TABLE 5.
Policy measures related to the use of (biosimilar) adalimumab.
| Country | Strategies | Aids to implementation | Outcomes | |
|---|---|---|---|---|
| Specific measures | Demand-side policies | |||
| Austria | — | Recommendations (insurance funds) | • Targeted information provided to prescribers | Competitive pricing keeps the market share of originator adalimumab high |
| • Recommendation to replace originator adalimumab with the more cost-effective biosimilars | ||||
| • Information on subsequent price reductions disseminated (including price comparisons and market dynamics) | ||||
| Belgium | • Annual targets (non-binding) • Financial incentive |
— | Depending on the annual target reached (5%, 10% or 20% of prescribed adalimumab and etanercept biosimilars), an amount of €750, €1,000 or €1,500 is paid | Minimal success (adalimumab biosimilars = 7.1% market share in June 2019) |
| Bulgaria | — | Internal referencing pricing | • Patient co-payments may influence physician’s decision to switch | May encourage more physicians to switch |
| Denmark | • Multi-winner tender | - Guidelines | • Therapeutic guidelines introduced (2–3 years before implementation in Nov 2018) | >90% of patients switched to biosimilar 3 weeks after implementation |
| • Statement to doctors to prescribe originator for no longer than 3 months (Aug 2018) | ||||
| • Alignment of stakeholders | Letter to patients to inform about switching (Sep 2018) | |||
| • Nurses present during implementation | ||||
| Estonia | — | Prescribing by INN (since July 2019) | Pharmacies dispense the least expensive product | — |
| Finland | — | Prescribing of least expensive product | • Physicians obliged to prescribe least expensive product | Minimal success |
| • Have to justify selection of more expensive alternative in medical records | ||||
| Germany | — | • Target agreements (government) | • Target agreements per region (government) | — |
| • Guidelines (government) | • Economic prescribing (government) | |||
| • Rebate controls (insurance companies) | • Rebate contracts with manufacturers (insurance companies) | |||
| Greece | — | Guidelines | Economic prescribing | Greece, however, did not have any adalimumab biosimilars on the market at the time of the study |
| Iceland | — | Guidelines | Use of adalimumab managed by one specific hospital (Landspitali University Hospital) following clinical guidelines for each indication | — |
| Ireland | — | Best value biological policy | Recommendation to use the best value biologicals | — |
| Italy | — | Guidelines/recommendations | Communication with physicians on purchasing and formulary decisions | — |
| Latvia | — | • Internal referencing pricing | • Incentive of patient co-payments almost disappeared due to discount on originator adalimumab that reduced co-payments | Co-payments on originator minimal – no economic incentive to switch |
| • Mandatory INN prescribing for new patients | ||||
| • INN prescribing | • INN prescribing also allowed for patients already being treated | |||
| Lithuania | — | Treatment guidelines | New patients prescribed the least expensive TNF-α inhibitor | — |
| Malta | — | • Tendering | Only one adalimumab product is procured by the national health services for the whole country (for the most recent cycle this was the biosimilar) | Takes advantage of competition |
| • Negotiation | ||||
| Norway | — | Tendering | Recommend the use of originator adalimumab after Humira® won the national tender | — |
| Romania | — | Biosimilar fully reimbursed | Patient co-payment for originator but not biosimilar. However, patient co-payment waiver possible for originator but have to re-apply every 3 months | — |
| Scotland | • Multi-stakeholder approach | — | • Etanercept case study made available to increase awareness | Very few patients have requested to stay on the originator |
| • Switching plans | • Additional staffing | |||
| • Patient training on new device | ||||
| • Sharing of statistics on biosimilar uptake | ||||
| • Treatment cost comparator shared with Health Boards | ||||
| Spain | — | • Target agreements for biosimilars | •Target agreements for all hospitals in Catalonia that are financed by the public health system | In December 2019, only 26% of patients on adalimumab are treated with a biosimilar |
| • Tendering | •Computer systems have been implemented by some regional health services in order to allow monitoring of the use of biosimilars in the hospitals | |||
| • Pharmacotherapeutic recommendations | ||||
| Sweden | — | Guidelines/recommendations | Communication with physicians on purchasing and formulary decisions | — |
| Netherlands | • Grants | — | Measures provided by insurance companies | Prevent originator monopoly and encourage competition |
| • Higher reimbursement | ||||
| England | Multi-winner tender | Commissioning framework for biological medicines (including biosimilar medicines) | Contracts with different size of each lot are awarded by NHS England | Competition stimulated |