Will Spain adopt a hybrid of the Franco-German and Anglo-Saxon approaches to HTA and drug pricing?

A low-key document could have profound implications for the way Spain conducts HTA and prices medicines. The statement appears to be the opening gambit in a two-year review of pharmaceutical pricing and reimbursement by the Comité Asesor para la Financiación de la Prestación Farmacéutica del Sistema Nacional de Salud (CAPF; Advisory Committee for the Funding of the Pharmaceutical Benefit of the National Health System).

The recently published consensus document outlines a vision for the evolution of informes de posicionamiento terapéutico (IPTs; therapeutic positioning reports). The CAPF describes these brief assessments of new drugs as “an important tool for the selection of medicines from the available alternatives, for prescribing and for informing pricing and reimbursement decision making.” The Comisión Interministerial de Precios de los Medicamentos (CIPM; Interministerial Commission on the Pricing of Medicines) uses IPTs in setting prices.

The CAPF is proposing reforms to the structure and production process of IPTs. Priorities for change include the following:

• Addressing issues related to the binding nature of IPTs: the CAPF recommends that, where it is deemed appropriate to deviate from general criteria for IPTs, such exceptions should be explicitly justified in the relevant IPTs.
• Refining the decision-making process, especially in cases of incomplete information, uncertainty or methodological deficiencies in analyses.
• Providing adequate resources to produce IPTs—specifically, increased funding and recruitment to build a team of internal experts in clinical and economic evaluation, as well as a network of external evaluators.
• Potentially producing complementary documents: it is difficult to tackle all problems related to the adoption of new medicines in a single document.
• Establishing the role and timing of health economic evaluation and budget impact assessments as determinants of therapeutic positioning that could be based on comparative pharmacological/clinical assessment alone.
• Quantifying uncertainty, incremental clinical benefit, cost differentials, incremental cost-effectiveness, budget impact, etc., and using these data for decision making.
• Prioritising which medicines and indications should be the subject of IPTs.

The CAPF’s proposals for comparative clinical evaluation and economic evaluation will be of particular interest to the pharmaceutical industry.

Comparative clinical evaluation

According to the CAPF, “the objective of comparative evaluation should be to quantify clinical benefit and its uncertainty, taking into account, where necessary, the various therapeutic scenarios within the approved indication, the different situations of benefit uncertainty in patient subpopulations, the therapeutic positioning of the drug in relation to current clinical practice or possible options (where appropriate), and the assessment of the relevance of the benefit provided. The analysis must be multidisciplinary and based on the methodology most suitable for the evaluation of the available scientific evidence and the therapeutic positioning.” In addition, comparative clinical evaluation must go hand in hand with economic evaluation in pricing and reimbursement decision making.

Economic evaluation

The statement notes that value-based pricing and reimbursement decisions “should not be interpreted as equivalent to maximum willingness to pay. The price of a medicine should be adjusted in a range with a maximum range equal to the cost-utility threshold and a minimum equal to the drug’s manufacturing and research costs. The CAPF is aware of the difficulty of knowing the minimum price limit, but it must be stressed that it is important for the industry to provide the actual costs of production and drug research.”

The CAPF envisages two stages to economic evaluation. Manufacturers would submit their economic modelling, budget impact assessment and proposed pricing in their dossier. Sensitivity analysis would be used to measure the uncertainty of cost-effectiveness or cost-utility calculations and to determine an appropriate incremental cost-effectiveness ratio (ICER), which would then be compared with reference values. The drug’s ICER, budget impact, and manufacturing and research costs, along with its incremental clinical benefit, would be the key elements in pricing negotiations. Once the price has been set, the economic evaluation may need to be revised, taking into account the determination of the level of incremental clinical benefit. Only then could the drug’s therapeutic positioning be finalised.

Implications for the pharmaceutical industry

The relatively short consensus document (13 pages) is thought-provoking but raises more questions than it answers. The pharmaceutical industry will certainly want to see much more detail and clarity on how the proposed new procedures would work in practice.

Intriguingly, the CAPF seems to be advocating a hybrid of the Franco-German and Anglo-Saxon approaches to HTA and pricing. Will the focus on incremental clinical benefit lead to the introduction of a clearly defined rating scale along the lines of the amélioration du service médical rendu (ASMR; improvement in actual benefit) in France or the Zusatznutzenbewertung (additional benefit assessment) in Germany? On the other hand, the increased emphasis on cost-effectiveness would follow the lead of countries such as England, Scotland, Canada and Australia. The CAPF has already indicated that it intends to explore the possibility of introducing a QALY threshold in Spain.

The CAPF’s view that it is it is difficult to tackle all problems related to the adoption of new medicines in a single document is interesting. The committee does not specify what other documents it would like to see published, and whether that requirement would entail an additional administrative burden on manufacturers.

The consensus document makes no mention of the potential impact of the proposed changes to the timelines for producing IPTs, but an increased workload would presumably require more time to complete. A recent analysis found that IPTs were already taking an average of 265 days to produce—nearly three times the 93 days allowed. Would delays increase under the new system?

The CAPF recognises that its reforms would have significant resource implications. Will the Spanish government be prepared to invest in recruiting and training the experts required?

The impact of the CAPF’s recommendations will ultimately depend on the government: will it embrace the reforms? If so, when would the changes be implemented? The pharmaceutical industry will eagerly await answers to these questions.

I have recently updated coverage of Spain and other major European markets in my multi-client training programme on market access environments. Please get in touch if you would like to know more about this flexible programme.