Positive Recommendations made by the PBAC March 2003
Positive Recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) in March 2003
| Drug and form | Drug use / type | Proposed listing or request | PBAC Recommendation |
|---|---|---|---|
| Darbepoetin alfa, injection 150 µg in 0.3 mL pre-filled syringe, Aranesp®, Amgen Australia Pty Ltd
New listing |
Treatment for anaemia associated with chronic renal failure | Section 100, as for the other listed strengths of this product, for treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, associated with chronic renal failure, defined as glomerular filtration rate of less than 60 mL per minute, where treatment is initiated by, or follows consultation by the prescriber with, a nephrologist. | Recommended for listing as requested. |
| Desmopressin acetate, tablet, 100mg and 200mg, Minirin Tablets® - Ferring Pharmaceuticals Pty Ltd
New listing |
Drug that decreases urinary volume | Authority required listing for 'Treatment of diabetes insipidus'. | Recommended for listing for cranial diabetes insipidus on a cost-minimisation basis
compared with desmopressin acetate nasal spray, with 16 mg of the tablet formulation
being equivalent to 1 mg of the nasal spray.
The PBAC noted that bioavailability via the oral route is poor. The studies presented indicate the dose relativity between the tablet and nasal spray ranges widely from 11:1 to 47:1. The most acceptable data indicate a ratio of 16:1. The PBAC recommended listing on this relativity with the advice that there is no clinical advantage for the tablet presentation. The recommendation to restrict use to cranial diabetes insipidus was based on the ADEC's recommendation for marketing approval. |
| Desmopressin acetate, tablet, 200mg, Minirin Tablets® - Ferring Pharmaceuticals Pty Ltd
New listing |
Drug that decreases urinary volume | Authority required listing for the treatment of primary nocturnal enuresis in patients
over 6 years of age: who are refractory to an enuresis alarm; or for whom an enuresis alarm is contraindicated. The reason that an alarm is contraindicated must be included in the authority application. |
Recommended for listing as requested on a cost-minimisation basis compared with desmopressin acetate nasal spray, with 16 mg of the tablet formulation being equivalent to 1 mg of the nasal spray. |
| Infliximab powder for injection, 100 mg, Remicade® Schering-Plough Pty Ltd New listing |
Used to treat rheumatoid arthritis and Crohn's disease | Section 100 listing for the treatment of adult patients with severe active rheumatoid arthritis who have a record of rheumatoid factor positive status, who have failed other treatment regimens. | Recommended for listing on a cost-minimisation basis compared with etanercept, which should include the infusion administration costs for infliximab. In order to ensure a consistent approach for compliance and auditability, the PBAC indicated its preference for written applications to be approved by the Health Insurance Commission, in keeping with the arrangements proposed for etanercept (as an authority required item under section 85). The PBAC also recommended monitoring of, and thus being advised in due course of, the proportions of responders to etanercept and infliximab, both as initial therapy and any attempt to try the alternative following an inadequate response to the first-tried therapy. This would be facilitated by the Health Insurance Commission authorising applications for both drugs and thus maintaining individual patient records across both drugs. Thus, infliximab should be made available under section 100 arrangements, similar to those in place for imatinib under the "Special Authority Program". |
| Ipratropium bromide, metered aerosol CFC-free, 20 micrograms per dose, 200 doses, Atrovent® Boehringer
Ingelheim Pty Ltd
New listing |
Used to treat asthma and chronic obstructive airways disease. | Unrestricted listing | Recommended for listing on the basis that the CFC-formulation is of similar safety and efficacy compared to the current CFC-containing formulation. Provided the premium is acceptable to the PBPA (based on previous situations), it is acceptable to the PBAC. |
| Drug and form | Drug use / type | Proposed listing or request | PBAC Recommendation |
|---|---|---|---|
| Morphine sulfate, tablets 10mg and 20mg, Sevredol® Mundipharma Pty Ltd
New listing |
Narcotic analgesic | Restricted benefit listing for 'Severe disabling pain not responding to non-narcotic analgesics'. | Recommended for listing for severe disabling pain due to cancer not responding to non-narcotic analgesics, on the basis that pricing is acceptable to the PBPA using its usual criteria for lower strength formulations. The recommendation to restrict use to cancer pain only was for consistency with the TGA registered indication for the product. |
| Mycophenolate sodium, tablet, 180mg and 360mg Myfortic® Novartis Pharmaceuticals Australia Pty Ltd New listing |
