Table 2.
Positive elements | Negative elements | |
---|---|---|
Key problems | ▸ Office can/must decide ▸ ‘WZW’ at center of decision-making ▸ CED integrates HTA (evidence generation) and decision-making |
▸ Should provide expertise but remain neutral ▸ Pricing (in Switzerland) independent from evaluation ▸ Time frame varies too much |
The role of rules | ▸ Safeguard against arbitrariness and randomness ▸ Guarantees accountability and reasonableness (clear processes as eg, NICE in England has it) |
▸ Random variations over time are reality ▸ Rigid process blocks flexibility; pragmatic and potentially very efficient decisions in individual situation not possible |
Transparency vs confidentiality | ▸ Transparency essential for fair process, reasonableness and accountability ▸ Confidentiality permits members to be honest and open during the meeting |
▸ Transparency induces public pressure on committee members and lobbying ▸ Transparency can violate the interests of manufacturers ▸ Confidential information cannot be used for other purposes, for example, economic assessment, price negotiations. ▸ Confidentiality carries risk of inefficiency |
Efficiency and resources | ▸ Commissioners are devoted to task ▸ Swiss process is lean and efficient |
▸ Risk of work overload for committee members through time constraints, poor preparation of meetings, broad range of topics and language barriers ▸ Not all technologies get the same attention ▸ Decision can be arbitrary |
Political pressure | ▸ Department in principle follows recommendation of commission | ▸ Pressure on commissioners less severe than in drug commission (no individual products; rather class products) ▸ Pressure by pressure groups, med tech industry, media |
CED as a struggle | ▸ CED for controversial medical technologies is part of the reimbursement decision-making process and should improve ‘WZW’ ▸ Different interests are represented in commission ▸ Commission and FOH realise key deficiencies in process |
▸ Evidence frequently not better after CED phase but difficult to say ‘no’ at the end of a CED process. ▸ No rules yet in Swiss CED process: (a) when to use CED; (b) how to define and what methodology to use for open questions; (c) how to guarantee the quality of the evaluation (compliance of service providers, financing) ▸ Bad compromises, not necessarily the most competent experts are chosen ▸ Time constraints, Transparency, Resources, Process definition, Feedback to the commission (evaluation of the evaluation) |
Changes over time | ▸ Decisions more based on evidence, more scientific ▸ More realistic perception of CED (and its possibilities and limits) ▸ More diverse commission |
▸ More cases, more documents, more work (over)load, ▸ High turnover of people at BAG (loss of knowledge) ▸ More heterogeneous commission |
Different interests need to be balanced | ▸ Patients demand access ▸ Physicians want to use novel, promising therapies ▸ Industries (researchers) want to sell products ▸ Payers need to control costs ▸ Federal office follows laws ▸ Commissioners strive for correct decisions |
Based on qualitative structured interviews (for details see methods).
CED, coverage with evidence development; FOH, Federal Office of Public Health; HTA, health technology assessment; NICE, National Institute for Health and Care Excellence; WZW, decision criteria (effectiveness, appropriateness and cost-effectiveness).