Evaluation process

Contemporary Swiss thinking on the constitution is committed not only to a focus on the rights already mentioned, but also to the idea of procedural justice. From this follows the demand for broad involvement of all those affected (stakeholders) and their interests, as well as a careful weighing of different aspects on a case-by-case basis.

The proposed processes are also inspired by a concept of “accountability for reasonableness” modified with a view to its practical feasibility, underpinned by the following principles: maximum possible transparency, relevance in the sense of evidence-based aspects and fairness (cf. in the concept criteria for individual and social benefits), rights of appeal (cf. below; supplemented in the concept by broad stakeholder involvement) and commitment (cf. in the concept implementation, enforcement of decisions and quality assurance).

Scope and balance of the HTA process

Health Technology is a comprehensive concept and includes (without any claim to being an exhaustive list) medicines, medical devices, diagnostic measures, medical and surgical procedures, complex clinical care pathways and organizational and administrative settings.

With the exception of medical services reimbursed in an “open benefit catalogue”, new technologies are usually not included in a benefit catalogueof the compulsory health insurance until after an assessment (“rHTA”, see below) and are thus automatically subject to a Health Technology Assessment.

But particularly high potential for efficiency and quality improvement can be realized in the area of existing technologies. To take this into account, a special program should be defined for the systematic evaluation of existing technologies (“cHTA”, see below), the scope of which must be measurable on the basis of defined quantifiable target criteria. To ensure there is a degree of balance in this respect, a minimum of 12 to 18 completed cHTAs per annum is proposed as a target parameter.

Criteria for the selection of technologies for HTAs

Robust HTAs are not only qualitatively challenging and complex in their implementation, but also need to satisfy the criterion for efficiency themselves. So not all conceivable services covered by the compulsory health insurance should undergo an HTA. The following are therefore proposed as criteria for the selection of HTA issues:

  1. New technologies (products and procedures) before a decision on their inclusion in a positive list and/or in the event of predictably high costs (budgetary relevance) and/or in the case of a specific dispute
  2. Established technologies (products and procedures) based on their system relevance:

    • Budgetary burden (/opportunity costs);
    • Prevalence and/or burden of disease;
    • (also) in the case of a dispute with unclear evidence;
    • in particular (also) when clinical (or other use) guidelines are to be developed for a group of indications
  3. Reevaluation of technologies usually after three years (in individual cases also after between two and five years, adapted according to the situation concerned)

Separation of assessment, appraisal, decision

The responsibility for HTAs could be assigned to a Swiss “HTA Institute” or, if need be, in the context of the federal quality initiative, also to a Swiss institute for technology evaluation and quality in healthcare).

  1. Assessment:
    Task: rigorous formal synthesis of available evidence as target-oriented support for the following Appraisal
  2. Appraisal:
    Task: comprehensive evaluation, identification of evidence gaps, and recommendations based on the assessment as a basis for Decisions.

Decisions on reimbursement, prices and other decisions are not a part of the actual HTA process, which establishes the essential basis of information for this (primarily through allocation to evidence-based benefit categories and, beyond this, the determination of cost implications and cost/benefit relations):

Decisions consequently remain the responsibility of the Federal Department of Home Affairs (FDHA) and the FOPH:

  • Decisions on reimbursement and prices,
  • Research conditions and their implementation,
  • Quality-assured medical care: development of guidelines on use and clinical guidelines (with the medical societies) including monitoring of an implementation.

