Council for Choices in Health Care in Finland Secretariat and divisions

Theme proposal

Provisions regulating service choices and COHERE's activities do not define which stakeholders may propose recommendation themes. Proposals could be made by:

  • medical specialists' associations and other professional and scientific medical societies
  • patient organisations
  • hospital districts and municipalities (future counties)
  • Fimea
  • Social Insurance Institution (Kela), healthcare supervisory authorities and other authorities
  • private persons
  • Ministry of Social Affairs and Health
  • COHERE divisions and individual members of the Council or its divisions.

The proposed theme must fall within COHERE's remit to issue recommendations on which healthcare and medical care procedures and rehabilitation methods should be included in or excluded from the service choices. In this connection, method means a medicinal product, a medical device or medical and surgical procedures as well as measures for disease prevention, diagnosis or treatment used in healthcare (definition of health technology in Article 3(l) of Directive 2011/24/EU on the application of patients' rights in cross-border healthcare).

The Council itself, too, should identify themes that need to be determined more closely.  Recognising themes that need to be determined and preparing them for the Council's decision-making are the key tasks of the divisions.

Theme proposals can be sent by email to palveluvalikoima@stm.fi.

A theme proposal should include grounds for why the proposer considers that COHERE should process the theme. The proposal should also include relevant material about the matter or inform the reader where such material is available. When necessary, COHERE may ask for further information from the proposer.

 

Preparatory drafting

The secretariat carries out the preparatory drafting together with the divisions. Council meetings make the decisions. When preparing the themes for processing, COHERE will consider, for example, the following questions:

  • Regional variation in clinical practices and availability as well as equity (regarding a method already in use)
  • How severe and common the health problem is
  • Safety of the healthcare intervention (potential adverse effects, among other things)
  • Economic impacts
  • Ethical questions (need for public discussion on values, particularly vulnerable patient groups, equality issues, a strong marketing drive of a method etc.)

 

COHERE's decision on further measures

Based on the preparatory drafting, the COHERE meeting will decide either to continue the preparation of a recommendation or makes a decision that no recommendation will be issued in the matter. The grounds for a negative decision will be recorded in the minutes of the meeting or its appendices.

 

Recommendations on medicines

COHERE may, in accordance with the process described above, start to prepare a recommendation on the use of a particular medicine for the treatment of a particular disease. However, COHERE will not assess medicines for outpatient care unless there are special reasons to do so. Such a reason may be, for example, that the medicine has not been granted a reimbursement status or a reimbursement status has not been applied for.

Regarding new medicines for use in hospital conditions, themes are selected as follows: Fimea produces assessment reports on new hospital medicines (new active ingredient or a significant extension of the indication for use). The objective is to produce information on the therapeutic and economic value of medicines for hospital use in situations where hospitals are considering whether to take into use a new medicine. Fimea notifies COHERE of starting a new assessment process and of its time schedule. COHERE may also request Fimea to assess a medicine.

COHERE aims at drawing up recommendations for all hospital medicines assessed by Fimea. COHERE's General Secretary decides, based on an authorisation from the Council, to start the process, and the Council meeting will be informed of it. If there are several new medicines considered for the same indication for use, the aim is to process them simultaneously unless it delays the process unreasonably.

 

Giving information of starting the process

In the case of all recommendations, the following sources will provide information of starting the process and of the assessed time schedule for the processing:

  • COHERE website under XXXX and an electronic newsletter to its subscribers
  • email to the parties concerned (the holder of a marketing authorisation for the medicine or the party applying for a marketing authorisation)
  • email to the medical directors of hospital districts and to the chief assessment physicians
  • the proposer of the theme will be informed, too.

 

Preparation

COHERE's recommendations consist of the actual recommendation and an explanatory memorandum to the recommendation. The recommendation may also include appendices, such as a literature review.

The division concerned and the secretariat prepare together a recommendation to be considered by the Council. Division members' task is to act as a link to the field of healthcare and bring their expertise and practical clinical approach into the preparation process.

