Jurisdiction(s):
United Kingdom

UK medicines and medical devices pricing, reimbursement and HTA reforms—horizon scanner and tracker (VPAG, Statutory Scheme, NICE thresholds, ILAP/IDAP)

Published by a LexisNexis Life Sciences expert

Practice notes

This Practice Note is designed and intended as a horizon-scanning tool to monitor the ongoing evolution of key UK regulatory and legal developments concerning the pricing and reimbursement of medicinal products and medical devices throughout the UK.

It outlines changes and initiatives linked to the UK health technology assessment (HTA) and evaluation process, which forms the basis for pricing and reimbursement decisions for innovative or novel healthcare technologies and treatments across the UK.

In particular, it charts key ongoing activity relating to:

Voluntary Scheme for branded medicines
Statutory Scheme for branded medicines
commercialisation and HTA reform
innovative health technologies—medicines and medical devices

For more detail on the operation of the present systems for pricing and reimbursement of medicinal products in the UK and EU, see Practice Note: Pharmaceutical pricing and reimbursement.

For a briefer introduction to the pricing and reimbursement stage of the commercialisation pathway, when developers seek to move treatments from the lab to patients, see Practice Note: An introduction to the regulation of medicinal products—Pricing and reimbursement and Commercialisation—overview, which can be visually supported by: Lifecycle of a pharmaceutical product—flowchart and Lifecycle of a medical device—flowchart.

Popular documents

Using the Judicial College Guidelines to assess general damages in personal injury claims

When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...

Tomlin orders in England and Wales: CPR guidance on drafting, confidentiality, approval, variation, enforcement, limitation, CCA issues, court-specific requirements, sample wording and precedents

This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...

Precedent: Deed of Surrender of Lease with Optional Premium, Settlement and Release, Landlord, Mortgagee and Guarantor Consents, Reimbursement and HM Land Registry Provisions (England and Wales)

Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...

Precedent Statutory Declaration: Standard Wording under the Statutory Declarations Act 1835

I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...