President Biden’s Build Back Better agenda has reignited the debate about drug pricing. Arguments generally fall into two camps. On the one hand is concern about the increasing burden of health care costs. On the other hand, are arguments that drug prices are needed to support innovation and recoup the high cost of failures.
For impact investors, this is an important issue. In a previous article we talked about how it is possible to reconcile pricing power and impact across a range of themes.1 However, we called out pharmaceutical companies as an example where exploitation of that power can reduce impact. That occurs when the positive benefit of the treatment comes at an unjustifiable cost, that in turn leads to limited access and unsustainable burdens on vulnerable individuals and their families.
More recently we have looked at several pharmaceutical companies and tried to answer the question: what cost is justified?
Outlining the problem
Inevitably, the issue is not straightforward. The common perception of ’evil pharma’ or governments attacking innovation are unhelpful and oversimplify a complex challenge.
There is clearly significant public interest in supporting innovation that leads to new drugs. Patent protection is needed to enable innovative firms to make the investments needed to develop these new drugs. However, there is a difficult balance to strike. Patents can encourage investment, but if the protection is too generous, the incentive to invest further is reduced.2
In addition, patent incentives are currently skewed towards incremental improvements which carry lower risks than truly innovative drugs where there is a greater chance of failure.3 This problem is compounded by a lack of transparency in pricing, particularly in the US system. There is also a lack of information about costs.4
US-specific issues
Potentially the biggest issue in the US is the absence of value-based pricing. Many OECD countries require companies to submit a cost-benefit analysis and will only pay up to a maximum level. This is usually defined with reference to the number of years of added life and takes into account quality of life.5 The US has no such requirement.
Bargaining power is also important. In many countries one government body negotiates drug prices. In the UK the National Institute for Health and Care Excellent (NICE) plays this role. In the US, government bodies like Medicare are explicitly prohibited from participation in negotiations. These are carried out by individual commercial insurers which dilutes their bargaining power.
Finally, there are major information asymmetries. Often neither doctors nor patients have accurate pricing information. This is partly due to a complex network of intermediaries. Rebates and reimbursements also mean the published list price is often very different to the price actually paid.
The result is that US drug prices are substantially higher than in other developed countries.6 The US pharma industry argue that the US is subsidising drug development for those countries and therefore the premium is warranted. Evidence suggests that claim may be inflated.7
From system-level to company analysis
The easy answer to this problem is to punt it to government and say that these are policy challenges best addressed by governments. But this approach ignores the risks that the current cost of US healthcare creates for the drug therapy companies. It also ignores the extent to which management teams can mitigate this risk for their businesses.8
Instead, our approach is to analyse drug pricing systematically. This leads to a more holistic view of impact and a better understanding of risk. The first step is analysing the positive impact, taking into account the health need being addressed and the level of innovation.
There are then three important aspects of pricing to consider: company policy, internal processes and performance. Policies tell you more about governance structures and transparency. Internal processes provide an insight into whether the company takes a value-based approach that considers costs and benefits, or whether it is simply trying to maximise profit. Performance then looks at the outcome: how has the company behaved in practice? For example, is there a history of aggressive price increases?
The lack of transparency in the industry means this can be difficult on a drug-by-drug basis. However, there are some useful external sources. In the UK any approved drug will have published evidence demonstrating an assessment of the health outcomes against the cost.9 In the US, there is a body called ICER that does similar work, although on a narrower range of drugs.10
Reaching a conclusion on whether a given drug price is “justifiable” is fraught with challenges. The price is part of the story, but the key is understanding the value. Overall, we think a more systematic approach that builds on evidence of value with analysis of policies, processes and performance provides a much clearer picture of impact and risk and ultimately likely returns as well.
1WHEB (2017), Sharing the wealth: pricing power and impact – WHEB (whebgroup.com)
2 BMJ (2020), https://www.bmj.com/content/368/bmj.l4627
3 Blood Cancer Journal (2020), “The high cost of prescription drugs: causes and solutions” https://www.nature.com/articles/s41408-020-0338-x
4 World Economic Forum (2019), Why transparency in drug pricing is more complicated than it seems (https://www.weforum.org/agenda/2019/10/transparency-drug-pricing/)
5 PubMed (2017), The NICE cost-effectiveness threshold: what it is and what it means, https://pubmed.ncbi.nlm.nih.gov/18767894/#:~:text=The%20National%20Institute%20for%20Health,sterling%20for%20over20years
6 Harvard School of Public Health (2019), The need to treat the ailing US Pharmaceutical Pricing System, https://www.hsph.harvard.edu/ecpe/united-states-pharmaceutical-pricing/
[7] Health Affairs (2017), R&D costs for pharmaceutical companies do not explain elevated US drug prices, https://www.healthaffairs.org/do/10.1377/forefront.20170307.059036/full/
[8] As one of the largest sources of lobbying spending, this argument also ignores the role that the drug industry plays in shaping the regulatory framework.
[9] NICE (2012): The guidelines manual: Assessing cost effectiveness, https://www.nice.org.uk/process/pmg6/chapter/assessing-cost-effectiveness
[10] ICER (2022), Cost-effectiveness, the QALY, and the evLYG, https://icer.org/our-approach/methods-process/cost-effectiveness-the-qaly-and-the-evlyg/