New Listings and Changes 1 November 2010

ADDITIONS

Additions - Items

5281Y Adalimumab, Injection 40 mg in 0.8 mL pre-filled syringe (Humira)
5283C Adalimumab, Injection 40 mg in 0.8 mL pre-filled syringe (Humira) (Diff. Max. Rpts)
5282B Adalimumab, Injection 40 mg in 0.8 mL pre-filled pen (Humira)
5284D Adalimumab, Injection 40 mg in 0.8 mL pre-filled pen (Humira) (Diff. Max. Rpts)

The PBAC (March 2010) recommended listing adalimumab as a pharmaceutical benefit for people with severe active polyarticular course juvenile idiopathic arthritis (JIA). Adults who have a documented history of severe active polyarticular JIA with onset prior to the age of 18 years will be able to access adalimumab under a section 85 Authority Required listing and for people 18 or younger access will be under a section 100 (Highly Specialised Drugs Program) Public and Private Hospital Authority Required listing. (See Section 100 Additions – items).
Adalimumab is the second drug listed for JIA and therefore will provide an alternative choice for prescribers. Adalimumab will substitute for a proportion of the current use of etanercept. However, additional costs are anticipated as patients can have three treatment attempts to achieve a response to either etanercept or adalimumab in the one 12-month period: this compares with only one treatment attempt previously. Once a patient has either failed or ceased to respond to treatment 3 times, they can retry after 12 months if they are under 18 years of age or after 5 years if over 18 years of age. It is expected that a small proportion of people may need to try both therapies.

5285E Amlodipine with valsartan and hydrochlorothiazide, Tablet 5 mg (as besylate)-160 mg-12.5 mg (Exforge HCT 5/160/12.5)
5286F Amlodipine with valsartan and hydrochlorothiazide, Tablet 5 mg (as besylate)-160 mg-25 mg (Exforge HCT 5/160/25)
5287G Amlodipine with valsartan and hydrochlorothiazide, Tablet 10 mg (as besylate)-160 mg-12.5 mg (Exforge HCT 10/160/12.5)
5288H Amlodipine with valsartan and hydrochlorothiazide, Tablet 10 mg (as besylate)-160 mg-25 mg (Exforge HCT 10/160/25)
5289J Amlodipine with valsartan and hydrochlorothiazide, Tablet 10 mg (as besylate)-320 mg-25 mg (Exforge HCT 10/320/25)

The PBAC  (July 2010) recommended listing of amlodipine with valsartan and hydrochlorothiazide on the PBS as a Restricted Benefit listing for hypertension in a patient who is not adequately controlled with any two of the drugs in the combination in accordance with the combination Guidelines.  These items were listed on a cost-minimisation basis compared with the constituent components at equivalent doses. 

The listing will facilitate the quality use of medicines, allowing prescribers to add additional therapies to control blood pressure without adding to pill burden of the patient.  This type of add-on therapy is consistent with current clinical guidance.

 

5296R Artemether with lumefantrine, Tablet (dispersible) 20 mg-120 mg (Riamet 20mg/120mg Dispersible)

The PBAC (July 2010) recommended listing artemether with lumefantrine dispersible tablets on the PBS as an Authority required listing for the treatment of malaria due to Plasmodium falciparum.  Artemether with lumefantrine dispersible tablets will provide an alternative formulation to the currently PBS listed tablets for infants and children under 12 years and for those who cannot swallow whole tablets. Listing this product is expected to improve treatment of malaria in refugee populations. 

 

5298W Brimonidine tartrate, Eye drops 1.5 mg per mL (0.15%), 5 mL (Alphagan P 1.5)
5563T Brimonidine tartrate, Eye drops 1.5 mg per mL (0.15%), 5 mL (Alphagan P 1.5) (Optometrical)

The PBAC recommended listing brimonidine 0.15% eye drops on the PBS as an unrestricted benefit listing in the General and Optometrical Schedules on a cost-minimisation basis against brimonidine 0.2 % eye drops.   Brimonidine 0.15% eye drops is formulated with an alternative preservative to brimonidine 0.2 % eye drops: sodium chlorite is used as a preservative instead of benzalkonium chloride. 

