Developing drugs is a long-term ball game. Many promising drugs are at different development stages, in ‘the pipeline’, at any given time. The drugs may be in one of the phases of clinical trials, for example, or pending under consideration of the European Medicines Agency. Many of these drugs, especially those for rare diseases, are likely to be highly expensive once they reach the decision-making setting for provision or reimbursement. A positive reimbursement decision often has a sizeable impact on the total health care budget of a country.
Governments and organizations that are at arm’s length from the government that are responsible for provision or reimbursement decisions commonly engage in ‘horizon scanning’. In essence, horizon scanning means keeping an eye on pharmaceutical companies’ pipelines. This is serious business. Europe has recently seen the launch of the International Horizon Scanning Initiative (IHSI). It unites Belgium, Denmark, Ireland, Norway, Portugal, Sweden, Switzerland, and the Netherlands, representing 74 million citizens and 35 billion euros spent on health care. The idea is that prospective monitoring leads to a better overview of what is in store and, consequently, to more accurate budgets. Further, the initiative makes an explicit link with better-informed price negotiations: “with IHSI data-driven negotiations, prices for new pharmaceutical products can be reduced on average by minimum 1%”. It would seem that IHSI envisions this to come mainly through united efforts, as negotiations would be on behalf of several countries (IHSI, 2019).
Many investments have been made into making better predictions, and being able to forecast the horizon's future, de-emphasize that we could – and probably should – also spend time on the horizon of the past. By this, I mean reducing the prices of drugs after a positive reimbursement or provision decision. The standard, often unspoken assumption is that after the period of market exclusivity ends for a particular drug, the market will do its job. Competing generic drugs enter the market, leading to a price reduction. In reality, the market for rare disease drugs does not function like this. The Dutch Health Care Institute recently brought out its ‘Monitor for Orphan Drugs in Practice 2020’. This document shows that in the Netherlands, price reductions of orphan drugs after the end of the market exclusivity period are 1.5% on average (Zorginstituut Nederland, 2020). However, it is essential to note that this price reduction is just that: an average. In about a quarter of the cases, a generic competitor did enter the market and achieved a 24% price reduction (Zorginstituut Nederland, 2020). However, three-quarters of the drugs remained unchallenged and therefore saw approximately a 5% increase in price (Zorginstituut Nederland, 2020). As the Dutch appraisal committee responding to this Monitor advised the Minister of Health:
“price agreements [should] take into account a price decrease at the end of the period of market exclusivity, regardless of whether a generic product comes on the market" (Advisory Committee Package, 2020)
It would be interesting to see what would happen if efforts on the horizon of the past were to match those on the horizon of the future. As the committee suggested, one way could be by setting different prices for the period of market exclusivity and afterward. Another solution may lie in social innovation initiatives to (help) develop treatments that are more readily available for vulnerable patient populations.
Written by: Tineke Kleinhout-Vliek, email@example.com
Advisory Committee Package. (2020, October 23). ACP advice on the 'Monitor orphan drugs in practice 2020'. Zorginstituut Nederland. Retrieved January 12, 2021, from https://www.zorginstituutnederland.nl/publicaties/adviezen/2020/10/23/acp-advies-over-de-%E2%80%98monitor-weesgeneesmiddelen-in-de-praktijk-2020%E2%80%99
International Horizon Scanning Initiative. (2019, December 31). IHSI - Governments change the conversation with real data. International Horizon Scanning Initiative. Retrieved January 12, 2021, from https://ihsi-health.org/
Zorginstituut Nederland. (2020, October 12). Monitor Orphan drugs in practice 2020. Zorginstituut Nederland. Retrieved January 12, 2021, from https://www.zorginstituutnederland.nl/publicaties/rapport/2020/12/10/monitor-weesgeneesmiddelen-2020
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