SCOTTISH HOSPITAL NEWS
PATIENTS WITH ADVANCED SKIN CANCER DENIED DRUG
Bristol-Myers Squibb has announced that the Scottish Medicines Consortium (SMC) has issued guidance which does not recommend the use of Opdivo®q (nivolumab) as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults.
The decision will leave Scottish patients with advanced skin cancer without access to this potentially life-extending medicine. In contrast, the National Institute for Health and Care Excellence (NICE) recently approved the NHS use of nivolumab for patients in England and Wales. Melanoma is a growing health burden in Scotland with incidence having risen by 30% over the last decade - more than any other common cancer.
“Advanced melanoma is a serious disease, which frequently results in short survival. Prompt access to innovative treatments developed in the past few years is vital. Immunotherapies such as nivolumab have been shown to improve significantly survival in metastatic melanoma and also are generally well tolerated, so the decision to withhold funding is disappointing”, says Dr Marianne Nicolson, Consultant Medical Oncologist.
In Scotland, there were around 1,200 people diagnosed with skin cancer in 2013, and around 200 people died from the disease. Nivolumab is in a new class of medicines (PD-1 immune checkpoint inhibitors), with an innovative mode of action that works by harnessing the ability of the immune system to fight advanced skin cancer.
Through a range of clinical studies, nivolumab has been shown to significantly improve outcomes in advanced melanoma compared to chemotherapy, regardless of whether a patient has received prior treatment or not. Phase III study results have included those from the CheckMate -066 study, assessing patients without BRAF mutation who had not received prior therapy.
In this study, 72.9% of patients on nivolumab were still alive at one year (n=210 95% CI, 65.5- 78.9), compared with 42.1% of those treated with chemotherapy, dacarbazine (n=208 95% CI: 33.0-50.9).
Calls for harmonised definition of medicines shortage
The European Medicines Agency (EMA) has called for the establishment of a harmonised definition of a medicine shortage after hosting a meeting of national regulatory authorities, the pharmaceutical industry, and other stakeholders such as EAHP, to discuss the development of proactive approaches to preventing shortages in supply.
The formal report of the October 2015 meeting has now been published and provides insights to current intended direction of medicines agencies in Europe towards the shortages issue.
As preparation for the meeting a survey was conducted which revealed that most Member States do not have a definition for a shortage (18 out of 28 responses). The lack of a common definition was highlighted several times during the workshop as an obstacle for a common approach in dealing with shortages. The report of the meeting notes: “This lack of clarity about what a shortage is means that the conditions for reporting shortages differ from one country to another which makes benchmarking and
comparisons very difficult.”
The report of the survey revealed 86% of hospital pharmacists report that medicines shortages are a current problem in the hospital they work in, with 66% stating that shortages are affecting their hospital on a daily or weekly basis.
Reported impacts for patients included delayed or interrupted chemotherapy treatment, additional side effects, heightened Clostridium difficile risk and deterioration in their condition. EAHP emphasised the need for greater international co- ordination of efforts to combat what is clearly a global problem.
Recommendations from the workshop
The recorded recommendations from the workshop are: • the need for a harmonized definition of a medicines shortage;
• the requirement to identify at what point a manufacturing or quality issue becomes likely to lead to a meaningful disruption as well as when it should trigger a report to authorities;
• national regulators should agree
on common trigger points for notification as well as harmonised data requirements across the EU; • a European shortages
communication network, similar to a rapid alert network, should be constructed; and,
• the pharmaceutical industry should consider the value of stress tests to evaluate effectiveness of measures in place to prevent shortages.
Commenting on the published report of the meeting, EAHP Board Member Aida Batista, who is the Board lead on medicines shortages, said, “The headline recommendation of this meeting on the need for a harmonized definition on medicines shortages is absolutely right. However it is imperative that that definition is not of a highly restrictive nature. For example, some at the meeting advocated only defining a medicines shortage if it could be categorized as providing a “high risk”. This will not do. Every medicines shortage causes problems for patients and healthcare professionals, with risks of error contained from substitution to alternatives. This problem must be dealt with holistically and in totality.”
Health boards’ £500 million uplift distributed.
The allocation of more than £500 million additional funding for Scotland’s health boards has been announced by Health Secretary Shona Robison, taking health spending in 2016-17 to a record level of almost £13 billion.
Territorial health boards will receive a 5.5% resource increase over 2015-16 budget levels, which will enable investment of an additional £250 million to support the integration of health and social care and build the capacity of community-based services.
The funding for the integration of health and social care will be split
between the new partnerships, which from April will bring together health board and local authority responsibilities by integrating health and social care services across Scotland.
Capital investment will increase by £292 million to £495 million. This will support the new Edinburgh Royal Hospital for Sick Children, Dumfries & Galloway Royal Infirmary, National Blood Transfusion Centre, and the replacement Balfour Hospital in Orkney.
It will also allow work to begin on the new network of diagnostic and
elective treatment centres, so that people can be treated more quickly for planned surgery and to help the NHS meet increasing demand from a growing elderly population.
Health Secretary Shona Robison said, “This funding will allow people to be supported to maintain their independence for as long as possible, in their own homes and communities and mean that fewer people need to go to hospital to receive care. Where hospital care is necessary and appropriate, they will spend less time there and return home more quickly.”
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