DORSET MEDICINES ADVISORY GROUP

COMMISSIONING STATEMENT ON THE USE OF BISPHOSPHONATES FOR TREATING OSTEOPOROSIS

SUMMARY NHS Dorset Clinical Commissioning Group commissions in accordance with NICE TA464 bisphosphonates (alendronic acid, ibandronic acid, risedronate sodium and zoledronic acid) for treating osteoporosis

Alendronic acid, ibandronic acid, risedronate sodium and zoledronic acid are bisphosphonates, licensed for treating osteoporosis. Currently clinicians offer bisphosphonates to people with osteoporosis who are eligible for risk assessment and who have a high fracture risk. To simplify the criteria for treatment and bring the guidance into line with NICE's guideline on osteoporosis, the evidence on bisphosphonates has been reviewed. A new network meta-analysis confirms that bisphosphonates are more effective at reducing the risk of fracture than placebo. Risk assessment tools are used in clinical practice (FRAX and QFracture), in line with NICE's guideline on osteoporosis. These tools measure risk differently and can give different levels of risk in the same person. Oral bisphosphonates are recommended because new analyses show they are cost effective for people with at least a 1% risk of osteoporotic fragility fracture, irrespective of the assessment tool used. Similarly, intravenous bisphosphonates are recommended because they are cost effective for people with at least a 10% risk of osteoporotic fragility fracture, irrespective of the risk assessment tool used. BACKGROUND For some people with a 1% risk of osteoporotic fragility fracture, oral bisphosphonates may be contraindicated or not tolerated, or taking them might be difficult or impossible. For these people intravenous bisphosphonates are recommended. Oral bisphosphonates (alendronic acid, ibandronic acid and risedronate sodium) are recommended as options for treating osteoporosis in adults only if:  The person is eligible for risk assessment as defined in NICE's guideline on osteoporosis  The 10‑year probability of osteoporotic fragility fracture is at least 1%. Intravenous bisphosphonates (ibandronic acid and zoledronic acid) are recommended as options for treating osteoporosis in adults only if:  The person is eligible for risk assessment as defined in NICE's guideline on osteoporosis (recommendations 1.1 and 1.2) and  The 10‑year probability of osteoporotic fragility fracture is at least 10% or  The 10‑year probability of osteoporotic fragility fracture is at least 1% and the person has difficulty taking oral bisphosphonates (alendronic acid, ibandronic acid or risedronate sodium) or these drugs are contraindicated or not tolerated.

The choice of treatment should be made on an individual basis after discussion between the responsible clinician and the patient, or their carers, about the advantages and disadvantages of the treatments available. If generic products are available, start treatment with the least expensive formulation, taking into account administration costs, the dose needed and the cost per dose. These recommendations are not intended to affect treatment with alendronic acid, ibandronic acid, risedronate sodium and zoledronic acid that was started in the NHS before this guidance was published. Adults having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop

NICE TA 464 Bisphosphonates for treating osteoporosis NICE TA160 Alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women RELEVANT NICE GUIDANCE NICE TA161 Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women Osteoporosis Quality Standard QS149

Green Status Drugs: Alendronic Acid, Ibandronic Acid, Risedronate FORMULARY STATUS Sodium Red Status Drugs: Zoledronic Acid

PBR STATUS Drug costs included within PbR tariff

We do not expect this guidance to have a significant impact on resources that is, it will be less than £5m per year in England (or £9,100 per 100,000 COMMISSIONING population). IMPLICATIONS We do not think practice will change substantially as a result of this guidance and the cost of treatment is low.

RELEVANT CLINICAL COMMISSIONING Planned and Specialist Clinical Commissioning Group PROGRAMME

PATIENT PATHWAY NHS Dorset, NHS Bournemouth and Poole – Medical Management of men IMPLICATIONS and women who have or are at risk of osteoporosis (2012)

PRESCRIBING INFORMATION & COST

Drug Cost Per Pack Cost Per Year Alendronic Acid Tablets 10mg £1.76 x 28 £22.94 Alendronic Acid Tablets 70mg 78p x 4 £10.14 Alendronic Acid Oral Solution 70mg/100ml £27.60 4x 100ml £358.80 Ibandronic Acid Tablets 150mg £1.10 x 1 £13.20 Ibandronic 3mg/3ml Injection £65.20 £260.80 Risedronate Tablets 5mg 18.85 x 28 £245.72

Risedronate Tablets 35mg 89p x 4 £11.57 Zoledronic Acid (Aclasta®) 5mg/100ml infusion £253.38 x 1 £253.38 Zoledronic Acid Solution for infusion 50mg/100ml vials (Dr Reddy’s) £253.58 x 1 £253.58

Drug Dose The recommended dosage is one 70 mg tablet once weekly, on the Alendronic Acid 10 & 70mg tablets same day each week, or 10mg once daily.

Alendronic Acid Oral Solution The recommended dosage is one 70mg unit-dose (100 ml) once 70mg/100ml weekly. The recommended dose is one 150 mg film-coated tablet once a Ibandronic Acid 150mg tablets month. The tablet should preferably be taken on the same date each

month.

Ibandronic 3mg/3ml Injection One injection every three months. The recommended dose in adults is one 35 mg tablet orally once a Risedronate 35mg tablets week. The tablet should be taken on the same day each week.

Risedronate 5mg tablets The recommended daily dose in adults is one 5 mg tablet orally.

For the treatment of post-menopausal osteoporosis, osteoporosis in Zoledronic Acid – (Aclasta® and men and the treatment of osteoporosis associated with long-term generics) systemic glucocorticoid therapy, the recommended dose is a single intravenous infusion of 5 mg zoledronic acid administered once a year. Prices from the Drug Tariff August 2017 and dm+d accessed August 2017.

REFERENCES NICE TA 464 Bisphosphonates for treating osteoporosis

DATE August 2017

REVIEW DATE August 2019 or before, in light of new information.

CONTACT FOR Vanessa Sherwood, Senior Pharmacist, NHS Dorset Clinical Commissioning Group. THIS POLICY