Abiraterone rejection in Scotland must be overturned, Prostate Cancer advocate says

Advocating for advanced prostate cancer patients in Scotland, Alister Walker, Chairman and volunteer in Perth & Kinross Prostate Cancer Support Group, writes in the Scottish newspaper The Herald:

"Last week we read the good news that Moderator-Designate of the General Assembly of the Church of Scotland, the Reverend Dr Angus Morrison, has overcome the disease (Church leader in cancer warning , The Herald, April 23). With prostate cancer so often being symptomless in its early stages he is right to urge other men to consider speaking to their GP about the disease. This is particularly important for men aged over 50, black men and men whose father or brother has had the disease - who are at a higher risk.

Prostate Cancer in the UK kills 1000 men a year.
Prostate Cancer kills 10,00 men a year in the UK.

"Less encouraging is the news, also rightly highlighted in The Herald, that men with an incurable form of the disease are to be denied access to the life-prolonging and life-enhancing drug abiraterone before chemotherapy on NHS Scotland ('Review decision to reject cancer treatment, says drugs firm' The Herald, April 15).

"This was despite emphatic support from clinicians and from patients, who told Prostate Cancer UK they would feel 'cheated', 'dismayed', 'marginalised' and' 'abandoned' in the event of SMC rejection of the drug. But rejected it was. Men for whom time is at a premium must now face an agonising wait on the outcome of an appeal against this cruel decision.

"The conclusions from these two stories are clear. For more positive outcomes, like Dr Morrison's, men in higher risk groups should speak to their GP or call Prostate Cancer UK's nurses on 0800 074 8383 about their own situation. For men, like me, for whom no cure is possible, the SMC's rejection of abiraterone before chemotherapy simply must be overturned. And soon."

Sources, Links, Background

Source: Herald Scotland, , April 30 2015, The rejection of abiraterone in Scotland must be overturned

Government health insurance providers in the UK including Scotland claim that abiraterone (brand name Xytiga) is "too expensive" to prescribe for men with advanced prostate cancer: Prostate cancer drug abiraterone 'too expensive' to use on terminally-ill patients August 14, 2014

Abiraterone development and use

Abiraterone, researched and developed initially in the UK, is an oral drug (pill or capsule) used in combination with prednisone in metastatic castration-resistant prostate cancer (formerly hormone-resistant or hormone-refractory prostate cancer). In men with this stage of the disease, cancer cells have invaded skeletal bones and/or distant organs like liver or lungs and the tumors are not responding to androgen deprivation or treatment with antiandrogens.

After an expedited six-month review, abiraterone was approved by the U.S. Food and Drug Administration (FDA) in April 2011.In Phase III trials, it extended median survival to 14.8 months versus 10.9 months placebo. The trial was stopped because of the successful outcome.

In the UK, Until May 2012 the National Institute for Health and Clinical Excellence (NICE) did not recommend use of the drug within the NHS on cost-effectiveness grounds. This position was reversed when the manufacturer submitted revised costs. The use is currently limited to men who have already received one docetaxel-containing chemotherapy regimen.

Abiraterone Side Effects

Side effects of abiraterone range from Very common (more than 10% of patients):
Urinary tract infection
Hypokalemia (low potassium)
Hypertension (high blood pressure)
Diarrhoea
Peripheral oedema (swelling, typically of ankles or legs, from fluid retention)

To Fairly common (1-10% of patients):
High triglycerides (Hypertriglyceridaemia)
Sepsis
Cardiac failure
Angina pectoris
Arrhythmia
Atrial fibrillation
Tachycardia
Dyspepsia (indigestion)
Rash
Alanine aminotransferase increased
Aspartate aminotransferase increased
Fractures
Hematuria (blood in urine)

Uncommon and rare (under 1%):

Adrenal insufficiency
Myopathy
Rhabdomyolysis
Allergic alveolitis

Abiraterone Global Marketing

Abiraterone is marketed under the trade name Zytiga. Intas Pharmaceuticals has recently started marketing Abiraterone acetate under the trade name Abiratas, Cadila Pharmaceuticals has recently started marketing Abiraterone acetate under the trade name Abretone & by Glenmark Pharmaceuticals as Abirapro.