The costs of branded pharmaceuticals are regulated by a voluntary scheme, the Association of the British Pharmaceutical Industry’s (ABPI) Pharmaceutical Price Regulation Scheme (PPRS), and a statutory scheme for companies that decide not to join the voluntary scheme. The outcomes of this year’s consultations on updates to the voluntary scheme are reviewed in a prior MAP news article here.
The statutory scheme is covered by the Branded Health Service Medicines (Costs) Regulations 2018 (“the 2018 Regulations”). In August 2018 the Government consulted on changes to the statutory scheme, which operates under the Branded Health Service Medicines (Costs) Regulations 2018 (“the 2018 Regulations”), and in October accepted external consultation on the proposed changes. The Government has now published its response document to this.
The document includes responses to criticisms made of the proposals made in the consultation, stating that claims the scheme would limit research and development due to a lack of funding are unsubstantiated as the proposals are in line with the growth rate in the 2014 PPRS and companies can instead use existing mechanisms, such as the the maximum price increase mechanism, to increase prices if the costs are not viable.
Confirmation is given that the overall allowed growth rate for medicines will be set at 1.1%, all biosimilars are planned to be included in the scheme and an annual review of the scheme will take place, the first of which will no later than April 2019 to assess whether the scheme is delivering the Government’s objectives.
The rebate companies under the Statutory Scheme will make to the Government under the new regulations will be payment percentages of 9.9%, 14.7% and 20.5% in 2019, 2020 and 2021 respectively.