LARC Perspectives from Both Sides of the Atlantic

LARC Perspectives from Both Sides of the Atlantic • Pablo Rodriguez, MD (USA) • Chris Wilkinson, MBBS, FFFP (UK) October 2, 2009

Faculty Disclosure • Dr. Rodriguez is a speaker for Duramed and Schering-Plough • Dr. Wilkinson has no financial interests or affiliations to disclose Note: Additional faculty, staff, and committee disclosures printed in final program.

History of LARC Licensing and Litigation

US LARC History: ‘ 60 s 1962 Lippes Loop introduced 1966 Implant R&D 1968 Contraceptive action of intrauterine copper reported 1967 "T" shaped device developed

US LARC History: ‘ 70 s & ‘ 80 s 1976 Copper T 200 becomes first copper IUD 1988 Copper T 380 IUD available in the United States 1980 1986 Levonorgestrel IUD tested Dalkon Shield in randomized clinical removed from trials market

US LARC History: ‘ 90 s 1990 Norplant launch US 1998 Implanon enters international market 1992 FDA approves Depo Provera 3 -month progestin Hatcher RA, et al. Contraceptive Technology. 2007 Organon Data on File

US LARC History: ‘ 00 s 2002 2000 LNG IUD available in the Jadelle approved but not marketed in US; Norplant removed from US United State 2000 FDA approves Lunelle estrogen plus progestin Hatcher RA, et al. Contraceptive Technology. 2007 Population Council. www. popcouncil. org Organon Data on File 2006 FDA approves Implanon

US Labeling

Misinformation: DMPA US Providers believe: The facts: Bone density testing required BMD testing not required Increased resorption is permanent BMD returns in within 1 - 3 years once Development of menopausal osteoporotic fractures Estrogen supplementation not necessary Labeling Issues for Depot Medroxyprogesterone Acetate. 2008

Fear of exposure to lawsuits

UK PERSPECTIVE BAG IUD 1984 Depo-Provera 1991 Norplant 1995 LNG-IUS 1999 Implanon

UPDATED PRESCRIBING ADVICE ON THE EFFECT OF DEPO-PROVERA CONTRACEPTION ON BONES (November 2004) The Committee on Safety of Medicines advises that: “In adolescents, Depo-Provera may be used as first-line contraception but only after other methods have been discussed with the patient and considered to be unsuitable or unacceptable In women of all ages, careful re-evaluation of the risks and benefits of treatment should be carried out in those who wish to continue use for more than 2 years In women with significant lifestyle and/or medical risk factors for osteoporosis, other methods of contraception should be considered”

How do health care professionals respond to advice on adverse side effects of contraceptive methods? : the case of Depo Provera (Glasier et al 2007 Contraception) • • • Awareness of CSM advice on Depo Provera Effect on practice GPRD 169 GPs (79% response rate) 148 practice nurses (72% response rate)

How do health care professionals respond to advice on adverse side effects of contraceptive methods? : the case of Depo Provera (Glasier et al 2007 Contraception) • 89% aware of CSM advice • 1% dismissed evidence as unreliable • 73% reported change in practice (esp. <50)

How do health care professionals respond to advice on adverse side effects of contraceptive methods? : the case of Depo Provera (Glasier et al 2007 Contraception) • • • 1/3 would deter young people from DMPA (men) 16% would deter all women from DMPA Less than 5% would deter older women from DMPA 22% would limit use to 2 years Only 10% would suggest Implanon as alternative

Prevalence of use

US Contraceptive Use (2002) 23% % of US women ages 15 -44 by method type 19% 11% 3. 3% Sterilization OC 2. 5% 1. 3% 0. 8% IUD Other Male DMPA Hormonal Condom Other Withdrawal Non-hormonal Chandra A, et al. 2005. 13

UK Contraceptive use 2007 ONS data 2007

Current use of contraception: by age Omnibus 2005/06 (% including sterilisation) 16 - 18 - 2017 * 19 * 24 2529 3034 3539 4044 4549 All Pill 61 60 63 47 43 23 15 6 32 IUD - 2 0 6 6 8 9 12 7 IUS - - 4 2 1 3 2 DPr 4 17 6 7 5 4 2 1 4 Imp 8 4 7 2 1 0 0 - 2

Declining rates of female sterilisation in Scotland 1998 -2006

Continuation rates

US Continuation Rates % of Women Experiencing an Unintended Pregnancy within the First Year of use Method Typical Use Perfect Use Depo-Provera 3 0. 3 Lunelle 3 0. 05 Para. Gard (copper T) 0. 8 0. 6 Mirena (LNG-IUS) 0. 1 Norplant & Norplant-2 0. 05 % of Women Continuing Use at One Year Hatcher RA, et al. Contraceptive Technology. 2007 56 56 78 81 84

