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KEMENTERIAN KESIHATAN MALAYSIA(!rliltigtry of Health Mataysia)Pejabat Pengarah Kan-an Perkhidmatan Farmasi(Offi99 of the Senior Director of pharmaceuticatseruices)Lot 36, Jalan Universiti46200 Petaling JayaSelangorMALAYSIA
Ruj. TuanRuj. KamiTarikh
:
: KKM.600-34t4t04 Jtd. 2 (t+): 29 Julai 2018
No. TelefonNo. FaksimiliPortal RasmiE-mel
03 - 7841 320103 - 7968 2248http ://www. p h a rm acy. g ov, m yC r" al- a n b ara@rirerh€ey, mYpejabatpkpf@moh. gov.my
SEPERT! SENARAI EDARAN
YBhg. Datuk/Dato'/Datin/Tuan/puan,
PEKELILING PINDAAN/TAMBAHAN KEPADA FORMULARI UBAT-UBATANKEMENTERIAN KESTHATAN MALAYSIA BILANGA N 212018
saya dengan segala hormatnya merujuk kepada perkara di atas.
2. Sukacita dimaklumkan bahawa Mesyuarat Panel Kaji Semula Senarai UbatKKM Bil. 212018 yang diadakan pada 12 Julai 2o1B telah mempertimbangkanpermohonan-permohonan pindaan/tambahan kepada Formulari Ubat KKM(FUKKM)" Keputusan pindaan/ tambahan tersebut adalah seperti berikut:
2.1 Pindaanffambahan kepada FUKKM yang diluluskan (JadualA):Lampiran 1: penyenaraian ubat baru ke daram FUKKM.Lampiran 2: Tambahan indikasi bagi ubat-ubatan dalam FUKKM.Lampiran 3: Pindaan kategori preskriber bagl ubat-ubatan dalamFUKKMLampiran 4: Pemansuhan indikasi bagi ubat yang tersenarai dalamFUKKM.
2.2 Permohonan-permohonan yang tidak diluluskan (Jadual B).
3' Penggunaan ubat-ubatan yang terdapat dalam FUKKM perlu dipantaudengan rapi dan sebarang kesan advers hendaklah dilaporkan kepadaJawatankuasa Penasihat Kesan Advers Ubat Kebangsaan (MADRAC) di BahagianRegulatori Farmasi Negara (NpRA).
4. Sebagai makluman, harga yang terdapat datam senarai di lampiran adalahharga yang diisytiharkan oleh pihak syarikat kepada bahagian ini untukmenyenaraikan ubat berkenaan ke dalam FUKKM. Sebarang perbezaan harga(melebihi harga yang ditawarkan) di peringkat hospital/ institusi KKM hendaklahdilaporkan beserta bukti dengan kadar segera supaya tindakan selanjutnya dapatdiambil.
5' Sehubungan dengan itu, diharapkan YBhg. Datuk/Dato'lDatinl-fuan/puandapat menyampaikan maklumat ini kepada fasiliti yang berkaitan di negeri ataujabatan masing-masing. segara kerjasama yang diberikan amaflah dihargai.
Sekian, terima kasih.
,BERKHIDMAT UNTUK NEGARA'
Saya yang menurut perintah,
(DR. RAMLI BIN ZATNAL) *rn. roo/Pengarah Bahagian Regulatori Farmasi Negarab.p. Pengarah Kanan Perkhidmatan FarmasiKementerian Kesihatan Malaysia
FAMY/sar/shmd
X [email protected]/[email protected]/[email protected] +603 - 7841 3366/36'14/3619E *ooa -7g\azz22
2ls
SENARAI EDARAN
1. Timbalan pengarah Kesihatan Negeri (Farmasi)Johor/ Kedah/ Kerantan/ Meraka/ Negeri sembiranT pahang/ perak/sabah/ sarawak/ serangor/ Terengganu/ wirayah persekutuanPutrajayal Wilayah persekutuan Labuan
2. Ketua pegawai FarmasiHospital Kuala Lumpur
3. Ketua Pegawai Farmasilnstitut Kanser Negara
4. Pegawai Farmasi y/mlnstitut Perubatan Respiratori.
5. Pegawai Farmasi y/mPusat Darah Negara
s.k.
