Widening of funding restrictions for rituximab and eltrombopag

Transcription

1 20 February 2014 Widening f funding restrictins fr rituximab and eltrmbpag PHARMAC is pleased t annunce the apprval f prpsals t widen the restrictin n rituximab use in DHB hspitals and expand the funding f eltrmbpag in bth hspitals and the cmmunity. This was the subject f cnsultatin letters dated 13 September 2013 and 4 Nvember 2013 respectively. The cnsultatin letters can be fund at: In summary, the effects f the decisins are that: The restrictin n rituximab use in hspitals will be widened t include nine new indicatins; and The funding fr eltrmbpag will be widened t include patients with 20,000 t 30,000 platelets per micrlitre and evidence f significant muccutaneus bleeding. Details f the decisins Rituximab Frm 1 March 2014, the restrictin n the use f rituximab in hspitals will be widened t include nine new indicatins. These will be in additin t the seven indicatins in which rituximab is already able t be used. The new indicatins are: Cld haemagglutinin disease (CHAD); Warm autimmune haemlytic anaemia (warm AIHA); Immune thrmbcytpenic purpura (ITP); Thrmbtic thrmbcytpenic purpura (TTP); Pure red cell aplasia (PRCA); ANCA assciated vasculitis; Systemic lupus erythematsus (SLE); Antibdy-mediated renal transplant rejectin; and ABO-incmpatible renal transplant. Rituximab use in the indicatins abve will be subject t restrictin criteria which are detailed in the attached Appendix ( Please nte that, fllwing cnsideratin f cnsultatin feedback, an additinal indicatin (abve thse cnsulted n) was added - pure red cell aplasia. Several amendments were als made t the access criteria initially cnsulted upn, and these are identified in the Feedback received sectin belw. A Page 1 f 5

2 Eltrmbpag When PHARMAC cnsulted n a prpsal t list eltrmbpag in Nvember 2013, we received feedback that access t the treatment shuld als include patients with platelet cunts between 20,000 and 30,000 platelets per micrlitre. Eltrmbpag was listed in Sectin B and Part II f Sectin H f the Pharmaceutical Schedule frm 1 January 2014 but this patient grup was excluded because PHARMAC wanted t btain further clinical advice befre making a decisin. PTAC and the Haematlgy Subcmmittee have since advised PHARMAC that they cnsider this change t be apprpriate. The changes t the eltrmbpag access criteria are detailed in the attached Appendix ( Feedback received We appreciate all f the feedback that we received and acknwledge the time peple tk t respnd. All cnsultatin respnses were cnsidered in their entirety in making a decisin n the prpsed changes. Mst respnses were supprtive f the prpsal, and the fllwing issues were raised in relatin t general and specific aspects f the prpsal: Theme Clinicians (haematlgists, rheumatlgists and nephrlgists) and rganisatins like Arthritis New Zealand as well as the New Zealand Rheumatlgy Assciatin (NZRA) are supprtive f this prpsal as it wuld reflect rituximab usage prir t 1 July 2013 (the inceptin f the Hspital Medicines List (HML)) and reduce the administrative wrk required currently fr NPPA applicatins. Bay f Plenty DHB is supprtive f the rituximab prpsal. Suthern DHB respnded that this prpsal wuld result in increased cst t them as rituximab use was mre restricted in the DHB when cmpared t the access criteria in this prpsal. Feedback nted. Feedback nted. PHARMAC respnse We acknwledge the fiscal impact f this prpsal n sme DHBs. This prpsal is in line with PHARMAC s effrts t establish a natinal HML frm 1 July 2013 and it was always anticipated that with a natinally cnsistent list there wuld be different levels f impact at different DHBs. In the last few years, the PHARMAC Bard has apprved a number f transactins which resulted in cst-shifting frm DHB hspitals t the Cmbined Pharmaceuticals Budget which wuld help mitigate the cst increases as a result f the HML. Examples f these include, the funding f influenza vaccines, filgrastim and pegfilgrastim which were previusly funded by DHB hspitals. A Page 2 f 5

