Some patients with advanced colon cancer living in Scotland can now get routine access to Sanofi's Zaltrap (aflibercept), after cost regulators agreed that the drug's use should indeed be funded on the National Health Service after all.
In July last year patients with metastatic colorectal cancer resistant to an oxaliplatin-containing treatment regimen were told that they could not get Zaptrap on the NHS because its 'relatively modest clinical benefit' did not justify its price.
However, a new Patient Access Scheme offered by Sanofi has now helped sweeten the deal, improving the drug's cost effectiveness and thereby enabling the Scottish Medicines Consortium to accept its use alongside a chemotherapy regimen known as FOLFIRI (irinotecan/5-fluorouracil/folinic acid).
Elsewhere, AstraZeneca's Forxiga (dapagliflozin) has been accepted for restricted use within NHS Scotland when used in combination with insulin to help improve glycaemic control in adult patients with type II diabetes.
In a Phase III randomised, controlled study, dapagliflozin treatment, when added to an insulin-containing regimen, was associated with: greater reductions in glycosylated haemoglobin (HbA1c), in body weight, and similar rates of hypoglycaemia when compared with placebo, the regulator said.
Also making it into NHS Scotland were: Boehringer ingelheim's Giotrif (afatinib), specifically for the treatment of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);
Janssen-Cilag's Prezista (darunavir), co-administered with low dose ritonavir in combination with other antiretroviral (ART) medicinal products for the treatment of HIV infection in paediatric patients 12 to 17 years of age and at least 40kg body weight who are: ART naïve; or, ART-experienced with no darunavir resistance associated mutations and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count _100 cells/mm3;
Janssen-Cilag's Stelara (ustekinumab) for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug therapy has been inadequate, with the added restriction of using only in patients with active psoriatic arthritis who have failed on, or are unsuitable for, treatment with an anti-TNF drug; and
Celgene's Revlimid (lenalidomide) for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.
On the down side, Novo Nordisk's Tresiba (insulin degludec) and Takeda UK's Vipdia (alogliptin), both diabetes drugs, were turned away after the companies failed to present "sufficiently robust clinical and economic analysis to gain acceptance by SMC".