HEPATITIS C & PHARMACY Dimitra Tsucalas BPharm, FPS Ascot Vale Pharmacy

Promote Hep C treatment availability Encourage & facilitate adherence Decide whether you can supply or find out where to refer Script processing issues Manage the $$ side to pay the wholesaler Don’t forget GST – monthly BAS & $$ buffer

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Learning Objectives ________________________________________________________________________

Understand the complexities that face community pharmacies who participate in the provision of Hepatitis C medication

IMPORTANT POINTS ________________________________________________________________________

Peak of new Hep C infections has come & gone but, with 230,000 HCV positive Australians, peak of liver disease health burden is yet to come – anticipated by 2030 New HCV Tx provides excellent cure rate & improves liver related deaths & all cause mortality Exciting & unprecedented opportunity to eliminate HCV in Australia & reduce harms and costs

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IMPORTANT POINTS ________________________________________________________________________

Burnet Institute Treatment as Prevention (TAP) Study examines the feasibility of whether a new community based model of care, utilising nurses in outreach vans & clinics to simultaneously provide treatment & prevention strategies to high-risk transmitters, can reduce HCV transmission & prevalence Includes novel approach of a treat & ‘bring your friends’ arm (using non-PBS funded drugs sofosbuvir & ledipasvir) Australia is only country where government strategically funds treatment! Very lucky residents!

BARRIERS ___________________________________________________________________________

Fear of previous treatments (interferon & ribavirin - now interferon-free for genotypes 1, 2 & 3) Previous poor response rates now more effective Long treatments – now shorter at 8 – 12 weeks Liver biopsies now not common Previous ivory tower hospital/specialist treatment now community/GP based, Hospital attendance unnecessary except for those with cirrhosis Available to injecting drug users & to prisoners Single GP blood test request to ID virus type Can now re-treat in relapse or re-infection Simple therapeutic regimens – once daily oral dosing

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IMPRESS ON YOUR PATIENTS ___________________________________________________________________________

Excellent cure rate 95% Chance of relapse is 0.1% Excellent tolerability with few S/E: tiredness, headache, vomiting, diarrhoea – similar to placebo High cost Importance of adherence for successful treatment and adherence also respects treatment cost Use 12 week Sustained Virological Response (SVR) test as a goal for adherence SVR12 = no HCV at 12 weeks = cure!

IMPRESS ON YOUR PATIENTS ___________________________________________________________________________

Plan ahead & talk to pharmacist- 4 weeks meds at a time (eg. holidays, work, pharmacy hours, payment etc) Re-infection is possible so future HCV protection required safe tattooing, sterile unshared needles, unsafe dental or cosmetic surgery procedures (eg. overseas), safe sex – use condoms etc

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TO SUPPLY OR NOT TO SUPPLY ___________________________________________________________________________

• Predictability of some ongoing high cost Tx can accord some

level of financial manageability HOWEVER • Current HCV $ load on top of the existing HIV, RA, MS & rapidly growing Diabetes cohort begs some questions: - is it possible? - is it worth it for $70? • Yes for the patient • Very highly questionable from accounting, business &

management points of view because of the unaffordability, lack of return & high risk financial precipice!

TO SUPPLY OR NOT TO SUPPLY ___________________________________________________________________________

• So, many pharmacies choosing not to provide HCV meds • But referring their patients on to other pharmacies or hospitals

• ? pharmacy number stats & geographical spread across

Australia, but service gaps could be critical RED FLAG • Unnecessary Achilles heel & major weak point for successful implementation of HCV elimination strategy • Pharmacy organisations including PSA & PGA have been politically active but with no real results • Ask that politicians of the Australian Government, Health Department & relevant organisations with an interest consider unnecessary consequences of failed strategy implementation & some easily implementable solutions

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OUR EXPERIENCE ___________________________________________________________________________

Decision to provide treatment - philosophically supportive of concept & community health benefits - supportive of our existing HCV patients - business decision to not refuse or refer on an existing p’cy patient Treated 11 since Mar 2016 - all regular patients - 10 successful - unfortunately, one failure (hospital cirrhosis treated patient), who is now having some more tests - highly rewarding for us & great celebratory joy for our patients

OUR FINANCIAL ADVENTURE ___________________________________________________________________________

August stressful surprise! • 5 patients (old & new) resulting in massive wholesaler bill & not looking like enough money in the bank to pay! • Complications of supply include: - cost of drugs alone (20K – 27K per person) - GST (2K – 3K per person) - Medicare payment timing

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LESSONS LEARNT ___________________________________________________________________________

Be aware & manage: • no. of existing patients already on treatment • no. of new patients seeking new treatment & when

they can be accommodated (ie. can they wait?) • do the maths & calculate how many patients the

pharmacy business can actually afford at any one time

LESSONS LEARNT ___________________________________________________________________________

Don’t forget: • concurrent financial impact of other ongoing high

cost drugs required for other existing patients (HIV, RA, MS, Diabetes) • to check with patients exactly when next scripts

are needed (some submit Rx but don’t collect immediately; some collect Rx but don’t start immediately)

