Legal & Regulatory > Denmark > HTA Decision Analysis Framework: Denmark

Taken from PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on the HTA decision analysis framework in Denmark. Buy The Pharma Legal Handbook: Market Access & HTA – Denmark here for £359.

1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country?

The Danish Medicines Council

New medicines (or product with new indications) that are intended for the Danish hospital market, must first be assessed by the Danish Medicines Council.

The objective of the Danish Medicines Council is to provide guidance and recommendations on new medicines and standard therapies used in the Danish hospital sector.

The Danish Medicines Council does this through two separate processes: assessments of new medicine, where a new compound is compared to the standard therapy used in Denmark and guidelines, where several medicines for a specified disease are compared. The guideline process results in a recommendation with a prioritized list of medicines to be used for patients with the specified disease.

The Danish Medicines Council consists of three units: the expert committees, the Secretariat and the Council.

Amgros

Amgros is the Danish wholesale distribution company responsible for the majority of procurement on behalf of the Danish Regions (the Danish hospitals). Price negotiations are done in collaboration with the Danish Medicines Council, the Drug and Therapeutics committees and the pharmacies at the hospitals. After tendering, Amgros enters into contracts with the winning suppliers on behalf of the Danish Regions. Amgros also provides economic evaluations to the Danish Medicines Council.

The Danish Health Technology Council

As mentioned above, the Danish regions have also established the Danish Health Technology Council (Danish: Behandlingsrådet). The objective of the Health Technology Council is to target Danish healthcare resources at the technologies and interventions that provide best value for money, across both physical and mental health services, in order to help raise the quality of health services, ensure more equality in treatments, and reduce cost pressure in the healthcare system. The Health Technology Council conducts evaluations and issues recommendations on use of medical devices and healthcare technologies (primarily those used in hospitals) based on evaluations of whether expenses are proportional with the related effects.

The Health Technology Council might accept proposals for evaluations from the Danish regions, hospital management and companies. The assessments of technologies include:

1. i) clinical effectiveness and safety;
2. ii) patient experiences;

iii) organizational impact; and

1. iv) health economics.

However, new technologies do not have to be approved by the Health Technology Council in order to be used at the Danish hospitals.

Drug formularies in primary care

In an effort to promote rational and appropriate use of medicines within primary healthcare, the Institute for Rational Pharmacotherapy (Danish: Indsatser for Rationel Farmakoterapi) under the Danish Health Authority drafts advice targeted general practitioners based on available evidence to help general practitioners prescribe medicines in accordance with rational pharmacotherapy.

Further, in order to help general practitioners within primary care, the Danish Health Authority has developed a national drug formulary.[1] Each region has also developed a drug formulary called “basislisten” based on the national drug formulary.

Hospital drug formularies (secondary care) are also widely used in Denmark – these are based on the treatment guidelines from the Danish Medicines Council.

2. Do regulators/payers require HTA studies in your country?

New medicines (or product with new indications) that are intended for the Danish hospital market, must first be assessed by the Danish Medicines Council.

3. How are HTA assessments translated into pricing conditions in your country?

On the basis of an assessment report from Danish Medicines Council, Amgros will negotiate the price of the medicine with the company. Negotiations with Amgros take place at the same time as the company has the draft assessment report for review. When negotiations with the company have been completed, Amgros will send a negotiation note to the Secretariat of the Medicines Council with the negotiated prices. The Secretariat updates the assessment report on the basis of the agreed prices from Amgros.[2]

4. How are HTA assessments translated into reimbursement conditions in your country?

When applying for reimbursement in Denmark, it is optional for companies to include health economic evaluations. If submitted, such evaluations must comply with the guidelines issued by the Danish Medicines Agency.[3]

5. Which are the evaluation criteria, processes or models and analyses framework used for HTA in your country?

Assessment criteria

Recommendations by the Danish Medicines Council are based on:

• A medical assessment of the added clinical value to patients
• An economic assessment of the added costs per patient (and impact on the overall budget)
• Price negotiations (between the pharmaceutical company and Amgros) to ensure that there is a reasonable relationship between the added costs and the added clinical value of the medicine as compared to the current standard treatment

The recommendations are also based on the seven overarching principles for prioritization of hospital medicine issued by the Danish Parliament. The seven principles are:

1. Professional competence
2. Independence
3. Geographical equality
4. Transparency
5. Rapid update of new, effective medicines
6. Value for money in health
7. Access to treatment

Process of assessments

The Danish Medicines Council’s process for assessing new medicines and extensions of indication uses the following steps:[4]

1. Request for assessment.

The assessment process at the Danish Medicines Council is in principle independent of the marketing authorization process, but a company wanting a medicine assessed by the Danish Medicines Council must submit its request for assessment to the council (the Secretariat) no earlier than day 120 in the assessment process at the EMA for new medicines under the normal approval procedure at the EMA and no earlier than day 1 for extensions of indications or new medicines under the accelerated procedure at the EMA. The relevant form must be downloaded from the Danish Medicines Council’s website and sent to the Danish Medicines Council’s e-mail: medicinraadet@medicinraadet.dk.

The following information must be included in the form:

• Name of company
• Contact person and possibly power of attorney, if the company uses an external representative.
• Information about the medicine (incl. ATC code, form of administration, dose)
• Expected timeline for issuing marketing authorisation and for the final application to the Danish Medicines Council
• Brief account of the disease and existing treatment in Denmark
• The new medicine
• Any relationship with existing treatment guidelines
• Any further information as needed for dialog with the Secretariat

Based on an assessment request, the council’s Secretariat will enter into a dialogue with the company about the content of its application and plan the assessment process.

