Learnings from Danish Medicines Council

The Danish Medicines Council (DMC) has been a reality since January 2017 and is currently under evaluation. Therefore, it is relevant to analyse whether trends in their decisions can be observed, and whether the findings may be relevant for future cases.

Since the initiation of the DMC, amendments has been made in the methods guidelines for both the benefit assessments and the health economic evaluations. A version 2 of the methods guideline for the benefit assessments is applicable for protocols developed after January 1st, 2019.

The revised methods guideline for the benefit assessments includes several changes, including an additional benefit category (7 categories on total) and a more detailed definition of the inferential thresholds per group of outcomes, making them mutually exclusive. In addition, minimal clinically important differences are now based on either the upper or lower limits of the confidence intervals instead of the point estimates, thereby taking the uncertainty around the point estimate into consideration.

The amendments in the health economic guideline include a change in the requirements for the chosen time horizons in the economic models. Up until August 30th, 2018 the DMC defined the relevant time horizon in the health economic model. Now the time horizon is chosen by the applicant but must be in line with the following statement: “The time horizon of the model should be long enough to capture all relevant differences in costs between options. I.e. the time horizon must be of a duration that any further extension will not affect the result significantly.”

In addition, it is also an option for both the DMC and Amgros to reject an application if it does not comply with the methods guidelines.


About this analysis

Nordic HTA have reviewed all decisions made by the DMC from January 1st, 2017- April 10th, 2019 and assessed them according to their benefit categories, incremental costs in list prices (PPP), and DMC recommendations.

The analysis only includes products that has been evaluated according to the old methods guideline for the benefit assessment and therefore these amendments will not affect how to interpret the observed categories. However, the amendments in the economic guidelines will affect how the results of the economic assessments are presented in some cases, and thereby potentially affecting the final decision made by the DMC.


Decisions made by the DMC

In this timeframe the DMC has made decisions on standard treatment for 119 clinical questions. In 64% of the decisions the product has been recommended as possible standard treatment.

3% were given a High added clinical value, 13% an Important added clinical value, 20% a Low added clinical value, 45% a no added clinical value, 17% a non-documentable added clinical value, and 2% a negative clinical value. Products with a negative clinical value were excluded from our analysis as these products per default can not be recommended as standard treatment.


Products with high added clinical value

All products with a High added clinical value were recommended as possible standard treatment by the DMC. The product associated with the greatest incremental cost had incremental costs of approximately 2,4 million DKK.


Products with an important added clinical value

Only two products with an Important added clinical value were not recommended as possible standard treatment and it is therefore difficult to observe a clear trend. However, all products with incremental Costa below 700,000 DKK were recommended as possible standard treatment by the DMC indicating a willingness to pay (WTP) higher than 700,000 DKK for this benefit category.


Products with a low added clinical value

For products with a low added clinical value the trend is clearer, where products with incremental costs below 200,000 DKK were recommended as standard treatment, and products with incremental costs higher than 600,000 DKK were not recommended as possible standard treatments. However, for incremental costs between 200,000 DKK and 600,000 DKK the trend is less clear.


Products with no added clinical value

For products with no added clinical value there is a very clear trend, where all products with incremental costs below 325,000 DKK were recommended as possible standard treatments, and all products with incremental costs above that level were not recommended. Question mark indicates that Amgros were not able to quantify the incremental costs.


Products with non-documentable added clinical value

For products with a non-documentable added clinical value there is a clear trend that products with incremental cost of 240,000 DKK or higher are not recommended as possible standard treatments. However, one product associated with incremental costs of only 115,000 DKK was not recommended as standard treatment. Question marks indicate that Amgros were not able to quantify the incremental costs.


Limitations

This analysis has certain limitations. One limitation is that incremental costs for some products are presented as costs per year, for some products in total incremental costs, and for the rest of the products over different arbitrary time horizons. This element makes the comparison misleading for some products. The mentioned amendments in the Amgros methods guidelines will make future comparisons more accurate. The other limitation is that the analysis is performed based on list prices. Amgros has obtained discounts for a majority of the products evaluated, and in 93% of the decisions the estimated incremental costs are lower than the costs presented here, when using actual discounted prices. The analysis is therefore not completely representative of the actual WTP by the DMC.


Conclusions

This analysis is a recap of the evaluations made by the DMC and Amgros the first 27 months using version 1 of the DMC methods guideline. There seems to be a trend in the decisions made by the DMC and their observed WTP. It will be interesting to see how the amendments will affect the decisions made by the DMC in the future. Nordic HTA will follow the development closely.

Please feel free to contact us if you have any questions or would like to learn more about the decision process in the DMC.

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