1. Ketua SetiausahaKementerian Kesihatan Malaysia
2. Ketua Pengarah KesihatanKementerian Kesihatan Malaysia
3. Setiausaha Bahagian (perolehan & penswastaan)Kementerian Kesihatan MalaysiaAras 7, Blok E7, parcel EPresint 1, pusat pentadbiran Kerajaan persekutuan62509 Putrajaya(u.p Pegawai Farmasi)
4. Pengarah Kanan (Kesihatan pergigian)Kementerian Kesihatan MalaysiaAras 5, Blok E10, pusat pentadbiran Kerajaan persekutuan62590 Putrajaya
5. PengarahBahagian perkembangan perubatanAras 5-7, Blok E1, parcel EPresint 1, Pusat pentadbiran Kerajaan persekutuan62509 Putrajaya
Pulau Pinang/ perlis/Kuala Lumpur dan
3t5
6. PengarahBahagian Pembangunan Kesihatan KeluargaAras 5, Blok E6, Parcel EPresint 1, Pusat Pentadbiran Kerajaan persekutuan62509 Putrajaya
7. PengarahBahagian Kawalan penyakit
Kementerian Kesihatan MalaysiaAras 3, Blok E10, parcel E
Presint 1, Pusat pentadbiran Kerajaan persekutuan62509 Putrajaya
8. Semua Pengarah Kesihatan NegeriKementerian Kesihatan Malaysia
9. Semua Pengerusi JK Kerja Ubat-ubatanKementerian Kesihatan Malaysia
10. Semua Ahli Panel Kajisemuta Senarai Ubat-ubatanKementerian Kesihatan Malaysia
11. PengarahBahagian Regulatori Farmasi NegaraKementerian Kesihatan Malaysia
12. Semua Timbalan PengarahBahagian Amalan & perkembangan FarmasiKementerian Kesihatan Malaysia
13. Ketua Penolong Pengarah KananSektor Bekalan FarmasiCawangan Dasar Polisi perkhidmatanBahagian Perkembangan Kesihatan AwamKementerian Kesihatan Malaysia
14. Timbalan PengarahCawangan Teknologi Maklumat & lnformatik FarmasiBahagian Dasar dan perancangan Strategik Farmasi(bagi tujuan pengemaskinian sis/em phts).
15. Ketua PustakawanKementerian Kesihatan MalaysiaAras 4, Blok E7, Parcel EPresint 1, Pusat Pentadbiran Kerajaan persekutuan62509 Putrajaya
4t5
16. Penolong pegawai perpustakaanlnstitut Pengurusan KesihatanKementerian Kesihatan MalaysiaJalan Rumah SakitOff Jalan Bangsar59100 Kuala Lumpur
17. Unit Teknikat Bantuan perubatanPejabat rimbalan Ketua pengarah Kesihatan (perubatan)Aras 7, Blok E1, parcel EPresint 1, pusat pentadbiran Kerajaan persekutuan62509 Putrajaya.
18. Pengarah FarmasiBahagian perkhidmatan KesihatanKementerian pertahanan MalaysiaJalan padang Tembak50634 Kuala Lumpur
19. Ketua Jabatan FarmasiHospital Canselor Tuanku MukhrizPusat Perubatan Universiti Kebangsaan MalaysiaJalan Yaacob LatifBandar Tun Razak56000 Cheras, Kuala Lumpur
20. Ketua Pegawai FarmasiPusat Perubatan Universiti MalayaLembah Pantai59100 Kuala Lumpur
21. Ketua Pegawai FarmasiHospital Universiti Sains MalaysiaJalan Raja perempuan Zainab ll16150 Kubang Kerian, Kelantan
22. Ketua Pegawai FarmasiPusat Perubatan Universiti rsram Antarabangsa Maraysia (ppurAM)Jalan Sultan Ahmad Shah,25200 Kuantan, pahang
23. Pegawai Farmasilnstitut Jantung Negara
5t5
TERHAD - Edaran dalaman sahaja
PINDMN/TAMBAHAN KEPADA FORMULARIUBAT KKM (FUKKM)BIL,2 TAHUN 2018
PERMOHONAN PINDMN/TAMBAHAN KEPADA FUKKM YANG OILULUSKAN
B, PERMOHoNAN P|NDMN/TAMBAHAN KEPADA FUKKM YANG IIUK_g.lluLusKAN*M _ Formulari Ubat KKM)
1t8
NAMA.UBAT. ." '' ,
losfomycin trometamol 3llranules D1 - penyenaraan uOat OaruVortioxetine 10 mg tablet Dl - penyenaraianlGt baru
Tegafur 100 mg & uracil 224 mgcapsule
Leucovorin Calcium (Calcium Folinate) 15 mg tabletD1- tambahan -lndikasr,
Secukinumab 1S0 mg lnjection (pre_fiiled syringe/pen)
Cetirizine 10 mg tabtetpreskriber A/KK ke B
Etanercept 25 mg and 50 mg injection
BIL NAMA UBAT CADANGAN
PINDAAN JUSTIFIKASI
1
Eribulin Mesilate 0.S mg/mlsolution forinjection
D1 - penyenaraian
ubat baruMarginal clinical benefit
2Pertuzumab 420 mgl14 ml-concentration for solution for infusion
Trastuzumab 440 ng injection
D1 - penyenaraian
ubat baru
a) Moderate effectiveness; no
changes in quality of life despitelonger overall survival whencompared to Trastuzumab +
Docetaxelalone.
