Managed Entry Decisions

Managed Entry Decisions

wdt_ID Drug Decision Link to guidance Status Date added to website
1
Eculizumab (Soliris®)

​In Northern Ireland, eculizumab (Soliris®) is not accepted for use in the treatment of adults with refractory generalised myasthenia gravis who are anti-acetylcholine receptor antibody-positive.
People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.
For further information seeSMC2236
https://www.scottishmedicines.org.uk/medicines-advice/eculizumab-soliris-nonsub-smc-2236/ Not Accepted 17/12/2019
2
​Pentosan polysulphate sodium (Elmiron®)

​In Northern Ireland, pentosan polysulphate sodium (Elmiron®) is accepted for use as an option for treating bladder pain syndrome with glomerulations or Hunner’s lesions in adults with urinary urgency and frequency, and moderate to severe pain, only if:
 - their condition has not responded to an adequate trial of standard oral treatments
 - it is not offered in combination with bladder instillations
 - any previous treatment with bladder instillations was not stopped because of lack of response
 - it is used in secondary care and
 - the company provides pentosan polysulfate sodium according to the commercial arrangement.
Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.
For further information seeNICE TA610
https://www.nice.org.uk/guidance/ta610 Accepted 17/12/2019
3
​Voretigene neparvovec (Luxturna®)
In Northern Ireland, voretigene neparvovec (Luxturna®) is accepted for use, within its marketing authorisation, as an option for treating RPE65-mediated inherited retinal dystrophies in people with vision loss caused by inherited retinal dystrophy from confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. It is recommended only if the company provides voretigene neparvovec according to the commercial arrangement.
Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.
For further information seeNICE HST11
https://www.nice.org.uk/guidance/hst11 Accepted 17/12/2019
4 ​Rucaparib (Rubraca®) ​In Northern Ireland, rucaparib (Rubraca®) is accepted for use as an option for maintenance treatment of relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy in adults, only if the conditions in the managed access agreement for rucaparib are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information seeNICE TA611 https://www.nice.org.uk/guidance/ta611 Accepted 17/12/2019
5 ​Imiquimod (Zyclara®) ​In Northern Ireland, imiquimod (Zyclara®) is accepted for use for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate. Use is restricted to the treatment of large field actinic keratosis (>25cm2). For further information seeSMC2211 https://www.scottishmedicines.org.uk/medicines-advice/imiquimod-zyclara-full-smc2211/ Accepted 17/12/2019
6 ​Glibenclamide (Amglidia®) ​In Northern Ireland, glibenclamide (Amglidia®) is not accepted for use in the treatment of neonatal diabetes mellitus, for use in newborns, infants and children.   People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information seeSMC2237       https://www.scottishmedicines.org.uk/medicines-advice/glibenclamide-amglidia-nonsub-smc2237/ Not Accepted 20/11/2019
7 ​Eribulin (Halaven®) ​In Northern Ireland, eribulin (Halaven®) is not accepted for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information seeSMC2231 https://www.scottishmedicines.org.uk/medicines-advice/eribulin-halaven-non-submission-smc2231/ Not Accepted 20/11/2019
8 ​Idelalisib (Zydelig®) ​In Northern Ireland, idelalisib (Zydelig®) is not accepted for use, within its marketing authorisation, for treating follicular lymphoma that has not responded to 2 prior lines of treatment in adults.  People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information seeNICE TA604 https://www.nice.org.uk/guidance/ta604 Not Accepted 20/11/2019
9 ​Rivaroxaban (Xarelto®)   ​In Northern Ireland, rivaroxaban plus aspirin is accepted for use, within its marketing authorisation, as an option for preventing atherothrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease who are at high risk of ischaemic events. For further information seeNICE TA607     https://www.nice.org.uk/guidance/ta607 Accepted 20/11/2019
10 ​Dolutegravir + lamivudine (Dovato®) ​In Northern Ireland, dolutegravir + lamivudine (Dovato®) is accepted for use for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information seeSMC2205 https://www.scottishmedicines.org.uk/medicines-advice/dolutegravir-lamivudine-dovato-abbreviated-smc2205/ Accepted 20/11/2019
Drug Decision Link to guidance Status Date added to website