To prevent rejection in kidney transplant | Section 100 for 'Management of rejection under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection. Management includes initiation, stabilisation and review of therapy as required'. | Recommended for listing as requested on a cost-minimisation basis compared with mycophenolate mofetil with 1.44 g mycophenolate sodium being equivalent to 2 gm mycophenolate mofetil. Also recommended for listing with an authority required restriction for maintenance therapy of patients with renal transplants following initiation and stabilisation in a transplant unit, where therapy remains under the supervision and direction of the transplant unit reviewing that patient. |
| Oestradiol hemihydrate, nasal spray, 150 micrograms/actuation, 4.2 mL, Aerodiol Servier Laboratories (Australia) Pty Ltd New listing |
Hormone replacement therapy for women | To request PBAC recommend listing on a cost-effectiveness basis with a price premium over oestradiol patches. | PBAC considers that oestradiol hemihydrate is cost-effective at the price requested, on the basis that mastalgia is reduced with this formulation, resulting in a saving in terms of visits to the GP. |
| Peginterferon alfa-2b powder for injection 50 µg, 80 µg,100 µg, 120 µg and 150 µg ribavirin capsule 200
mg, Pegatron® Schering-Plough Pty Ltd New listing |
A combination therapy for hepatitis C | Section 100 listing for treatment of chronic hepatitis C who have had not previously received interferon treatment. Patients must be 18 years of age or older and have compensated liver disease. Treatment course is 24 weeks for genotypes 2 and 3 for patients without hepatic cirrhosis or bridging fibrosis and 48 weeks for the remainder. Company proposes tests at 12 and 24 weeks to ensure patients are responding to treatment for genotypes 1,4,5 and 6. | Recommended for listing on the basis of acceptable cost-effectiveness compared with
Rebetron® (interferon alfa-2b with ribavirin) for genotypes 1, 4, 5, 6 and on a cost-minimisation
basis compared with Rebetron® for genotypes 2 and 3. The recommended restriction is
as follows: Treatment of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment and who satisfy all of the following criteria: Histological evidence of Metavir (or equivalent index) stage 2, 3 or 4 fibrosis or stage 1 with grade A2 or A3 inflammation i.e. moderate to severe inflammation evident on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy); · Abnormal serum ALT levels in conjunction with documented chronic hepatitis C infection (repeatedly anti-HCV positive and/or HCV-RNA positive); · Female patients of childbearing age are not pregnant or breastfeeding and are practising adequate forms of contraception (one for each partner). Male patients and their partners are both using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant. For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks. Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. (An HCV RNA assay at Week 12 is unnecessary for genotype 2 and 3 patients because of the high likelihood of early viral response by Week 12). Patients with genotype 1, 4, 5 or 6 who are viral positive at Week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at Week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at Week 24. An HCV RNA qualitative assay at Week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at Week 12. |
| Drug and form | Drug use / type | Proposed listing or request | PBAC Recommendation |
|---|---|---|---|
| Riluzole 50 mg tablet Rilutek® Aventis Pharma Pty Ltd New listing |
Treatment of motor neurone disease | Treatment of amyotrophic lateral sclerosis in patients with disease duration of less
than 2 years, with greater than or equal to 60% normal respiratory forced vital capacity
within 2 months of commencing therapy and age less than 75 years. Continuing treatment in patients who have not undergone tracheostomy; or who have not experienced respiratory failure; or who are ambulatory and able to use upper limbs; or who are ambulatory and able to swallow. |
Recommended for listing on the basis of acceptable cost-effectiveness, in the context
that the PBAC considers that the "rule of rescue" should apply. Whilst uncertainty
remained about the clinical benefit of riluzole, restriction to the patient group
that was expected to benefit most and the application of the "rule of rescue" supported
a positive recommendation to list.
The recommended restriction is as follows: The date of diagnosis and the date and results of spirometry (in terms of percent of predicted forced vital capacity) must be supplied with the initial authority application. Patients receiving treatment with riluzole prior to 1 March 2003 who would have qualified
under the initial treatment criteria for PBS subsidy. Continuing treatment of amyotrophic lateral sclerosis in patients who have previously
been issued with an authority application for this drug and who: |
| Simvastatin tablets 5 mg, 10 mg, 20 mg, 40 mg, 80 mg, Zocor® Merck Sharp & Dohme (Australia) Pty Ltd Change to listing |
Lipid-lowering drug | To amend the criteria for lipid lowering drugs to include a new category of patients with cholesterol > 3.5 mmol/L (replacing the > 4 mmol/L) for patients with existing coronary heart disease, occlusive disease of non-coronary arteries (cerebrovascular disease and peripheral vascular disease) and diabetes mellitus in patients > 40 years. | Proposal to amend criteria was accepted, with slight modification to the wording.