b) High budget imptication that isnot sustainable to MOH.
?D1 - tambahan indikasi
(metastatic breastcancef
4.Pomalidomide t mg7 mg 3 mg & 4mg capsules
D1 - penyenaraian
ubat baru
High budget imptic-tion to trrtOH wrtfr
marginal benefit.
E Racecadotrit 10 mg (infant) and 30 mg(children) granules for oral suspension
D1 - penyenaraian
ubat baru
HO1unctive for symptomatic
treatment and non essential
medicine for treatment of acutediarrhoea in infant and children.High drug cost.
a)
b)
6.PembrolizumaO tOO m[ soiution torinfusion
D1 - penyenaraian
ubat baru
Flrgn budget implication which is notsustainable to MOH
7.Ezetimibe/ Atorvastatin (10 mg/20 mg& 10 mgl40 mg)tabtet
D1 - penyenaraian
ubat baru
a) Sufficientalternatives availablein the MoHMF.
b) No added therapeutic/ clinicalbenefit as compared to co_
administration of separate
tablets.
Pindaan FUKKM Bit. 2/2018 (Jutai2018)
TERHAD - Edaran dalaman sahaja
UBAT.UBATAN BARU YANG DILULUSKAN UNTUK DISENARAIKAN DALAM FUKKM
LAMPIRAN 1
BIL NAMA UBATCADANGAN
PINDMN JUSTIFIKASI
8. Golimumab'l 2.5 mg/ml injectionD2 - tambahan
formulasi
Sufficient alternatives available in
the MoHMF
0 Etoricoxib 90 mg tablet
D3 - pindaan kategori
preskriberI Etoricoxib 90 mg is a recommended
dose for Rheumatoid Arthritis and
not recommended for otherindications (as listed in MoHMF
based on registration details by
Drug Control Authority).
With the change of category ofprescriber from A* to A, there is
possibility that Etoricoxib gOmg will
be used for unregistered indlcations,
Ihis wlll make monitoring difficult.
Pindaan FUKKM Bil.2/2018 (Jutai 2018)2t8
TERHAD - Edaran dalaman sahaja
fosfomycin trometamol hrve=hownl;hazard to the foetus. Fosfomycin should onlybe used in pregnancy when the expectedbenefit outweighs the risk.
Fosfomycin has been shown to cross intobreast milk. lt should not be given to lactatingwomen except in the case of real need.
Severe renal impairment (creatinineclearance < 10ml/min) and patientsundergoing haemodialysis - fosfomycintrometamol is contraindicated.
Contraindication(s):
Documented hypersensitivity to the drug,
Severe renal impairment (creatinineclearance < 10 ml/min)
Patients undergoing haemodialysis.
lnteraction(s):
Meal can decrease levels of fosfomycin in
blood and urine. Hence it should be taken on
an empty stomach,
Metoclopramide can decrease levels in urineand should be avoided.
Probenecid can decrease renal clearanceand excretion of fosfomycin and should beavoided.
Adverse reaction(s):
Fosfomycin is generally well tolerated by
adults and overdose data is limited.
Common: Diarrhea, nausea, dyspepsia,vulvovaginitis, headache and dizziness
Uncommon: Vomiting, abdominal pain, rash,urticaria, pruritus, paraesthesia and fatigue.
Rare: Tachycardia.
Pindaan FUKKM Bit.2/2018 (Julai 2018)
J/O
TERHAD - Edaran dalaman sahaja
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330-T32-
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Generic name:
Vortioxetine 10 mg
tablet
Cost:
RM4,71ltablet
Treatment of major depressive episodes in
adults.
