Manish Banker. Declared receipt of grants; member of a company advisory board, board of director or similar group

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1 Manish Banker Nova IVI Fertility Pulse Women's Hospital Gujarat, India Declared receipt of grants; member of a company advisory board, board of director or similar group

2 The Indian point of view Manish Banker India

3 Outline Role of LH Science Perception Indian ART scenario LH practice in India Conclusions

4 Outline Role of LH Science Perception Indian ART scenario LH practice in India Conclusions

5 The role of LH Historically, follicular stimulation protocols have included both FSH and LH in an attempt to mimic the natural human physiology. However, with the advent of recombinant gonadotropins, and newer regimens, the importance of LH has come under debate. Caglar G, RBM online, 2005; Levy et al, Human Reproduction 2000

6 LH determines follicular fate early in the cycle Theca cells express LH receptors from early antral follicle stage 5 mm 5 10 mm >10 mm Granulosa cells No LH receptor expression in granulosa cells Expression of LH receptor observed in granulosa cells of 80% of follicles Expression of LH receptor increases while FSH receptors decrease Jeppesen JV, et al. J Clin Endocrinol Metab 2012;97:E1524 E1531

7 The role of LH Historically, follicular stimulation protocols have included both FSH and LH in an attempt to mimic the natural human physiology. However, with the advent of recombinant gonadotropins, and newer regimens, the importance of LH has come under debate. Now recombinant LH use is being recommended by fertility specialists globally, to reduce the total gonadotropin dose required, and improve the outcome of ovarian stimulation, esp. in situations like: Hypogonadotropic hypogonadism Advanced maternal age Poor ovarian reserve Caglar G, RBM online, 2005; Levy et al, Human Reproduction 2000

8 Most of the Asian assisted reproduction practitioners make use of both long agonist and antagonist protocols for ovarian stimulation; majority using the former approach. Published literature on the beneficial effects of exogenous LH in patients with previous suboptimal response or low baseline serum LH concentrations is more extensive in long agonist protocols. Documented results associate poorer outcomes with patients whose LH concentration was low after GnRH agonist treatment. Wong PC et al. Current opinion on use of luteinizing hormone supplementation in assisted reproduction therapy: An Asian perspective. Reprod Biomed Online. 2011;23:81 90.

9 The Asia Pacific Fertility Advisory Group in 2011 strongly recommended r-hlh co-treatment with r-hfsh in patients with a history of poor response as in: Suboptimal response on day 6 in long agonist cycles absence of >10 mm follicles endometrial thickness of <6 mm estradiol levels <200 pg/ml r-hlh may also be beneficial in women aged >35 years undergoing ovarian stimulation with long agonist or antagonist protocols. Wong PC et al. Current opinion on use of luteinizing hormone supplementation in assisted reproduction therapy: An Asian perspective. Reprod Biomed Online. 2011;23:81 90.

10 Outline Role of LH Science Perception Indian ART scenario LH practice in India Conclusions

11 Adoption of LH in Patient Cycles IN doctors recognize the benefits of LH adoption. About 9 in 10 doctors think that LH addition will benefit certain patient types, whereas the remaining are in favour of adding LH to all cycles. 89% 11% LH adds no benefit at all to the outcome of the IVF cycles LH adds benefit to only certain patients profiles undergoing IVF cycles LH improves the outcome and should be used in all IVF cycles Base: All Respondents (n=54) Market research, IPSOS Healthcare research agency

12 Patients who will benefit from LH activity Among doctors who are positive about LH adoption, majority think that poor responders are likely to benefit from additional LH activity. Others include older patients (37 years old and above), patients with low LH levels followed by normal and hypo-hypogonadotropic patients. % of Doctors selecting patient type Arranged in descending order of % of doctors Poor responders Older patients Patients with low LH levels Normal responders Hypo-Hypogonadotropic patients High responders 46% 37% 35% 35% 22% 70% Average age 37 years old PCOS patients 6% Base: All Respondents who will add LH to patient cycles (n=54) Market research, IPSOS Healthcare research agency

