There are different drug licencing processes in Scotland and England and matters such as the access to drugs are within the responsibility of the Scottish Parliament and the Scottish Medicines Council (SMC).
While Kadclya was not approved by the SMC, the SNP Scottish Government have substantially increased access to new medicines, particularly for cancer, due to reforms and investment in recent years. They have introduced the New Medicines Fund, which provides financial support to NHS Boards for End of Life, Orphan and Ultra Orphan medicines which can be accessed by patients in a number of ways such as by Individual Patient Treatment Reviews (IPTR). IPTRs can be used by patients to gain access to a drug which has not been licensed by the SMC.
The New Medicines Fund is intended to ensure that availability of funding is not a barrier to implementation of policy to increase access to new medicines and in 2015/16 funding of £90 million was made available to Health Boards by the SNP Scottish Government that helped increase patient access to licensed orphan, ultra-orphan and end of life medicines.
As well as creating the New Medicines Fund, the SNP Scottish Government have just recently announced reforms to the access of new medicines after committing to take forward all 28 recommendations made in Dr Brian Montgomery’s review into how changes made to the Scottish Medicines Consortium (SMC) process in 2014 affected access to medicines for rare and end-of-life conditions. In addition to the review recommendations, the SNP’s Scottish Health Secretary, Shona Robison MSP, also announced changes to IPTRs to go beyond the recent reforms and improve consistency and to ensure patients in Scotland get access to the right treatment at the right time.
In October 2014, the SMC did not permit Kadclya for routine use in Scotland as they felt that treatment cost in relation to its health benefits was not sufficient. I understand that the manufacturer has resubmitted an application to the SMC and I sincerely hope that hope the manufacturer will set the drug at a fair price to allow it to be considered for approval for use in the NHS in Scotland, which would enable the drug to be routinely available on the NHS, and see people across Scotland have the opportunity to benefit from more treatment options that could give them precious extra time with their families.
Moreover, a number of bisphosphonate medicines are licensed and have been accepted for use in Scotland for the treatment of osteoporosis and also for the reduction of bone damage when cancer has already spread to the bone. At this time no bisphosphonate has a license to reduce the risk of breast cancer spreading to the bone, therefore the Scottish Medicines Consortium cannot consider whether to accept them for routine use in Scotland in this situation; however, where a medicine does not have a license for a specific condition NHS Boards in Scotland have guidance and procedures in place to manage off-label prescribing.