Pricing and Reimbursement

Arnold & Porter’s Future Pharma Forum invites you to a complimentary regulatory seminar aimed at junior lawyers and new joiners in the UK/EU life sciences industry. We will provide a comprehensive introduction to key EU regulatory law topics from an in-house practitioner’s perspective and touch on the implications of Brexit.

Topics

  • Overview of the EU pharmaceutical law framework
  • Clinical trials, unlicensed supply and compassionate use
  • Obtaining marketing authorisations
  • Incentives: regulatory data protection, marketing protection, orphan market exclusivity and paediatric rewards
  • Pharmacovigilance
  • Advertising and promotion of medicinal products
  • Pricing and reimbursement in the UK
  • Supply chains

Who is it relevant for?

The Future Pharma Forum is a group established to provide training and networking opportunities for junior and mid-level lawyers in the life sciences industry. We conduct seminars and events aimed at junior and mid-level lawyers up to around 8 years PQE. There are no formal entry or membership requirements— please feel free to pass this to colleagues who might be interested in attending.

More information is on the website, and you can sign up here.

The case arose from the reimbursement by the Italian authorities of medicinal products used for an indication for which they are not authorised, in circumstances where there is an alternative authorised product available. Italian law permits the reimbursement of such products “provided that the [unlicensed] indication is known and is in line with research conducted by the national and international medical-scientific community on the basis of economic and suitability considerations”. In these cases the Italian Medicines Agency (AIFA) puts in place monitoring arrangements intended to protect patient safety.

Avastin® (bevacizumab), which is licensed for administration by intravenous infusion for various oncology indications, was added to the Italian reimbursement list in 2014, for intravitreal injection in the eye for the treatment of ophthalmology conditions, on the following conditions:

  • To ensure sterility, packaging of bevacizumab in single dose syringes must be carried out solely by hospital pharmacies satisfying defined requirements and following rules to ensure the doses are properly prepared.
  • The product can be administered only by highly specialised ophthalmological departments in designated public hospitals.
  • Administration may take place only once the patient has signed an informed consent, including the scientific reasons, accompanied by adequate information about the existence of approved alternative therapies at higher cost to the Italian health service.
  • A monitoring record must be created with an adverse reactions declaration form.

Novartis Farma challenged the inclusion of Avastin® in the reimbursement list on the basis that this was incompatible with EU pharmaceutical law. In particular: (i) the general use of medicinal products “off-label”, for financial reasons, in circumstances where the suitability of the licensed product for such use has not been tested, breaches the mandatory character of a marketing authorisation (MA) under Art 6 of Directive 2001/83/EC and is incompatible with Directive 89/105/EEC (the Transparency Directive); (ii) by allowing AIFA to establish monitoring mechanisms to safeguard patient safety, Italian law permits AIFA to encroach on the role of the EMA as established by Regulation No 726/2004; and, (iii) the repackaging of Avastin® does not comply with the conditions required for the exemption under Art 3.1 of Directive 2001/83/EC to apply.

The Italian Court referred four questions to the CJEU.

Continue Reading Novartis Farma SpA v AIFA

The UK Government (Department of Health and Social Care, DHSC) and the ABPI have announced today that they have agreed the Heads of Agreement for what will now be called a Voluntary Scheme for Branded Medicines Pricing and Access, expected to become effective from 1st January 2019 following the end of the current 2014 Pharmaceutical Pricing Regulation Scheme (PPRS”).

The details of the new Voluntary Scheme are still being finalised and, if agreed in full, will be published in December, at around the same time as publication of the new Statutory Scheme is expected to take place. Companies will then be asked to decide whether to agree to participate in the Voluntary Scheme or be subject to the Statutory Scheme.

The new Voluntary Scheme, which has been described as “a good deal for patients, the NHS and the UK life science industry” by the Health Secretary, Matt Hancock, provides a guarantee that growth of the NHS branded medicines bill will not exceed 2% per year for the next 5 years, delivering expected savings of around £930 million to the NHS in 2019. In assessing growth sales by Voluntary Scheme members, Statutory Scheme companies and parallel import sales will be taken into account. As under the 2014 PPRS, the new Scheme will require industry to make rebate payments in respect of expenditure by the NHS that exceeds the permitted growth. Other important aspects are said to be:

Continue Reading The UK 2019 Voluntary Scheme