3448L Etanercept, Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL (Enbrel) (Diff. Max. Rpts)
3446J Etanercept, Injections 50 mg in 1 mL single use pre-filled syringes, 4 (Enbrel)
3449M Etanercept, Injections 50 mg in 1 mL single use pre-filled syringes, 4 (Enbrel) (Diff. Max. Rpts)
3447K Etanercept, Injection 50 mg in 1 mL single use auto-injector, 4 (Enbrel)
3450N Etanercept, Injection 50 mg in 1 mL single use auto-injector, 4 (Enbrel) (Diff. Max. Rpts)

These items have been changed to be consistent with the listing of adalimumab for JIA.

 

5292M Olmesartan with amlodipine, Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as
besylate) (Sevikar 20/5)
5293N Olmesartan with amlodipine, Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as
besylate) (Sevikar 40/5)
5294P Olmesartan with amlodipine, Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg
(as besylate) (Sevikar 40/10)

The PBAC (July 2010) recommended the addition of a new combination tablet of olmesartan and amlodipine to treat patients with hypertension. The recommendation is on a cost-minimisation basis compared with the corresponding strengths of the constituent components, amlodipine and olmesartan given concomitantly.  This combination medicine is indicated for the control of hypertension in a patient who is not adequately controlled with either of the drugs in the combination in accordance with current guidelines for treating hypertension (elevated blood pressure).

 

5295Q Palonosetron, Injection 250 micrograms (as hydrochloride) in 5 mL (Aloxi)

Palonosetron was recommended for PBS listing for the management of nausea and vomiting associated with cytotoxic chemotherapy, which occurs within 48 hours of chemotherapy administration.  Palonosetron was recommended on a cost minimisation basis compared to intravenous ondansetron.

5299X Tacrolimus, Capsule 0.5 mg (once daily prolonged release) (Prograf XL)
5300Y Tacrolimus, Capsule 1 mg (once daily prolonged release) (Prograf XL)
5451X Tacrolimus, Capsule 5 mg (once daily prolonged release) (Prograf XL)

The PBAC (July 2010) recommended listing of tacrolimus prolonged release capsules on the PBS as an Authority Required listing for patients with organ or tissue transplants on a cost-minimisation basis with immediate release tacrolimus on a mg per mg basis at the same price per mg.  The Section 85 listing allows for maintenance therapy.  See “Section 100 Highly Specialised Drugs – Additions” for initiation listings.

5297T Triptorelin, Powder for I.M. injection (prolonged release) 22.5 mg (as embonate) with solvent, syringe and needles (Diphereline)

The PBAC (July 2010) recommended the listing of a new 6-month prolonged release formulation of triptorelin on a cost-minimisation basis with the currently PBS-listed leuprorelin acetate.  Triptorelin is listed for locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate.

 

Alterations — Maximum Quantity

9299K Hydromorphone hydrochloride, Tablet 4 mg (modified release) (Jurnista)
5023J Hydromorphone hydrochloride, Tablet 4 mg (modified release) (Jurnista) (Dental)
9406C Hydromorphone hydrochloride, Tablet 8 mg (modified release) (Jurnista)
3357Q Hydromorphone hydrochloride, Tablet 8 mg (modified release) (Jurnista) (Dental)
9407D Hydromorphone hydrochloride, Tablet 16 mg (modified release) (Jurnista)
3358R Hydromorphone hydrochloride, Tablet 16 mg (modified release) (Jurnista) (Dental)
9408E Hydromorphone hydrochloride, Tablet 32 mg (modified release) (Jurnista)
3367F Hydromorphone hydrochloride, Tablet 32 mg (modified release) (Jurnista) (Dental)
9409F Hydromorphone hydrochloride, Tablet 64 mg (modified release) (Jurnista)
3368G Hydromorphone hydrochloride, Tablet 64 mg (modified release) (Jurnista) (Dental)

The PBAC recommended that the maximum quantity for all strengths of currently listed hydromorphone modified release tablets be increased from 10 to 14 at the same price per tablet as the 10 tablet packs.  This change brings the listing in line with some other currently PBS listed opioid analgesics, fentanyl patches (Durogesic®) and buprenorphine patches (Norspan®), which provide 15 and 14 days treatment respectively.