Rapid (r)HTA and Complete (c)HTA process

To guarantee a proper, differentiated process for the evaluation both of new and of existing technologies along with standardized criteria of assessment at the same time, two separate sub-processes will be introduced:

Process: primarly for new technologies:

Rapid (rHTA-)Prozess		 primarly for existing technologies:

Complete (cHTA-)Prozess
Primary Objectives:   Management of services
Systematic review of available evidence and its quality Systematic review of available evidence and its quality
Definition of research needs Definition of research needs
Basic principles for decisions on reimbursabilty and maximum prices Basic principles for development of binding guidelines for use and if needed a review of reimbursabilty and maximum prices
Responsibility: Applicant's dossier

Review by HTA institute/academic reviw group (Dossier Assessment Group, DAG)		 Academic institution (Academic Assessment Group, AAG; commissioned by HTA institute)

Phasen: Early Consultation (HTA institute, optional)

Dossier submission/triage (FOPH): Bypass, Fast Track or standard-rHTA		 Assignment (FOPH; consolidated proposals from HTA institue)

Scoping (HTA institute)
Assessment (HTA institute; DAG) Assessment (HTA Institute; AAG)
Appraisal (HTA institute; commissions) Appraisal (HTA Institute; commissions)
Decision (FOPH) Decision (FOPH)
Finanzierung: Applicant (fees) Mixed funding: equally through compulsory health insurance (contributions; confederation; fees.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rapid (r)HTA process

The special features of the rHTA process include a range (that can be seen by the applicants as an option) of “early consultations” (subject to a fee), which serve as an exchange of information with the institute that will be responsible later on for implementing an rHTA. The objects of an early consultation arise primarily from the consulting needs of the technology developer.

Furthermore, a “triage” of the dossier submitted (to the FOPH) at the start of the rHTA process ensures that the evaluation process can be conducted as quickly and efficiently as possible. Dossiers shown in a formal preliminary review to be incomplete or deficient are returned to the applicant within two weeks for revision and possible resubmission. Based on transparent criteria the options of a bypass and a fast-track process remain.

Key stakeholders (represented in each case by their associations at federal level) are basically patients, the medical profession and other service providers, health insurers and also technology providers (the latter also individually when directly concerned). Other stakeholders are, for example, scientists, HTA experts and health policy makers.

Complete cHTA process

The cHTA process begins with a structured collection of issues at the FOPH, which are assessed by an expert committee of the HTA institute according to the defined criteria for selection (see above) and submitted to the FOPH in a consolidated list of proposals for a decision. On this basis, the FOPH commissions the HTA institute to carry out cHTAs (Assignment).

On completion of the assignment, the HTA institute initiates the evaluation process, starting with an operationalization of the issue with the participation of stakeholders and experts (Scoping) with regard to e.g. comparators, sub-group analyses and the nature, perspective and timetable of analyses (Assessment Protocol).

The cHTA process envisages clearly defined co-determination options for stakeholders during the phases of assessment and appraisal.

Rights of appeal (appeals process)

The appeals process must be safeguarded against possible misuse by representatives of particular interests. Therefore appeals do not in principle have any suspensive effect on decisions.

Appeals are only permitted after a decision has been made.

Rights of appeal against (positive and negative) decisions are (only) granted to those materially or economically affected; this includes manufacturers and their associations, as well as - at federal level - the national associations of insurers, of service providers and of patients. Appeals may be lodged against formal errors and against flawed decision-making frameworks (assessments, appraisals). They are dealt with before one of the Appraisal Committees and the Appeal Committee, which is independent of the decision makers, and on this basis a decision is quickly reached (within not more than three months).

From a legal point of view, it has to be borne in mind, amongst other things, that it may be necessary for a general contestability to be anchored in law. Consequently, this would always require the issuing of decrees instead of ordinances. It may be enshrined in the health insurance act (KVG) that, based on the result of an HTA process, decisions can be taken further by means of an appeal within 30 days to the appropriate Appeal Committee (independent authority for appeals). Any right of appeal for associations would likewise have to be enshrined in law.

Transparency

Within the meaning of the Swiss law on transparency in administration (BGÖ) of 2004 and internationally recognized standards for “Good HTA Practice” – and taking account also of the criteria for “Accountability for Reasonableness” – the greatest possible transparency is sought in the HTA process. This entails publication of the evaluation criteria and methods, as well as all HTA process-related standards; publication of process-related information; publication of the key documents of assessments and appraisals; preservation of the confidentiality of all personal information with disclosure of potential conflicts of interest of those involved in the HTA process at the same time.