On 7 November, the Scottish Medicines Consortium issued guidance on the reimbursement of Orencia, Humira, Emend, Jevtana, Simponi, Vimovo, Xeplion, Lucentis and Saizen.
IHS Global Insight Perspective | |
Significance | The Scottish Medicines Consortium (SMC) has issued guidance following its review of Orencia, Humira, Emend, Jevtana, Simponi, Vimovo, Xeplion, Lucentis and Saizen. |
Implications | Xeplion and Saizen have been recommended for reimbursement in Scotland; Orencia, Humira, Simponi and Lucentis have been recommended for reimbursement with restrictions; and Emend, Jevtana and Vimovo have been rejected. |
Outlook | Following the issuance of SMC guidance, primary care trusts in Scotland must start funding within three months for Xeplion and Saizen in the indication reviewed, and for Orencia, Humira, Simponi and Lucentis in the reviewed indication subject to the restrictions stipulated by the SMC. |
SMC Recommends Reimbursement of Xeplion and Saizen
Scotland's health technology assessment agency, the Scottish Medicines Consortium (SMC), has recommended the reimbursement of US firm Janssen-Cilag's Xeplion (paliperidone palmitate) for the maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, it may be used without prior stabilisation with oral treatment if psychotic symptoms are mild-to-moderate and a long-acting injectable treatment is needed. The positive recommendation came following a resubmission after the manufacturer's original full submission was rejected by the SMC in July. German firm Merck Serono's Saizen (somatropin) was approved for reimbursement on the basis of an abbreviated submission for the treatment of growth disorder in children, adolescents and adults due to inadequate endogenous growth hormone secretion, gonadal dysgenesis (Turner Syndrome), chronic renal failure, being born small for gestational age, or growth hormone deficiency.
Orencia, Humira, Simponi and Lucentis Face Restrictions
The SMC recommended the reimbursement of US firm Bristol-Myers Squibb's Orencia (abatacept), in combination with methotrexate, for the treatment of moderate-to-severe active polyarticular juvenile idiopathic arthritis (JIA) in paediatric patients aged six and older who have had an insufficient response to other disease modifying antirheumatic drugs (DMARDs), including at least one tumour necrosis factor (TNF) inhibitor. Reimbursement of Orencia, however, will be restricted to use within specialist rheumatology services (including those working within the network for paediatric rheumatology) and for use in adults with severe active rheumatoid arthritis (RA), in line with the recommendations of the National Institute for Health and Clinical Excellence's multiple technology appraisal number 195. Orencia was recommended following an abbreviated submission.
The use of US firm Abbott's Humira (adalimumab) has been recommended by the SMC for reimbursement, in combination with methotrexate, for the treatment of active polyarticular JIA in children and adolescents aged 4–17 years who have had an inadequate response to one or more DMARDs. Adalimumab can be given as monotherapy in the case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Reimbursement will be restricted to use within specialist rheumatology services (including those working within the network for paediatric rheumatology). This product has previously been recommended by the SMC for restricted use in this indication for adolescents aged 13–17 years, and for RA in adults. The new guidance was based on an abbreviated submission.
The SMC also recommended the use of Simponi (golimumab), in combination with methotrexate, for the treatment of moderate-to-severe active RA in adult patients when the response to DMARD therapy including methotrexate has been inadequate. Reimbursement is restricted for use in accordance with British Society for Rheumatology guidance on prescribing TNF-alpha blockers in adults with RA. Golimumab is restricted to use only at a dose of 50 mg, which was the only dose for which the economic case was demonstrated. The SMC also noted that because the company's submission related only to use of the drug in patients with an inadequate response to methotrexate, it could not recommend reimbursement of golimumab in its other licensed indication—the treatment of severe, active and progressive RA in adults not previously treated with methotrexate.
Novartis's Lucentis (ranibizumab) was recommended for restricted use within the Scottish National Health Service for the treatment of visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) in adults. Reimbursement will be restricted to use in patients with macular oedema secondary to CRVO. The benefits of a patient access scheme (PAS) proposed by the manufacturer had a positive influence on the decision, and reimbursement will only remain in effect as long as the PAS is available. Otherwise, the SMC ruled that the submitting company did not present a sufficiently robust economic analysis for ranibizumab in the treatment of BRVO (branch retinal vein occlusion) to gain acceptance by the SMC. The recommendation was made following a full manufacturer submission.
Emend, Jevtana and Vimovo Are Rejected
The SMC rejected reimbursement of Merck & Co.'s US unit Merck Sharp and Dohme's Emend (aprepitant), an anti-emetic used in patients undergoing cancer chemotherapy. The rejection came following the manufacturer's resubmission after a full submission was rejected in March 2006. A lack of sufficiently robust clinical and economic analyses was cited as the reason for the rejection. Weaknesses of the economic analysis were behind the rejection of UK pharma AstraZeneca's Vimovo (naproxen + esomeprazole) for symptomatic treatment of osteoarthritis, RA and ankylosing spondylitis. French firm Sanofi's Jevtana (cabazitaxel), meanwhile, was rejected following a full submission, due to a lack of justification of the drug's cost in relation to its health benefits.
Outlook and Implications
As the new SMC decisions demonstrate, there can be a variety of reasons for a drug's rejection for reimbursement. In the November decisions, no drugs were rejected due to the absence of manufacturer submission. Of the three rejected, cost seems to be the main issue for Jevtana and Vimovo. Given the concerns about both inadequate clinical data and cost-effectiveness analysis in the case of Emend, however, securing reimbursement for that drug in Scotland could prove difficult.
Meanwhile, the approval of Lucentis for reimbursement—after the manufacturer's offer of a PAS—indicates that the SMC remains open to reversing reimbursement decisions fairly readily if its cost-effectiveness ratio concerns are addressed.
Following the issuance of SMC guidance, primary care trusts in Scotland have to start funding within three months for Xeplion and Saizen in the indication reviewed, and for Orencia, Humira, Simponi and Lucentis in the reviewed indication subject to the restrictions stipulated by the SMC.