Tugas FarmakoekonomiDimas Rizki Faluti051515153022

1. Tujuan PenelitianApakah tujuan dari penelitian sudah dinyatakan secara jelas a. Apakah permasalahan yang jelas telah dijawab dengan dilakukannya penelitian ?Permasalahan kurang sesuai dijawab dengan tujuan penelitian yang dilakukan. Judul penelitian adalah cost-minimization analysis. Sedangkan tujuan penelitian adalah untuk meneliti cost effectiveness.

Objective : To study the costeffectiveness of metformin and acarbosetwo extensively adopted agentsin treating T2DM.

b. Apakah perspektif penelitian telah dinyatakan secara jelas ?Perspektif penelitian telah dinyatakan secara jelas dengan menggunakan perspektif pemerintah

The perspective of the payer was used in this study

c. Dalam kelompok apakah pasien yang diteliti ?Pasien yang diteliti berupa pengelompokan berdasarkan perbedaan berat badan

Clinical scenarios for patients with T2DM with different body weights

d. Apakah relevansi klinik dari penelitian ?Penelitian yang dilakukan bersesuaian dengan guideline internasional tentang penggunaan metformin sebagai First line terapi T2DM dan sangat sedikit penelitian yang membandingkan metformin tersebut dengan akarbose

Metformin is thefirst-line oral hypoglycemic agent fortype 2 diabetes mellitus (T2DM) per international guidelines with proven efficacy, safety, and cost-effectiveness. However, little informatif comparing it with acarbose exists

2. Pemilihan SampelApakah pengelompokan pasien telah sesuai a. Apakah tipe pasien sesuai ?Tipe pasien yang diteliti telah sesuai yaitu untuk pasien Diabetes Mellitus Tipe 2

b. Apakah karakteristik demografi pasien dijelaskan ?Karakteristik demografi pasien disebutkan seperti kutipan berikut ini :

Diabetes is one of the common chronic diseases worldwide[1].China leads among the countries with the highest prevalence ofdiabetes. In 2010, the prevalence of diabetes in Chinese adults 18years and older was 11.6% (113.9 million)[2]. Because of the longduration and expensive treatment, diabetes not only affectspatients quality of life but also brings a heavy economic burdento both the family and the society. A study on the epidemic andeconomic burden of diabetes in China [3] indicates that theaverage annual growth rate of direct medical cost of diabeteswas 19.9% in recent years, which was higher than the grossdomestic product and national health care expenditure growthover the same period, ranking the second in all surveyed chronicdiseases

c. Apakah kriteria diagnosa telah ditetapkan ?Kriteria diagnosa tidak ditetapkan dalam penelitian ini.

3. Deskripsi perbandinganApakah studi alternatif dijabarkan secara jelas ?a. Apakah penelitian alternatif bersesuaian dengan tujuan penelitian ?

Penelitian alternatif lainnya tidak diketahui bersesuaian dengan tujuan penelitian dikarenakan, penelitian ini adalah penelitian yang pertama kalinya.

Regardless of these limitations, our study has a noteworthy strength that it is the first economic evaluation focusing on the comparison of metformin with acarbose in T2DM treatment, which is conducted on the basis of results from a meta-analysis study with large sample sizes and adequate clinical data.

b. Apakah semua penelitian alternatif yang relevan dijadikan acuan ?Penelitian alternatif sebelumnya, yang dijadikan acuan, yaitu yang menyatakan bahwa metformin adalah pilihan pertama dalam manajemen terapi Diabetes Mellitus tipe 2,

Findings from this study are consistent with those from previous studies That metformin is undoubtedly the first choice in the management of T2DM, with significant glucose-lowering effects and low treatment costs.

c. Apakah ada studi alternatif penting lainnya yang tidak dijadikan acuan ?Tidak ada studi alternatif lainnya yang tidak dijadikan acuan, dikarenakan penelitian ini adalah penelitian yang pertama kali (idem konteks pernyataan poin a)

4. PerspektifApakah perspektif penelitian sesuai ?a. Apakah perspektif penelitian telah disebutkan dengan jelas ?Perspektif penelitian telah disebutkan dengan jelas, yaitu dengan menggunakan sudut pandang penjamin (pemerintah).