Dose:
1Omg once daily in adults less than 65 years
of age. Depending on the individual patient
response, the dose may be increased to amaximum of 20mg vortioxetine once daily ordecreased to a minimum of Smg vortioxetine
once daily. After the depressive symptomsresolve, treatment for at least 6 months isrecommended for consolidation of the anti-depressive response.
Precaution(s):
Suicide/suicidal thoughts or clinicalworsening, seizures, serotonin syndrome orneuroleptic malignant syndrome,
hyponatraemia, renal lmpairment, hepaticimpairment, elderly & paediatric populations,
pregnancy & lactation.
Contraindication(s):
Hypersensitivity to the active substance or toany of the excipients. Concomitant use withnon-selective monoamine oxidase inhibitors(MAOls) or selective MAO-A inhibitors,
Interaction(s):
Vortioxetine is extensively metabolized in theliver, primarily through oxidation catalysed by
CYP2DO and to a minor extend Cyp3A4/5and CYP2C9, and subsequent glucuronic
acid conjugation.
No inhibitory or inducing effect of vortioxetinewas observed in the drug-drug interaction
studies for the CYP isozymes CyplA2,CYP2A6, CYP286, CYP2C8, CYP2Cg,
CYP2C1 9, CYP2D6, CYPZEI or Cyp3A4/S.Vorlioxetine is a poor P-gp substrate and
inhibitor. The major metabolite of vortioxetine
is pharmacologically inactive.
Pindaan FUKKM Bil. 2/2018 (Jutai Z01B)
4t8
TERHAD - Edaran dalaman sahaja
LAMPIRAN 2
TAMBAHAN INDIKASIYANG DILULUSKAN BAGI UBAT.UBATAN YANG TERSENARAIDALAM FUKKM.
Adverse reaction(s):
Nausea, decreased appetite, abnormaldreams, dizziness, diarrhoea, constipation,vomiting, generalized pruritus.
CURRENT DRUG,IN
MoHMF
Secukinumab 150
mg/ml injection (pre-
filled syringe/pen)
Approved to add indication(s):Plaque psoriasis
Secukinumab is indicated for thetreatment of moderate to severeplaque psoriasis (PsO) in adultpatients who are candidates for
systemic therapy orphototherapy
Cost:
RM 1,400 per 150m9/ml solution
for injection in a pre-filled syringe
or pre{illed pen
Category of Prescriber:
A*
Dose:
Plaque psoriasis:
The recommended dose is 300 mg bysubcutaneous injection with initial dosingat weeks 0, 1, Z and 3, followed bymonthly maintenance dosing starting atweek 4. Each 300 mg dose is given as twosubcutaneous injections of 150 mg.
For some patients, a dosage of 150mgmay be acceptable.
Precaution(s):
. Pregnancy: Secukinumab should be
used during pregnancy only if thebenefits clearly outweigh the potential
risks,
. Breastfeeding: lt is not knownwhether secukinumab is excreted in
immunoglobulins are excreted inhuman milk, caution should beexercised when secukinumab is
administered to a woman who isbreastfeeding.
Patients with hepatic and renalimpairment: Secukinumab has not
been studied specifically in thesepatient populations,
Elderly patients: Based on population
PK analysis, clearance in elderly
Pindaan FUKKM Bit. il2018 (Jutai2018)
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TERHAD - Edaran dalaman sahaja
. DETAILS
patients and patients less than 65years of age was similar. Therefore,
no dose adjustment is required.
. Paediatric patients: Safety and
effectiveness in paediatric patients
below the age of 18 years have notyet been established.
Contraindication(s):
Severe hypersensitivity reactions to theactive substance or to any of theexcipients.
lnteraction(s):
Live vaccines should not be
concurrently with Secukinumab.
Adverse reaction(s):
Upper respiratory tract infection,
nasopharyngitis, rhinitis, pharyngitis, oral
herpes, rhinonhoea, diarrhoea, urticaria.
Tegafur 100 mg &
uracil224 mg capsule
Approved to add indication(s):Tegafur Uracil plus folinic acid
(leucovorin) combination therapy
is indicated for the treatment ofcolorectal cancer in:
a) Metastatic stage,
b) Adjuvant setting,
c) Concurrent setting.
