faster and more efficient, further research is necessary to formalize guidelines to improve its implementation and effectiveness.
In the future, local data could be adapted from expanded cost and other data sources in India to address the current research that is skewed towards high-income countries.