In recommending this widened eligibility for PBS subsidy for patients at high risk,
the PBAC also noted that the projected increase in costs, together with current expenditure,
means that the lipid lowering group of drugs will approach one fifth of the costs
of the entire PBS.
The PBAC recommends that, as a high priority, the current eligibility criteria and utilisation of these drugs be subject to review, to determine whether the current and projected expenditure on this group of drugs is supported by evidence of acceptable cost-effectiveness across all risk factor combinations. |
| Amino acids - synthetic, formula 400 g, Neocate Advance® Scientific Hospital Supplies New listing |
A food for inborn errors of metabolism | Authority required for initial treatment, for up to 3 months, for combined intolerance
(not infant colic) to cows' milk protein, soy protein and protein hydrolysate formula
in children up to the age of 2 years, when the child has failed to respond to a strict
cows' milk protein free and strict soy protein free diet with a protein hydrolysate
(with or without medium chain triglycerides) as the principal formula. The age of
the patient must be included in the authority application. Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formula in children up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician. The age of the patient must be included in the authority application. Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formula in children aged 2 years and over, where the child has been assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months. The age of the patient must be included in the authority application. Sever intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed or the patient has been receiving parenteral nutrition. |
Recommended for listing as requested. Recommended for listing on a cost-minimisation basis, on a kilojoule per kilojoule energy basis compared with Neocate® and Elecare®. |
| Amino acid formula with vitamins and minerals without phenylalanine and tyrosine, 25 g x 30, TYR Express® Vitaflo Australia Pty Ltd New listing |
A food for an inborn error of metabolism | Restricted benefit listing for tyrosinaemia | Recommended for listing as requested. Listing was recommended on an equivalent cost per gram of protein basis against Xphen, Tyr Maxamum. |
Palliative Care Drugs
| Product | Proposed Restriction | Comments | PBAC Recommendation |
|---|---|---|---|
| Palliative care medications
(Application from Palliative Care physicians and supported by the companies concerned) |
The Department is to continue to investigate the most efficient mechanism of supply whilst ensuring that usage beyond the intended population is minimised. | ||
| Saliva Substitute, solution, | For use in people with advanced progressive life-limited illness where dry mouth is a symptom. | Recommended for listing as requested. | |
| Hyoscine Butylbromide, injection, 20mg/ml | For use in people in the terminal stages of an advanced progressive life-limiting illness where colicky pain is a symptom | Recommended for listing as requested. | |
| Paracetamol, suppository, 500mg. | For use in people with advanced progressive life-limiting illness who cannot tolerate an alternative formulation (or dosage schedule) but require paracetamol for analgesia or fever. | Recommended for listing as requested where suppositories containing non-steroidal anti-inflammatory drugs are not tolerated. | |
| Paracetamol, extended release tablets, 665mg. | For use in people with advanced progressive life-limiting illness who cannot tolerate an alternative formulation (or dosage schedule) but require paracetamol for analgesia or fever. | Recommended for listing as requested on a cost-minimisation basis compared with paracetamol 500 mg. | |
| Methadone, liquid, 5mg/ml | Methadone is a suitable analgesic in conditions where morphine would make a reasonable alternative or where other analgesic measures have failed. | Does not have marketing approval for this indication and is only TGA-registered for use for treatment of opioid dependence. | Recommended for listing for chronic severe disabling pain which is unresponsive to non-narcotic analgesics |
| Promethazine Hydrochloride, 10mg & 25mg tablets, elixir 5mg/5ml, | For use in people with advanced progressive life-limited illness where nausea and vomiting or pruritus is a problem. | Recommended for listing for use in nausea and vomiting only (pruritus is outside the approved TGA-indications) | |
| Sennoside B, tablet, 7.5mg | Unrestricted | Recommended for listing for use in advanced progressive life-limiting illness where constipation is a problem. | |
| Docusate Sodium with Sennoside B, tablet, 50mg/8mg | Unrestricted. | Recommended for listing for use in advanced progressive life-limiting illness where constipation is a problem. |
Restriction recommended by the PBAC at its March 2003 Meeting
Restriction recommmended by the Pharmaceutical Benefits Advisory Committee (PBAC) at its March 2003 meeting - Infliximab
Infliximab powder for injection 100 mg, Remicade® - Schering-Plough Pty Limited
Restriction: Section 100 authority required - Special authority
NOTE:
Any queries concerning the arrangements to prescribe infliximab may be directed to
the Health Insurance Commission on 1800 005 750.