13 Patients who will benefit from LH activity Among doctors who are positive about LH adoption, majority think that poor responders are likely to benefit from additional LH activity. Others include older patients (37 years old and above), patients with low LH levels followed by normal and hypo-hypogonadotropic patients. % of Doctors selecting patient type Arranged in descending order of % of doctors Poor responders Older patients Patients with low LH levels Normal responders Hypo-Hypogonadotropic patients High responders 46% 37% 35% 35% 22% 70% Average age 37 years old PCOS patients 6% Base: All Respondents who will add LH to patient cycles (n=54) Market research, IPSOS Healthcare research agency

14 Start of LH Activity About 1 in 3 doctors would start their patients on LH activity at the start of the cycle, while the rest of the majority tend to start in the middle of the cycle, typically on Day 6. Day 1 33% 67% Day 6 of doctors will start LH activity at the beginning of stimulation of doctors will start LH activity in the middle of stimulation Base: All Respondents who will add LH to patient cycles (n=54) Average day of the cycle when LH activity is started Market research, IPSOS Healthcare research agency

15 Preferred FSH:LH Ratio In terms of the preferred FSH:LH ratio, about half of the doctors prefer a ratio of 2:1, while another third of them are inclined towards the use of 3:1 ratio. % of Doctors selecting FSH:LH Ratio Arranged in descending order of % of doctors 2:1 3:1 1:1 17% 35% 48% Base: All Respondents who will add LH to patient cycles (n=54) Market research, IPSOS Healthcare research agency

16 Real LH vs. hcg-driven LH activity from hmg More of the sampled IN doctors associate hcg-driven LH with higher potency and better efficacy. They are also generally aware that this LH type has longer half life. In contrast, real LH is deemed to be better in terms of safety. Safer (17 mentions) Shorter half life (6 mentions) Higher number of oocytes (3 mentions) Higher number of embryo (3 mentions) Better quality of oocytes (2 mentions) Better quality of embryo (2 mentions) Longer half life (1 mention) More expensive (1 mention) Longer half life (50 mentions) Higher potency (48 mentions) Better quality of oocytes (34 mentions) Better quality of embryo (31 mentions) Higher number of oocytes (30 mentions) Higher number of embryo (30 mentions) Safer (7 mentions) Higher risk of contamination (1 mention) Base: All Respondents who will add LH to patient cycles (n=54) Market research, IPSOS Healthcare research agency

17 Outline Role of LH Science Perception Indian ART scenario LH practice in India Conclusions

18 Indian infertility scenario 1.3 billion population 27.5 million infertile couples 275,000 couples seek ART treatment ~100,000 IVF cycles/yr E& Y market survey Sayeed UNISA Infertility and Treatment Seeking in India: Findings from District Level Household Survey F, V & V IN OBGYN, 2010, MONOGRAPH: 59-65

19 IVF potential in India India s population has a high youth percentage, with approximately 50% of the population in the fertility age bracket India has a potential to conduct approximately 1500 cycles /million population. The market is expected to grow at a CAGR (Cumulative Average Growth Rate) of ~20% from the current 100,000 cycles to 260,000 cycles in The increase in the proportion of women is skewed towards those aged years, and is forecast to increase by ~20% between 2010 to The estimated IVF market is projected to be 1260 million USD by 2020.

20 Awareness and access

21 Affordability 1 Mill INR ~ 15,000 USD

22 Conclusions: Ovaries from Indian women seem to age at an earlier stage than Caucasian. Similar ovarian reserve markers and ovarian response was observed in women with a 6-year difference in favour of Caucasian, which suggest ethnic differences in ovarian aging. July 2014