The perspective of the payer was used in this study

b. Apakah perspektif penelitian yang ditetapkan sudah tepat bila dikaitkan dengan tujuan penelitian ?

Perspektif yang digunakan sudah tepat, dikarenakan kedua jenis obat yang dibandingkan termasuk obat yang dijamin oleh pemerintah.

The perspective of the payer was used in this study because bothdrugs are covered by the payer.

5. KeluaranApakah semua keluaran penelitian telah diidentifikasi dan diukur ?a. Apakah keluaran yang relevan dan keuntungan yang penting telah diukur dengan alat ukur yang tepat (satuan mata uang dan kualitas hidup, misalnya) ?

Satuan mata uang yang digunakan adalah mata uang Renminbi (China), Parameter biaya yang digunakan adalah direct Medical cost,, average treatment cost tahunan dan persentase saving dari biaya tahunan.

only direct medical costs were included. Formetformin (brand name Glucophage, specification 500 mg20tablets), the highest price set by the government is 29.2 and thelowest set by the market is 24.82; for acarbose (brand nameGlucobay, specification 50 mg30 tablets), the highest and thelowest price is 74.2 and 61.92, respectively [2023]. Both thelowest and highest prices were used to estimate the annualaverage treatment cost. Because both drugs are common oralhypoglycemic agents and tolerated well and have similar treatment efficacy and gastrointestinal adverse reactions, which canbe alleviated by starting at a low dose and escalating the dosegradually[7,11,2426], we, therefore, assume that patients takingboth drugs have the similar frequency of doctor visits. Thus, weassume that the relevant costs in treating T2DM, such as doctorvisit, diagnostic, inspection, and hospitalization cost, and so forth[27], can be set to be equivalent and not included in this study. Allcosts were based on 2014 prices and expressed in Renminbi ().

b. Apakah keluaran penelitian menjawab tujuan penelitian ?Keluaran penelitian menjawab tujuan penelitian yang berupa cost effectiveness, yaitu metformin sebagai terapi lini pertama (paling bermakna klinik) dibanding acarbose, dan metformin ini dapat menghemat pengeluaran biaya pemerintah dalam satu tahun.

Under the same level of glycemiccontrol, metformin could achieve annual cost savings by 39.87%(lowest price) or 40.97% (highest price) compared with acarbose.

c. Apakah waktu penelitian tepat digunakan untuk menyatakan keuntungan yang didapatkan dari hasil penelitian ?Waktu penelitian dilaksanakan telah tepat, dimana saat penelitian dilakukan, pemerintah China sedang membutuhkan informasi kajian farmakoekonomi dalam merumuskan kebijakan pengadaan obat diabetes mellitus tipe 2 bagi masyarakatnya, dengan pertimbangan obat yang paling ekonomis, tetapi memberikan hasil terapi yang maksimal.

A study on the epidemic andeconomic burden of diabetes in China [3] indicates that theaverage annual growth rate of direct medical cost of diabeteswas 19.9% in recent years, which was higher than the grossdomestic product and national health care expenditure growthover the same period, ranking the second in all surveyed chronicdiseases.Type 2 diabetes mellitus (T2DM) accounts for at least 90% of allcases of diabetes[4]. It has brought great burden in terms of healthcare cost and socioeconomic consequences, reaching $26.0 billionin 2007 in direct medical costs and predicted to be $47.2 billion by2030 in China [5]In the context of currenthealth policy, with more and more governments trying to limitthe escalation in health expenditure, there is an increasing needto find medical treatment strategies that are as effective but lesscostly.