If there is a need to set up a new expert committee to carry out the assessment, the

Secretariat will start establishing the expert committee upon receipt of a request for an assessment.

2. Dialogue before application. When a company has submitted a request for assessment, it can request a meeting with the Secretariat’s project group for advice on the application and process. Prior to the meeting, the company should submit any questions and relevant material, e.g., information on clinical studies or expected health economic analysis.

3. Application. When EMA (CHMP) has given a positive opinion, the company can submit a formal application to the Danish Medicines Council. Applications must consist of a completed application form (format can be found on the website of the Danish Medicines Council), a health economic analysis and a budget impact analysis.

The Secretariat will carry out a technical validation of the application by reviewing the application materials to ensure that all the specifications of requirements have been met. The company will be notified on whether the application can be approved and considered as satisfactory as soon as possible, and by no later than within 10 business days.

Day 0 is the day that the Danish Medicines Council receives an application that has been validated by the Secretariat as complete.

4. Assessment report. The Secretariat and the expert committee work together on reviewing and assessing the application material from the company. The assessment report includes a description and assessment of the clinical studies, the effect and safety of the medicine against comparator(s), and a description and assessment of the health economic analysis from the company.

When the expert committee and the Secretariat have completed the assessment report, it will be sent to the company and to Amgros. This will usually be 12 weeks after day 0.

The company will be asked to review the draft assessment report and comment on any errors and redaction of confidential information.

5. Negotiation. On the basis of the assessment report, Amgros will negotiate the price of the medicine with the company. Negotiations with Amgros take place at the same time as the company has the draft assessment report for review.

When negotiations have been completed, Amgros will send a negotiation note to the Secretariat with the negotiated prices. The Secretariat updates the assessment report on the basis of the agreed prices from Amgros.

6. Decision regarding recommendation. When the Council is to make a decision on recommendation of a medicine, it must determine whether the efficacy and safety of a product is proportionate to the cost of putting the medicine into use. As mentioned above, the assessment will, i.e., be based on the Danish Parliament’s seven overall principles for prioritising hospital medicines, as well as the principles of caution and severity.

The Council will formulate its recommendation, and publish the recommendation immediately thereafter.

Normally, the assessment process takes up to 16 weeks from the date of receipt of a complete application by the Secretariat (i.e., day 0) to a final recommendation by the Danish Medicines Council.

The Danish Medicines Council’s recommendations for standard treatment that are largely followed by the physicians.

Updating treatment guidelines

The Danish Medicines Agency can also assess new medicines (and extensions of indications or new formulas) by updating existing treatment guidelines or drawing up new guidelines. This process can be followed if the effect and safety profile of the medicine is comparable with existing treatment options.

If the expert committee and the Council agree that the Danish Medicines Council should assess the medicine in a treatment guideline, the following standard process will be used:[5]

1. In the request for assessment, the company must state that the Danish Medicines Council is requested to assess the medicine by preparing or updating a treatment guideline. The request must include appropriate documentation to support that the medicine has the same efficacy and safety in the form of a comparison with the relevant comparator medicine.
2. The expert committee will assess whether they agree with the company’s request, and submit its recommendations to the Council that a treatment guideline should be prepared or updated.
3. The Danish Medicines Council will prepare or update the treatment guideline, after which the Council will approve.
4. The Danish Medicines Council will prepare or update the relevant cost analysis, and the Council will approve on the basis of comparison.
5. Amgros will inform the Secretariat of the new prices.
6. The Secretariat will update or prepare the medicine recommendation, and this will subsequently be approved by the Council.

Generic/biosimilar medicines

For generic and biosimilar medicines, it is possible to place these products on the Danish hospital markets without having to go through the Danish Medicines Council, e.g. by simply participating in tenders that are based on active ingredients or therapeutic use (please see more information on Amgros and the tender procedures below).

6. What is the methodology used in your country for HTA assessment?

A recommendation for a medicine by the Danish Medicines Council is based on an assessment of whether the effect (measured as quality-adjusted life-years (QALY)) and safety of a medicine is reasonably proportionate to the cost of bringing the medicine into use.[6]

7. Which are the other decisions impacted by the assessed outcome in your country?

Please see answers to questions above.

8. Does your HTA review or inquire other international HTAs during the assessment process? If so, which ones are the usual partners?

The guidance from the Danish Medicines Council provides that documentation of clinical effect and safety should be derived from full-text articles published in scientific, peer-reviewed journals, European Public Assessment Reports (EPAR) prepared by the European Medicines Agency (EMA), reports by the Food and Drug Administration (FDA) or the HTA agencies.

References

[1] https://www.sst.dk/da/viden/laegemidler/rationel-farmakoterapi/den-nationale-rekommandationsliste-_nrl_

[2] The Danish Medicines Council methods guide for assessing new pharmaceuticals (Version 1.2, Document.no: 107707), page 13. Available at: https://medicinraadet.dk/om-os/in-english

[3] https://laegemiddelstyrelsen.dk/en/reimbursement/general-reimbursement/application/health-economic-analyses-in-reimbursement-applications/

[4] The Danish Medicines Council methods guide for assessing new pharmaceuticals (Version 1.2, Document.no: 136636), pages 8-14. Available at: https://medicinraadet.dk/om-os/in-english

[5] The Danish Medicines Council methods guide for assessing new pharmaceuticals (Version 1.2, Document.no: 136636), pages 17-8. Available at: https://medicinraadet.dk/om-os/in-english

[6] The Danish Medicines Council methods guide for assessing new pharmaceuticals (Version 1.2, Document.no: 107707), page 5. Available at: https://medicinraadet.dk/om-os/in-english