Table 7.

Comparison of conditional reimbursement policy options for managing decision uncertainties

Country	Centralized reimbursement review/decision-making body (role)	Policy options for addressing decision-making uncertainties
		Reassessment	Value-based pricing/reimbursement	Reimbursement as part of a formal study	Risk-sharing schemes/payment by results	Other
Austria	Association of Austrian Social Security Institutions (decisions)55 Pharmaceutical Evaluation Board (recommendations)56	Yes Association of Austrian Social Security Institutions may remove pharmaceutical from benefit list in the wake of new clinical or economic evidence Manufacturer may suggest delisting pharmaceutical21	No56	No information found	No information found	No information found
Belgium	Minister of Social Affairs (decisions) Drug Reimbursement Committee (recommendations)9	Yes – automatic reassessment of pharmaceuticals offering added therapeutic value 1.5 to 3 years after inclusion on benefit list Minister of Social Affairs or manufacturer may suggest delisting a pharmaceutical41,49	No information found	No information found	Financially or clinically based: For pharmaceuticals offering added therapeutic value for which the Drug Reimbursement Committee formulated a negative reimbursement recommendation49 Financially based: Price-volume agreements – “Provision Fund” established – Advances paid by manufacturers are used to cover 75% of overrun41	Creation of Special Solidarity Fund – Grants, on an individual basis, reimbursement of pharmaceuticals for rare diseases or rare indications unavailable in Belgium – Only granted if patient meets certain criteria and has exhausted all other treatment options – Must be prescribed by relevant specialist – Reimbursement decisions made by College of Medical Doctors Directors62
Czech Republic	State Institute for Drug Control (decisions)65	Yes – for “highly innovative” pharmaceuticals without evidence of effectiveness and “efficiency” Granted provisional reimbursement for 1 year, after which pharmaceutical is reassessed65	Manufacturer may request a surcharge of up to 30% over the basic reimbursement level if evidence suggests pharmaceutical demonstrates “superior” therapeutic benefits66	No information found	No information found	No information found
Denmark	Danish Medicines Agency (decisions)68,69,121 Reimbursement Committee (recommendations)68,121	Pharmaceuticals reassessed as part of therapeutic class reviews every 5 years Pharmaceutical may be scheduled for a separate reassessment when initial reimbursement decision is made if Reimbursement Committee considers it necessary to collect additional information about the use of the pharmaceutical in clinical practice before making a definitive decision50	No information found	No information found	Clinically based: Example: “No cure no pay” scheme for valsartan for high blood pressure Individual level schemes – Patient may apply for reimbursement on an individual basis, which requires evidence of treatment effect for continued reimbursement46 – Typically for patients who have exhausted all other options – Period of reimbursement varies68	No information found
Estonia	Ministry of Social Affairs (decisions)72 Pharmaceuticals Committee (recommendations)72	No information found	No information found	No information found	Financially based: For all new pharmaceuticals – price-volume agreements mandatory for 1 year following reimbursement decision41	No information found
Finland	Pharmaceuticals Pricing Board (decisions)73,74,76 Pharmaceuticals Pricing Board Expert Group (recommendations)75	Yes – for all pharmaceuticals Automatic reassessment every 3 to 5 years after inclusion on benefit list182,203	No information found	No information found	No information found	No information found
France	Ministry for Health and Social Security (decisions)20,78 French National Authority for Health (recommendations)78	For pharmaceuticals Yes – for all pharmaceuticals Automatic reassessment every 5 years after inclusion on benefit list20 For medical devices Yes – for devices Automatic reassessment within 5 years of inclusion on benefit list20,162	No information found	May provide provisional coverage for a set period during which “real-world” effectiveness and/or economic implications must be assessed through a study: – To be carried out: By skilled teams in a limited number of selected centers Under well-defined conditions of use Using a protocol approved by French National Authority for Health Transparency Committee Applies to pharmaceuticals that: Target a large population; May be prescribed outside their labeled indications; or May have a significant impact on health care organizations16,20 Also applies to medical devices – French National Authority for Health specifies study protocoll20	For pharmaceuticals Financially based: Price-volume agreements – Manufacturer must “pay back” the cost of sales exceeding those forecasted for the first 4 years 23,43 – Pharmaceuticals exempt from such schemes for various periods depending on their “improvement in medical benefit” (ie, improvement in medical benefit) level: “improvement in medical benefit” I – 36 months; “improvement in medical benefit” II – 24 months; “improvement in medical benefit” III – 24 months at 50%; and “improvement in medical benefit” IV – 24 months at 25% – Also applies to “orphan drugs” (eg, eculizumab for paroxysmal nocturnal hemoglobinuria and galsulfase for mucopolysaccharidosis type VI)41	For pharmaceuticals for serious or rare diseases May be granted temporary access in a hospital setting for 1 year162 For “innovative” medical devices May establish “innovation point of contact” and an internal multidisciplinary network162