6. BiayaApakah semua biaya telah teridentifikasi dan terukur ?a. Apakah semua variabel biaya yang penting dan relevan telah diukur secara akurat dengan satuan yang sesuai (terkait perspektif penelitian) Variabel biaya yang diukur adalah biaya langsung, dengan satuan mata uang renmibi.

b. Apakah biaya modal dan biaya teknis operasional dicantumkan dalam penelitian ?Biaya yang diukur hanya biaya langsung.

c. Apakah sumber data dari biaya dicantumkan dalam penelitian ?Sumber data biaya dan harga dicantumkan dalam penelitian, seperti kutipan berikut ini

For metformin (brand name Glucophage, specification 500 mg20tablets), the highest price set by the government is 29.2 and thelowest set by the market is 24.82; for acarbose (brand nameGlucobay, specification 50 mg30 tablets), the highest and thelowest price is 74.2 and 61.92, respectively [2023]

d. Apakah harga yang digunakan adalah harga saat penelitian dilakukan ?Iya, seperti pada kutipan c

e. Apakah biaya spesifik pada area geografis penelitian ataukah pada skenario medis ?Biaya yang diteliti spesifik pada daerah penelitian dan juga berdasarkan skenario medis

Based on physicians prescribing behaviors in China and thepotential increased risk for elevated serum transaminases inpatients with low body weight[25], the usual maximum dose ofacarbose is slightly different in different weight groups (150 mg/dfor weight r60 kg and 300 mg/d for weight460 kg)[2830].Meanwhile, because of the difference in clinical prescribinghabits and cognition of physicians in China, metformin alsohas two usual maximum doses (1500 and 2000 mg/d) in clinicalpractice, which is not strongly associated with patients weight.Eight clinical scenarios, therefore, were developed according todifferent therapeutic regimens for patients with T2DM withdifferent body weights to model different clinical conditions thatmay reflect real-world usage patterns of patients with T2DM.

7. Apakah discounting digunakan? Mengapa?Pada penelitian tersebut tidak digunakan discounting, dikarenakan semua biaya diukur dalam kurun waktu 1 tahun saja.

No cost discounting was applied because all costs were measuredby a period of 1 year8. Sensitivitas analisis penelitianApakah sensitivitas analisis telah diimplementasikan dalam penelitian ?a. Apakah sensitivitas analisis telah disertai justifikasi untuk rentangan nilai yang dianalisa ?Sudah disertai justifikasi, seperti pada kutipan berikut

Because physicians compliance with drugs instruction recommendations or national guidelines with regard to the initiationand monitoring of drug dosage in treating T2DM is unknown, insensitivity analysis, several different clinical scenarios weredeveloped after interviews with physicians treating diabeticpatients, to illustrate potential clinical situations as well as toanalyze the difference in annual average treatment costs withmetformin and acarbose.

b. Apakah hasil penelitian sensitif terhadap perubahan nilai ? Iya, dikarenakan justifikasi terapi tipe 2 diabetes dari dokter bisa berubah / berbeda seiring perkembangan ilmu dan teknologi. Sehingga skenario yang ditetapkan bisa berubah nilainya.

9. Tipe analisisApakah telah digunakan tipe analisa farmakoekonomi yang sesuai ?Telah sesuai digunakan tipe analisa minimalisasi biaya, dikarenakan untuk kepentingan penghematan anggaran pemerintah dalam pertanggungan biaya kesehatan masyarakat.

10. Hasil PenelitianApakah hasil penelitian telah dijabarkan secara jelas ?a. Apakah hasilnya telah disajikan secara utuh, jelas dan akurat ?Hasil penelitian telah disajikan secara utuh, jelas dan akurat seperti kutipan berikut ini

ResultsAnnual Average Treatment Cost of Metformin and Acarboseat Base CaseIn base-case cost analysis, the annual treatment cost of metformin was 1358.90 while that of acarbose was 2260.08 whenreferring to the lowest price; the annual treatment cost ofmetformin and acarbose was 1598.70 and 2708.30 referring tothe highest price, respectively. Under the same level of glycemiccontrol, metformin could achieve annual cost savings by 39.87%(lowest price) or 40.97% (highest price) compared with acarbose(Table 2).