3 Rituximab fr ITP Restricting rituximab in ITP t patients wh have already had splenectmy r in whm splenectmy is "an abslute" cntraindicatin is pen t subjective interpretatin, unjustifiably restrictive and cntrary t internatinal practice. PHARMAC s clinical advisrs, PTAC and the Haematlgy Subcmmittee, recmmended that splenectmy is used ahead f rituximab in ITP treatment algrithms because splenectmy is mre effective and results in mre durable respnses. The Subcmmittee als nted that there are significant side effects assciated with rituximab therapy and its lng term safety with repeated use in ITP is unknwn. The Subcmmittee nted that althugh the criteria splenectmy is an abslute cntraindicatin culd be subjective it was difficult t further define the criterin and it shuld be left unchanged. Patients with gd respnses f less than 12 mnths, pssibly as shrt as fur mnths, shuld be cnsidered fr retreatment, especially if n maintenance was used fllwing the first treatment and/r sterids were withdrawn cmpletely. The platelet threshld fr rituximab treatment shuld be 30,000 platelets per micrlitre rather than 20,000, which is in line with internatinal guidelines. PTAC and the Haematlgy Subcmmittee cnsidered that it wuld be apprpriate t maintain the requirement that patients wuld nly be cnsidered fr funded rituximab retreatment if they have had a respnse lasting at least 12 mnths t prir rituximab treatment, which reflects current New Zealand practice. PTAC and the Haematlgy Subcmmittee have advised that this wuld be apprpriate and the criteria have been amended accrdingly. Rituximab fr TTP The criterin clinical respnse t plasma exchange was sub-ptimal r plasma exchange is cntra-indicated is t vague. The access criterin has been amended fr clarity after cnsultatin with the Haematlgy Subcmmittee f PTAC. Rituximab fr ANCA assciated vasculitis Rituximab shuld nly be used if pulse intravenus cyclphsphamide has failed t achieve cmplete absence f disease after six mnths rather than three mnths, because cyclphsphamide ften nly starts t wrk after fur mnths and may take up t six r nine mnths t achieve a cmplete absence f disease. PTAC recmmended that the criterin be amended t prvide flexibility t clinicians t use their judgement regarding the apprpriate length f cyclphsphamide treatment, and t enable thse wh truly have prgressive, unrespnsive disease t have the ptin f changing t rituximab. The criterin has been amended accrdingly. A Page 3 f 5

4 Mycphenlate shuld nt be used ahead f rituximab in MPO psitive vasculitis as there is very weak evidence supprting mycphenlate as an inductin agent in this cnditin. Mycphenlate is nt even funded fr this based n its Special Authrity restrictin because azathiprine is nt a treatment ptin fr inductin therapy in this patient grup. Male fertility can be affected by expsure t cyclphsphamide, and rituximab shuld be allwed as an alternative treatment fr a man wh wishes t preserve his fertility and sperm banking is unavailable, unsuccessful r unacceptable. The Special Authrity restrictin shuld allw the alternative dsing regimen where rituximab 1 g is given n Day 0, again n Day 15, then a 1 g single infusin every six mnths fr ttal f tw years (i.e. six dses in ttal). PTAC cnsidered it reasnable t keep this requirement nting mderate evidence f effect f mycphenlate in MPO-ANCA vasculitis cmpared with cyclphsphamide. The Cmmittee recmmended that this funding applicatin fr rituximab in MPO- ANCA assciated vasculitis is referred t the Nephrlgy Subcmmittee fr advice and PHARMAC intends t d s. PHARMAC staff are currently reviewing the mycphenlate Special Authrity restrictin. In the meantime, clinicians can apply fr mycphenlate funding fr patients with MPO-ANCA vasculitis by anntating the Special Authrity frm with the relevant clinical infrmatin. PTAC nted that cyclphsphamide is knwn t affect male fertility; hwever, in sme centres sperm banking prir t cyttxic treatment is funded. PTAC had sympathy fr patients fr whm sperm banking was nt an ptin, hwever cnsidered that if the criteria were amended as prpsed it wuld be assciated with significant financial risk as effectively it culd result in all male patients bypassing the requirement t have tried cyclphsphamide prir t rituximab. When cnsulted abut this alternative dsing regimen, the New Zealand Rheumatlgy Assciatin cnfirmed that there is emerging evidence fr maintenance treatment in ANCA vasculitis, but cnsidered that the first pririty is fr rituximab t be funded as an inductin agent as prpsed. Rituximab fr PRCA Rituximab is als currently used t treat PRCA and it wuld be restricted t PRCA cnsidered t be autimmune and assciated with a demnstrable B-cell lymphprliferative disrder. PTAC and the Haematlgy Subcmmittee f PTAC cnsidered that it was reasnable that rituximab be funded fr this small grup. Access t rituximab has been widened t include this patient grup. Rituximab fr idipathic nephrtic syndrme Rituximab is als used t treat idipathic nephrtic syndrme, including children, and the Sectin H listing shuld be widened t include this grup. PHARMAC is intending t seek clinical advice n the use f rituximab in this patient grup frm the Nephrlgy Subcmmittee, which is in the prcess f being established. Eltrmbpag in ITP The qualifying platelet cunt f 20,000 platelets per micrlitre cut-ff is dangerusly lw and nt in line with internatinal cnsensus that ITP patients with a platelet cunt f 30,000 platelets per micrlitre require treatment. PTAC and the Haematlgy Subcmmittee cnsidered that this was reasnable and the criteria have been amended accrdingly. A Page 4 f 5

5 Mre infrmatin If yu have any questins abut this decisin, yu can us at r call ur tll free number (9 am t 5 pm, Mnday t Friday) n A Page 5 f 5