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EDITOR-
There has been a lot of confusion in the medical press about the use of above two drugs in wet AMD. Both drugs i.e. Avastin (bevacizumab) and Lucentis (ranibizumab) are licensed in clinical practice and both are equally effective in wet AMD. Both of them inhibit the vascular endothelial growth factor and thereby improve the condition.
Avastin is not licensed in wet AMD. It is licensed for use in metastatic colorectal cancer, metastatic breast cancer, metastatic renal cell carcinoma, un-resectable advanced small cell lung cancer, mainly used as combination therapy. Avastin is also licensed for use in ovarian and peritoneal cancers. It is administered as intravenous infusion. The cost of Avasin is £924.40 for 400mg. 1.2mg which is normally given in wet AMD costs about £2.77.
Lucentis is licensed in wet AMD, macular oedema and choroidal neovascularisation. This is administered by intravitreal injection. The dose is single injection of 500 micrograms monthly . 230 mcg is available commercially costing £742.17. Therefore a single injection of 500mcg will cost around £1500.00
However there is discount to the NHS Hospitals for bulk buying which could be 50% cheaper for both drugs. Whatever the cost of purchase the fact is that Avastin is 500times cheaper than Lucentis
Because of the huge difference in the cost, Avastin is currently used as off label in wet AMD. Is it legally and ethically right? Use of Avastin is both legally and ethicaly wrong. A doctor can be reported to the GMC .
The current law is if a doctor can justify its (Avastin) off label use before a Court of Law then it is lawful. Both GMC and Courts will not take any action. The current advice from the GMC1 is that if a drug is not licensed but effective in a condition that drug can be given in the best interest of the patient provided there is no licensed alternative. Usual practice is, the doctor explains the situation to the patient and patient should sign to give consent for the unlicensed but effective drug licensed for other conditions. The situation here is that there is an alternative drug i.e. Lucentis which is licensed.. The doctor can not justify in this situation before the court that his/her actions are legally right. Therefore a government minister has ruled that Avastin’s use in wet AMD is unlawful.2 He is right but David Lock QC gave the advice to BMJ that if a drug is licensed in one condition, can be used in other conditions.2 This sends a very wrong message to the doctors in the UK. He argues that use of a drug is up to CCGs but not up to ministers or civil servants. Although it is generally acceptable but use of an unlicensed drug is not only dangerous but also unethical t. The proper route is for the manufacturer to get the licence for Avastin for use in wet AMD.
The situation is very clear. There is no need to wait for the British court ruling. European Court of Justice (ECJ) found against Poland, it was importing unlicensed drug Avastin on economic grounds when a licensed alternative was available ( European Commission v Republic of Poland, C-185/10 in 2012)
Reference
1.The GMC’s stance on Avastin BMJ 2015;350 (April 25):22
2.The BMJ: Minister rules out use of Avastin for wet AMD 2015:350 (April 25): 25
Competing interest: None
Professor K C Mohanty MD FRCP LLB LLM Dip HCE (Ethics)
Consultant Physician & Permanent Member of Employment Appeal Tribunal (High Court of Justice) London
email. kmohanty@me.com
Competing interests:
No competing interests
01 June 2015
KAILASH C MOHANTY
Professor
BOLTON UNIVERSITY
Centre for Research in to Health & Wellbeing, Deane Road, Bolton BL3 5AB
Avastin versus Lucentis for wet AMD
Avastin versus Lucentis for wet AMD
EDITOR-
There has been a lot of confusion in the medical press about the use of above two drugs in wet AMD. Both drugs i.e. Avastin (bevacizumab) and Lucentis (ranibizumab) are licensed in clinical practice and both are equally effective in wet AMD. Both of them inhibit the vascular endothelial growth factor and thereby improve the condition.
Avastin is not licensed in wet AMD. It is licensed for use in metastatic colorectal cancer, metastatic breast cancer, metastatic renal cell carcinoma, un-resectable advanced small cell lung cancer, mainly used as combination therapy. Avastin is also licensed for use in ovarian and peritoneal cancers. It is administered as intravenous infusion. The cost of Avasin is £924.40 for 400mg. 1.2mg which is normally given in wet AMD costs about £2.77.
Lucentis is licensed in wet AMD, macular oedema and choroidal neovascularisation. This is administered by intravitreal injection. The dose is single injection of 500 micrograms monthly . 230 mcg is available commercially costing £742.17. Therefore a single injection of 500mcg will cost around £1500.00
However there is discount to the NHS Hospitals for bulk buying which could be 50% cheaper for both drugs. Whatever the cost of purchase the fact is that Avastin is 500times cheaper than Lucentis
Because of the huge difference in the cost, Avastin is currently used as off label in wet AMD. Is it legally and ethically right? Use of Avastin is both legally and ethicaly wrong. A doctor can be reported to the GMC .
The current law is if a doctor can justify its (Avastin) off label use before a Court of Law then it is lawful. Both GMC and Courts will not take any action. The current advice from the GMC1 is that if a drug is not licensed but effective in a condition that drug can be given in the best interest of the patient provided there is no licensed alternative. Usual practice is, the doctor explains the situation to the patient and patient should sign to give consent for the unlicensed but effective drug licensed for other conditions. The situation here is that there is an alternative drug i.e. Lucentis which is licensed.. The doctor can not justify in this situation before the court that his/her actions are legally right. Therefore a government minister has ruled that Avastin’s use in wet AMD is unlawful.2 He is right but David Lock QC gave the advice to BMJ that if a drug is licensed in one condition, can be used in other conditions.2 This sends a very wrong message to the doctors in the UK. He argues that use of a drug is up to CCGs but not up to ministers or civil servants. Although it is generally acceptable but use of an unlicensed drug is not only dangerous but also unethical t. The proper route is for the manufacturer to get the licence for Avastin for use in wet AMD.
The situation is very clear. There is no need to wait for the British court ruling. European Court of Justice (ECJ) found against Poland, it was importing unlicensed drug Avastin on economic grounds when a licensed alternative was available ( European Commission v Republic of Poland, C-185/10 in 2012)
Reference
1.The GMC’s stance on Avastin BMJ 2015;350 (April 25):22
2.The BMJ: Minister rules out use of Avastin for wet AMD 2015:350 (April 25): 25
Competing interest: None
Professor K C Mohanty MD FRCP LLB LLM Dip HCE (Ethics)
Consultant Physician & Permanent Member of Employment Appeal Tribunal (High Court of Justice) London
email. kmohanty@me.com
Competing interests: No competing interests