Germany	Federal Joint Committee (decisions)19 Institute for Quality and Efficiency in Health Care (recommendations)19			For medical devices and procedures May provide provisional coverage for a set period during which “real-world” effectiveness and/or economic implications must be assessed through a study204	For pharmaceuticals Financially based: Price-volume agreements – “target agreements”: if prescription volume target is exceeded by 25%, manufacturers must “pay back” sickness funds (eg, insulin analogs, olanzapine, risperidone, clopidogrel, zolendronate, mycophenolic acid, everolimus, and cyclosporine)41	No reimbursement limit for potentially effective technologies used to manage life-threatening technologies for which there are no alternatives82
Greece	Transparency Committee in the Reimbursement and Medicinal Products (makes decisions)85	No information found	No information found	No information found	No information found	No information found
Hungary	Ministers of Health and Finance National Health Insurance Fund Administration (recommendations)88,89	No information found	No information found	No information found	Financially based: Price-volume agreements – 12% of reimbursed sales must be paid to the Ministry by the manufacturer – If Ministry spending on pharmaceutical exceeds agreed-to budget, the manufacturer must refund the Ministry an additional amount based on a predefined formula41	No information found
Ireland	Products Committee of Corporate Pharmaceuticals Unit of Health Service Executive (decisions)91,92	No information found	No information found	No information found	No information found	No information found
Italy	Italian Medicines Agency Technical Scientific Committee (decisions)94 Italian Medicines Agency Pricing and Reimbursement Committee (recommendations)95	No automatic/routine reassessment, with the exception of pharmaceuticals reimbursed under condition that additional studies would be conducted25	No information found	For pharmaceuticals classified as “potentially innovative” May require manufacturer to conduct additional studies within 3 years Pharmaceuticals for patients enrolled in the studies must be covered by the manufacturer25 Have established ongoing registries to monitor prescribing and assess “therapeutic value” in practice (real-world settings) in order to inform future management and reimbursed pricing decisions (eg, cetuximab, lenalidomide, ibritumomab, tiuxetan, palifermin, temporfin, and trastuzumab)41	Clinically based: Pharmaceutical initially reimbursed by National Health Service at 50% or 100% for a fixed number of treatment cycles, after which it is only reimbursed for patients achieving predefined clinical response; manufacturer may be required to refund the cost of pharmaceutical in non-responding patients (eg, sunitinib, sorafenib, dasatinib, and nilotinib) Registries used to track outcomes included in scheme47 Manufacturer initially provides pharmaceutical at no cost for a fixed period, after which National Health Service pays for pharmaceutical in patients achieving predefined clinical response (eg, donepezil)41 Financially based: Expenditure cap – Cost per patient per year cannot exceed a certain amount (eg, bevacizumab)41	Individual reimbursement – Patients may be granted individual reimbursement of pharmaceuticals not on the benefit list if: No alternative exists Requested pharmaceutical is available in other European Union states Clinical trials are underway Pharmaceutical is already reimbursed for a different indication96,205 Establishment of “innovative medicines fund” – Commits 20% of available resources to reimbursement of “innovative” pharmaceuticals, ranked from most to least innovative using the following criteria: Treats serious conditions that are lifethreatening or cause hospitalization or permanent disability Used for risk factors for serious conditions Used for nonserious conditions25,188 – If fund is overspent, manufacturers participate in refunding the system proportional to market share95
Norway	Norwegian Medicines Agency (recommendations/decisions)34,98 Ministry of Health and Care Services (recommendations/decisions) Department of Pharmacoeconomics (recommendations)98	Pharmaceuticals may be reassessed as part of ongoing therapeutic class reviews34	No information found	No information found	No information found	Individual reimbursement – For patients who have exhausted all reimbursed alternatives and/or have serious or rare conditions – May be requested by specialists only – Reimbursement decision made by Norwegian Labour and Welfare Organization – Pharmaceutical does not need to have obtained market approval34
Poland	Ministry of Health (decisions)99 Drug Management Team (recommendations)99	No information found	No information found	No information found	No information found	No information found
Portugal	Ministry of Health (decisions) INFARMED (recommendations)44,101	No information found	No information found	No information found	Financially based: Price-volume agreements – Growth rate in pharmaceutical expenditures fixed per year; if exceeded, manufacturers must refund the system up to 69.6% of the coverage up to a predetermined amount, eg, €35 million (2006)44	No information found
