UK Law and Practice Contributed by: Jackie Mulryne, Ewan Townsend, Adela Williams and Libby Amos-Stone, Arnold & Porter
amendments to the Statutory Scheme to bring it in line with changes in the Voluntary Scheme, including harmonising certain exemptions from the requirement to make Statutory Scheme pay- ments, with those applicable in the Voluntary Scheme. Prices may also be limited as a result of com- petition, including through tenders. In primary care, the price of some medicinal products may be indirectly controlled by the reimbursement price, as set out in the Drug Tariff (a monthly publication specifying the amounts to be paid to contractors for providing relevant goods and services). These prices are calculated based on sales information provided by pharmacies, manufacturers and wholesalers. Where the Drug Tariff does not list a reimbursement price for a medicine, or where a product is prescribed by brand name, it will be reimbursed at the manu - facturer’s NHS list price. Medical devices will only be routinely dispensed in primary care through the NHS if they are included in the Drug Tariff. The DHSC/NHS Busi- ness Services Authority (NHSBSA) agrees the reimbursement price of the medical device with the manufacturer at launch, and this is princi- pally determined by comparing the device with similar products on the market and their respec- tive prices. If there are no comparable devices or if the applicant submits evidence to support a different price, the reimbursement price is deter- mined by negotiation between the parties. 8.2 Price Levels of Pharmaceuticals or Medical Devices There is no formal system of international refer- ence pricing, although the cost of the presen- tation in other markets is specifically listed as a relevant criterion to which the DHSC should
have regard when agreeing or directing a price under the VPAG or the Statutory Scheme. 8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds All authorised medicines validly prescribed on an NHS prescription may in principle be reimbursed from public funds, unless expressly excluded. In primary care, patients receive medicines pre- scribed by their GPs from community pharma- cies. Patients in England must pay a fixed price for NHS prescriptions, unless exempt. Prescrip- tion charges have been abolished in Northern Ireland, Scotland and Wales. Medicinal products used in NHS hospitals are funded by commissioners in accordance with the “national tariff” , a set of prices for defined proce- dures and items of care (currencies) established under the Health and Social Care Act 2012. Hospitals are paid for procedures performed or care provided (including the costs of associated medicines and devices), based on amounts fixed in the national tariff. Certain new and high-cost medicines and medical devices are reimbursed outside the tariff system, and enhanced pay- ments may be made for some patients. In England, most new medicines (and new indi- cations for existing products) undergo health technology appraisal by the National Institute for Health and Care Excellence (NICE), which issues recommendations on NHS use based on its assessment of clinical effectiveness and cost effectiveness. NHS bodies in England are required by regulations to make funding avail- able so that patients can access treatments recommended by NICE. NICE assesses some medical devices and diagnostic tests through parallel procedures.
372 CHAMBERS.COM
Powered by FlippingBook