Cost:
RM 3.97/capsule
Cateqory of Prescriber:
A*
Dose:
a) Adjuvant setting
300m9/mz/day , Day 1-28, rest Z
days; Leucovorin Calcium Ts
mg/day, Day 1-28, rest 7 days for 5cycles;
b) Concurrent setting
300m9/m2lday; Leucovorin Calcium
25 mg lday, D8- D3O, for 4 weeks;
c) Metastatic stage
300mg/mz/day , Day 1-28, rest 7
days; Leucovorin Calcium Ts
mg/day, Day 1-28, rest 7 days for 5cycles.
Precaution(s):
Bone marrow depression. History of CV
disease. Hepatic & renal disorders.lnfectious complications, varicella, Gastric
or duodenal ulcers. Abnormal glucose
Pindaan FUKKM Bil. 2/2018 (Jutai2018)6/8
TERHAD - Edaran dalaman sahaja
tolerance. Patients on chemotherapy.
Children and elderly.
Contraindication(s):
Patient with serious bone marrow, serious
diarrhea, serious infectionl, patient
receiving treatment with tegafur, gimeracil,
oteracil potassium combination product orwithin 7 days after withdrawal of thisproduct , pregnancy and lactation.
lnteraction(s):
lncreased action of phenytoin, warfarin,
other antineoplastics or radiatron therapy.
Adverse reaction(s):
Gastrointestinal disturbances, blood
dyscrasias, pigmentation, severe hepatic
disorder eg fulminant hepatitis, hepatic
cirrhosis, dehydration, severe enteritis,
cardiovascular disease, acute renal
failure, nephrotic syndrome, anosmia,
interstitial pneumonia, acute pancreatitis,
severe stomatitis, gastrointestinal
ulceration & haemorrhage, Stevens-
Johnson syndrome, Lyell's syndrome,
Leucovorin Calcium
(Calcium Folinate) 15
mg tablet
Approved to add indication(s):
Folinic acid (leucovorin) plus
Tegafur-Uracil combination
therapy is indicated for the
treatment of colorectal cancer in:
a) Metastatic stage,
b) Adjuvant setting,
c) Concurrent setting
Cost:
RM 3,50/tablet
Cateqory of Prescriber:
A*
Dose:
a) Adjuvant settingLeucovorin Calcium 75 mg/day, Day1-28, rest 7 days for 5 cycles;Concurrent settingLeucovorin Calcium 25 mg /day, DB-D36, for 4 weeks;
Metastatic stageLeucovorin Calcium 75 mg/day, Day1-28, rest 7 days for 5 cycles.
Precaution(s):
Pregnancy, lactation, seizure disorder
Pindaan FUKKM Bil.2/2018 (Julai 2018)7 t8
TERHAD - Edaran dalaman sahaja
LAMPIRAN 3PINDAAN KATEGORIPRESKRIBER BAGI UBAT.UBATAN DALAM FUKKM YANG DILULUSKAN.
LAMPIRAN 4INDIKASI YANG DILULUSKAN UNTUK DIMANSUHKAN DARIPADA FUKKM
Hypersensitivity to leucovorin, pernicious
anaemia or megaloblastic anaemia wherevitamin B'12 is deficienr.
lnteraction(s):
May diminish the effect of anti-epileptic
substances such as phenobarbitone,
phenytoin. When calcium folinate is given
in conjunction with a folic acid antagonist(e.9. cotrimoxazole, pyrimethamine) theefficacy of the folic acid antagonist mayeither be reduced or completelyneutralised. Concomitant administration
with S-fluorouracil may enhance theefficacy and toxicity of S-fluorouracil
Adverse reaction(s):
Nausea, vomiting, mucosal toxicity,diarrhoea
ru0. CURRENT DRUG.IN MoHMF AMENDMENT .DETAILS
1 Cetirizine 10 mg tablet Approved to amend category
of prescriber from IVKK
kepada B
Alldetails as in MoHMF
/Vo.CARRENT DRUG,/IV]'
MoHMFA;MENDMENT REASO,VFOR APPR?VAL
1. Etanercept 25 mg lnjection
& Etanercept 50 mg
lnjection
Approved to remove indication:Moderate to severe plaque psoriasis
who failed to respond to, or who have acontraindication to, or are intolerant to
other systemic therapy including
cyclosporine, methotrexate or pUVA.
Etanercept shows the lowest
effectiveness as compared to
other alternatives available in
MoHMF
Pindaan FUKKM Bil. 2/2018 (Jutai 201 8)
8/8