UK Continuation rates (%) (Cox 2002, Lakha & Glasier 2006) Method 1 year 3 years 5 years Implanon 75 47 -

UK Continuation rates (%) (Cox 2002, Lakha & Glasier 2006) Method 1 year 3 years 5 years Implanon 75 47 - IUD 74 47 33

UK Continuation rates (%) (Cox 2002, Lakha & Glasier 2006) Method 1 year 3 years 5 years Implanon 75 47 - IUD 74 47 33 IUS 70 50 40

Acceptability & attitudes

US Providers: Acceptability and Attitudes Towards LARC • Lack information/ misinformed • Believe LARC methods are safe • Few discuss LARC with patients

US Patients Acceptability and Attitudes Towards LARC

Attitudes of women in Scotland to contraception: A qualitative study to explore acceptability of long-acting methods. (Glasier A, Scorer J, Bigrigg A. JS&RH 2008) Focus Groups: 55 women in Scotland “It’s less hassle – you don’t have to remember”

“Horrible…you could see it and play with it” “I don’t like the idea of 3 years – it sounds too long” “I don’t like the idea of something inside me” “It’s not something I fancy…it’s a foreign body” “It’s what my mother would use…it’s for old women” “With a long term method, you’d worry what it was doing to your insides” “I don’t want to feel not fertile” “I hate the idea of a stranger poking around down there. That’s worse than having something out in your arm”

Attitudes towards long acting methods of contraception in General Practice in the UK (Wellings et al 2007 Contraception) • GPRD • 169 GPs (79% response rate) • 148 practice nurses (72% response rate)

Attitudes towards long acting methods of contraception in General Practice in the UK (Wellings et al 2007 Contraception) • 80% endorsed LARC in reducing teenage pregnancy • 47% saw LARC as becoming popular

Attitudes towards long acting methods of contraception in General Practice in the UK (Wellings et al 2007 Contraception) • • 80% endorsed LARC in reducing teenage pregnancy 47% saw LARC as becoming popular COC still mainstay of prescribing 60% lack of skill barrier to LARC 50% irregular bleeding barrier to use of LARC 21% concerned about high discontinuation rates Still many misconceptions about side effects

Service delivery, costs, equity and accessibility

Average US Cost of LARC Methods LARC Method Average Cost Copper IUD (Para. Gard) $200 -$380 LNG IUD (Mirena) $400 -$550 Implant (Implanon) $450 -$550 DMPA $55 -$65 per vial Hatcher RA, et al. Contraceptive Technology. 2007

US Healthcare System

US: Equity and Accessibility • Limited access to adequate women's health care for low-income women • Fewer preventive screenings • Few nearby publicly-funded family planning clinics • Limited access to insurance coverage – insurance coverage overall for reversible contraception – Attracting qualified physicians to disadvantaged areas is a challenge

Cost of LARC in the UK (Method costs from BNF 2009: Overall costs from NICE 2005) Method IUD (TT 380) Method cost (BNF 2009) £ 12 ($18) Overall Cost 1 year 3 or 5 years £ 133 ($204) £ 159 ($243)

Cost of LARC in the UK (Method costs from BNF 2009: Overall costs from NICE 2005) Method IUD (TT 380) Method cost (BNF 2009) £ 12 ($18) Overall Cost 1 year 3 or 5 years £ 133 ($204) £ 159 ($243) LNG-IUS £ 83 ($127) £ 207 ($317) £ 232 ($355)

Cost of LARC in the UK (Method costs from BNF 2009: Overall costs from NICE 2005) Method cost IUD (TT 380) £ 12 ($18) Overall Cost 1 year 3 or 5 years £ 133 ($204) £ 159 ($243) LNG-IUS £ 83 ($127) £ 207 ($317) £ 232 ($355) Implanon £ 81 ($124) £ 175 ($268) £ 230 ($352)

Cost of LARC in the UK (Method costs from BNF 2009: Overall costs from NICE 2005) Method cost IUD (TT 380) £ 12 ($18) Overall Cost 1 year 3 or 5 years £ 133 ($204) £ 159 ($243) LNG-IUS £ 83 ($127) £ 207 ($317) £ 232 ($355) Implanon £ 81 ($124) £ 175 ($268) £ 230 ($352) Depo Provera £ 6 ($9) £ 144 ($220) £ 540 ($826)

UK • Accessibility • Equity of access

I THE NHS

Case 1: Implanon • Age 25 years • Fit and well • One TO P 2008 • No mo ney • Wishes Implano n • Discuss her likel y manage ment

Case 1: Implanon • Has Im planon fitted • Return s six months later wit h irregular bleeding • She is f ed up • Discuss her likel y manage ment • Still ha s no mo ney

Case 2: IUD • Age: 20 • TOP ag ed 16 ye ars • Chlamy dia aged 18 years • Works as an es cort • Nullipa rous • Hates h ormone s • Discuss fitting an IUD for h er