In addition to collecting data on own initiative, the secretariat may request clarifying information from experts, institutions in the administrative branch of the Ministry of Social Affairs and Health or other stakeholders, or acquire information through a procurement procedure from private operators. When acquiring systematic literature reviews in order to collect research evidence, a structured letter requesting information is used. A PICO tool is used for the assignment if PICO is suitable to describe the topic. Provisions on public procurement are complied with in the procurement procedure. 

When drawing up recommendations, information sources mainly include peer-reviewed, controlled medical research publications. If no such publications are available, even other kind of research may be taken into account. When preparing a recommendation on a hospital medicine, Fimea's assessment report is the main source of information. The report may be supplemented by data that are more recent.

In addition to COHERE's own expertise, Etene's expertise may be utilised for  the assessment of ethical viewpoints.

When necessary, COHERE will arrange a separate meeting with patients' representatives. The patient perspective is sought primarily via patient organisations. Even other stakeholders may be contacted if the patient perspective cannot be examined via patient organisations in the case of the particular theme and the patient group concerned.

 

Draft recommendation processing

When the division concerned considers that the recommendation draft is ready or when the division needs to know the Council's opinion for further preparations, the matter will be  referred for discussion at a COHERE meeting. The meeting may decide to

publish the draft recommendation on the website Otakantaa.fi

return the draft to preparation and give guidance on further preparation or

cease the preparation of the recommendation.

 

Website Otakantaa.fi

COHERE publishes the draft recommendations and its explanatory memorandum, inclusive of any appendices, on Otakantaa.fi website for public commenting. The planned time schedule for the comment round is available on COHERE website under "Draft recommendations".

Information of the comment round will be:

  • published on COHERE website under XXXX and by an electronic newsletter to its subscribers
  • sent to patient organisations, medical specialists' associations etc.
  • sent by email to the concerned parties (the holder of a marketing authorisation for the medicine or the party applying for a marketing authorisation)
  • sent by email to the medical directors of hospital districts and to the chief assessment physicians
  • sent to the proposer of the theme.

The purpose of the comment round is to ensure that all relevant material has been taken into account, the recommendation is based on correct data, all perspectives on the matter have been considered well enough and the wording of the recommendation is understandable.

The draft is commented part by part in accordance with the recommendation's sections. Background information of the sender of the comment is also requested. The comments are public, as laid down by the Act on the Openness of Government Activities. Data of individual patients must not be included in the comments.

COHERE tries to reserve three weeks at least for each comment round. In some situations, the commenting time needs to be shortened due to the meeting schedules of divisions and the Council.

A summary of the comments is usually published simultaneously with the final recommendation.

 

Finalisation and COHERE's decision

The secretariat and the division will continue processing the recommendation and the explanatory memorandum on the basis of the comments received. When the documents are finalised, the matter will be submitted to the Council for their final decision. Even at this stage, the Council may return the matter for further preparation.

COHERE's rules of procedure lay down that the Council should primarily seek to reach a unanimous decision.  If that is not possible, the majority shall prevail. Where the votes are equal, the chair shall have the casting vote.

A recommendation will be valid until further notice, unless COHERE decides otherwise. A recommendation may be issued for a fixed term if it is foreseeable that the development of medical science or new information will call for revision. However, COHERE may take up the matter for reconsideration already before the fixed term ends if there is reason to suspect that the recommendation is not up to date anymore.

 

Recommendation issued

The recommendation and the explanatory memorandum are published on COHERE website. The recommendation is published in Swedish and English, too.

Information on issuing the final recommendation will be:

  • published on COHERE website under and by an electronic newsletter to its subscribers
  • sent to patient organisations, medical specialists' associations etc.
  • sent by email to the parties concerned (the holder of a marketing authorisation or the party applying for a marketing authorisation)
  • sent by email to the medical directors of hospital districts and to the chief assessment physicians
  • sent to the Centre of Expertise in Healthcare Benefits at the Social Insurance Institution (Kela)
  • sent to the proposer of the theme.