19 Jul, 12 | by BMJ Group
Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.
NICE consultation on denosumab
The National Institute for Health and Clinical Excellence (NICE) has issued a second appraisal consultation document on the use of denosumab as a treatment to delay or prevent skeletal-related events in people with bone metastases from solid tumours. This follows the committee’s reconsideration of evidence in light of information received during the first consultation. The latest draft guidance makes the following preliminary recommendations:
- denosumab is recommended as an option for preventing skeletal-related events in adults with bone metastases from breast cancer, if the manufacturer provides denosumab with the discount agreed in the patient access scheme
- denosumab is not recommended for preventing skeletal-related events in adults with bone metastases from prostate cancer
- denosumab is recommended as an option for preventing skeletal-related events in adults with bone metastases from solid tumours other than breast and prostate if zoledronic acid or disodium pamidronate would otherwise be prescribed for these patients and the manufacturer provides denosumab with the discount agreed in the patient access scheme
- adults with bone metastases from solid tumours currently receiving denosumab for the prevention of skeletal-related events that is not recommended according to the above, should be able to continue treatment until they and their clinician consider it appropriate to stop.
The consultation period closed on 2 July 2012. For more information click here.
Pregabalin oral solution launched in UK
Pregabalin oral solution 20mg/mL (Lyrica; Pfizer, Sandwich, Kent, UK) has been launched in the UK and is licensed in adults for:
- peripheral and central neuropathic pain
- epilepsy as adjunctive therapy in adults with partial seizures with or without secondary generalisation
- general anxiety disorders.
The NHS cost of a 473mL bottle = £99; 28 days @75mg, 150mg, or 300mg b.d. = £44, £88 and £177 respectively, whereas the oral capsules cost £64 for 28 days treatment at the above doses for all 3 strengths. Pregabalin oral solution has been shown to be bioequivalent to pregabalin capsules. For the SPC click here.
The Scottish Medicines Consortium (SMC) has accepted pregabalin oral solution for restricted use within NHS Scotland for the following indications in patients who find it difficult to or are unable to swallow tablets:
- patients with peripheral neuropathic pain who have not achieved adequate pain relief from, or have not tolerated, conventional first and second line treatments for peripheral neuropathic pain. Treatment should be stopped if the patient has not shown sufficient benefit within 8 weeks of reaching the maximally tolerated therapeutic dose
- adjunctive therapy in adults with partial seizures with or without secondary generalization. It should be initiated only by physicians who have appropriate experience in the treatment of epilepsy and should be used principally in patients who have not benefited from treatment with an older anti-convulsant drug such as carbamazepine or sodium valproate, or for whom these drugs are unsuitable because of contra-indications, interaction or poor tolerance.
Pregabalin is not recommended for use in the treatment of generalized anxiety disorder in adults as the company has not made a submission to SMC for use in this indication. For more information click here.
AWMSG recommendations for Buccolam
The All Wales Medicines Strategy Group (AWMSG) has approved midazolam oromucosal solution 5mg/mL (Buccolam, ViroPharma) as an option for use within NHS Wales for the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to <18 years). For infants between 3–6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. AWMSG state Buccolam should be prescribed by brand name to reduce the risk of medication errors. For more information click here.
Prepared by Sarah Charlesworth and Andrew Wilcock