This change will benefit people with chronic pain, reducing the number of prescriptions required for treatment.

 

Alterations – Restrictions

8511Y Alendronate sodium, Tablet equivalent to 70 mg alendronic acid (Adronat, Alendrobell 70mg,
Alendronate-GA, Alendronate Sandoz, Alendro Once Weekly, APO-Alendronate, Chem mart Alendronate
70mg, Ossmax 70mg, Terry White Chemists Alendronate 70mg, Fosamax Once Weekly)
9012H Alendronate sodium with colecalciferol, Tablet equivalent to 70 mg alendronic acid with 70 micrograms colecalciferol (Fosamax Plus)
9183H Alendronate sodium with colecalciferol, Tablet equivalent to 70 mg alendronic acid with
140 micrograms colecalciferol (Dronalen Plus, Fosamax Plus 70 mg/140 mcg)
9351E Alendronate sodium with colecalciferol and calcium carbonate, Pack containing 4 tablets containing the equivalent of 70 mg alendronic acid with 140 micrograms colecalciferol and 48 tablets calcium carbonate 1.25 g (equivalent to 500 mg calcium) (Fosamax Plus D-Cal)

The PBAC (July 2010) recommended that alendronate and its combination products be listed for people with corticosteroid-induced osteoporosis. This additional indication has been added to the above item codes.  This will provide prescribers with alternative preparations to risedronate and its combinations, that are currentlyPBS-listed.

 

2646G Amino acid formula with vitamins and minerals without lysine and low in tryptophan, Powder 500 g (XLYS, LOW TRY Maxamaid)

The PBAC (July 2010) recommended changing the listing for this food to improve the targeting of the product to the cost effective population. This item is not considered newsworthy

9459W Etanercept, Injection 50mg in 1mL single use auto-injector, 4 (Enbrel)
9089J Etanercept, Injections 50mg in 1mL single use pre-filled syringes, 4 (Enbrel)
8637N Etanercept, Injection set containing 4 vials powder for injection 25mg and 4 pre-filled syringes solvent 1mL (Enbrel)
9460X Etanercept, Injection 50mg in 1mL single use auto-injector, 4 (Enbrel) (Diff. Max. Rpts)
9090K Etanercept, Injections 50mg in 1mL single use pre-filled syringes, 4 (Enbrel) (Diff. Max. Rpts)
8638P Etanercept, Injection set containing 4 vials powder for injection 25mg and 4 pre-filled syringes solvent 1mL (Enbrel) (Diff. Max. Rpts)

Indications relating to severe active polyarticular course juvenile chronic arthritis have been transferred from these items to new items 3447K, 3446J, 3445H, 3450N, 3449M and 3448L (for the indication of juvenile idiopathic arthritis as seen in ‘additions’ above).  There is no impact to the current availability.

9403X Lanthanum, Tablet, chewable, 500 mg (as carbonate hydrate) (Fosrenol)
9404Y Lanthanum, Tablet, chewable, 750 mg (as carbonate hydrate) (Fosrenol)
9405B Lanthanum, Tablet, chewable, 1000 mg (as carbonate hydrate) (Fosrenol)
The PBAC (July 2010) recommended that the listing for lanthanum be changed to authority required (streamlined) on the PBS. Prescribers will no longer be required to phone Medicare Australia for an authority. Lanthanum is prescribed for treatment of hyperphosphataemia in adults with chronic kidney disease on dialysis. While lanthanum is initiated by specialists and available through section 100, patients can obtain supply of continuing or maintenance treatment through their community pharmacy.