Scotland	National Health Service Scotland (decisions)30 Scottish Medicines Consortium (recommendations)	Yes – for all pharmaceuticals Automatic reassessment, but review period varies with the pharmaceutical; depends upon when additional evidence is expected to be available128	No information found	No information found	No information found	No information found
Slovakia	Ministry of Health (decisions) Reimbursement Committee for Medicinal Products (recommendations)105,106	No information found	No information found	No information found	No information found	No information found
Spain	Ministry of Health Directorate General of Pharmacy and Health Products; Inter-Ministerial Pricing Commission (decisions)21,108	No information found	No information found	No information found	No information found	No information found
Sweden	Dental and Pharmaceutical Benefits Board Expert Board (decisions)15,206–209	Yes – for all pharmaceuticals Automatic reassessment, but review period varies with the pharmaceutical; depends upon when additional evidence is expected to be available51,135 Pharmaceuticals may also be reassessed as part of ongoing therapeutic class reviews51,135	Reimbursement price may be adjusted to reflect actual costs and benefits once such information becomes available (eg, continuous intraduodenal infusion of levodopa/carbidopa for advanced Parkinson’s disease)209	May require submission of evidence from studies collecting “real-world” data on clinical, economic, and quality of life outcomes205,209	No information found	No information found
Switzerland	Swiss Federal Office of Public Health (decisions) Federal Drug Commission (recommendations)113,114	No information found	“Innovation premium” – Granted to innovative pharmaceuticals (ie, therapeutic breakthrough products) – Surcharge of ≤20% of external reference price is added for a maximum of 15 years113,114,205	No information found	No information found	No information found
The Netherlands	Ministry of Health, Welfare and Sport (decisions) Dutch Healthcare Insurance Board Committee of the Dutch Healthcare Insurance Board (recommendations)31	Yes – for all pharmaceuticals Automatic reassessment – time period not specified31,210,211	No information found	New inpatient pharmaceuticals with projected costs >5% of hospital budget Granted provisional reimbursement for 3 years, during which studies collecting “real-world” data on cost-effectiveness must be conducted119 High-cost pharmaceuticals for rare conditions Granted provisional reimbursement for use in an academic hospital for 4 years, during which manufacturer must sponsor studies collecting “real-world” data on cost effectiveness and budget impact119	No information found	No information found
United Kingdom	National Institute for Health and Clinical Excellence (decisions) Technology Appraisals Committee (recommendations)7	Yes – for all technologies Automatic reassessment, but review period varies with the pharmaceutical; depends upon when additional evidence is expected to be available13,29,157	Proposed “flexible pricing” scheme: – Manufacturers can adjust the price of a pharmaceutical in response to emerging additional evidence on actual benefit or approval of a new indication which alters the value that the pharmaceutical offers to patients – National Institute for Health and Clinical Excellence assesses whether new price and evidence represents “value for money” and may veto a new price on an existing indication45,48	“Innovation pass” – Selected “innovative” technologies are made available for 3 years, during which studies to collect data needed to inform standard National Institute for Health and Clinical Excellence processes are conducted48	For pharmaceuticals “Patient access schemes”42 Financially based: Manufacturer proposes discounts or rebates to reduce the cost of a pharmaceutical to the National Health Service, thus improving its cost-effectiveness – Manufacturer must obtain approval for such a scheme from the Department of Health prior to National Institute for Health and Clinical Excellence review29,212–214 Expenditure cap – Cost per patient per year cannot exceed a certain amount (eg, ustekinumab and erlotinib)45 Clinically based: Manufacturer covers the cost of initial fixed number of cycle(s) of treatment, after which National Health Service pays for patients achieving predefined clinical response (eg, sunitinib)45 National Health Service covers the cost of initial fixed number of cycles of treatment, after which manufacturer refunds the cost of treatment in patients failing to achieve predefined clinical response (eg, bortezomib)40 National Health Service covers the cost of the pharmaceutical for a fixed period, after which the price is reduced or refunds are issued to achieve predefined ICER (eg, interferon β, glatiramer acetate, and azathioprine)45	End-of-life medicines guidance – Pharmaceuticals used to extend life by at least 3 months for patients with less than 24 months to live may be reimbursed, even if ICER exceeds threshold range37–48 Pharmaceuticals for rare conditions guidance – May be reimbursed when ICER exceeds threshold range if: – Target conditions in which incidence <7000 patients/year in the UK – There is sufficient evidence demonstrating that pharmaceutical offers substantial average increase in life expectancy over alternatives205
Wales	Ministry for Health and Social Services (decisions) All Wales Medicines Strategy Group New Medicines Group (recommendations)120	Yes – for all pharmaceuticals Automatic reassessment, but review period varies with the pharmaceutical; depends upon when additional evidence is expected to be available174	No information found	No information found	No information found	No information found