Recommendation 5

HM Government Accepted in Part

47. The government accepts this recommendation in part. 48. As set out in the response to recommendation 4, we are committed to reducing prescription charges for HRT. The implementation of the bespoke HRT PPC will reduce annual prescription charges for HRT to the equivalent of two single prescription charges, which is currently £18.70. This will significantly reduce the cost for most, if not all, women who pay for prescriptions. The government has no plans to implement any additional approaches to further reducing HRT prescription charges. 49. Regarding formularies, under the NHS Constitution, patients in England have a right to medicines and treatments that have been recommended by NICE for use in the NHS, if a prescriber discusses treatment options with the patient and says they are clinically appropriate for them. There are also arrangements in place for additional, local decision making in the absence of a relevant NICE recommendation. 50. Prescribers in primary care are already able to prescribe from all licensed products using the British National Formulary (BNF). Prescribers can, and should, prescribe the medicine or appliance that is the most appropriate treatment option for the patient, using their clinical discretion and after a shared discussion with the patient taking into account the patient’s values and preferences. Therefore, a national formulary specifically for HRT is not required. 51. Local formularies for HRT are in place in some, but not all, areas as part of locally tailored support for prescribing. With the establishment of Integrated Care Systems, the governance and processes for developing, reviewing and updating formularies is likely to change. NHS England is undertaking work to gather data about the status of and processes associated with maintaining and updating local formularies in England. The data gathered will be considered as part of the national transforming and integrating medicines optimisation programme to determine next steps and actions. 52. Regarding HRT supply, there are over 70 HRT products available in the UK and most remain in good supply. A range of factors including an increase in demand has led to supply issues with a limited number of products. 53. The HRT supply position has improved significantly in recent months. Actions taken and impacts include: i. Access to in-demand products has improved since we issued Serious Shortage Protocols (SSPs) on HRT products to limit dispensing to three months’ supply to even out distribution and allow specified alternative products to be supplied, as necessary. ii. Some HRT products have also been added to the list of products that cannot be exported or hoarded in the UK, including estradiol, estradiol/ levonorgestrel, estriol and conjugated oestrogens/ medroxyprogesterone acetate. Suppliers have taken swift action to secure additional stock of HRT products which are experiencing supply issues and deliveries of further stock have been expedited. These actions have increased near-term supply and we are encouraged by suppliers’ plans to further build capacity to support continued growth in demand, such as the announcement of a new production line for Oestrogel and plans from other companies to introduce new products to the UK. iii. We have held roundtables with suppliers, wholesalers and community pharmacists to discuss the challenges they are facing, what they are doing and what needs to be done to address them. iv. We share regular communications about shortages and discontinuations with the NHS and have issued several communications about HRT supply issues to date. v. We update supply information about all HRT products, including those currently affected by supply issues, on the Specialist Pharmacy Services Medicine Supply Tool for NHS staff—including GPs—to access. 54. The HRT Supply Taskforce was a time-limited intervention which has now ended. We announced on 30 August that Madeleine McTernan was returning to her role as head of the Vaccines Taskforce, ahead of the autumn booster campaign. 55. The HRT Supply Taskforce made a series of recommendations which the Government has accepted and is taking forward. These recommendations included: vi. Continued dialogue with industry via regular industry roundtables and individual engagement. vii. Continued use of Serious Shortage Protocols when appropriate to manage shortages as steps are taken by suppliers to increase production. viii. Continued assessment of whether NHS formularies may be impacting access to HRT. ix. Improved access to data on prescriptions to more easily see where there are shortfalls between HRT packs prescribed and HRT packs supplied by manufacturers. x. Taking lessons from the HRT supply chain work to inform broader medicine supply work. 56. The government will next provide an update to the Committee on HRT supply following the next industry roundtable, expected to take place in February 2023.