2142R Sevelamer hydrochloride, Tablet 800 mg (Renagel)

The PBAC (July 2010) recommended the listing for sevelamer be changed to authority required (streamlined) on the PBS. Prescribers will no longer be required to phone Medicare Australia for an authority. Sevelamer is prescribed for treatment of hyperphosphataemia in adults with chronic kidney disease on dialysis. While sevelamer is initiated by specialists and available through section 100, patients can obtain supply of continuing or maintenance treatment through their community pharmacy.

 

SECTION 100 – HIGHLY SPECIALISED DRUGS

Additions - Items

9661L Adalimumab, Injection 20mg in 0.4mL pre-filled syringe (Humira) (Public)
96678J Adalimumab, Injection 20mg in 0.4mL pre-filled syringe (Humira) (Private)
9662M Adalimumab, Injection 40mg in 0.8mL pre-filled syringe (Humira) (Public)
9679K Adalimumab, Injection 40mg in 0.8mL pre-filled syringe (Humira) (Private)
9663N Adalimumab, Injection 40mg in 0.8mL pre-filled pen (Humira) (Public)
9680L Adalimumab, Injection 40mg in 0.8mL pre-filled pen (Humira) (Private)

The PBAC (March 2010) recommended listing as a pharmaceutical benefit under Section 100 (Highly Specialised Drugs Program) Public and Private Hospital Authority Required for patients under 18 years of age with a documented history of severe active polyarticular course JIA.  The PBAC also recommended listing for patients aged 18 years and over with an authority required restriction (see Section 85 additions – items).  These items are interchangeable with etanercept items and patient numbers are expected to remain unchanged.

9664P Tacrolimus, Capsule 0.5 mg (once daily prolonged release) (Prograf XL) (Public)
9681M Tacrolimus, Capsule 0.5 mg (once daily prolonged release) (Prograf XL) (Private)
9665Q Tacrolimus, Capsule 1 mg (once daily prolonged release) (Prograf XL) (Public)
9682N Tacrolimus, Capsule 1 mg (once daily prolonged release) (Prograf XL) (Private)
9666R Tacrolimus, Capsule 5 mg (once daily prolonged release) (Prograf XL) (Public)
9683P Tacrolimus, Capsule 5 mg (once daily prolonged release) (Prograf XL) (Private)

The PBAC (July 2010) recommended listing of tacrolimus prolonged release capsules under Section 100, Highly Specialised Drugs, for the management (including initiation, stabilisation and review of therapy as required) of patients with organ or tissue transplants. The recommendation was made on a cost-minimisation basis with immediate release tacrolimus on a mg:mg basis at the same price per mg. 

 

9667T Thalidomide, Capsule 100 mg (Thalomid) (Public)
9684Q Thalidomide, Capsule 100 mg (Thalomid) (Private)

The PBAC recommended the listing of two new strengths of thalidomide capsules on the PBS for treatment of multiple myeloma. 

 

Alteration – restriction

5733R Etanercept, Injections 50mg in 1mL single use pre-filled syringes, 4 (Enbrel) (Public)
9615C Etanercept, Injections 50mg in 1mL single use pre-filled syringes, 4 (Enbrel) (Private)
5735W Etanercept, Injection 50mg in 1mL single use auto-injector, 4 (Enbrel) (Public)
9641K Etanercept, Injection 50mg in 1mL single use auto-injector, 4 (Enbrel) (Private)
5734T Etanercept, Injection set containing 4 vials powder for injection 25mg and 4 pre-filled syringes solvent 1mL (Enbrel) (Public)
6367D Etanercept, Injection set containing 4 vials powder for injection 25mg and 4 pre-filled syringes solvent 1mL (Enbrel) (Private)

These restrictions have been amended to allow for the addition of adalimumab for juvenile idiopathic arthritis and for interchangeability between the 2 medications. 

 

Sources:
Recommendations from PBAC short minutes.  The drug background comes from the “Clinical place for the proposed therapy” section of the PBAC long minutes (when available). The estimated cost to the PBS comes from information provided in Section E of submissions to the PBAC, revised where required during the evaluation process or after the PBAC or where a different price has been agreed by the PBPA and is agreed in the PB11b document provided to the Government.