- Peginterferon beta‑1a recommended for relapsing–remitting multiple sclerosis.
- Restrictions recommended for use of cyproterone due to meningioma risk.
- Plerixafor recommended in combination for lymphoma or solid malignant tumours.
- Dolutegravir/lamivudine recommended for HIV-1.
- Supply updates published for:
- Salofalk (mesalazine) suppositories (500mg and 1g)
- Salbutamol 2mg/5ml syrup update.
- Gene therapy treatment for blindness goes ahead.
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
PEGINTERFERON BETA‑1A RECOMMENDED FOR RELAPSING–REMITTING MULTIPLE SCLEROSIS
The National Institute for Health and Care Excellence (NICE) has published final guidance which recommends peginterferon beta-1a (Plegridy), within its marketing authorisation, as an option for treating relapsing–remitting multiple sclerosis in adults.
Peginterferon beta‑1a is an established drug for relapsing–remitting multiple sclerosis. There is clinical trial evidence showing that the drug slows disease progression and reduces the frequency of relapses when compared with placebo. There is also an indirect comparison suggesting that there are no differences in effectiveness when comparing peginterferon beta‑1a with its main comparators, that is, other beta interferons and glatiramer acetate. However, it involves less frequent injections than other beta interferons, so improves choice for people with relapsing–remitting multiple sclerosis.
The cost-effectiveness estimates for peginterferon beta‑1a compared with other treatments for relapsing–remitting multiple sclerosis, such as other beta interferons and glatiramer acetate, are in line with what NICE usually considers a cost-effective use of NHS resources.
EUROPEAN MEDICINES AGENCY
RESTRICTIONS RECOMMENDED FOR USE OF CYPROTERONE DUE TO MENINGIOMA RISK
The European Medicines Agency’s safety committee (PRAC) has recommended that medicines with daily doses of 10 mg or more of cyproterone should only be used for androgen-dependent conditions such as hirsutism, alopecia, acne and seborrhoea once other treatment options, including treatment with lower doses, have failed. Once higher doses have started working, the dose should be gradually reduced to the lowest effective dose.
The medicines should only be used for reduction of sex drive in sexual deviations in men when other treatment options are not suitable.
There is no change in use of the medicines in men for prostate cancer.
The recommendations follow a review of the risk of the rare tumour meningioma with cyproterone. Overall, this side effect is rare: it may affect between one and 10 in 10,000 people, depending on the dose and duration of treatment. The risk increases with increasing cumulative doses.
Available data do not indicate a risk for low-dose cyproterone medicines containing 1 or 2 milligrams cyproterone in combination with ethinylestradiol or estradiol valerate and used for acne, hirsutism, contraception, or hormone replacement therapy. However, as a precaution, the PRAC recommends they should not be used in people who have or have had a meningioma. This restriction is already in place for the higher dose medicines.
The PRAC advises doctors to monitor patients for symptoms of meningioma, which can include changes in vision, hearing loss or ringing in the ears, loss of smell, headaches, memory loss, seizures or weakness in arms and legs.
As part of the ongoing surveillance of the safety of the medicines, companies marketing medicines containing 10 mg or more of cyproterone will be required to carry out a study to assess doctors’ awareness of the risk of meningioma and how to avoid it.
ALL WALES MEDICINES STRATEGY GROUP
PLERIXAFOR RECOMMENDED IN COMBINATION FOR LYMPHOMA OR SOLID MALIGNANT TUMOURS
Plerixafor (Mozobil®) is recommended for use within NHS Wales in combination with granulocyte colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children aged ≥ 1 to <18 years with lymphoma or solid malignant tumours either:
- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired haematopoietic stem cells yield, or;
- who previously failed to collect sufficient haematopoietic stem cells.
DOLUTEGRAVIR/LAMIVUDINE RECOMMENDED FOR HIV-1Dolutegravir/lamivudine (Dovato®) is recommended as an option for use within NHS Wales for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.
PHARMACEUTICAL SERVICES NEGOTIATING COMMITTEE
SUPPLY UPDATES PUBLISHED
The Pharmaceutical Services Negotiating Committee has issued supply updates for the following:
- Salofalk (mesalazine) suppositories (500mg and 1g) – resupply date now expected mid-April 2020 for the 500mg suppositories, mid-September 2020 for the 1g suppositories. The notice, originally published 24th October 2019, provides information on alternative agents and management options.
- Salbutamol 2mg/5ml syrup update: resupply date now expected end of March 2020. The notice states that supplies are available from specialist importers on an ‘unlicensed’ basis.
GENE THERAPY TREATMENT FOR BLINDNESS GOES AHEAD
Infants born with the inherited retinal disorder Leber’s Congenital Amaurosis, have poor sight which swiftly deteriorates, with many ultimately losing their vision completely in childhood. The condition blocks messages for making proteins in the eye that are essential for normal vision, the drug works by recreating these processes like that in a healthy functioning eye.
The treatment for children and adults – voretigene neparvovec – is the first in a new generation of gene therapies that can be directly administered to patients through an injection. Many patients in the trials recovered their night-time vision with this treatment. Until now no treatment has been available and it is estimated that as many as 100 patients could benefit from the new gene therapy.
Patients here will benefit from voretigene neparvovec, also known as Luxturna, after NHS England reached a NICE-endorsed deal with manufacturer Novartis to fund the drug.
The treatment for adults will initially be available from three national specialist centres in Manchester, London, and Oxford, with the option to roll-out the treatment to other hospitals.