IHS Global Insight Perspective | |
Significance | The UK's National Institute for Health and Clinical Excellence (NICE) has failed to recommend Orencia for the treatment of moderate-to-severe active rheumatoid arthritis in adults whose disease has responded inadequately to one or more conventional non-biological disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate. Nplate is recommended for the treatment of adults with chronic idiopathic (immune) thrombocytopaenia purpura (ITP). |
Implications | Although this is not the final guidance for both drugs, it is increasingly likely that Orencia will not be made available on the National Health Service (NHS) in England and Wales, however Nplate will be reimbursed under the NHS. |
Outlook | Nplate is now in a better position to capture market share given that one of its rivals Revolda has recently been rejected by the cost regulator. |
Orencia Faces Rebuff in Second-Line Setting
The United Kingdom's National Institute for Health and Clinical Excellence (NICE) has issued an appraisal consultation document, rejecting the use of Orencia (abatacept; Bristol-Myers Squibb; US) for the treatment of moderate-to-severe active rheumatoid arthritis in adults whose disease has responded inadequately to one or more conventional non-biological disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate. To show cost-effectiveness, the manufacturer developed an economic model based on cost-utility analyses to compare the cost effectiveness of Orencia compared with three comparators: all other biological DMARDs, conventional DMARDs and Remicade (infliximab; Johnson & Johnson/Schering-Plough, US) plus methotrexate. According to the base-case results, the incremental cost-effectiveness ratio (ICER) for Orencia plus methotrexate compared with conventional DMARDs was GBP29,916 (USD47,878) per quality adjusted life year (QALY) gained. When Orencia plus methotrexate was compared with all treatments (including other biological DMARDs and conventional DMARDs), Orencia was dominated by Humira (adalimumab; Abbott, US) and Cimzia (certolizumab pegol; UCB, Belgium). According to the sensitivity analysis, the variable with the biggest impact on the ICERs was the time horizon. When the time horizon in the analysis was reduced to five years, the ICER for Orencia plus methotrexate compared with conventional DMARDs increased to GBP84,390 per QALY gained. The ACD is available here.
Nplate Gets Thumbs Up in FAD
In another document, NICE has issued a final appraisal determination (FAD) recommending US biotech company Amgen's Nplate (romiplostim) for the treatment of adults with chronic idiopathic (immune) thrombocytopaenia purpura (ITP). The recommendation does come with conditions in that only patients whose condition is refractory to standard active treatments and rescue therapies, or who have severe disease and a high risk of bleeding that requires frequent courses of rescue therapies will be eligible for the drug. Furthermore, haematologists can initiate treatment. In addition to these clinical restrictions, a patient-access scheme (PAS) has been agreed between Amgen and the Department of Heath, under which there will be a rebate on the list price of the 250-ug vial of Nplate. The size of the rebate has not been disclosed.
According to the economic analysis, ICERs for the non-splenectomised subgroup, were GBP24,795 and GBP28,278 per QALY gained for the realistic scenario and the conservative scenario respectively. For the splenectomised group ICERs were GBP4,615 and GBP16,530 per QALY gained for the realistic scenario and the conservative scenario respectively. According to NICE, the most plausible ICERs would be under GBP20,000 per QALY gained for the treatment for splenectomised patients, and around GBP30,000 per QALY gained for non-splenectomised patients. The FAD is available here.
Outlook and Implications
Orencia has previously been rejected by NICE for use in combination with methotrexate for the treatment of severe, active RA in adult patients after the failure of treatment with a tumour necrosis factor (TNF) inhibitor (see United Kingdom: 3 March 2011: NICE Recommends Four RA Drugs Subject to Conditions, But Rejects One). This latest rebuff is yet another setback for the drug as its major rivals such as Enbrel (etanercept; Wyeth, US), Remicade, Humira, Cimzia and MabThera/Rituxan (rituximab; Roche, Switzerland) are all recommended by NICE. Essentially Orencia can expect limited uptake in the UK market if NICE sticks to the negative decision when the final guidance is issued. It is likely that this situation will prevail unless a type of price deal is struck as seen in the example of Cimzia (see United Kingdom: 21 January 2010: UCB Offers Patient-Access Scheme for RA Drug Cimzia, Secures NICE Approval). The annual cost of treatment is estimated to be GBP10,171.14 for the first year and GBP9,444.63 for subsequent years.
The positive FAD for Amgen's Nplate is a positive development especially as another innovative drug in the same indication—UK pharma major GlaxoSmithKline's Revolade (eltrombopag)—has been rejected by NICE, while its use has been restricted to second-line setting in non-splenectomised patients, where surgery is contraindicated (see United Kingdom: 15 September 2010: NICE Issues Positive FAD for Prolia But Rejects Revolade). The acquisition cost of the drug is estimated to be GBP484 for 250 ug, and the annual cost of treatment for a person weighing 80 kg is estimated to be GBP8,020.