23 Results: Indian women differed significantly from white Caucasian women in baseline characteristics like age (30.6 ± 0.2 versus 37.6 ± 0.1 years; p<0.001), BMI (22.3 ± 0.2 versus 26.6 ± 1.0 kg/m2; p<0.05), duration of infertility (6.9 ± 3.0 versus 2.5 ± 0.1 years; p<0.001) and antral follicle count (AFC) (8.9 ± 0.4 versus 7.5 ± 0.2; p<0.001). Indian women had lower implantation rate (30.1% versus 39.6%: p<0.001) and OPR (35.1% versus 41.7%: p<0.001) compared with white Caucasian women. Regression analysis proved independent effect of ethnicity on OPR (OR 0.944; 95% CI : p<0.001) In Press

24 Cost of IVF in India USD Total IVF Cost rec-fsh + u-hmg ( ) rec-fsh + rec-lh ( ) u-hmg (300) Cost of only drugs

25 Outline Role of LH Science Perception Indian ART scenario LH practice in India Conclusions

26 TITLE IMPROVING THE PATIENT S LIFE THROUGH MEDICAL EDUCATION

27 LH use at NIF : Source SiviS H/O previous 1 IVF cycle with 300 rec-fsh

28 LH use in NIF [ July 2014 Dec 2015 ] 180 out of 8252 self stimulations : 2.2% IU 75 IU 150 IU Indications : 1. Advanced maternal age 2. Poor ovarian reserve / Poor responder 3. Endometriosis

29 LH use in NIF : IVF Total no: 180 ET Done: 114 No ET: 66 Positive: 45 Negative: 69 No Embryos: 13 Pooling: 51

30 Usage rates at NIF based on stimulation protocols 60% 50% 52,5% 40% 30% 20% 10% 26,5% 18,8% 0% 2,2% rec-fsh u-hmg rec-fsh + u-hmg rec-fsh + rec-lh % Usage

31 Patient Profile rec-fsh u-hmg rec-fsh + u-hmg rec-fsh + rec-lh Age

32 Average oocytes retrieved rec-fsh u-hmg rec-fsh + u-hmg rec-fsh + rec-lh Age Average no. of eggs retrieved

33 Pregnancy and live birth rates at NIF based on stimulation protocols 60% 50% 40% 50% 40% 38% 42% 38% 30% 27% 31% 28% 20% 10% 0% rec-fsh u-hmg rec-fsh + u-hmg rec-fsh + rec-lh Clinical pregnancy rate Live Birth rate

34 Why is IVF market potential not realized?

35 Why is IVF market potential not realized? Affordability

36 Affordability There is still a lack of conviction amongst IVF practitioners that rec FSH + rec LH is atleast as cost effective as rec FSH + u-hmg, in the patient population (patients with advanced maternal age and poor ovarian reserve) where LH use is recommended. Most doctors use u-hmg as a surrogate LH supplement, to reduce costs and thus reduce the patient s financial burden.

37 Why is IVF market potential not realized? Affordability Fragmented market

38 Fragmented market 55% of all IVF cycles being performed in the 8 main metro cities. The IVF market is highly under-penetrated with addressable demand being 9 to 12 times higher than the current market. Poor geographic distribution of infertility treatment facilities highlights the difficulty in accessing treatment options faced by patients

39 No. of clinics NARI: Distribution of clinics according to number of cycles < >1000 No. of cycles / year

40 Why is IVF market potential not realized? Affordability Fragmented market Awareness and access

41 Awareness and access Poor access to human infrastructure (IVF specialists) and physical infrastructure (diagnostic and treatment facilities) Lack of awareness about potential problems, the need for infertility treatment and options available.

42 Awareness and access Number of qualified Gynecologists and Embryologists

43 Why is IVF market potential not realized? Affordability Fragmented market Awareness and access Lack of a regulatory framework for quality management

44 Lack of a regulatory framework for quality management No legal registration is required for ART clinics and banks currently. Hence the compliance with best practices and ethical guidelines are circumspect. The Assisted Reproductive Technologies (Regulation) Bill still awaiting legislative approval in India

45 To summarise Potential Perception Reality Patient profile

46 What is needed? Evidence and awareness Science v/s commerce Cost effectiveness of rec LH in Indian Population Effect of ethnicity : Early ovarian ageing Lower reproductive outcomes

47 Thank You

48

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