Kidney Cancer Scotland – Enhancing access to new medicines

Kidney Cancer Scotland was invited to work with and provide evidence both orally and written to The Health and Sports Committee to help determine the best way forward for patients with rarer conditions to gain access to new medicines that will have major impacts on their medical condition. The charity will continue to work with the committee to ensure that the best outcomes are achieved for kidney cancer patients in Scotland.
Key points are as follows:
Scottish Medical Council Review
SMC has defined an end of life medicine as a medicine used to treat a condition at a stage that usually leads to death within three years with currently available treatments. SMC has defined an orphan medicine as a medicine used to treat a condition affecting fewer than five in 10,000 people (or around 2,500 people in Scotland). SMC has defined an ultra-orphan medicine as a medicine used to treat a condition with a prevalence of one in 50,000 or less (or around 100 people in Scotland). The definitions in the SMC report are broader than those used by National Institute for Health Care Excellence/ European Medicines Agency.
SMC will have input from a patient and clinician engagement (PACE) group panel and will use existing modifiers to allow increased access.
Pharmaceutical companies will also have an additional opportunity in the new process to put forward a Patient Access Scheme (SMC pause)
SMC should engage with Health Boards and Area Drug and Therapeutic Committee’s to determine which medicines should have priority on resubmission according to patient needs.
The new process will apply from April/May 2014
The new system will be reviewed after one year to measure how effective the new system is in delivering new medicines to patients.
PACS – Peer Approved Clinical System
The new Peer Approved Clinical System (PACS) process will replace IPTRs from May 2014, detailed guidance was not yet announced
Rarer Conditions Medicine Fund
The RCMF will support applications through IPTRs and via PACS from May 2014.
 
This is very positive news in terms of increasing access and patient group involvement. Scottish Government Announcement can be found here.