DT: Lung cancer is one of the most common cancers overall in the world and it’s really a public health issue of global health relevance. One of the most important treatments to treat patients with advanced non-small cell lung cancer, that’s the most common type of lung cancer, is immunotherapy, in particular PD-1, PD-L1 immune checkpoint inhibitors. While these drugs have really provided major advancement in cancer care and improved the survival of patients, they are broadly inaccessible overall. That’s why we investigated what could be a financially justified fair pricing to access the immunotherapy in low- and middle-income countries with key specific country studies.
What was the methodology and the findings?
GS: With pleasure. So, as Dario was saying, what we tried to do is to understand and tackle the dimension and to try to understand how we can reach affordability or cost effectiveness for these medicines in the low- and middle-income countries. We decided to assess two countries, which are India and South Africa, for which we assessed the cost effectiveness of three medicines that are used in this setting, which are pembrolizumab, atezolizumab and cemiplimab. We applied a partitioned survival model which is the model that is most commonly used in these settings. We compared the efficacy of these drugs with the standard of care in low- and middle-income countries, which is usually platinum-based chemotherapy, and we identified in the absence of a widely-recognised willingness to pay threshold we identified three GDP-based thresholds. So we assessed the incremental cost effectiveness ratio per QALY at one times the GDP of the country, two times the GDP of the country and three times the GDP of the country.
We made the assessment from the perspective of a public health system. We collected data either through the clinical and safety data of the pivotal randomised clinical trials of the three medicines or through key informant interviews with country national stakeholders. The length of the treatment for the immune checkpoint inhibitor arm was assumed to be up to 35 cycles, so two years, or until disease progression while for chemotherapy it was between 4-6 cycles.
What we have identified is that the range at which these medicines reach cost effectiveness is between $14 per patient per cycle to around $650 per patient per cycle. What does this mean? It means that if we make the comparison between the current acquisition costs of these medicines in the countries, so in India and South Africa, compared to the price that we have identified as the cost effective price, we need to get a considerable price reduction which is up to… the maximum price reduction that we identified is 93% in India and 85% in South Africa.
However, the good news is that we tried to understand how different techniques that can be applied together such as dose optimisation or vial sharing, if this strategy can be successful in achieving at least partial price reduction and the result was positive. So putting all the evidence together, what we realised is that, yes, the price reduction that is needed to achieve cost effectiveness is relevant, however, different medicines which are as well monoclonal antibodies for cancer treatment, did manage to reach this price rationalisation in the past, such as trastuzumab, and exactly in the countries that we assessed, so India and South Africa. One of the key enablers to reach trastuzumab price rationalisation was really the availability of biosimilar versions of the drug.
So the results show that if biosimilar availability can be matched to dose rationalisation or vial sharing or other strategies such as a shortened duration of treatment, can be successfully and can be put together, combined together, to reach what is the cost effective price that we identified through the assessment.
What are the clinical implications of these findings?
DT: You have clinical implications but also public health implications. Because at this point, and for the first time, we have a benchmark for which we can understand what is a fair pricing for the access to immunotherapy in low- and middle-income countries and broadly at the global level. We know where to set a trade-off to understand what is the balance between the access and sustainability of the healthcare that can inform the national policies for the pharmaceutical policies to uptake and invest on this new, high-value immunotherapy now that immunotherapy is coming towards becoming something very relevant for global health we need strategies to improve and optimise the access.
This is really the first time that we have a benchmark to understand where to work around which is the goal eventually for a fair pricing for immunotherapy in lung cancer.