Annual Average Treatment Cost of Metformin and Acarboseat Different ScenariosThe annual treatment cost of metformin ranged from 452.97 to2131.60 whereas that of acarbose ranged from 753.36 to2708.30 at the four different scenarios (scenarios 14) in whichpatients weight is 60 kg or less. Under these assumptions,metformin also minimizes the cost in all the four scenariosregardless of changes in daily dosage or medication cost, remaining a cost-saving strategy of 19.83% to 40.97% (Table 2).The annual treatment cost of metformin ranged from 452.97to 2131.60 whereas that of acarbose ranged from 753.36 to5416.60 at thefive different scenarios (scenario 1, and 58) inwhich patients weight is more than 60 kg. For all thefivescenarios, metformin administration was the lower cost strategycompared with acarbose, for which savings ranged from 39.87%to 70.49% (Table 2).

b. Apakah peneliti mengijinkan pertimbangan biaya lainnya dan keuntungannya ?Peneliti mengijinkan dalam penelitian selanjutnya untuk menggunakan variabel biaya yang lain dan keuntungan yang didapat bisa berupa deskripsi hasil yang lebih akurat sebagai bahan pertimbangan pemerintah mengambil keputusan.

Terkutip seperti di bawah ini :Thus, more studies are needed to understand the comprehensiveannual costs to provide disease burden information for guidingdecision making of resource allocation.11. DiskusiApakah penulis secara utuh mendiskusikan penelitiannya ?a. Apakah asumsi, batasan dan kemungkinan terjadinya bias penelitian didiskusikan ?IyaSeperti kutipan berikutThis study, furthermore, considers only asingle monotherapy for 1 year; however, in clinical practice,because of the complexity of diabetes, drug combination therapyis common and patients may switch drugs, which can have animpact on the cost; over a longer period, more complicationsrelated to diabetes, including microvascular and macrovasculardisease, may occur[6], which can also add treatment costs. Thus more studies are needed to understand the comprehensiveannual costs to provide disease burden information for guidingdecision making of resource allocation.Regardless of these limitations, our study has a noteworthystrength that it is thefirst economic evaluation focusing on thecomparison of metformin with acarbose in T2DM treatment,which is conducted on the basis of results from a meta-analysisstudy with large sample sizes and adequate clinical data

b. Apakah hasil penelitiannya dibandingkan dengan penelitian sebelumnya yang mengangkat masalah penelitian yang sama ?Tidak

c. Apakah implikasi klinik disebutkan ?IyaSeperti kutipan berikut Furthermore, a review of the economic evaluationof metformin hydrochloride and acarbose suggests that theyhave a similar role in prolonging the life of patients, improvingthe cardiovascular disease, and preventing or delaying the onsetof T2DM[51]. Metformin hydrochloride is a preferred treatmentfor patients with T2DM, with a higher efficiency in reducingfasting blood glucose and minimum cost compared with otherhypoglycemic drugs. Although acarbose is good at reducingpostprandial blood glucose, it has a higher cost[51]. Moreover,in patients with impaired glucose tolerance, metformin demonstrates a better value for money[51]. Metformin is more costeffective not only in treating T2DM but also in preventing theonset of diabetes compared with acarbose[52,53]

d. Apakah semua masalah yang terkait dengan pengguna hasil penelitian didiskusikan ?Tidake. Apakah permasalahan etika tergambar dalam penelitian ?Tidak

12. KesimpulanKesimpulan apa yang dapat diambil dari penelitian ?a. Apakah kesimpulan yang diambil valid dan berdasarkan hasil dan desain penelitian ?Iya Seperti kutipan berikut ini : Metformin appears to provide better value for money than doesAcarbose

b. Apakah kesimpulan terjustifikasi ?IyaSeperti kutipan berikut :Findings from this study are consistent with previousstudies that metformin is undoubtedly the first choice in themanagement of T2DM, with significantly glucose-lowering effectsand low treatment costs.

c. Saran apa yang telah disampaikan peneliti ?Tidak ada saran

d. Apakah kedapatgunaan penelitian dalam menemukan jawaban permasalahan penelitian yang lainnya dan kelompok pasien lain telah dijabarkan ?Belum dijabarkan