Written applications for authority to prescribe infliximab should be forwarded to:
Health Insurance Commission
Prior Written Approval of Specialised Drugs
Reply Paid 9826
GPO Box 9826
HOBART TAS 7001
Public and private hospital authority required
Initial treatment by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, in combination with methotrexate, of adults with severe active rheumatoid arthritis who have a record of rheumatoid factor positive status;
AND
(a) who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if the predetermined response criteria do not support continuation of PBS-subsidised treatment;
AND
(b) who have failed to achieve an adequate response to methotrexate alone, at a dose of at least 20 mg weekly;
AND
(c) who have failed to achieve an adequate response to methotrexate, in combination with 2 other disease modifying anti-rheumatic drugs, for a minimum of 3 months;
AND
(d) who have subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with:
(i) leflunomide alone; or
(ii) leflunomide in combination with methotrexate; or
(iii) cyclosporin.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, the patient is exempted from demonstrating an inadequate response to the above treatment regimens. Details of the contraindication or intolerance, including the degree of toxicity, must be provided at the time of application.
The following criteria must be met in order to demonstrate failure to achieve an adequate response:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L;
AND either
(i) an active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list:
- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
- shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be in writing and must include sufficient information to determine the patient's eligibility according to the above criteria. The date of joint assessment must be provided.
Up to a maximum of 3 repeats may be authorised.
Where fewer than 3 repeats are requested at the time of the initial authority application, authority approvals for sufficient repeats to complete a maximum of 4 months of treatment may be requested by telephone. Under no circumstances will telephone approvals be granted for initial or continuing authority applications, or for treatment that would otherwise extend the initial treatment period beyond 4 months.
The assessment of the patient's response to the initial course of treatment should be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. Applications for continuing treatment with infliximab should be made prior to the completion of 16 weeks of treatment to ensure continuity for those patients who meet the criteria.
Public and private hospital authority required
Initial PBS-subsidised supply for continuing treatment by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, in combination with methotrexate, of adults with severe active rheumatoid arthritis who have a record of rheumatoid factor positive status, and who were receiving treatment with infliximab prior to 1 March 2003;
AND
(a) who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if the predetermined response criteria do not support continuation of PBS-subsidised treatment;
AND
(b) who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with infliximab.
The authority application must be in writing and must include sufficient information to determine the patient's eligibility. The date of assessment of the patient must be provided.
Up to a maximum of 2 repeats may be authorised.
Public and private hospital authority required
Continuing PBS-subsidised treatment by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, in combination with methotrexate, of adults with severe active rheumatoid arthritis who, at the time of application, demonstrate an adequate response to treatment with infliximab as manifested by:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND 1 or more of the following:
(i) an active joint count of fewer than 10 active (swollen and tender) joints; or
(ii) a reduction in the active (swollen and tender) joint count by at least 50% from
baseline;
or
(iii) a reduction in the number of the following active joints, from at least 4, by at least 50%:
- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
- shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All authority applications for continuing treatment with infliximab must be in writing and must include sufficient information to determine the patient's response according to the above criteria. The date of assessment of the patient must be provided.
Up to a maximum of 2 repeats may be authorised.
Patients who fail to demonstrate an adequate response, as specified in the criteria for continuing treatment with infliximab, will not be eligible to recommence treatment with infliximab within 12 months of the date on which treatment was ceased.
Where re-treatment with infliximab after a break in PBS-subsidised treatment with infliximab is being sought, the reason for and date of cessation of the previous treatment course with infliximab must be included in the application.
NOTE:
At the time of the authority application medical practitioners should request the
appropriate quantity of vials, based on the weight of the patient, to provide sufficient
for a single infusion at a dose of 3 mg per kg.
Restriction recommended by the PBAC at its March 2003 Meeting:
Restriction recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) at its March 2003 meeting - Lipid-lowering Drugs
PBAC March 2003 Recommendation for amendments to the General Statement for lipid-lowering drugs prescribed as Pharmaceutical Benefits.
|
Patient Category |
Lipid Level for PBS Subsidy |
|---|---|
Patients with one or more of the following:-
|
cholesterol > 3.5 mmol/L |
Other patients at high risk with one or more of the following:
|
cholesterol > 6.5 mmol/L or cholesterol > 5.5 mmol/L and HDL < 1 mmol/L |
| Patients with HDL < 1 mmol/L | cholesterol > 6.5 mmol/L |
Patients not eligible under the above:
|
cholesterol > 7.5 mmol/L or triglyceride > 4 mmol/L |
| Other patients not included in the above | cholesterol > 9 mmol/L or triglyceride > 8 mmol/L |