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MEDICARE POINTS ______________________________________________________________________

When accepting new patients, consider: Medicare payment cycle on Fridays every 2 weeks & up to 10 business days from process date Check and confirm through Medicare

AND THE TAX MAN ______________________________________________________________________

Monthly BAS if not already doing this – get it back asap! $$ Buffer required for GST = 2-3K per person per Rx Calculate how much extra $$ is needed Check if you have it or can afford it

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OTHER SUPPORT ___________________________________________________________________________

• Psychological and emotional impact of HCV overshadowing

one’s life is enormous • Also need some strong support people and systems for

those clients whose treatment fails • Hopefully successful future Tx in the pipeline CASE STUDY – TF our one Tx failure to date A little bit special – 1st Methadone client since 1986 TF physically drained & feeling unwell Also emotionally exhausted & distraught Our limited offers of assistance (eg. deliveries of regular meds) More importantly offer of time for discussion, distraction, conversation, emotional support & hope

OTHER SUPPORT ___________________________________________________________________________

• Symptomatic S/E treatment with OTC meds • Anecdotal herbals & CAMs being used to support S/E,

immunity & liver function – no good data • All meds & CAMS to be checked for interactions • Relaxation & meditation • Support groups through Hepatitis Australia

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PHARMACY ACTIONS ______________________________________________________________________

• Inform local GPs & clinics know you are facilitating •

• • •

treatments Contact & link in with your Public Health Network (PHN) & utilise their programs, materials, training & communication systems Improve your knowledge - attend education sessions (PSA, PHN, other) Run in-house pharmacy information sessions on HCV Tx (targeted & untargeted groups) Use your own pharmacists as speakers or seek support for a speaker from PHN

GET THE MESSAGE OUT THERE! ___________________________________________________________________________

• Health promotions – pharmacy display • Information brochures (POS counter, in bags, on

methadone/bup counter/area) • Information brochure in each client’s signing book • Client discussions & engagement – targeted or linked

to promotions & information leaflets • Use opportunity to promote Hep A & B vaccination • Information note/point with OC & MAP supplies &

condom sales • A4 or A5 brochure/information prompts in strategic

pharmacy categories

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Hepatitis NSW Hospital Foyer Health Promotion

Ascot Vale Pharmacy Health Promotion

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Ascot Vale Pharmacy Health Promotion

People Stories

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Promotional Posters

Promotional Posters

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Pharmacy Prompts

Ascot Vale Pharmacy Information Sessions

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ADHERENCE TIPS ______________________________________________________________________

• Provide written information prior to starting therapy • Follow up patient with telephone call within the week of

starting therapy to encourage continuity, check for S/E and any other support required • Diary notes to call & remind patients within the week

prior to needing repeat dispensing • Re-invite patients to discuss condition & treatment • Check, interact with & encourage treatment continuity

with more regularly seen patients (eg. pharmacotherapy clients) • Remember to record your relevant Clinical Interventions

DRUG INTERACTIONS ______________________________________________________________________

Few ADR & few Drug-Drug interactions but notable points: • Amiodarone - bradycardia; some deaths • Carbamazepine, Oxcarbazepine, Phenytoin & Phenobarbitone –

hepatotoxicity risk in already HepC challenged liver

• Levetiracetam may be better choice • Pantoprazole & Omeprazole can ↓ absorption & therefore

effectiveness of Ledipasvir (Harvoni®)

• Statin levels can ↑ with protease inhibitor Tx – monitor for increased

muscle injuries & rhabdomyplysis & decrease dose or cease

• Potential for interactions exists & can be managed & prevented • Patient education prior & during treatment is essential • Health Care Professionals should watch for clinically emerging Sx &

interaction data with new studies

• www.hep-druginteractions.org

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CHANGING LANDSCAPE ______________________________________________________________________

• Increased international usage showing new issues, patterns

& results • Hepatitis Australia news bulletins & email mailing list to

keep up to date with international & Australian information sources • October News: New case reports of possible HBV reactivation when taking HCV meds leads to new FDA boxed warning on HCV drug labels (Sovaldi ®, Harvoni ® & Viekra Pak ®) with similar European & Japanese investigations & reviews starting Recommended to screen & monitor for HBV in HCV treated patients

RESOURCES • www.hepvic.org.au - HepChat regular E-News bulletins & support groups

• www.hep-druginteractions.org - comprehensive, up to date, evidence based free drug interaction charts

• www.hepatitisaustralia.com - up to date Hep C information, facts, news, articles, statistics

• www.hepatologyassociation.com.au • www.gesa.org.au - Gastroenterological Society of Australia together with the Australian

Liver Association - A4 clinical guidelines summary for treating Hep C

• www.ashm.org.au - Australasian Society of HIV Medicine

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www.hepcguidelines.org.au www.hepatitiscentral.com www.befreefromhepc,org.au www.pbs.gov.au – hep C factsheets

NATIONAL HEPATITIS INFORMATION LINE 180 437 222 (1800 HEP ABC)

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