Request
In December 2021 Paxlovid, a drug developed by Pfizer, was approved in the United Kingdom. Please could you answer the following questions:
1. Were clinical trials carried out in the UK prior to it's approval? And if so, what?
2. How many times has this drug been prescribed by NHS GPs & Hospitals in the United Kingdom?
3. What is the typical course prescribed - i.e. quantity of tablets, frequency and days
4. What is the cost to the NHS of each box/course prescribed to a patient?
5. How many adverse reactions have been reported via the Yellow Card Scheme for this drug?
Response
Question 1
I am writing to advise you that following a search of our paper and electronic records, I have established that the information you requested is not held by the NHS Business Services Authority.
Having reviewed your request, I believe that it is possible that the Health Research Authority may hold some or all of the information you require. They can be contacted at:
Health Research Authority
2 Redman Place
Stratford
London
E20 1JQ
Email: FOI@hra.nhs.uk
Question 3
I am writing to advise you that following a search of our paper and electronic records, I have established that the information you requested is not held by the NHS Business Services Authority. Other than the quantity, we do not hold the dosage or number of days treatment for drugs.
Question 5
I am writing to advise you that following a search of our paper and electronic records, I have established that the information you requested is not held by the NHS Business Services Authority.
Having reviewed your request, I believe that it is possible that the Medicines and Healthcare products Regulatory Agency (MHRA) may hold some or all of the information you require. They can be contacted at:
MHRA Freedom of Information Team
10 South Colonnade
London
E14 4PU
United Kingdom
Email: foi.request@mhra.gov.uk
Online form: https://www.gov.uk/government/collections/mhra-freedom-of-information-foi-disclosure-log
Question 2 and 4
Under Section 21 of the FOIA we are not required to provide information in response to a request if it is already reasonably accessible to you.
Information with regards to Paxlovid is publicly available in the English Prescribing Dataset (EPD) and Hospital Prescribing Dispensed in the Community.
EPD
English prescribing data (EPD) | NHSBSA
https://www.nhsbsa.nhs.uk/prescription-data/prescribing-data/english-prescribing-data-epd
You will need to filter on the chemical substance Nirmatrelvir with Ritonavir (BNF code 0503060B0) as this drug can be prescribed generically.
The EPD does hold each quantity paid for each practice. As this drug is packaged as a special container of 30, all quantities are in multiples of 30. The drug is currently listed in the Drug Tariff, products under Part VIIIC(i) with a basic price 250(p) for each container of 30.
Drug-tariff - https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/drug-tariff
Hospital Prescribing Dispensed in the Community
https://opendata.nhsbsa.net/dataset/hospital-prescribing-dispensed-in-the-community
We only hold hospital prescribing dispensed in the community, not all hospital data.
Hospital prescribing dispensed in the community data
You will need to filter on the BNF name code generic Nirmatrelvir 150mg tablets and Ritonavir 100mg tablets (BNF code 0503060B0AAAAAA) and Paxlovid 150mg/100mg tablets (BNF code 0503060B0BBAAAA).
Both reports include Net Ingredient Cost (NIC) And Actual Cost.
There are Data Dictionaries under each dataset for more information.
We do not hold data for prescribing in all the UK, these datasets contain prescriptions issued in England that have been dispensed in England, and may include dispensing in Wales, Scotland, Guernsey, Alderney, Jersey, and the Isle of Man.